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HomeMy WebLinkAbout2024-11-04 Ordinance Item Number: 9.a. r 1 CITY OF IOWA CITY a Qa, COUNCIL ACTION REPORT November 4, 2024 Ordinance amending Title 14, entitled "Zoning Code", to address tobacco sales oriented retail uses. (REZ24-0006) (First Consideration) Attachments: Memo from City Attorney Goers PZ Memo - 09.04.2024 PZ 9.4.24 Final Minutes Ordinance r CITY OF IOWA CITY M�=aumm"' MEMORANDUM Date: October 10, 2024 To: City Council From: Eric R. Goers, City Attorney Re: Tobacco permit ordinance grandfather rights You may recall that at your October 1 st formal meeting Council inquired whether an amendment changing the grandfather rights expiration time from 90 days to one year for cessation of tobacco sales would constitute a substantive change. After expressing some hesitation, I opined that it was not. I have been reconsidering that opinion ever since and have now come to the opinion that it is in fact a substantive change. The vote to approve the amendment was 3-2, giving indication that the matter was of enough substance that it garnered vocal opposition and votes in the negative. Since that time, it has been reported to me that some members of the public in affected areas consider it important enough to articulate their opposition to the change. Finally, because this may be the subject of future litigation, out of an abundance of caution, I think it would be the best course to take the conservative approach and treat the October 15th meeting as the first reading. Absent future changes, I do not see reason to send the ordinance back to the Planning and Zoning Commission for additional consideration. As always, please feel free to contact me directly if you have questions or concerns. Copy to: Geoff Fruin, City Manager Kellie Grace, City Clerk Kirk Lehman, Assistant City Manager Sue Dulek, First Assistant City Attorney Tracy Hightshoe, NDS Director Danielle Sitzman, Development Services Coordinator Anne Russett, Senior Planner r � CITY OF IOWA CITY MEMORANDUM Date: August 29, 2024 To: Planning &Zoning Commission From: Eric R. Goers, City Attorney Re: Zoning Code Amendments to create a Tobacco Retailer use, and create limitations on where they can be located Introduction At their April 2nd, 2024 formal meeting, the Iowa City Council denied several tobacco permit applications and expressed a desire to give thought and study to what could be done at a local level to address the proliferation of tobacco retailers within City limits. At their May 7th, 2024 formal meeting, Council passed a moratorium on the issuance of new tobacco permits while they studied more about what could be done. The moratorium runs until January 1st, 2025. Council then engaged in several work sessions to discuss how to better address the tobacco retailers, and the harmful health effects they bring to the community. At their July 16th, 2024 work session they direction the City Attorney to bring forth three draft ordinances for consideration. Those included the following: 1. A zoning code amendment to impose 500' separation distance requirements between tobacco retailers and other tobacco retailers, k-12 schools, and university property. 2. A cap on tobacco permits at the present 63. 3. A ban on kratom products. At their August 6th and 20th, 2024 work sessions, Council discussed the ordinances, ultimately deciding to proceed with the zoning code ordinance amendment and the creation of the kratom ban, but not the permit cap. They tweaked the draft zoning code amendment on the topic of grandfather rights, but otherwise accepted the draft ordinance as presented as appropriate to send to Planning and Zoning for your consideration. I have attached that draft hereto (Attachment 1.) Because it is a text amendment initiated by the City Council, the submittal requirements of Iowa City Code 14-8D-5C do not apply. Current Regulations At present, there is no "Tobacco Sales Oriented Uses" under the City's zoning code. Nor are there any restrictions specific to where tobacco retailers can operate, other than general provisions related to commercial retail uses. Proposed Amendments The proposed amendment(Attachment 1) helps to enhance land use regulations related to tobacco retailers in an effort to improve public health. This is consistent with advancing the City's strategic value of safety and well-being for our community members. The CDC has long concluded that there are significant health concerns related to public consumption of tobacco, tobacco products, alternative nicotine products, and vapor products. They report that smoking tobacco causes cancer, heart disease, stroke, lung diseases, diabetes, and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis. in Ordinance No. 15-4634 (codified at Section 6-10-2 of the City Code), the City Council found that the use of e-cigarettes presents a serious and unknown public health threat and that in the interests of protecting the health of the public and providing a healthy work-place environment for its employees the City of Iowa City and prohibited the use of electronic cigarettes in all areas where it is illegal to smoke tobacco products. Research shows that greater access and availability of tobacco, tobacco products, alternative nicotine products, and vapor products leads to greater use of those products, and thus greater public harm. Iowa Code Chapter 453A governs the sale of tobacco, tobacco products, alternative nicotine products, and vapor products within the state of Iowa, all of which are covered by retail tobacco permits issued by the City. Chapter 453A grants cities the authority to issue retail tobacco permits located within their city limits. Chapter 453A further grants cities the discretion to issue, or not issue, tobacco permits within their city limits, pursuant to the city's own policies. For these reasons, managing the location of tobacco retailers is an appropriate subject of zoning law. The proposed amendment contains seven parts, presented in the order in which they appear in the ordinance, as follows: 1. Amends the table of allowable uses in commercial zones. 2. Amends the table of allowable uses in industrial and research zones. 3. Amends the table of allowable uses in form-based code areas. 4. Creates a new use category—"Tobacco sales oriented", for use in later sections. 5. Provides a definition tracking that use category. 6. Imposes a 500' separation buffer between tobacco retailers and other tobacco retailers, k-12 schools, and colleges and universities, including all University property. These provisions are modeled after our separation distance requirements for drinking establishments. 7. Addresses grandfather rights for those tobacco retailers already operating. Under these provisions, tobacco retailers would lose their grandfather rights if they have their permit revoked, allow their permit to expire for more than 60 days, cease the sale of tobacco products for at least 90 days, or change their use. Analysis Staff and Council believe controlling the density of tobacco retailers, as well as keeping them at least 500' from youthful populations such as those found on and near school properties, including college property (legal age for tobacco products is 21), will reduce the use of tobacco products and their related substitutes. Current retailers are protected via the grandfather provisions so as to prevent the forceful shuttering of businesses, or elements of those businesses. The federal Centers for Disease Control and Prevention (CDC) has an abundance of information available about the detrimental health effects of both tobacco products and tobacco alternatives. For more information, see their website here: https://www.cdc.gov/tabacco/index,html. For more information about the effects of greater tobacco retailer density, see the following article from the Journal Preventative Medicine, from their January, 2022 volume: Associations Between Disparities in Tobacco Retailer Density and Disparities in Tobacco Use, by Allison M. Glasser, MPH, Nathaniel Onnen, PhD, Peter F. Craigmile, PhD, Elli Schwartz, BS, and Megan E. Roberts, PhD. https://www.ncbi.nlm.nih._qov/pmc/articles/PMC8750533/ The journal article also describes an association between greater exposure to tobacco retailers and their marketing and price promotions and greater tobacco use. Anticipated Impact Staff anticipates that the proposed zoning ordinance will stem the proliferation of tobacco retailers in areas where there is already high density, such as downtown and along the Highway 1 and 6 corridors. The City has created a map showing the location of current tobacco retailers, K-12 school property, and property owned by the Regents. Also included are 500' buffers for both the retailer and school property. The map link can be found here: htt s:llma s.iowa- cit .org/porta I/a slinstant/basichndex.htmI?a ppid=ef233a2608104fa48ba72e5bf360aca0 Map layers can be turned on and off via the layer function in the lower right-hand corner. Over time, density may be reduced by attrition. Staff Recommendation Staff recommends that Title 14 Zoning be amended as detailed in Attachment 1 to enhance land use regulations related to tobacco retailer use and to further implement the City's goals related to public health. Attachments 1. Proposed Zoning Code Text Amendments r Approved by: _Z:�� Eric Goers, City Attorney ATTACHMENT 1 Draft Zoning Code Text Attachment 1 Draft Zoning Code Text Underlined and/or bold text(within tables) is suggested new language. Strike-through notation indicates language to be deleted. Section 1. Amendments 1. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article C entitled "Commercial Zones", Table 2C-1, entitled "Principal Uses Allowed in Commercial Zones", is amended by adding the following bolded text to the "Retail uses" use category: Table 2C-1: Principal Uses Allowed in Commercial Zones Use Subgroups CO- CN- CH- Cl- CC- CB- CB- CB- MU Categories 1 1 1 1 2 2 5 10 Retail uses' Alcohol sales PR PR P P PR PR PR PR oriented retail Delayed deposit PR service uses Hospitality oriented PR PR P P P P P P PR retail Outdoor storage and P PR display oriented Personal service P PR P P P P P PR oriented Repair oriented P P P P P Sales oriented PR PR P P P P P PR Tobacco sales PR PR PR PR PR PR PR PR oriented 2. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article D entitled "Industrial and Research Zones", Table 2D-1, entitled "Principal Uses Allowed in Industrial and Research Zones", is amended by adding the following bolded text to the "Retail' use category: Table 2D-1: Principal Uses Allowed In Industrial And Research Zones Use Categories Subgroups 1-1 1-2 RDP ORP Retail Sales oriented Personal service oriented Alcohol sales oriented Repair oriented Hospitality oriented retail S S Outdoor storage and display oriented Tobacco sales oriented 3. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article H entitled "Form-based Zones and Standards", Table 14-2H-3B-1, entitled "Uses", is amended by adding the following bolded text to the "Retail' use category: Table 14-21-1-313-1: Uses Use T3NE T3NG T3NG- T4NS T4NS- T4NM T4NM- T4MS Specific Categories O O O Standards Retail Uses Sales - P' - P' - P' P Oriented Personal - - P' - P' - P' P Service Oriented Alcohol - - - - S' - S' S 14-4B-4B- Sales 15 Oriented Hospitality PR PR PR PR PR PR PR PR 14-4B-4B- Oriented 18(CN-1) Tobacco - - PR' - PR' - PR' PR 144B-413- Sales 24 Oriented Indoor - - - - - - - PR/S 14-4B-4B- Commercial 7 Recreational Uses General - - - S' - S' PR 14-4B-4B- Animal 2(CN- 1) Related Commercial Uses 4. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article A, entitled "Use Categories", Section 4, entitled "Commercial Use Categories", Subsection I, entitled "Retail Uses", is amended by adding the following Paragraph 2.(h.): h. Tobacco Sales Oriented: Any retailer actively engaged in the sale of tobacco products, cigarettes. alternative nicotine products, or vapor products all as defined_ in Iowa Code Chapter 453A, as amended, pursuant to a tobacco permit. 5. Title 14, entitled "Zoning Code", Chapter 9 entitled "Definitions", Article A, entitled "General Definitions", Section 1, entitled "Definitions" is amended by adding the following definition: Tobacco Sales Oriented Use: See "Retail uses" "Tobacco Sales Oriented" as defined in chapter 4. Article A "Use Categories", of this Title. 6. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article B, entitled "Minor Modifications, Variances, Special Exceptions, and Provisional Uses", Section 4, entitled "Specific Approval Criteria for Provisional Uses and Special Exceptions", Subsection B, entitled "Commercial Uses", is amended by adding the following Paragraph 24, entitled "Tobacco Sales Oriented Uses": 24. Tobacco Sales Oriented Uses: A tobacco sales oriented use as defined in this title must be separated by a minimum distance of five hundred feet 500' from any other tobacco sales oriented use, any general educational facility, and any college and university, as defined by this title. For purposes of the distance separation requirements within this Paragraph, "college and universities" shall include all property owned by the Iowa Board of Regents. Distance shall be measured along a straight line from the nearest property line or nearest point of the leased building space)of the Proposed use to the nearest property line or nearest point of the leased building space) of any other tobacco sales oriented usegeneral educational facility, or any college or university. For example, in the case of a tobacco sales oriented use that is located on a lot with multiple leased building spaces, such as a shopping mall, the distance is measured from the nearest point of the leased building space occupied by a tobacco sales oriented use to the nearest property line or leased building space of any other tobacco sales oriented usegeneral educational facility, or college and university. 7. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article E, entitled "Nonconforming Situations", Section 5, entitled "Regulation of Nonconforming Uses", is amended to add the following Subsection H, entitled "Nonconforming Tobacco Sales Oriented Uses": H. Nonconforming Tobacco Sales Oriented Uses: In addition to the other provisions in this section the following rovisions apply to nonconforming tobacco sales oriented uses: 1. An "tobacco sales oriented uses" as defined in this title that was legally established priot to the effective date hereof and that is nonconforming with regard to separation distances required under this title may continue unless any of the following conditions occur. If any of these conditions occur, then nonconforming rights cease and the use must convert to a conforming use: a. The tobacco permit is revoked: or b. The tobacco permit lapses or is discontinued fora period of sixty 60 days or more; or c. The tobacco sales oriented use ceases fora period of ninety 90 days or more; or d. There has been a change of use as defined in Section 14-4E-5B. MINUTES FINAL PLANNING AND ZONING COMMISSION SEPTEMBER 4, 2024 —6:00 PM — FORMAL MEETING E M M A J. HARVAT HALL, CITY HALL MEMBERS PRESENT: Susan Craig, Maggie Elliott, Steve Miller, Scott Quellhorst, Billie Townsend, Chad Wade MEMBERS ABSENT: Mike Hensch STAFF PRESENT: Eric Goers, Anne Russett OTHERS PRESENT: Kristian Nixon, Jonathan Lewallen, Dana Haverkamp, Jenna Dyroft RECOMMENDATIONS TO COUNCIL: By a vote of 5-1 (Wade dissenting) the Commission recommends approval of REZ24-0006 an amendment to Title 14 Zoning as detailed in Attachment 1 to enhance land use regulations related to tobacco retailer use and to further implement the City's goals related to public health. CALL TO ORDER: Craig called the meeting to order at 6:00 PM. PUBLIC DISCUSSION OF ANY ITEM NOT ON THE AGENDA: None. CASE NO. REZ24-0006 Consideration of an amendment to Title 14, entitled "Zoning Code", to address tobacco sales- oriented uses. Goers began the staff report with a little bit of the history about why tobacco regulation comes before the Planning & Zoning Commission as it is not something they are normally tasked with addressing. At the April 2 City Council meeting the Council voted to deny several tobacco permits, notifying staff that there was something up and that Council wanted to discuss the issue of tobacco regulation. Staff came back with a moratorium at their May 7 meeting that put the halt on all new tobacco permit applications at that point so Council would have time to consider how to regulate, if at all, tobacco permits. Goers explained that moratorium runs through the end of this calendar year. Council then engaged in several work sessions, the first being on July 16, at which Council tasked him with drafting three ordinance amendments. One is a zoning ordinance amendment that is for their consideration this evening having to do with distance separations between retailers and each other, and also retailers and either K - 12 schools or University property. The second ordinance amendment was having to do with putting a cap on tobacco permits issued throughout the City and the third had to do with banning kratom, an herbal substance that he is still learning about. Ultimately through a couple of additional work sessions on August 6 and August 20, Council directed to not to move forward with the permit cap, but to move forward with the other two ordinance amendments of a kratom band and the zoning ordinance. Goers noted the draft ordinance amendment was included in the agenda packet and he worked Planning and Zoning Commission September 4, 2024 Page 2 of 8 closely with the assistance of the urban planning staff on it. He also just wanted to make it clear tobacco retailers use is not something that's currently regulated under Iowa City zoning and it is a use that they've had to create in order to effectuate change that Council would like to consider. Therefore, there's nothing in the zoning code at present to compare to see how this is going to fit in with present regulation. The ordinance structure is modeled on alcohol zoning which at present has a couple of different separation distance measures in the code. One is 500 feet between drinking establishments, places that have licenses for on-premises consumption (bars), and the other is 1000-foot separation distance for off-premises consumption (liquor stores or places that sell alcohol for off-premises consumption). With the alcohol ordinance there are a couple of other caveats regarding accessory uses and so forth and it gets to be a little tricky but with tobacco is quite a bit more straightforward, either they have a tobacco permit or they don't. Staff did include some grandfather provisions, as they are apt to do on zoning measures because there are a number of retailers that are within 500 feet of each other at present or are within 500 feet of a school or university property. In the ordinance amendment it is stated that grandfathered retailers will have 60 days to allow their permit to lapse and if their permit lapses for more than 60 days they lose their grandfather rights and will have to cease selling tobacco. Goers noted that could mean a rehabilitation or remodeling project that would close down a shop and not sell for more than 60 days would also lose grandfather rights and their tobacco permit revoked. Goers showed a map that displayed the present location of both school property and current tobacco retailers, of which there are presently 62. He pointed out the tobacco retailers within a 500-foot buffer around University property or K - 12 school property. He noted in the downtown area there would likely not be an ability of any new retailers to come in but in other parts of the City there would be a little bit more opportunity. In so far as staffing is concerned, because the clerk's office already does tobacco permit applications and manages all of that, they would likely just continue managing this part of it and all they would really need to do is type in an address and then see whether it falls under one of the buffers or if it was in the clear and thus could be approved. Therefore, staff recommends that Title 14 Zoning be amended as detailed in Attachment 1 to enhance land use regulations related to tobacco retailer use and to further implement the City's goals related to public health. Townsend asked if this is a new issue and are there more tobacco retailers. Goers explained there has been an increase in tobacco retailers recently, insofar as tobacco retailers include convenience stores, grocery stores, drug stores, a lot of businesses for which the sale of tobacco and tobacco products is not their primary concern. Additionally vape shops and everything they sell would fall under the tobacco licensing. Goers also clarified the tobacco permits cover both traditional tobacco products like cigarettes and cigars, pipe tobacco, but also vapes, alternative nicotine delivery systems, but not kratom, that is a separate ordinance amendment. Wade noted Goers mentioned alternative nicotine products and that the definition of tobacco sales-oriented business would include any business that sells alternative nicotine products. Looking at the definition in the Iowa code it seems pretty broad, like it might pull in, for example, Target which sells nicotine lozenges, is that accurate, and if so, is that the intent of the ordinance. Goers stated he would need to look to see whether nicotine lozenges fall under the definition of products that require a tobacco permit. For this ordinance amendment the definition Planning and Zoning Commission September 4, 2024 Page 3 of 8 is if they need a tobacco permit, then this applies to them. If they do not need a tobacco permit, then it does not. Wade stated he is just trying to understand whether these restrictions would apply to something like ZYN which is an alternative to chewing tobacco and would be sold at a grocery store or pharmacy, it's more of a recreational nicotine product, as opposed to lozenges and gums which would typically be used for smoking cessation. Goers will look at Iowa Code Chapter 453A which defines some of those products and can circle back. Wade also asked if this were to pass would new tobacco shops need to seek approval for a provisional use from the Board of Adjustment or would they just go to the City Clerk. Goers stated it would be handed by the City Clerk's office. Goers noted in the ordinance that there are a number of charts that talk about whether they would be allowable under certain zones and there he would depend on the planning staff to help with the process by which they would secure the approvals that they need and if it's a provisional use, or something like that in a particular zone, planning staff would assist but in so far as the Clerk's concerned in issuing the tobacco permit, it would just be are they within 500 feet, yes or no. Wade asked if there would be any mechanism for an exception to that rule other than grandfathering. Goers confirmed there would not. Townsend asked if a company that has been grandfathered in goes out of business or for some reason can't continue to operate, no one can come in and replace that shop. Goers confirmed that would only be correct if there is a lapse of a permit of more than 60 days and/or a cessation of sales for more than 90 days. If a convenience store went out of business, and a month later got bought up by Casey's or something, Casey's can open up shop and get a permit, that would be fine. There are 62 permits at present and while Council originally wanted a cap on permits they chose not to move forward with that. Permits will be allowed so long as they are not within the 500 feet of another permit. Miller noticed when looking at the map he was just kind of surprised that Hy-Vee and grocery stores were on there, he was thinking that vape shops was what they're trying to limit with this legislation. It doesn't seem like anyone would want to limit having another grocery store within a certain radius of vape shop. Goers stated there was some discussion of that and City staff met a couple times with Susan Valetta, who's a Johnson County Public Health Educator, and based on her research she indicated that she's more concerned with the convenience stores and the grocery stores because there's greater exposure to children as children go into those places all the time. Whereas it would be surprising and unusual for a child to wander into a vape store and it's about exposure and normalizing of use that leads to greater problems down the line. If there's a higher density and higher availability of exposure, particularly to young people, then they're more likely to become users. Miller asked if all or most grocery stores have tobacco permits. Goers hasn't checked on that but believes most grocery stores have tobacco permits as well as most convenience stores also. Craig stated then if the Hy-Ve Drug that's on First Avenue, which certainly is within 500 feet of Regina, if that went out of business, unless someone else came along and bought the business or secured a permit within 60 days of a lapsed permit they would lose their grandfather rights. Goers confirmed that was correct. Planning and Zoning Commission September 4, 2024 Page 4 of 8 Craig stated the impetus for this concern from Council is a health one and Goers replied that was correct. Goers stated regarding the question about the alternative nicotine products and the list under State code which is incorporated through this ordinance states alternative nicotine product means a product not consisting of/or containing tobacco that provides for the ingestion, into the body of nicotine, whether by chewing (nicotine gum), absorbing, dissolving, inhaling, snorting or sniffing, or by any other means. Alternative nicotine product does not include cigarettes, tobacco products or vapor products as each of those also require a tobacco permit, or a product that is regulated by the Food and Drug Administration. So, it appears that any kind of nicotine gum or anything like that would require a tobacco permit. Wade asked if a location had a move because of loss of lease or something like that do they fall under the new rule as soon as they move locations and have to be greater than 500 feet, and the grandfathering would no longer apply. Goers confirmed that is correct because zoning regulation is about the use and not the user. So, if a tobacco retailer wants to move from location B to location C it has to be outside of 500 feet and eligible. Wade asked also about an explanation on why locations of education facilities from 18 and younger and college or universities are the treated the same. Goers stated the law used to be one only need to be 18 to consume tobacco products but now it is 21 and probably half or more of the student body at the University of Iowa is under 21. Craig opened the public hearing. Kristian Nixon (student, University of Iowa College of Law) was wondering if there's been any research on the increase in property value that the smoke shop owners might have, since they already have these locations that are close to the schools. Goers stated they haven't done any research on that but are cognizant of the changes because of the alcohol one upon which this tobacco ordinance is largely modeled. The proposed ordinance is kind of locking in some locations, because if they ever stop that use they will lose those grandfather rights and they are aware of landlords who require, as part of their lease with their tenants, that they continue to engage in the sale of alcohol and so forth as to preserve that right. Nixon also asked if there is currently a limit to how much product they could have, for example could one of these places expand upwards if they have a tall building. Goers replied that would be an expansion of a non- conforming use and would not be allowed. Jonathan Lewallen (student, University of Iowa College of Law) asked if there's been any consideration to the effect this ordinance could have on currently vacant properties with infrastructure for gas station use. For example, the closed gas station on Mormon Trek and the closed gas station downtown. Is there a risk that would be locking out the reopening of those businesses with this ordinance. Goers is not sure the Council would use the word risk to characterize that, but yes there is some possibility that if this passes and the use ceases. Currently there remains a tobacco permit in place for the former Kum & Go at Mormon Trek and Benton. He doesn't recall if there's one at the intersection of Burlington and Madison. Dana Haverkamp (student, University of Iowa College of Law) stated as per the Iowa code, under the alternative tobacco products, or nicotine products, nicotine patches would also fall under that definition, is there a benefit for restricting the sale of nicotine patches that an Planning and Zoning Commission September 4, 2024 Page 5 of 8 exception would not be a better idea to allow the sale for reducing the usage of nicotine in the first place. Goers noted there is an exception for products that are regulated as a drug or device by the US Food and Drug Administration and if nicotine patches fall under that category it would not apply. If they do not, and they otherwise fall under the definition of alternative nicotine products, this ordinance would apply to their application. Haverkamp stated there's no intent to make an exception for things that are preventative. Goers replied no, the City is bound by the State's regulations regarding alternative nicotine products and how they are defined. Haverkamp asked specifically for this new zoning permission why not make an exception for products that are aimed at reducing the use of nicotine, rather than having a blanket statement preventing this sale of nicotine and tobacco products. Goers stated the City is defaulting to the State's definition. There's a reason why some products are regulated and require a tobacco permit and that some are not and so they're just following the State code in that way. Haverkamp noted the majority of individuals that start smoking to begin with are individuals who are interacting with already people that smoke, such as family and friends, things of that nature, so how would they view restricting the locations themselves as a way that would actually reduce the influence of nicotine usage in the first place, like in children. The locations in themselves are not typically what's actually getting them to start smoking in the first place. Goers acknowledged it's difficult to regulate tobacco use within the home. Jenna Dyroft (student, University of Iowa College of Law) wanted to put forth the idea that perhaps this measure might be a little bit counterintuitive, they were speaking about how many grocery stores sell tobacco products, but primarily this seems like it's targeted at a typical vape shop, but because it's modeled off of alcohol prohibited measures it's including grocery stores, etc. She thinks it's worth considering looking at how the City is set up, a lot of the bars and liquor stores are concentrated in the downtown area and this measure is making it so that it's basically prohibiting any new stores from being in the downtown area which might encourage people to open new stores in the peripheral of the City, which would, in effect spread out tobacco use across the whole City, instead of maybe concentrating it in more of that downtown nightlife area. Russett noted residential zones do not permit tobacco or alcohol-oriented retail. Craig closed the public hearing. Elliott moved to approve REZ24-0006 an amendment to Title 14 Zoning as detailed in Attachment 1 to enhance land use regulations related to tobacco retailer use and to further implement the City's goals related to public health. Townsend seconded the motion. Quellhorst states he generally supports the proposal but would oppose the motion because he thinks that they should exclude alternative nicotine products, or at least tobacco cessation products like gums and lozenges. His concern is that this definition of alternative nicotine products sweeps pretty broadly and makes it would make it more difficult for businesses like pharmacies, for example, or Target to enter downtown and other areas. And then, relatedly, the impetus behind this measure is to protect public health and he doesn't see the same public health concerns with lozenges, gums and other tobacco cessation products as he does with vapes and cigarettes, for example. For those reasons he supports the notion behind the proposal but doesn't support this particular motion. Planning and Zoning Commission September 4, 2024 Page 6 of 8 Wade appreciates Quellhorst catching that because that's something he would not have realized, the nicotine patches and so on. Elliott noted they don't know for sure that that's the case, there is an exception perhaps for nicotine patches and she assumes they're somehow regulated by the FDA. Wade wouldn't want to get in a situation where a new Walgreens, for example, is interested in doing business downtown but either couldn't do so or would get caught up in a lot of red tape, due to this ordinance. Townsend would be in favor of this, 500 feet is not a long way to walk if someone can't find the products that they're looking for. Iowa City doesn't need more vape and tobacco shops in the downtown area there's already an abundance of the vape shops and tobacco shops and places that offer those things. Wade's concern is less with another vape shop, which he agrees that they don't need more of and more that a business that may happen to sell tobacco cessation products, like a Target or CVS, can't get a tobacco license because of the ordinance. If the City Attorney is of the opinion that those sorts of businesses wouldn't be prohibited by this ordinance, then he'd be comfortable supporting it. Goers noted looking it up, according to the CDC nicotine patches are an FDA approved medicine and nicotine gum, also, according to the Center for Disease Control, is an FDA approved medicine. Therefore, both would fall under the exception of alternative nicotine product. Miller asked just to clarify that would mean that they do not need a tobacco permit to sell it. Goers confirmed that is his reading of the definition of alternative nicotine products. Miller stated he will support this as the intent behind this is reducing the number of vape shops, especially downtown. His only concern is about what Commissioner Wade brought up with institutionalizing these locations as forever a vape shop. What happens if this becomes a problem. Goers replied there could be an ordinance amendment and because this is a zoning ordinance it would need to come before this Commission again before Council took it up if there was a change. He also noted insofar as the question about institutionalizing, that was something at the staff level they considered as well but also have to consider the alternative, and that there will just be more of them. Craig stated that's why she's in favor of this zoning change, because it's always a tradeoff, they have to trade something away to get something that they feel is important enough, and she thinks in this case, it's a fair trade. Wade thinks the intention is probably good, the devil is in the details and it may have some unintended consequences. He also thinks that 90 days without the sale of tobacco products is a little on the short side and would hate to have a business get hit with a tornado or natural disaster and then as a result lose their permit and ability to sell. Wade asked if there is a reason why they did not take a different approach, like a per capita permit approach, and instead really focused on zoning mechanism. Goers stated one point Council was considering that, and had him draft one, but ultimately looking at the map they Planning and Zoning Commission September 4, 2024 Page 7 of 8 thought that the zoning would really address their concerns and it wouldn't prevent a new grocery store from going into an area that maybe is underserved at present, part of a food desert or something. And if that grocery store felt like they needed to sell tobacco in order to pencil out and make a go of it, that that was probably a net benefit, and they didn't want a permit cap to get in the way of something like that. A vote was taken and the motion passed 5-1 (Wade dissenting). CONSIDERATION OF MEETING MINUTES: JUNE 26, 2024: Elliott moved to approve the meeting minutes from June 26, 2024. Wade seconded the motion, a vote was taken and the motion passed 6-0. PLANNING AND ZONING INFORMATION: Craig introduced the new Commission member, Steve Miller. Miller stated he is an architect who is really interested in planning and zoning and looking forward to learning more. His first City board or commission was public art and he did that for just over two terms. Russett updated that the two rezonings that were considered in June were both approved by Council, the 1215 Camp Cardinal Road and 2255 North Dubuque Road for the school district property. ADJOURNMENT: Elliott moved to adjourn, Wade seconded and the motion passed 6-0. Prepared by: Eric Goers, City Attorney,410 E. Washington Street, Iowa City, IA 52240; 319-356-5030 Ordinance Number Ordinance amending Title 14, entitled "Zoning Code", to address Tobacco Sales Oriented Retail Uses. (REZ24-0006). Whereas, Iowa City has seen within its borders an increased presence of retail outlets primarily focused on retail sales of tobacco, tobacco products, alternative nicotine products, and vapor products; and Whereas, there are significant health concerns related to public consumption of tobacco, tobacco products, alternative nicotine products, and vapor products; and Whereas, the Center for Disease Control (CDC) reports that smoking tobacco causes cancer, heart disease, stroke, lung diseases, diabetes, and chronic obstructive pulmonary disease (COPD), which includes emphysema and chronic bronchitis; and Whereas, according to the CDC, nearly 9 out of 10 adults who smoke cigarettes daily first tried smoking by age 18; and Whereas, according to the CDC, smokeless tobacco products can cause mouth cancer, gum disease, and tooth loss; and Whereas, according to the CDC, 1.5% of high school students in 2023 were current users of smokeless tobacco products; and Whereas, in Ordinance No. 15-4634 (codified at Section 6-10-2), the City Council found that the use of e-cigarettes presents a serious and unknown public health threat and that in the interests of protecting the health of the public and providing a healthy work-place environment for its employees the City of Iowa City and prohibited the use of electronic cigarettes in all areas where it is illegal to smoke tobacco products; and Whereas, according to the CDC, in 2023, 2.13 million U.S. middle and high school students had used e-cigarettes in the past 30 days, including 4.6% of middle school students and 10.0% of high school students; and Whereas, Chapter 142D of the Iowa Code, the Iowa Smokefree Air Act, prohibits smoking tobacco products in certain public spaces, places of employment and outdoor areas, including enclosed City buildings and vehicles operated by the City, the public grounds immediately adjacent to City buildings and bus shelters; and Whereas, as a result of these public health risks, the City has declared additional areas to be smoke free places including the municipal parking ramps, airport, City Plaza except for alleys and certain areas within Iowa City parks (see Chapter 10 of Title 6, "Public Health and Safety"); and Whereas, greater access and availability of tobacco, tobacco products, alternative nicotine products, and vapor products leads to greater use of those products, and thus greater public harm; and Whereas, Iowa Code Chapter 453A governs the sale of tobacco, tobacco products, alternative nicotine products, and vapor products within the state of Iowa, all of which are covered by retail tobacco permits; and Whereas, Chapter 453A grants cities the authority to issue retail tobacco permits located within their city limits; and Whereas, Chapter 453A further grants cities the discretion to issue, or not issue, tobacco permits within their city limits, pursuant to the city's own policies; and Whereas, it is in the best interest of the City to amend the ordinance to create a new"Tobacco Retailer Uses" category, and to regulate their locations within the City. Now, therefore, be it ordained by the City Council of the City of Iowa City, Iowa: Section I. Amendments 1. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article C entitled "Commercial Zones", Table 2C-1, entitled "Principal Uses Allowed in Commercial Zones", is amended by adding the following bolded text to the "Retail uses" use category: Table 2C-1: Principal Uses Allowed in Commercial Zones Use Subgroups CO- CN- CH- Cl- CC- CB- CB- CB- MU Categories 1 1 1 1 2 2 5 10 Retail uses' Alcohol sales PR PR P P PR PR PR PR oriented retail Delayed deposit PR service uses Hospitality oriented PR PR P P P P P P PR retail Outdoor storage and P PR display oriented Personal service P PR P P P P P PR oriented Repair oriented P P P P P Sales oriented PR PR P P P P P PR Tobacco sales PR PR PR PR PR PR PR PR oriented 2. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article D entitled "Industrial and Research Zones", Table 2D-1, entitled "Principal Uses Allowed in Industrial and Research Zones", is amended by adding the following bolded text to the "Retail" use category: Table 2D-1: Principal Uses Allowed In Industrial And Research Zones Use Categories Subgroups 1-1 1-2 RDP ORP Retail Sales oriented Personal service oriented Alcohol sales oriented Repair oriented Hospitality oriented retail S S Outdoor storage and display oriented Tobacco sales oriented 3. Title 14, entitled "Zoning Code", Chapter 2 entitled "Base Zones", Article H entitled "Form- based Zones and Standards", Table 14-2H-3B-1, entitled "Uses", is amended by adding the following bolded text to the "Retail" use category: Table 14-2H-3B-1: Uses Use T3NE T3NG T3NG- T4NS T4NS- T4NM T4NM- T4MS Specific Categories O O O Standards Retail Uses Sales - - P' - P' - P' P Oriented Personal - - P' - P' - P' P Service Oriented Alcohol - - - - S' - S' S 14-413-413- Sales 15 Oriented Hospitality PR PR PR PR PR PR PR PR 14-413-413- Oriented 18(CN-1) Tobacco - - PR' - PR' - PR' PR 14-4B-4B- Sales 24 Oriented Indoor - - - - - - - PR/S 14-413-413- Commercial 7 Recreational Uses General - - - - S' - S' PR 14-413-413- Animal 2(CN- 1) Related Commercial Uses 4. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article A, entitled "Use Categories", Section 4, entitled "Commercial Use Categories", Subsection I, entitled "Retail Uses", is amended by adding the following Paragraph 2.(h.): h. Tobacco Sales Oriented: Any retailer actively engaged in the sale of tobacco products, cigarettes, alternative nicotine products, or vapor products, all as defined in Iowa Code Chapter 453A, as amended, pursuant to a tobacco permit. 5. Title 14, entitled "Zoning Code", Chapter 9 entitled "Definitions", Article A, entitled "General Definitions", Section 1, entitled "Definitions" is amended by adding the following definition: Tobacco Sales Oriented Use: See "Retail uses", "Tobacco Sales Oriented" as defined in chapter 4, Article A, "Use Categories", of this Title. 6. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article B, entitled "Minor Modifications, Variances, Special Exceptions, and Provisional Uses", Section 4, entitled "Specific Approval Criteria for Provisional Uses and Special Exceptions", Subsection B, entitled "Commercial Uses", is amended by adding the following Paragraph 24, entitled "Tobacco Sales Oriented Uses": 24. Tobacco Sales Oriented Uses: A tobacco sales oriented use, as defined in this title, must be separated by a minimum distance of five hundred feet (500') from any other tobacco sales oriented use, any general educational facility, and any college and university, as defined by this title. For purposes of the distance separation requirements within this Paragraph, "college and universities" shall include all property owned by the Iowa Board of Regents. Distance shall be measured along a straight line from the nearest property line (or nearest point of the leased building space) of the proposed use to the nearest property line (or nearest point of the leased building space) of any other tobacco sales oriented use, general educational facility, or any college or university. For example, in the case of a tobacco sales oriented use that is located on a lot with multiple leased building spaces, such as a shopping mall, the distance is measured from the nearest point of the leased building space occupied by a tobacco sales oriented use to the nearest property line or leased building space of any other tobacco sales oriented use, general educational facility, or college and university. 7. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article E, entitled "Nonconforming Situations", Section 5, entitled "Regulation of Nonconforming Uses", is amended to add the following Subsection H, entitled "Nonconforming Tobacco Sales Oriented Uses": H. Nonconforming Tobacco Sales Oriented Uses: In addition to the other provisions in this section, the following provisions apply to nonconforming tobacco sales oriented uses: 1. Any "tobacco sales oriented uses", as defined in this title, that was legally established prior to the effective date hereof and that is nonconforming with regard to separation distances required under this title, may continue unless any of the following conditions occur. If any of these conditions occur, then nonconforming rights cease and the use must convert to a conforming use: a. The tobacco permit is revoked; or b. The tobacco permit lapses or is discontinued for a period of sixty (60) days or more; or c. The tobacco sales oriented use ceases for a period of ninety (90) days or more; or d. There has been a change of use as defined in Section 14-4E-:,B. 8. Title 14, entitled "Zoning Code", Chapter 4 entitled "Use Regulations", Article E, entitled "Nonconforming Situations", Section 5, entitled "Regulation of Nonconforming Uses", Subsection F is amended by adding the underlined text and deleting the strikethrough text, as follows: F. Discontinuance Of Nonconforming Use: Except as allowed in subsection E,,aPA-G, and H of this section, a nonconforming use that is discontinued for a period of one year must revert to a conforming use or, in qualifying situations, a special exception may be applied for according to the provisions of subsection B of this section. Section II. Repealer. All ordinances and parts of ordinances in conflict with the provision of this Ordinance are hereby repealed. Section III. Severability. If any section, provision or part of the Ordinance shall be adjudged to be invalid or unconstitutional, such adjudication shall not affect the validity of the Ordinance as a whole or any section, provision or part thereof not adjudged invalid or unconstitutional. Section IV. Effective Date. This Ordinance shall be in effect after its final passage, approval and publication, as provided by law. Passed and approved this day of , 2024. Mayor Approved by Attest: City Clerk City Attorney's Office It was moved by and seconded by the Ordinance be adopted, and upon roll call there were: Ayes: Nays: Absent: Alter Bergus Dunn Harmsen Moe Salih Teague Item Number: 9.b. r 1 CITY OF IOWA CITY COUNCIL ACTION REPORT November 4, 2024 Ordinance amending Title 14, Zoning Code, to allow redemption centers in commercial and industrial zones. (REZ24-0007) (Second Consideration) Attachments: REZ24-0017 Memo w Attachments Planning & Zoning Commission Correspondence PZ 9.18.24 minutes Ordinance r ��_. .® CITY OF IOWA CITY R& MEMORANDUM Date: September 18t", 2024 To: Planning & Zoning Commission From: Madison Conley, Associate Planner, Neighborhood & Development Services Re: Zoning Code Amendment (REZ24-0007) to allow redemption centers in commercial and industrial zones Introduction In 1978 the state of Iowa enacted Iowa's Beverage Containers Control Law, also known as the "Bottle Bill," which allows consumers to receive their return deposit when returning the empty beverage container to a store or redemption center. Redemption centers are facilities where consumers may return empty beverage containers and receive payment for the refund value of the containers. In June 2022, the Bottle Bill was amended to allow stores, like grocery stores, to opt out of redeeming containers if there is a redemption center nearby or if other criteria are met. Some grocery stores have redemption centers affiliated with them. For example, the North Dodge Hy-Vee located at 1125 N Dodge St. and zoned Community Commercial (CC-2) provides a space for customers to redeem empty cans and bottles. Additionally, Iowa City has an existing redemption center known as the Can Shed. This property is located at 611 Hollywood Blvd #3 and located in a General Industrial (I-1) zone; however, they would like to operate within a commercial zone to expand their services, improve their collection process, and provide easier access to the community. In order to allow for these changes, a code amendment is necessary. Staff developed the proposed amendment (Attachment 1) which creates redemption centers as a land use type, allows the use within commercial and research and industrial zones, and applies appropriate standards for this use within commercial zones. Current Regulations Currently, the Zoning Code (Title 14) does not contain any specific language that assists with defining, classifying, or regulating redemption centers. Historically, redemption centers located within grocery stores have been allowed within commercial zones. However, any stand-alone redemption center related use has been classified under the Waste Related Use category. The Waste Related Use category is characterized by any uses that receive solid or liquid wastes from others for disposal on the site or for transfer to another location; uses that collect sanitary wastes; uses that recycle solid waste or recyclable materials; and uses that manufacture or produce goods or energy from biological decomposition of organic material. Examples of this land use category include recycling process facilities, sanitary landfills, limited use landfills, waste composting, waste transfer stations energy recovery plants, sewage treatment plants, portable sanitary collection equipment storage and pumping, and hazardous waste collection sites (14-4A-4). This use is provisionally allowed in the General Industrial (I-1) and Heavy Industrial (I-2) zones. With this interpretation, stand-alone redemption centers are only allowed in industrial zones. In reviewing the proposal from the Can Shed, it became apparent to staff that classifying redemption center uses as very intense industrial land uses comparable to landfills and recycling facilities did not accurately reflect the intended use or how they proposed to operate. September 18, 2024 Page 2 Proposed Amendments The proposed amendment includes the following: 1. Creates a new use category—"Redemption Center", 2. Amends the table of allowable uses in commercial and industrial zones, 3. Provides a definition for "Redemption Center", 4. Creates provisional use standards for "Redemption Center", and 5. Outlines minimum parking requirements for "Redemption Center". Use Regulations The proposed amendment includes the creation of "Redemption Center" as a use category characterized as an indoor facility that collects empty bottles and cans from consumers, distributes payment of the refund value, and may utilize compressing machines. The proposed accessory uses are offices and off-street parking. This use would include the following exceptions: recycling processing facilities will continue to be classified as waste related uses, and establishments that offer beverages for sale are classified as either sales-oriented retail, alcohol sales oriented retail, eating establishment, or drinking establishment. The proposed amendment proposes changes to the tables of allowable uses in the commercial and industrial zones. Staff is proposing that redemption centers be allowed either as a use permitted by right (P) or a provisional (PR) use subject to additional standards. Table 1 provides further clarification. Table 1: Zones Allowing Redemption Centers Either Provisionally or Permitted By-Right. Zone Provisional v. Permitted Use Commercial Office CO-1 PR Neighborhood Commercial (CN-1) PR Highway Commercial (CH-1) P Intensive Commercial (CI-1) P Community Commercial (CC-2) PR Central Business Service (CB-2) PR Central Business Support (CB-5) PR Central Business CB-10 PR General Industrial I-1 P Heavy Industrial I-2 P Research Development Park (RDP) P Office Research Park (ORP) P Staff recommends allowing redemption centers by-right in research and industrial zones. Staff has determined that the size limitations and prohibition on outdoor storage recommended for provisional uses, which are discussed in the next section, are not needed in these more intensive zones that allow outdoor storage. Staff proposes that redemption centers be allowed by-right in the CH-1 and CI-1 zones. Although these are commercial zones, these zones allow outdoor storage when certain standards like adequate concealment of materials, setbacks, and screening requirements are met (14-2C-6). These zones would allow more flexibility with size and outdoor storage of redemption centers compared to the commercial zones in which this use is provisionally allowed. Staff recommends allowing redemption centers provisionally in most commercial zones in order to help protect the surrounding properties by mitigating potential negative externalities associated with this use. Redemption centers that are allowed provisionally would be required to meet specific use standards discussed below. September 18, 2024 Page 3 Use Specific Standards The proposed amendment recommends that zones where redemption centers are allowed as a provisional use be subject to the following use specific standards: 1. Size of use limited to no more than 5,000 square feet. 2. Outdoor storage of any materials is not allowed. The recommended use specific standards include a size limitation of no more than 5,000 square feet and the prohibition of outdoor storage. Based off the research of other local jurisdictions, restricting the size and outdoor storage is a common practice. Several jurisdictions in Oregon have a 5,000 square foot size limitation. Additionally, the City's zoning code already uses 5,000 square feet as a maximum for other uses in commercial zones, such as Indoor Commercial Recreational Uses in the CO-1 and CN-1 zones and Office Uses in the CN-1 zone. The proposed size limitation is consistent with other size restrictions in the zoning code. Regarding the prohibition on outdoor storage, the zones that would allow redemption centers provisionally already prohibit outdoor storage. However, staff recommends adding this use standard to provide further clarify to any redemption center business looking to operate in Iowa City. Staff is recommending that redemption centers be allowed in all commercial zones, including the neighborhood commercial zones and zones that apply to the core of the city. Staff determined it would be appropriate to apply these use specific standards in commercial zones that may abut residential land uses in order to maintain the character and scale of intensity of the surrounding properties. To further clarify, staff recommends applying these standards in all commercial zones except the CH-1 and CI-1 zones where this use would be permitted by right, as well as industrial zones. Therefore, if a redemption center wanted to increase their footprint or incorporate outdoor storage, they would have the option to locate in a zone with more permissive standards. Parking Requirements The proposed amendment alters the minimum parking standards to include an on-site parking ratio for redemption center uses. Staff recommends a ratio of 1 space per one thousand (1,000) square feet of floor area with no required bicycle parking. Staff does not anticipate that this use will require many parking spaces due to the nature of the business. Patrons will likely visit the space to quickly receive their redemption and leave. Additionally, this is a minimum requirement. If a particular redemption center anticipates a greater parking need, providing more parking spaces would be allowed. Analysis Since the City's current regulations do not contemplate redemption centers, staff looked to how other jurisdictions regulate this land use. Staff developed a list of local jurisdictions (Attachment 2) and analyzed how redemption centers are regulated. Staff found value in looking to the State of Oregon. In Oregon, redemption centers are most often considered commercial uses and viewed as some type of service provided to the community. Many of the Oregon jurisdictions viewed redemption centers as a commercial use, but also felt it was necessary to implement use specific standards in certain zones. Additionally, staff evaluated how redemptions centers are regulated in Iowa. In Iowa, redemption centers are typically industrial land uses, not the commercial land uses that exist in Oregon and envisioned by the Can Shed. Table 2 summarizes how the cities of Portland, Bend, Gresham, and Des Moines regulate redemption centers. September 18, 2024 Page 4 Table 2: Examples of Redemption Center Regulations City of Portland, OR Use Classification: Commercial, Retail Sales and Services, Repair Oriented Definition: Recycling Drop Off. A facility for the drop-off and temporary holding of materials such as paper, cardboard, glass, metal, plastic, batteries, and motor oil. Processing of materials is limited to glass breaking and separation. Recycling materials are not sold to a recycling drop-off center. A recycling drop-off center is intended for household or consumer use. Use by commercial or industrial establishments is not included. Unattended drop-off stations for single materials, such as newsprint, are also not included. Zones Allowed: Allowed in a variety of mixed use and commercial zones, including general employment and industrial zones. Use Specific Standards: None City of Bend, OR Use Classification: Commercial Definition: Indoor retail facility approved by the Oregon Liquor Control Commission facilitating the return of empty beverage containers and serving dealers of beverages, where any person may return empty beverage containers and receive payment of the refund value of such beverage containers. Zones Allowed: Allowed in both commercial and industrial zones. Use Specific Standards: - If the use is accessory to a primary industrial use, the size limit cannot exceed 10 percent or 2,500 square feet (whichever is greater). - If the total gross floor area of use does not exceed 2,500 square feet, the use is considered primary. If there are multiple uses that share one building, the total building area shall not exceed 5,000 square feet. A single use may occupy 5,000 square feet if approved through a Conditional Use Permit and comply with Commercial Design Review Standards. City of Gresham, OR Use Classification: Commercial, Business and Retail Service and Trade Definition: An indoor retail facility approved by the Oregon Liquor Control Commission facilitating the return of empty beverage containers and serving dealers of beverages, where any person may return empty beverage containers and receive payment of the refund value of such beverage containers. Zones Allowed: Allowed in a variety of commercial zones, including neighborhood commercial, downtown, and industrial zones. Use Specific Standards: None City of Des Moines, IA Use Classification: Industrial, Industrial Service-Intensive Definition: Industrial Services-Industrial: Light uses involving outdoor storage areas and uses involved in repair and maintenance directly to business consumers or involving large equipment. Examples include redemption centers. Zones Allowed: Industrial zones Use Specific Standards: - No part of the use may be a residential use. - No odors, gases, noise, vibration, pollution of air, water or soil, or lighting shall be emitted onto any adjoining property so as to create a nuisance. September 18, 2024 Page 5 For intensive uses, the owner or occupant must provide the neighborhood services director with an acceptable impacts statement describing the use and the nature of any odors, gases, noise, vibration, and other environmental impacts that may be generated by such use; and certifying that the use upon the property will be operated in a manner that does not permit any odors, gases, noise, vibration, pollution of air, water or soil, or lighting to be emitted onto any adjoining property as to create a nuisance. - For intensive uses, the use shall be operated in strict conformance with the written statement provided to the neighborhood services director. - For intensive uses, all outdoor storage areas shall be designed to allow no part of any stored material, vehicles, or equipment to encroach into the required setbacks. - Outdoor storage of inoperable or unsafe vehicles in quantities constituting a junk or salvage yard is prohibited. Table 2 demonstrates the range of different regulatory approaches that jurisdictions have taken. For example, the City of Portland considers redemption centers as a "Retail Sales and Services" use under the commercial category. "Retail Sales and Services" includes providing product repair or services for consumer and business goods. Portland views redemption centers as a "Repair- oriented" service and has classified them as "recycling drop-off' which accepts materials like paper, cardboard, glass, metal, plastic, batteries, and motor oil. The cities of Bend and Gresham categorize redemption centers as a commercial use. Both jurisdictions recognize redemption centers as a stand-alone use make it clear that redemption centers are indoor facilities that facilitate the return of empty beverage containers. This differs from the City of Portland, which treats this use as a "recycling drop-off' and accepts a variety of materials other than empty beverage containers. The City of Des Moines moves further away from the approach that the cities of Bend or Gresham have taken by considering redemption centers as an "Industrial Service". This jurisdiction finds redemption centers to be similar to uses that deal with repair, maintenance, and large equipment. Table 2 shows that while some jurisdictions consider redemption centers as a commercial service, others, like Des Moines, classify these uses as industrial. This is also how the City of Iowa City has historically classified these uses. Additionally, there is variation in how cities regulate this use within commercial zones. On one end, the City of Portland allows the recycling of all types of materials whereas the City of Gresham focuses on the redemption of empty beverage containers. Anticipated Impact Staff has prepared two maps that visually represent how the proposed amendment would apply to land within the city. Figure 1 shows the location of the zones where the proposed amendment would allow redemption centers. Most of the areas are concentrated in the southern portion of the city since most of the city's commercial and industrial land is in this area. Additional areas where the proposed amendment would allow redemption centers include the center of the city, Old Towne Village, Towncrest, and the area near the intersection of N. Dodge St and 1-80. See Attachment 3 for a larger version of this map. September 18, 2024 Page 6 Figure 1. Proposed Zones to Allow Redemption Centers N Proposed Zones to Allow Redemption Centers 5 F� a , F,iHN.rtp H.. - ��e`r' muRcn �E4 o A o � 2y2 w " ��INSOR AVE N JEFFERSON ST M y Is�' t a. � �2 �BnRLINGTON ST GOIIRT ST r taL4 Z C( ST ; MFj![ . m Sf'YlGti � LE[�Ni FVJ.. kk 6ENTON ST % KIRKVJOOn AVE Mr1fiGATiN AVE k•� L N 6 k� TT Legend �II Iowa City Zoning MCoMMUnIty commercial 0 General Industrial(n) (Cr2) Heavy Industrial(12) Mlxad use(Mu) Central Business Commercial Office -Services(CB2) Research Development _(col) Park(RDP) C entral Business Office Researh Park 0 0.5 1 2 Neighborhood Support(C65) ORP MEMEL commercial(CN1) antral business(cbly) ( ) NONE Miles Q Iowa City Limits Highway Commercial resew r<r� Intensive Commercial (CHI) ren w,- la mm�nser r. Figure 2 shows where the proposed amendment would allow redemption centers either as a permitted use or as a provisional use. The green areas identify the areas where redemption centers would be permitted by right. The yellow areas reflect land that would require compliance with the proposed provisional use standards. See Attachment 4 for a larger version of this map. September 18, 2024 Page 7 Figure 2. Redemption Centers: Proposed Permitted v. Provisional N Redemption Centers: Proposed Permitted v. Provisional W_(�_E S a n� st ENBEfT PARK Rl) C 5 w pL�E� O •-& �1 - n 1 ' a� h�(llyS.nR IOWAp JEFFERSON STN g q B�RNNGTON ST GOURT ST - ¢ � ST 1. AM1IERICAN RFNTON ST m � ~ MUSCATINE AVE LEGIpN1AU - _ HIRKWOOOAVE Legend Permitted Use:CH-1,CI-1,I-1,I-2,RDP,ORP 0 0.5 1 2 Provisional Use:CO-1,CN-1,CC-2,CB-2,CB-5,CB-101 MU Mlles Q Iowa City L 'units Consistency with Comprehensive Plan The vision of the Comprehensive Plan supports a resilient economy that increases tax base, stimulates job growth, and promotes the overall people's prosperity and progress. The plan includes a goal to "Increase and diversify the property tax base by encouraging the retention and expansion of existing businesses and attracting business that have growth potential and are compatible with Iowa City's economy". A strategy that supports this goal is to provide an attractive economic environment with streamlined, business-friendly culture by making regulatory and permitting processes clear, predictable, and coordinated. Allowing redemption center uses in commercial zones would make it easier for redemption center uses to locate in Iowa City. One of the plan's economic development goals focuses on "Encouraging a healthy mix of independent, locally-owned businesses and national businesses" with a strategy that aims to establish strategies to retain and encourage growth of existing locally-owned businesses. The Can Shed's proposition to expand to other areas of the community represents an opportunity to help support local businesses and remove barriers to their growth in the community. The proposed amendment helps existing businesses to want to stay in the community instead of looking to relocate to neighboring cities. The vision of the Comprehensive Plan focuses on protecting and enhancing the environment and encouraging the responsible use of our natural and energy resources with a goal to "Continue to track, measure and reduce energy consumption and greenhouse gas emissions," and "Raise awareness and expand opportunities for waste reduction, energy efficiency, stormwater management and other environmental issues". By allowing redemption centers in more areas of September 18, 2024 Page 8 the city, community members will have increased access and opportunities to contribute to waste reduction efforts. Since the IC2030 Comprehensive Plan was adopted in 2013, the city has increasingly focused on climate action. The city adopted the Climate Action and Adoption Plan in 2018, declared a Climate Crisis in 2019 and Adopted the Accelerating Iowa City's Action Plan in 2020. The goal set by these plans is to reduce carbon emissions by 45% from 2010 levels by 2030. The proposed amendment would help further these goals by promoting waste reduction and contributing to the community's recycling efforts. Staff Recommendation Staff recommends that Title 14, Zoning Code be amended as illustrated in Attachment 1 to allow redemption centers either as a provisional use subject to use specific standard or permitted use in commercial and industrial zones. Attachments 1. Proposed Zoning Code Text Amendments 2. Local Jurisdiction Research 3. Map of Proposed Zones to Allow Redemption Centers 4. Map of Permitted vs. Provisional Zones Approved by: +, • 1`I �- Danielle Sitzman, AICP, Development Services Coordinator Department of Neighborhood and Development Services ATTACHMENT 1 Proposed Zoning Code Text Amendments Attachment 1 Page 1 Draft Zoning Code Text Underlined text is suggested new language. Strike-through notation indicates language to be deleted Amend Table 2C-1, Principal uses allowed in commercial zones, as follows: Use Categories Subgroups CO-1 CN-1 CH-1 CI-1 CC-2 CB-2 CB-5 CB-10 MU Redemption Center PR PR P Amend Table 2D-1, Principal uses allowed in industrial zones, as follows: Use Categories Subgroups I-1 I-2 RDP ORP Redemption Center P P P P Amend 14-4A-4, Commercial use categories, as follows: J. Redemption Center Uses: 1. Characteristics: An indoor facility that collects bottles and cans from consumers, distributes payment of the refund value, and may utilize compressing machines. 2. Examples: Redemption center facilities. 3. Accessory Uses: Offices: off street parking. 4. Exceptions: a. Recycling processing facilities are classified as waste related uses. b. Establishments that offer beverages for sale are classified as either sales oriented retail, alcohol sales oriented retail, eating establishment, or drinking establishment. K J. Surface Passenger Services: L K Vehicle Repair Uses: Amend 14-4B-4, Specific approval criteria for provisional uses and special exceptions, as follows: B. Commercial Uses: 24. Redemption Center Uses in the CO-1, CN-1, CC-2, CB-2, CB-5, CB-10,And MU Zone: a. Redemption center uses are limited to five thousand (5,000) square feet gross floor area. b. Outdoor storage of any materials is not allowed. Amend Table 5A-2, Minimum parking requirements for all zones, except the CB-5, CB-10, Riverfront Crossings zones and Eastside Mixed Use District, as follows: Use Categories Subgroups Parking Requirement Bicycle Parking Redemption Center 1 space per 1,000 square feet of floor area None required ATTACHMENT 2 Local Jurisdiction Research E T 2" dio E E E E Y.Bdv aE E Yc E E E. E E e -E E E E I E E 2 i E E E E E E E E E c E E E E E E V E E-E-0 0 E E E E E- W E E E E E EE u u u E E E E E -E -E u 2 g E E E E E E o E E IE u E E E -o o u�E E u 7 u u u u u u I u u `E E E u E E E E E E E E u u E E E E E E o E- 8 E 11 E E E E E E E E E E E E E u u I u u kE 'E \\} \\} \\ \\t \\\} \ ��� \ - 9 E 2 2 E 0 E E E �u u }\E E \\\ 2\2 \�\\/ \}\\ \\} \\\E-E n T Ea Ea ATTACHMENT 3 Map of Proposed Zones to Allow Redemption Centers N N AIL �r w o co Z W a co W� v W y U w� "> y OnlB Ko 0 31b0�1b0 O a v /A��' Z Uro uvi v O �� �' gGP 1S32iOWdO.IS., - 0 } 1S ddVlO - �' w pRp,IRIE RD SUMMIT ST C � pU GHIEN 1S2iON2i3n0`J � OO Z y>� z m s' w z Y w m U is l'a38lIJ " : � -�1S NOSIaVW .5 w RIVERSIDE DR g BRYINGTON � C��MNO{gyp 3nV O O .a aNVHi) zo OapIIH f 1S32i01Ivo CL fa � w - a a� E /� 1S 13SNnS -0 C) a f � i U � 3: MORMON � _ � a p O o O TREK BLVD � 1 Nr E E 0 - -- .U) - w � U) U) E OLU ry^0 U C coC m C 0 CO CO CO N O 0 > 3nV2i IVW E N c c a �c `-' 1 O N N N 7 N C aU ULnULnU 0 W � � w EE E 1' •� � o E is N U O N U � N 0 N f6 -o E E 3 _. ..- U ZU 2 � 1.0 ATTACHMENT 4 Map of Permitted vs. Provisional Zones o 3nvldvl ; Z m W O W k. 2_ 0 0 •� W. �m -gyp O SCOTTBLVD Q � `N v ZA O N v g i O � U � Z U m � 3nH1S� � O •� �� ,.:,. �, J5G LS 32iOWVOk � OO } O, 1S ddVlO w x D�'C��EN RD SUMMIT ST C �� 1S 2iON2i3n0`J } o S _ ti�� w o z � � A] 1S 3f1Df18f14 x LL Z p� ,.... 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ILa § , (n (D k - � 2 \ � [ Cc: C. o 4- - c § E � § 1 2 (D 0 LU . � � G 7 ƒ 4 o m c > E k % o E 2 0) 0 -0 ° 0 § 0 , LL o 2 \ o m 0 a ƒ ƒ ■ ° � © � � o 2 un � o ® 2 @ -04-1 m ± O § / \ Q o f W W v � >" CD 40 E W z clac .c Ix u U 0 o 0 cz WI = o ) " W Cr � U Z � W m00 N Planning and Zoning September 18t", 2024 Page 1 of 9 CASE NO. REZ24-0007 Consideration of an amendment to Title 14, Zoning Code, to allow redemption centers in commercial and industrial zones. Conley began the staff report with some background information on why this code amendment is being proposed. Iowa's beverage containers control law, which is commonly known as the bottle bill, allows consumers to receive the return deposit when returning empty beverage containers to a store or redemption center. In June 2022, amendments were made to the bottle bill which allows stores to opt out of redeeming containers if a redemption center is nearby, or if other criteria are met. Redemption centers are facilities where consumers may return empty beverage containers and receive payment for the refund value of those containers. Sometimes redemption centers can be affiliated with some grocery stores as in the North Dodge HyVee, which is located in a CC-2 (Community Commercial) zone. Iowa City also has the Can Shed which is an existing redemption center located at 611 Hollywood Boulevard, Unit Three, located in a General Industrial (1-1) zone. The Can Shed would like to operate within a commercial zone in order to expand their services, improve their collection processes and provide easier access to the community. As a result, staff is proposing this code amendment to allow redemption centers to exist in commercial and industrial zones. Currently, the zoning code does not contain any specific language that assists with defining, classifying or regulating redemption centers and redemption centers are allowed in some grocery stores and therefore have been allowed in commercial zones already. However stand-alone redemption center related uses have historically been classified as a Waste Related Use. The Waste Related Use category in the zoning code is characterized by any uses that receive solid or liquid waste from others for disposal on the site or for transfer to another location; uses that collect sanitary waste; uses that recycle solid waste or recyclable materials; and uses that manufacture or produce goods or energy from biological decomposition of organic materials. Some examples of Waste Related Uses include recycling processing facilities, sanitary landfills, limited use landfills, waste composting, hazardous waste collection, etc. Waste Related Uses are currently allowed provisionally in the General Industrial (1-1) and Heavy Industrial (1-2) zones. For the purposes of the Can Shed the intended use and operation of this facility is not comparable to the types of intense industrial uses seen in the Waste Related Use category, therefore staff is proposing a code amendment which creates a new use category called Redemption Center, amends the table of allowable uses in commercial and industrial zones, provides a definition for Redemption Center, creates provisional use specific standards and outlines minimum parking requirements for this use category. The proposed amendment focuses on creating a new use category, Redemption Center which would be placed under the Commercial Use category in the zoning code. Redemption Centers would be characterized as an indoor facility that collects bottles and cans from consumers, distributes payment of the refund value and may utilize compressing machines. Examples of Redemption Center facilities accessory uses include offices and off-street parking. This use would include the following exceptions: recycling processing facilities will continue to be classified as a Waste Related Use, establishments that offer beverages for sale are classified as Planning and Zoning Commission September 18, 2024 Page 2 of 7 either sales-oriented retail, alcohol sales-oriented retail, eating establishment or drinking establishment. The characterization of this use category helps define and regulate what Redemption Centers would look like if this proposed amendment were to be adopted in Iowa City. Conley next shared the proposed zones that would allow this use. Redemption Centers would be allowed in commercial and industrial zones, either as a use permitted by right or a provisional use subject to additional use standards. The additional standards for this use would help protect surrounding properties and mitigate potential negative externalities associated with this use. In addition to be being permitted by right in all commercial and industrial zones, staff is recommending that Redemption Centers be permitted by right in the Highway Commercial (CH- 1) and Intensive Commercial (CI-1) zones, since one of the additional standards proposed discusses the allowance of outdoor storage and both zones allow outdoor storage when certain criteria are met, such as concealment of materials, setbacks and screening requirement. Staff has created use specific standards for Redemption Centers to adhere to when provisionally allowed in the commercial zones listed in the table. The proposed use specific standards are as follows, first, size of use limited to no more than 5000 square feet, and two, outdoor storage of any materials is not allowed. Staff determined it would be appropriate to apply these use specific standards in commercial zones that may abut residential land uses to help maintain the character and scale of intensity of the surrounding properties. Conley noted also the location jurisdiction research that staff conducted demonstrates the size restriction in many of the cities and also the prohibition of outdoor storage as a common practice. There are several jurisdictions in Oregon that utilizes the 5000 square foot maximum. Additionally, the Iowa City zoning code has a size limit for other commercial zone uses such as a size limit for indoor commercial recreational uses in the CO-1 and CN-1 zones as well as office uses in the CN-1 zone. Additionally, staff developed a proposed minimum park ratio of one space per 1000 square feet of floor area with no bicycle parking required. The justification for this parking ratio in is that a lot of the patrons that visit redemption center facilities will likely leave the space fairly quickly after they drop off their cans and receive their deposit so due to the nature of the business, staff does not anticipate that this use will require many parking spaces. Additionally, if the redemption center does find that they need more parking than the minimum, they are able to add more if they see fit. Conley next reviewed the analysis section. Since the City's current regulations do not really consider redemption centers staff developed a list of local jurisdictions to analyze how other areas regulate this use. Specifically, staff found value in analyzing jurisdictions in the state of Oregon and Iowa. In Oregon, redemption centers are most often considered a commercial use, viewed as a service provided to the community. This use is allowed in a variety of commercial and industrial zones. Then in Iowa, redemption centers are typically categorized as an industrial use, not as the commercial land uses that exist in Oregon and envisioned by the Can Shed and primarily the zones that this use would be allowed in is solely industrial. Some of the Oregon cities that they looked at were Portland, Bend, Gresham, Tigard and a couple more. In Iowa staff looked at Des Moines, Cedar Rapids, Cedar Falls and a couple others. The local jurisdiction research demonstrates the range of different regulatory approaches for redemption centers. These jurisdictions highlight specific differences in how each city has decided to regulate redemption centers in their zoning code. For this presentation Conley wanted to focus on the City Planning and Zoning Commission September 18, 2024 Page 3 of 7 of Portland, City of Bend and City of Gresham, as well as the City of Des Moines. Staff found there were two main approaches taken by these local jurisdictions, either categorize redemption centers as an existing use or to create a new use category. To start, the City of Portland chose to view redemption centers as an existing commercial use in their zoning code under the Retail Sales and Services category. Specifically, this use is considered repair-oriented and classified as a recycling drop-off. The City of Portland defines recycling drop-off as a facility for the drop-off and temporary holding of materials such as paper, cardboard, glass, metal, plastic, batteries and motor oil. The Cities of Bend and Gresham take a different approach and they decided to implement this land use as a standalone use category under the commercial use category in their zoning code. Both cities chose to define redemption centers as an indoor facility that facilitates the return of empty beverage containers. This differs from the City of Portland because they do not accept such a large range of materials and only focus on the collection of empty beverage containers. In Iowa, the City of Des Moines moves further away from both previous approaches by considering redemption centers as an example of an Industrial Service. The City of Des Moines code characterizes Industrial Service uses as uses that deal with repair, maintenance and operation of large equipment. Overall, the variation of all these different approaches demonstrates how drastically different each of these cities have chosen to regulate redemption centers and also serve as a good example for staff to understand how to regulate redemption centers in the proposed amendment. Staff then looked at the use specific standards for this land use in each jurisdiction. Some cities, for example, did not have any use specific standards, while others did. The City of Portland and the City of Gresham do not have any additional use specific standards, but the City of Bend decided to implement a size limit for 10%, or 2500 square feet, if the use is accessory and if it is a single use it may occupy around 5000 square feet if approved through a conditional use permit. The City of Des Moines includes standards that aim to mitigate any negative externalities of industrial services. Therefore, analyzing the use specific standards of redemption centers in other jurisdictions helped staff envision how the additional use standards would be appropriately implemented into Iowa City zoning code. It's also important to consider the anticipated impact of this proposed amendment so staff prepared two maps that visually represent how the proposed amendment would apply to the land within the City. The first map shows the location of the zones where the proposed amendment would allow redemption centers. Most areas are concentrated in the southern portion of the City, since most of the City's commercial and industrial land is in that area, and areas where the proposed amendment would allow redemption centers include the center of the City, Old Town Village, Towncrest, and the area near the intersection of North Dodge and I-80. The second map shows where the proposed amendment would allow redemption centers, either as a permitted or provisional use. Next staff looked at the proposed amendment's consistency with the Comprehensive Plan. The Comprehensive Plan includes a vision statement that supports a resilient economy, increases tax base, stimulates job growth and promotes the overall people's prosperity and progress. Additionally, the proposed amendment supports the following goals and strategies that are found in the economic development section of the Comprehensive Plan. One of those goals is to increase and diversify the property tax base by encouraging the retention and expansion of existing businesses and attracting businesses that have growth potential and are compatible with Iowa City's economy. A strategy that supports this goal is to provide an attractive economic environment with streamlined business friendly culture by making regulatory and permitting Planning and Zoning Commission September 18, 2024 Page 4 of 7 processes clear, predictable and coordinated. The second goal would be encouraging a healthy mix of independent locally owned businesses and national businesses. The strategy that supports this is to retain and encourage growth of existing locally owned businesses is allowing Redemption Centers uses in commercial zones which would make it easier for Redemption Centers uses to locate in Iowa City. The Can Shed's proposition to expand to other areas in the community represents an opportunity for the City to help support local businesses and remove barriers to their growth in the community. The proposed amendment helps existing businesses to also want to stay in the community instead of looking to relocate to other neighboring cities. Another part of the vision statement includes protecting and enhancing the environment and encouraging the responsible use of natural and energy resources. Environmental goals such as to continue to track, measure and reduce energy consumption and greenhouse gas emissions, raising awareness and expanding opportunities for waste reduction, energy efficiency, stormwater management and other environmental issues. The goals that the proposed amendment would also support if redemption centers are allowed in more areas of the City are community members will have increased access and opportunities to contribute to waste reduction efforts. Since the IC2030 Comprehensive Plan was adopted in 2013 the City has increasingly focused on climate action. The City adopted the Climate Action and Adoption Plan in 2018 and a Climate Crisis was declared by the City in 2019 and adopted the Accelerating Iowa City's Action Plan in 2020. These plans create a goal to reduce carbon emissions by 45% from 2010 levels by 2030 The proposed amendment would help further these goals by promoting waste reduction and contributing to the community's recycling efforts. Staff recommends that Title 14, Zoning Code be amended to allow redemption centers either as a permitted use or a provisional use subject to use specific standards in commercial and industrial zones. Hensch is curious about why it's provisional for some of the commercial areas because before the legislature did their misdeed and changed the law, all the convenience stores and grocery stores accepted returns so why not be consistent with that. Conley responded by saying that based off the local jurisdiction research that staff conducted, in addition to looking at the provisional uses allowed in the zoning code, it seemed to be consistent and allowed the City the ability to implement regulations that would help mitigate the negative externalities. Russett added that the redemption centers that exist now in commercial zones are associated with some other type of retail-oriented use, and with this amendment they are looking at stand alone, larger facilities. Hensch asked if then it's provisional use and additional standards are required, are there any additional standards other than the two listed (5000 square feet and no outdoor storage). Conley stated those are the two that staff are proposing. Hensch asked how those additional standards would be applied or determined. Russett explained those would go before the Board of Adjustment staff and would need to be determined as part of this text amendment. Hensch asked what if the Commission or City Council were to propose additional standards in the future. Russett stated they would have to go through another text amendment process. Elliott asked if the City knows of any issues with the current situation where they're in commercial zones within another building. Conley is not aware of any. Planning and Zoning Commission September 18, 2024 Page 5 of 7 Quellhorst asked why the areas of Office, Research and Research Development Park are included in the permitted versus provisional use category, it seems to be an odd use in that zone. Conley stated there's not a lot of areas that are zoned Office, Research and Research Development Park and those use categories allow kind of quasi-industrial uses in those zones so staff felt it appropriate to allow it as a permitted use. Craig wondered why the current location isn't sufficient, it is a pretty centrally located space. Conley noted currently the Can Shed is located in the general industrial zone and they are just wanting to expand to other areas of the City. Elliott noted she does see people on bicycles that look like they're going to redeem their cans so why no bicycle parking required. Quellhorst noted in this case the Redemption Centers definition is like an automated redemption centers, like at a HyVee with the machines versus a staffed redemption centers. Conley stated it depends on how the City wants to define it, but they chose that redemption centers would be defined as a staffed facility. Russett noted the definition doesn't expressly state that it needs to be staffed, that's something that is hard to regulate through zoning, but the Can Ched will speak to their proposal. They are proposing that it to be staffed, but also function similarly to ones with the automated machines. Goers stated the other thing he would note is on the exceptions, particularly the second bullet point, establishments that offer beverages for sale are classified, etc. and if something falls into one of those categories it would not be considered a redemption center under this definition. Townsend stated regarding the North Dodge HyVee having a redemption center that has not been operational for some time, if they wanted to restore that, as the machines are still there, could they. Conley replied yes, that would still be permissible. Craig noted they talk consistently about cans but there are also glass redemption, does the Can Shed take glass or are they proposing to take glass. Russett confirmed yes, the Can Shed will take anything that has a deposit. Townsend has a comment or a concern that why can't she go to any store that she pays deposit on bottles and cans and take them back to that place. Hensch stated that was the Iowa legislature and their wisdom in changing the law. Hensch opened the public hearing. Austin Geasland (Realtor, Q4 Real Estate) represents the Can Shed in their real estate expansion throughout the corridor area. One thing he wanted to bring up is the space that they are currently negotiating is on Gilbert Street, the old South Maple building and the space is 5500 square feet. Staff's amendment proposal is 5000 square feet maximum and while they understand the logic and the reasoning there, in an effort to keep this deal alive and not lose it, is there a way that they could structure the business and the layout to 5000 square feet of redemption center and leave the other 500 square feet for employee offices, employee break rooms, etc. That is a concern he has with the current wording of the amendment. Planning and Zoning Commission September 18, 2024 Page 6 of 7 Troy Willard (owner, Can Shed) stated what they're trying to do is raise their visibility, expand their services for which they need more space than the building they're currently in, they're maxed out. The current location is only about 2800-3,000 square feet. They have added a mobile app where people can drop off bags of containers outside of staffed hours so they need an area to drop those off as well. They also want to upgrade the equipment, the current automated machines only allow cans to be put in one at a time but there's a technology out there for more of a bulk dump. They take up about 25% of the time to count all the containers through and there's also a bigger footprint for that type of machinery. Another reason for wanting to move is the building Geasland was talking about has a lot more parking and there is a parking crunch where they're currently at, and that is some of the motivation to move. Willard confirmed the North Dodge HyVee hasn't redeemed containers since about 2020, back then and after the pandemic, the Can Shed started doing more direct business representing HyVee as the redemption spot in the City and took on all the responsibility for all the stores. Walmart is at the very end of using their machines, they've used up their useful life and they have no interest in replacing them and adding extra cost into their business model. He also wanted to note he understands the logic and the explanations about the square footage thing and that would be a clarification he would want to know before he makes any hard and fast decisions about leasing or buying space or building a building. Also one of the natural progressions of the bottle bill in other states is they have been taking it from carbonated and alcoholic beverages and moving to all beverage containers, which would include water bottles, sport drinks, any type of non-carbonated container so he is trying to look forward to that expansion and the space needs for that as well. Craig asked if they would be moving their facility and just still have one. Willard confirmed that was correct, they just need one that is more accessible and bigger and nicer. The new location is only four blocks but it's in a major intersection and closer to the bank they use to grab money to pay out to the customers so there's a lot of considerations going into that space there. Criag asked if they work directly with commercial establishments, like a restaurant that sells cans of beer, etc. Willard confirmed they do have business routes that they run, a couple times a week to pick up cans and bottles from the downtown bar scene and any of the restaurants. They generally cover an area anywhere from about 40 to 45 miles in and around Cedar Rapids. They're mainly in Johnson County and Linn County, they spill into Iowa County a little bit as well as Cedar County, Jones County, and Benton County. Criag asked about the business model how do they make money if someone pays five cents for a can and then gets the five cents back. Willard stated it is getting into some nuanced areas but as a consumer buying stuff at HyVee, the distributor, Coke, Pepsi, Budweiser, originates the deposit. When they sell it to the store, they collect the nickel from the store. The store collects a nickel from the consumer and then the consumer gets their nickel back from the Can Shed or the store. Then when the Can Shet takes the cans back to Coke, Pepsi or whatever distributor he gets his nickel back and they pay him three cents on top of that. One of the misconceptions is somehow the State's involved with that but it's totally managed financially through private enterprises. Craig asked what Coke does when they get their cans back. Willard explained they smash them up, bail them up and recycle them. He noted they redeem about 106 million containers a year through their five locations. They also go out and represent distributors and pick up other Planning and Zoning Commission September 18, 2024 Page 7 of 7 redemption centers and bring that material back to the facility in Cedar Rapids and combine it all to make sure it's going back to end users and markets. Aluminum can turn into aluminum cans again, the plastic has changed over the years, a lot of times it was being made into carpet products but now it's going back to a bottle-to-bottle processing facility in Wisconsin. The glass goes to Kansas City, there's a company down there that pulls all the brown glass out to make beer bottles for Boulevard Brewery and the rest of it goes to a fiberglass insulation plant and gets made into insulation. Hensch closed the public hearing. Craig moves to recommends that Title 14, Zoning Code be amended to allow redemption centers either as a permitted use or a provisional use subject to use specific standards in commercial and industrial zones. Elliott seconded the motion. Quellhorst noted it sounds like the Can Shed folks might want a space limit for provisional zones in excess of 5000 square feet, is that something that staff would want to look into further or are they still comfortable moving ahead with the 5000 square foot recommendation. Russett noted they could still operate a 5000 square foot redemption center within that 5500 square foot space they are looking at, the additional 500 square feet would just have to be used for some other purpose, like their administrative purposes. However, if the Commission wants to increase it to 5500 staff doesn't really have any concerns with that either. She stated the one benefit of sticking with 5000 is simply for consistency with how other size regulations are included in the zoning code, 5000 is a very common number when looking at size limitations for uses. Hensch noted right now it's limited to redeemable beverage containers but if the Iowa legislature expands that to water bottles and other things they would have to come back and amend the text. Russett stated yes, they would evaluate that at the time. Hensch is in favor of approving this because this is truly an example of where they can facilitate the public good. With the reduction of the redemption centers from what they formerly had; he would have to guess that the amount going into the landfill has increased dramatically. Additionally, a better location would make it better for the consumer in Iowa City and would be a very positive action. A vote was taken and the motion passed 7-0. Item Number: 10.b. CITY OF IOWA CITY COUNCIL ACTION REPORT November 4, 2024 Ordinance amending Title 6, entitled "Public Health and Safety", to create a new Chapter 11, entitled "Kratom", to prohibit its sale and distribution. (Pass and Adopt) Prepared By: Eric Goers, City Attorney Reviewed By: Kirk Lehmann, Asst. City Manager Fiscal Impact: None Staff Recommendation: No recommendation Commission Recommendations: N/A Attachments: Ordinance City Council correspondence from David Berg and Mac Haddow - American Kratom Association, and Susan Vileta - Health Educatior, Johnson County Public Health Executive Summary: At their July 16, 2024 meeting, the City Council directed the City Attorney to draft an ordinance banning the sale and distribution of kratom products within City limits, in an effort to protect the health, safety, and welfare of area residents. After reviewing the draft ordinance at their August 6th and 20th meetings, Council decided to proceed with the kratom ban, as part of a larger discussion on regulating tobacco retailers. Background /Analysis: Kratom is listed as a "drug of concern" by the federal Drug Enforcement Administration. The federal Food and Drug Administration has concluded from available information, including scientific data, that kratom is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury. Based on determinations by the FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods. There are no drug products containing kratom or its two main chemical components that are legally on the market in the U.S. The FDA has not approved any prescription or over-the-counter drug products containing kratom or its two main chemical components. Correspondence is included in Council packet. Prepared by: Eric Goers, City Attorney, 410 E. Washington Street, Iowa City, IA 52240; 319-356-5030 Ordinance Number Ordinance amending Title 6, entitled "Public Health and Safety", to create a new Chapter 11 , entitled "Kratom", to prohibit its sale and distribution. Whereas, kratom is listed as a "drug of concern" by the federal Drug Enforcement Administration; and Whereas, the U.S. Food and Drug Administration (FDA) has warned people not to use kratom because of possible harm it can cause; and Whereas, according to the Mayo Clinic, kratom hasn't been shown to be safe or to treat any medical conditions; and Whereas, according to the Mayo Clinic, poison control centers in the United States received more than 3,400 reports about use of kratom from 2014 through 2019; and Whereas, according to the Mayo Clinic, kratom has known side effects, including nausea and vomiting, liver damage, high blood pressure, dizziness, hallucinations, delusions, depression, tremors, and seizures; and Whereas, according to the Mayo Clinic, when a pregnant person uses kratom, the baby may be born with symptoms of withdrawal and need treatment; and Whereas, municipalities in Iowa have the authority to preserve and improve the safety, health, and welfare of its residents; and Whereas, it is in the best interest of the City to prohibit the sale and distribution of kratom within City limits. Now, therefore, be it ordained by the City Council of the City of Iowa City, Iowa: Section I. Amendments 1. Title 6, entitled " Public Health and Safety", is amended by adding the following Chapter 11, entitled, "Kratom": Chapter 11 Kratom 6-11-1: Definitions. As used in this chapter, the following definitions shall apply: Distribute: To furnish, give away, exchange, transfer, deliver or supply, whether or not for monetary gain or other consideration. Kratom product: Any part of the plant Mitragyna speciosa, whether growing or not, or any food product, food ingredient, dietary ingredient, dietary supplement, or beverage that contains any part of the plant Mitragyna speciosa or any extract, synthetic alkaloid, or synthetically derived compound of such plant or its leaf including, but not limited to, any powder, capsule, pill, beverage, or other edible product. Sell or sale: To furnish, exchange, transfer, deliver, or supply for monetary gain or other consideration. 6-11-2: Sale or distribution of kratom prohibited: Ordinance No. Page 2 It is unlawful to sell, advertise for sale, offer for sale, or distribute, directly or indirectly, any kratom product, or item labeled as a kratom product, in the City. 6-11-3: Penalties: Any violation of this chapter shall be considered a simple misdemeanor or a municipal infraction punishable by a civil penalty of seven hundred fifty dollars ($750.00)for a first offense and one thousand dollars ($1,000)for second and subsequent offenses. Section 11. Repealer. All ordinances and parts of ordinances in conflict with the provision of this Ordinance are hereby repealed. Section III. Severability. If any section, provision or part of the Ordinance shall be adjudged to be invalid or unconstitutional, such adjudication shall not affect the validity of the Ordinance as a whole or any section, provision or part thereof not adjudged invalid or unconstitutional. Section IV. Effective Date. This Ordinance shall be in effect after its final passage, approval and publication, as provided by law. Passed and approved this day of , 2024. Mayor Approved by Attest: City Clerk City Attorn AsOffice—09/24/2024 Ordinance No. Page 3 Moved by , seconded by ,that the Ordinance as read be adopted, and upon roll call there were: AYES: NAYS: ABSENT: Alter Bergus Dunn Harmsen Moe Salih Teague First Consideration: October 1, 2024 Vote for Passage: AYES: Harmsen, Moe, Salih, Teague NAYS: Alter ABSENT: Bergus, Dunn Second Consideration: October 15, 2024 VoteforPassage: AYES: Harmsen, Moe, Salih, Teague NAYS: Alt-or, RargijS, nimn ABSENT: None Date Published: Moved by ,seconded by ,that the rule requiring ordinances to be considered and voted on for passage at two Council meetings prior to the meeting at which it is to be finally passed be suspended,the second consideration and vote be waived, and the ordinance be voted upon for final passage at this time. AYES: NAYS: ABSENT: Kellie Grace From: David Berg <davidberg98642@gmail.com> Sent: Tuesday, October 15, 2024 6:48 PM To: *City Council Subject: Kratom killed my son - please consider wisely! A **Thi�s-emai' originated outside of the City of Iowa City email system. Please take extra care opening any links or attachments. ** Hello, I heard through a friend that there is a hearing tonight with the objective to consider the pros and cons of regulating or outlining the purchase of Kratom. I will be up front, I am not a resident of your city, but I have become a vocal advocate for the restriction of Kratom sales. It has been just two weeks under a year since we got a knock on our door on a beautiful Friday afternoon, a Chaplin was there and he informed us that our 20 year old beautiful son had died in his sleep. We were completely floored, he had no history of illegal drug use and was in perfect health. He was a beloved brother and son,the oldest of our five children. It took six agonizing months to get the testing back to prove that he died from Kratom toxicity, which is what happens when you take Kratom over a prolonged period of time. it slowly becomes less and less effective, and so a person must increase their dosage in order to get the same effects. In our sons case, he used it for energy and to combat anxiety, and although he never admitted it, I know now from study that it causes euphoria when used higher doses, and I'm sure he liked that feeling. it is available at gas stations, tobacco, shops, and online, with very little oversight. The FDA has said that this substance has many concerns and should not be used until further testing can be done, so I implore you to help take measures so that another family in your city doesn't get that same knock on a beautiful Friday afternoon and have their lives completely shattered 1 - y I. r• J - r + 1.40r7 �!r t r. 1 . I am more than happy to share more of my story by email or phone call, my phone number is (360) 857-8787. Respectfully, David Berg Sent from Gmail Mobile 3 CAN k*w AMERICAN KRATOM ASSOCIATION 4 a A M E R I CA N K R ATO M 13575 Heathcote Blvd STE 320 ASSOCIATION Gainesville.VA20155 �s'so cl l%'O www.americankratom.org 0 October 6, 2024 Mayor Bruce Teague Iowa City City Council 4,` = 410 E Washington St _ co ` Iowa City, IA 52240 Dear Mayor Teague and Members of the Iowa City Council: I write on behalf of the American Kratom Association (AKA)following the City Council's vote on October 1, 2024,to advance the proposal to ban kratom in Iowa City for future consideration.We heard the Council members concerns about the safety profile of kratom, and we would like to assure you that the AKA will provide additional, scientifically backed information to help address these concerns. Our organization is fully committed to ensuring that any deliberations about kratom are informed by the latest research and evidence regardingkratom's safety and responsible consumer use. However, the immediate purpose of this letter is to address a matter of grave concern that has surfaced during the public comment process on this issue.We have received reports from several Iowa City residents whose identities were misappropriated in fraudulent emails that were submitted in opposition to the proposed kratom ban.These emails falsely presented the individuals as opponents of the ban, when in fact, they did not write or authorize those communications.The AKA takes such illegal conduct very seriously, as it undermines the integrity of the democratic process and erodes trust in the public discourse on important policy decisions. The AKA regularly engages in advocacy campaigns in response to local government entities considering regulations or bans on kratom. In this instance, the AKA sent an advocacy alert that contained the names and email addresses of the Iowa City City Council and encouraged those Iowa residents to contact each member of the Council. We did not initiate a national campaign because we believe the actions of the Iowa City City Council would have an impact on both City residents and residents of the state of Iowa.The AKA has never asked any pro-kratom advocate to falsify attribute an advocacy message or misappropriate the identity of any other person. The AKA will file a formal complaint with the Iowa City Police Chief regarding these incidents.We will fully cooperate with the investigation and will request a digital copy of every email submitted to the Council so that the IP addresses associated with these fraudulent submissions can be trace to their source. It is crucial to identify whether these actions were taken by a well-intentioned pro-kratom advocate who resorted to illegal methods or by an anti-kratom advocate attempting to sabotage the credibility of our advocacy efforts. Regardless of the motivation, such actions are unacceptable and must be thoroughly investigated. Mayor Bruce Teague Iowa City City Council October 6, 2024 Page 2 of 2 Unfortunately, this is not the first time we have encountered such unethical tactics. During an advocacy campaign with the Virginia Board of Pharmacy, my identity, as the AKA Senior Fellow on Public Policy,was misappropriated in fake comments, and other high-profile kratom advocates experienced similar fraudulent activities. In a separate and particularly egregious case, a prominent anti-kratom trial lawyer deliberately doctored a photograph, replacing the original image of me with U.S. Senator Joe Manchin where he then inserted his image over Senator Manchin, all in an effort to falsely imply a personal friendship between himself and me for the apparent purpose of undermining my credibility in the kratom community. The AKA believes that it is vital to protect the integrity of public policymaking from these kinds of bad actors.We lookforward to working with the City Council and the Iowa City Police Department to ensure that the ongoing deliberations regarding kratom are based on factual, transparent, and legally sound inputfrom all stakeholders. Thankyou for your attention to this serious matter.We will continue to provide additional information regarding the safety of kratom, and we hope to engage in constructive dialogue with the Council in the weeks ahead. Sincerely, * k4 kr� Mac Haddow Senior Fellow on Public Policy American Kratom Association Email: mh.a.dd.owP-americ_an-kCatom org Phone: (571) 294-5978 cc: Megan Alter, Councilor, At-Large _ Laura Bergus, Councilor, District A ,' Andrew Dunn, Councilor, District C Shawn Harmsen, Councilor, District B -- Josh Moe, Councilor, At-Large Mazahir Salih, Mayor Pro Tem, At-Large co Dustin Liston, Police Chief Geoff Fruin, City Manager Eric Goers, City Attorney Kellie Grace From: Susan Vileta <svileta@johnsoncountyiowa.gov> Sent: Thursday, October 31, 2024 10:32 AM To: *City Council Subject: Kratom 1 RISIt **This email originated outside of the City of Iowa City email system. Please take extra care opening any links or attachments. ** Unfortunately I will not be able to attend the City Council meeting next week, but wanted to share the following. It's true that compared to deaths from other drugs, a smaller number of deaths have been linked to kratom products and those nearly all involve other drugs or contaminants. However, substituting one addictive drug for a different one that is unregulated would not be considered harm reduction in the sense it's meant. From my review,while many people anecdotally say Kratom helped them stop using Opioids,they still use Kratom often/daily. While there is some research saying it could be a possible harm reduction agent,there needs to be significantly more research conducted and regulation implemented. It is an unregulated addictive product that hasn't been shown to be safe or approved to treat any medical conditions. The FDA has warned people not to use kratom because of possible harm it can cause.The U.S. Drug Enforcement Administration calls kratom a drug of concern. In addition, we should be mindful that some people believe kratom can be helpful for them,and therefore,they might feel ignored/unvalued if it is banned. If you proceed with a ban, it is important to couple it with outreach about evidence based treatment and support available in Johnson County. Community Family Resources and Johnson County Public Health can assist with this outreach and education. Thanks, Susan Vileta https_//www.fda.2ov/news_ev_ents/�pubLic-health-focus/fda-and-kratom United Nations, Commission on Narcotic Drugs. Summery-f assessments,findings and recom_manda#ions-of the 44th World-H-P.a_Lth..D..rga.Ri2-at1on's -0--)ExpaELC-gmm.lt a on Drug Dependence(EQDDJ,11-115-0-0-t-ober 2021. Vienna; 9-10 December 2021. Report No. E/CN.7/2021/CRP.12 Post S, Spitler HA, Chounthirath T, Smith GA. Kratom exposures reporters to United States poison control centers: 2011-25}17. Clin Toxicol(Phila). 2019;57(10):847-854. doi:10.1080/15563650.2019.1569236 Henningfield JE, Grundmann O, Babin JK, Fant RV,Wang DW, Cone EJ. Risk of death associated with kratom user-QMPared to apia[ds. PrevMed. 2019;128:105851. doi:10.1016/j.ypmed.2019.105851 United Nations, Expert Committee on Drug Dependence. Pre-review report: Kratorn (Mytragyna speclo��),1�itragynine_and 7-hy. -Qxy. tr�gynine. 11-15 October 2021. Geneva. 1 Leong Bin Abdullah MFI, Singh D, Swogger MT, Rahim AA, Vicknasingam B. The prevalence of psychotic symptoms in Icratflm (Mitragyna speciosa korth) users in._Malaysia.Asian J Psychiatr. 2019;43:197-201. doi:10.1016/j.ajp.2019.07.008 Kronstrand R, Roman M,Thelander G, Eriksson A. unintentioflaLfata,l_intoxicafio...ns with mitragynine altd 0-desmethyltramado1 from the herbal blend Kry�tpn.JAnal Toxicol. 2011;35(4):242-247. d o i:10.1093/a n atox/35.4.242 How was your experience today?Your feedback will help us improve! Susan Vileta I She,Her,Hers Health Educator Johnson County Public Health 855 South Dubuque Street I Iowa City, IA 52240 Phone: 319-356-6040 1 Direct Line: 319-688-5910 svileta(cr?,johnsoncountyiowa.clov https://wwwjohnsoncountyiowa.gov/department-of_public-health in QU ITLI N E MY LIFE My QUIT GREATER IOWA CITY, INC. 2024 Ambassador PLEASE BE GREEN Notice of Confidentiality:This e-mail and any files transmitted with it may contain confidential or privileged information and is intended solely for the use of the individual(s) or entity to whom it is addressed.Any unauthorized review,use,disclosure or distribution is prohibited. If you have received this e-mail in error,please delete it from your system. This message and accompanying documents are covered by the Electronic Communications Privacy Act, 18 U.S.C. sections 2510-2521, and contain information intended for the specified individual(s) only. This information is confidential. If you are not the intended recipient or an agent responsible for delivering it to the intended recipient, you are hereby notified that you have received this document in error and that any review, dissemination, copying, or the taking of any action based on the contents of this information is strictly prohibited. If you have received this communication in error, please notify us immediately by e-mail, and delete the original message. 2 1 � t *VM 77Q1r ®®�� City Council Supplemental Meeting Packet -►�.� 4 L CITY OF IOWA CITY November 4, 2024 Information submitted between distribution of the meeting packet on Thursday and 4:00 pm on Friday. Late Handout(s): 9.b. Zoning Code Amendment - Redemption Centers - See revised comment. Comment: On September 18, 2024, the Planning and Zoning Commission recommended approval of REZ24-0007 by a vote of 7-0. Approval will amend Title 14, Zoning Code, to allow redemption centers in commercial and industrial zones. Staff is requesting expedited action. 10.b. ratom Ban - See correspondence from Stephanie Taylor, American Kratom Association November 4, 2024 City of Iowa City it�-ice, ,6 Kellie Grace Late Handouts Distributed From: staylor@americankratom.org Sent: Friday, November 1, 2024 12:10 PM 02 l To: *City Council (Date) Subject: Digital Packet regarding Kratom Science and Policy Attachments: We sent you safe versions of your files;AKA Policy Brief on FDA Shift on Kratom and CBD-2.pdf;AKA_ Policy Brief on kratom dose-finding study_022324_vfinal.pdf; AKA-Policy Brief on FDA Admission on Kratom Dangers_022324_vfinal (1)-1.pdf; American Kratom Association_Kratom Science Update Redesign_12.8.23_vfinal.pdf; Bergman Letter.pdf; FDA Kratom Danger Not Determined.pdf,- Statement on the science of kratom prod ucts_FINAL.pdf RISE{ **This email originated outside of the City of Iowa City email system. Please take extra care opening any links or attachments. ** Mimecast Attachment Protection has deemed this file to be safe, but always exercise caution when opening files. Good Afternoon Iowa City Council, I am writing on behalf of the American Kratom Association regarding the third reading of the Ordinance to Prohibit kratom sales to be discussed at the upcoming meeting on November 4th. The American Kratom Association represents kratom consumers nationwide and advocates for the appropriate regulation of kratom,not banning kratom. I have attached the following documents: -A Scientific Update on kratom -Briefing paper on the new FDA regulatory approach to kratom-regulate not ban -Briefing paper on the FDA Admission on Kratom Dangers with supporting documentation -Briefing paper on the kratom dose-finding study -Statement on the science of kratom products -Letter from Congressman Jack Bergman(R-MI)concerning the impact state and local bans have on veterans We hope you will take the time to review this information and let science guide your decision.Please feel free to reach out with any questions you might have. Best Regards, Stephanie Taylor Research and Project Assistant, The American Kratom Association 540-300-1605 1 stavlor(67a americankratom.org 13575 Heathcote Blvd#320 Gainesville VA 20155 1 (.4) ' POLICY AMERICAN KRATOM ASSOCIATION ' M"FEBRUARY 2024 FDA Deputy Commissioner Signals Significant Shift in FDA Policy on Kratom and CBD Regulation. New regulatory approach exposes deep flaws in FDA's decades-long claims about kratom being dangerous as new FDA study finds "kratom appears to be well tolerated at all dose levels." (presented by FDA at scientific conference, February 2024) ALLIANCE FAR A STRONGER FDA Deputy for Policy, • Deputy • International ■ CBD and kratom are being marketed in almost every neighborhood you go into. ■ FDA has been thinking about what the regulatory framework for these products should look like. ■ Based on what the FDA knows about CBD,in particular,the Agency does not think that those products would be able to meet the safety standards currently in place for foods and dietary supplements today. ■ Given wide availability of both CBD and kratom,the FDA wants to make sure consumers are educated on what they are taking and that adverse events are reported and minimized—especially in children. ■ The FDA wants to work with Congress on this effort,which includes how to ensure that CBD and kratom products are clearly labeled with all ingredients, and that these products are not making their way into the hands of children, ■ All adverse events need to be quickly and accurately reported in such a way that the FDA can identify any trends. ■ FDA wants to know who is making the products containing kratom and CBD,where they are being made, and that they are manufactured or produced in a way that is safe. ■ This effort will take collaboration with the Hill and with stakeholders so the FDA can determine what regulations are needed to ensure the safety of the products and the level of oversight that will be required. AMERICAN ♦ • t ASSOCIATION FDA completes a kratom "dose finding study" on humans where no significant adverse events were POLICY BRIEF observed even at very doses. concernsThe FDA acknowledged at a scientific meeting the data showed no significantsafety • • dose studyon • 0 and that clears the way for the planned Human Abuse Potential study. The FDA announced on January16, It is reported thatthe scientists at FDA accepted 2024, it will accept proposalsto conduct the safety data for its evidentiary value and are now preparing to make a public presentation a Human Abuse Potential ("HAP")study on the results ofthe dose finding study at a to assess the potential severity of a scientific conference in the fall of 2024. kratom dependency or addiction liability. That dose finding study data cleared the way The HAP study is authorized only for the HAP studyto be advertised and that is expected to be completed within 2 years. It is because the dose finding study showed important to note thatthe dose finding study kratom can be safely ingested. had to demonstrate kratom can be safely consumed before the HAP study could An FDA scientist reported on some of the results of the ethically be advertised. dose finding study atthe Third Annual Kratom Symposium Kratom researchers are excited that the next on February 14-15,2024. Researchers report that some of level of studies on the safety and addiction the policy staff atthe FDA were"profoundly disappointed" liability of kratom extract products, and safe atthe lack of adverse events that occurred among human consumption levels can be identified,and the participants in the dose finding study,where the ascending limits on kratom plant constituents in a kratom doses got to 12 grams of kratom material before just 2 of product before it is deemed to be adulterated. the participants experienced some nausea.That level of Those needed dose finding and HAP studies for kratom consumption is extraordinarily high among current kratom extract products will take several years kratom consumers. after the current HAP study is completed. i. https://grants,gov/search-results-detail/351644 ii. https://pharmacy.uf.edu/third-international-kratom-symposium/ hi, https://www,fda,gov/files/drugs/published/Botanical-Drug-Development-Guidance-for-Industry.pdf Q The American Kratom Association 1 13575 Heathcote Boulevard,Suite 320 1 Gainesville,VA 20155 www.americankratom.org—www.kratomanswers.org 0 AMERICAN POLICY BRIEF KRATOM ASSOCIATION February 2024 tellsFDA - • - • Court • "not yet determined kratom is dangerous!" Judge forces the FDA1 admit its evidence1 1. . 1 kratorn does not111 1 ' past and current claims I'sw Agencythe .1' about kratornbeing dangerous. The FDA has repeatedly made claims over the past 12 years that kratom is a dangerous substance that should be classified as a Schedule I substance under the federal Controlled Substances Act("CSA").Yet, when called by a Federal Judge to present witnesses and testimony under oath in a case in the Southern District of California at a Hearing on February 8,2024,on whether kratom is dangerous,the FDA refused to attend the Hearing or even provide under oath any documents ortestimonyto the Court) The explanation provided by the U.S.Attorney to the Court explaining the FDA's decision stated the following: They [FDA] have refused to provide us with witnesses or documents to support our position . . .The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous." The FDA has repeatedly made claims on its website and in recommendations to the Drug Enforcement Administration("DEA")to schedule kratom's constituents as Schedule I substances.The first rejection was issued by the DEA on October 13,2016"with a finding thatthe evidence and data was insufficientto justify scheduling. Then,on August 16,2018,the Assistant Secretary of Health at the US Department of Health and Human Services issued a scathing withdrawal letter on the FDA's second attemptto schedule kratom'sconstituents underthe CSA."'When confronted by former FDA Commissioner Scott Gottlieb on the decision. Dr. Giroir called the FDA recommendation"embarrassingly poor evidence and data"."' Finally,the FDA took its crusade to ban kratom to the international stage where the standards of scheduling are less rigorous than underthe federal CSA.On December 21-,2021,the WHO's Expert Committee on Drug Dependence unanimously concluded there was"insufficient evidence"to justify international scheduling of kratom and refused to even authorize a critical review. r- 3:,3 -rt0179-TWR�Ied Pa0e ID 1032 Exhibit 6;United Stat. ofAmenca,Plaintiff, . Nine2Five-ILC Scbosti,,: GW11ery(2),Defendants nttL /W4 rederalregeae:_yov,decumentJ201o '0/13/2G16-£a65`/waithorawa.-ofnot;�e-cfintent-to-ten;poiantyp!a• mltragyn.ne d•7-hydic.tymdrugyninc•into iutp�//sta+icl :quaiespacr- cr••n/s;and54d50ceee4b0579%634869c;/L',0145eah6df5° 7,?!a7cfrl/1a'1^47e9369S/dhillon8lr 2018•rs=n^^,e•lefret-froin•a;_h•,uim cgou pdf .aps /mw,i com/DrGiroar/ctatus'13958741143726 102533 `F Pp q Comm on Gr.:q Depen dance Summary of Assessmaris,Findiny nd Re-_onmendations of the 4=;th ECDP 12021 j,av,ui.olc =d http /cdn why .it —dia/riots!defauh.,oV r_e!convoll^d-s�•bstanrr•-'44eCdd_Jnsy_anr pdf 12.05.2023 Kratorn Science Update: Evidence-Based Annual Update December Jack Henningfield, PhD,-` Marilyn Huestis, PhD.-' Oliver Grundmann, PhD,3 Albert Garcia-Rorneu, PhD' 'Jack Henningfield,PhD Kratom science increased almost exponentially over the past Vice President.Research,Health decade with more than 450 new scientific publications Policy and Abuse Liability,Pinney Associates,Adjunct Professor, addressing kratom safety, benefits, and abuse potential since Behavioral Biology,Dept of Psychiatry and Behavioral Science, early 2018, and more than 100 since the 2022 Kratom Science The Johns Hopkins University School of Medicine Update was developed. The science provides evidence to guide consumer safety leading to kratom regulations now passed into law in eleven states,with many more states considering such laws.As discussed below,these new scientific findings also led the United States Department of Health and Human Services(US DHHS)to z Marilyn Huestis,PhD reverse its position on Controlled Substances Act(CSA)scheduling and, in August 2018,to rescind its earlier scheduling recommendation to the Drug Enforcement Science and Policy Advisor,Clinical Administration(DEA)•Pharmacology and Toxicology, Cannabinoid and Other CNS-Active Pharmacotherapies,Senior Fellow, More recently in 2021,the World Health Organization Expert Committee on Drug Institute on Emerging Health Professions,Thomas Jefferson Dependence(WHO ECDD),thoroughly reviewed all the evidence for international University,Honorary Professor, scheduling including written and oral statements from scientists around the world. and the London School of Medicineine and Dentistry,Queen Mary The WHO ECDD concluded there was insufficient evidence to recommend University of London,President, Huestis&Smith Toxicology,LLC scheduling kratom,meaning the available data did not show public health risks of kratom warranting international restrictions. What is clearly needed Is balanced regulation to ensure that kratom products purchased by consumers are pure and unadulterated, meeting the same types of standards applied to other food products, 3Oliver Grundmann,PhD and even bottled water.Steps toward such standards were taken in states that passed their own versions of kratom consumer protection act Clinical Professor of Medicinal laws. Ultimately,the Food and Drug Administration( Chemistry,University of Florida g Adminitrti (FDA)needs to College of Pharmacy,President- develop national performance standards for kratom as it does for other Elect,American College of Clinical Pharmacology products.Such standards will help ensure access to kratom products that are appropriately marketed and are without contaminants and adulterants that might pose safety risks. This Is the first annual update of the October 2022 Kratom Science Update.Many new studies related to kratom safety,the effects of its Albert Garcia-Romeu,PhD naturally occurring constituents,and the benefits reported by kratom Associate Professor,Psychiatry and consumers provide the basis for this 2023 update.The recent findings Behavioral Sciences,The Johns may also support implementation of regulatory efforts that were passed Hopkins University School of Medicine,Guest Researcherr,, into law in many states.Updates are provided at the end of each National Institute on Drug Abuse subsection. Intramural Neuroimaging Research Branch r Kratom12/5112023 • Specific regulatory and policy approaches V supported by new evidence. The Food and Drug Administration(FDA) request to schedule kratom(specifically, mitragynine and 7- hydroxymitragynine) In Schedule I of the Controlled Substances Act(CSA),was reversed by the lead Department of Health and Human Services(DHHS)official charged with Controlled Substances Act recommendations to the DEA, namely,the Assistant Secretary of Health,Dr. Brett Giroir. Dr.Giroir requested a review of the evidence pertaining to kratom scheduling and safety, and concluded In August 2018,that the evidence did not support Schedule I placement.See a summary of the findings of the review In Dr. Girolr's formal 2018 scheduling rescission letter to the DEA at: httu :flslallcl_s quares ace.comistaticf54d50ceee4b05797b34869cfft/60145eab6df59e7e36a7cfcll16119476936 k9a WE 95Idhilton-8.16.2018-resggnse-letter-from ash- dm iroir_pff. As discussed in the scheduling rescission - in the FDAs • scheduling.To the contrary,surveys and other data (see annotated bibliography)were sufficient-to support the conclusion that many thousands of kratom consumers use kratorn as a path away from opliolds was banned from lic7t markets.This led to the public health concern that"[Scheouling would lead to] ... kratorn users switching to highly lethal • . •s..- risking thousands ofdeaths._'. Dr. Giroirother concerns includingplacing kratomand mitragynine in Schedule I would discourage pregnant women • others,from . about their kratom The conclusions of the Assistant Secretary of Health were Similarly,at the international level,the large evidence base was consistent with those of the National Institute on Drug Abuse reviewed in 2021 by the World Health Organization Expert (NIDA),which states on its Kratom Facts webpage that"While Committee on Drug Dependence(WHO ECDD)to determine if there are no uses for kratom approved by the FDA,people kratom met criteria for being placed on a critical review pathway report using kratom to manage drug withdrawal symptoms and for international scheduling.The WHO ECDD came to essentially cravings(especially related to opioid use),pain,fatigue and the same conclusions as the Assistant Secretary of Health and mental health problems. NIDA.After conducting a thorough pre-review and a public hearing with input from leading international experts,the ECDD NIDA supports and conducts research to evaluate potential reported to the United Nations Office of Drug Control that there medicinal uses for kratom and related chemical compounds." was insufficient evidence to recommend kratom for critical review NIDA substantially expanded its kratom research support but that it should be kept under surveillance.It also stated, since 2017 and this research portfolio is rapidly expanding the "(k)ratom is used for self-medication for a variety of disorders but evidence base for kratom regulation and possibly new kratom there is limited evidence of abuse liability in humans..." derived medicines in the years to come. Addressing overdose risks,the ECDD noted: "Although mitragynine has been Both the Assistant Secretary, and the WHO ECDD also acknowledge beneficial analytically confirmed in a number of uses to abstain from opioids.Without labeling this as'therapeutic use',the deaths, almost all involve use of other Assistant Secretary clearly acknowledges such use and the public health risks of substances, so the degree to which banning kratom.This nuanced recognition of benefits of use,along with risks of kratom use has been a contributory banning access to use by Assistant Secretary Giroir,was absent in the 2017 and early 2018 position of FDA,but was since recognized by the Secretary of Health factor to fatalities is unclear." Becerra in a letter to Senator Mike Lee and Congressman Mark Pocan on March 16,2022.1 l https://assets.website-files.com/61 eO7df3l2afed l3238eb7fl/6261 ab3O3b46bb88f2l b6d 1 a_HHS%2OKratom%2OResponse.pdf 12/5/2023 KratonnUpdate Regulatory update: Uniform national regulation of kratom is vital because kratom product vendors vary widely in their product stewardship,quality control,and packaging and marketing related information and claims.Product testing revealed that some products were adulterated with dangerous substances and/or with high concentrations of mitragynine and other kratom alkaloids.Since October 2022,4 additional states(West Virginia,Virginia, Florida,and Texas)enacted various laws to ensure continuation of legal kratom sales in their states,but with regulatory oversight laws generally referred to as the Kratom Consumer Protection Act(KCPA).This brings the total to 11 states that now have consumer protections in place.Several other states are considering similar regulatory frameworks. Although the KCPA provisions and standards vary somewhat 5905 sponsored by Congressman Mark Pocan(D-WI)and across states,most include the following requirements for all Congressman Jack Bergman(R-MI).The Federal Kratom products sold in the state:(a)registration of products and Consumer Protection Act will provide a regulatory framework for vendors,(b)labeling that discloses that products contain kratom much like the Congress did in 1994 when they passed the kratom as well as the name and contact information of the Dietary Supplement Health and Education Act(DSHEA). distributing vendors, (c)products must be tested to show they are not contaminated with heavy metals and toxins,that are Specifically,among other provisions requiring the FDA to publish consistent with the standards for food products such as standards for the manufacturing and marketing of kratom oatmeal,tea leaves and coffee,or adulterated with drugs or products,the Federal KCPA will(1)require full transparency of all boosted levels of mitragynine and 7-hydroxymitragynine taxpayer-funded scientific research conducted on kratom;(2) (70HMG);(d)health claims are not permitted;and(e)the require the FDA to add peer-reviewed published kratom research minimum age of purchase is either 18 or 21 years,depending articles to their kratom website;and(3)require transcripts of on the choice of the state. public hearings where independent scientific testimony on kratom is provided.These requirements will allow the public to see a Several more states are in various stages of consideration balanced perspective on current research on kratom related to its and action on similar proposed KCPA laws.Federal KCPA safety,benefits,and addiction liability profile. regulatory oversight has bipartisan support in the U.S. Congress with the filing of S.3039,sponsored by Senator Mike Lee(R-UT)and Senator Cory Booker(D-NJ),and H.R. What is the current state of kratom •. Kratom research effort update science and evidence? Kratom was studied for decades,primarily in Southeast The pace of kratom research and publication of peer-reviewed Asia(SEA),where kratom trees grow in abundance,but research remains rapid and continues to accelerate with research escalated substantially in the US and globally expanded funding from government agencies in the US and with support by NIDA,SEA countries,and philanthropies. internationally,as well as private sector efforts to support dietary New science over the past 5-10 years includes investigations supplement notifications and potential new drug applications on kratom/mitragynine chemistry and medicinal development, derived from kratom.Since,October 2022,more than 450 new neuropharmacology, brain imaging,preclinical and clinical studies were published through October 2023,most supported by studies,and surveys in the US and SEA.The rate of the National Institute on Drug Abuse(NIDA)and others from published kratom research continues to increase,along with Southeast Asia.These studies provide the basis for the"Science presentations and symposia at a wide spectrum of national Updates"noted at the end of each of the subsections in the and international scientific meetings,such as the Society for November 2023 Kratom Science Update. Neuroscience,College on Problems of Drug Dependence, The International Conference on the Science of Botanicals, The following summary and conclusions are based on peer- reviewed scientific publications,many conducted by international the International Association of Forensic Toxicologists and the Society of Forensic Toxicologists. leaders in kratom research and supported by NIDA.A bibliography with links to key articles is provided. 12/5/202,3 Kratom logo What is kratom? logo Kratom is a tree in the coffee family. Not surprisingly, its diverse effects include coffee-like alerting, stimulating,and mood enhancing effects,which are quite distinct from the effects of morphine-type oploids. It also has some opioid-like effects that Include pain relief,possible opioid withdrawal symptoms after chronic frequent use and unpleasant side effects like constipation,but without the potentially lethal respiratory depressing or highly addictive brain rewarding effects that are driving the opioid epidemic. Is kratom an opioid? Animal and human studies,as well as neuropharmacology mechanisms of action studies,show that kratom does not carry While some naturally occurring substances in kratom act on the substantial opioid-like risks of deadly respiratory depression opioid receptors,kratom is not a prototypical opioid based or powerfully addictive euphoria.A misunderstanding of one of on its chemical structure,botanical origins,or law— kratom's self-reported beneficial uses,recognized by researchers nationally or internationally.Like many natural products it has and NIDA,providing relief of opioid withdrawal, is sometimes diverse effects and mechanisms of action that contribute to interpreted as evidence that it must be an opioid. In fact,the these effects and the reasons people use kratom.Some nonopioid adrenergic blocking drugs developed for treating high kratom constituents bind to opioid receptors and relieve pain blood pressure,clonidine and lofexidine,were prescribed for whereas others do not. Unlike opioids which sedate and can decades to treat opioid withdrawal. FDA approved lofexidine impair mental functioning,kratom is used by many people in (Lucemyra)for treating opioid withdrawal in 2018. Mitragynine, place of coffee for its alerting,mental focusing,and currently considered kratom's primary active compound, and occupational performance enhancing effects. other kratom constituents also produce adrenergic and other effects that might contribute to relief of withdrawal symptoms in people dependent on opioids,alcohol and stimulants. Who uses kratom and why? According to surveys in the US,most consumers are White adults,aged 35-55,with jobs and health care insurance,who report that their consumption is primarily for health and well-being.This includes consumption as an alternative to caffeinated products for alertness and increased focus,for the self-management of pain,and to improve mood.Many consumers state that kratom worked better for them,had fewer side-effects than the FDA-approved medicines they had taken,and/or that they preferred natural products.A smaller but important fraction of consumers are people who consider kratom as a"lifeline"or a path away from opioids. They use kratom to manage opioid withdrawal and reduce or eliminate opioid use. Update.Continuing surveillance and studies monitoring Update:Kratom addiction related research findings. individual kratom consumers confirm the 2022 Update The percentage of people who reported becoming"addicted to findings summarized above. However, new research kratom"is small based on early studies and new research; provides additional insights into the reasons for use and however,there is currently no objective basis for estimating this effects of use that are important to consider in regulatory percentage in the US.Estimates of the fraction of kratom efforts.In brief,users primarily report use for a broad consumers who report addiction are confounded by many factors range of perceived benefits including energy and including the following: productivity,as well as to self-manage withdrawal and addiction to stimulants,alcohol and other substances in Many people equate'withdrawal symptoms"with addiction or a addition to opioids that have been the primary focus of substance use disorder and apparently are not aware that the earlier studies.Studies from NIDA by Dr.Kirsten Smith American Psychiatric Association,FDA,NIDA,and the World and colleagues found that whereas the motivations of Health Organization acknowledge that withdrawal can occur with many kratom consumers to initiate use were to address many substances that are not ordinarily considered addicting,and specific health concerns,many continue to use for that withdrawal alone is not the basis for a substance use disorder additional reasons such as increasing energy and or"addiction"diagnosis,as discussed in reports from these productivity,relaxation,and mood. organizations in the bibliography, 12/5,12023 Kratom Science Update C, Some people with prior addictions to opioids,stimulants,and in frequent multiple-times per day consumers,many such people alcohol used kratom to achieve abstinence from those do not report experiencing withdrawal upon discontinuation of substances and continue to use kratom,reporting addiction kratom. and difficulty discontinuing,in some cases in fear of returning to the far more deadly addictions that kratom helped them People with chronic opioid use histories report that kratom escape.Such use might be more appropriately considered provides relief of opioid withdrawal.As was discussed,alleviation "harm reduction"or therapeutic use,much as is maintenance of opioid withdrawal may be due to some of kratom's effects that of use of medicines such as antidepressants and approved are not mediated by opioid receptors but also by effects that are addiction treatment medicines,such as buprenorphine and similar to those of medicines used to treat high blood pressure naltrexone,maintained long term to reduce the risk of relapse including one that is FDA approved for treating opioid withdrawal to the more deadly substances; —lofexidine.These results are consistent with human reports that kratom may be therapeutically useful for managing opioid Distinguishing between the mood enhancing effects of kratom withdrawal though FDA has not approved kratom for this or any reported as therapeutic or beneficial in surveys from other medical use.Clearly more research is needed to guide recreational users,and reasons that are not necessarily to consumer use and potentially support applications to FDA for address a specific disorder are not always clear.This is also acceptance and approval for such use. the case with respect to reported kratom use to"improve sexual health" and as part of exercise regimens; What led to increased kratom use in the United States? `.1 Finally,the factors that contribute to a diagnosis of a Although kratom was taken as a natural traditional medicine in "substance use disorder" include personally and socially destructive aspects,and indicators of regular and compulsive SEA for centuries,its use in the US was largely limited to Asian use that are not necessarily a risk to personal health,violent immigrants from the early 1970s through the 1990s. In the early crime,society,or the US drug overdose epidemic. 2000s,with a rising general interest in natural products as alternatives to conventional medicines and growing public access to information via the Internet,kratom use began to increase. Reasons for use appear generally similar from the US to SEA,as Withdrawal update As discussed above,the potential for an alternative to coffee and tea for its alerting and mild stimulant Kral to produce withdrawal , the relevance of withdrawal effects,to improve mood and relieve pain,and to manage in kratorn use,safety and addiction are widely misundersiood. withdrawal and help people to reduce or discontinue use of To address Onis,a virtual • �,y opioids,alcohol and other addictive substances.Many survey conference was convened in late 2022 and the results �! respondents report that kratom was either more effective,carried rXiblished in a leading • - fewer side effects of concern such as the sedating effects of addiction-relatedspecializing in opioid pain relievers,and/or that they prefer natural products over Dependence Reports isee . . conventional medicine.Estimates of the present market vary available by Open Access and provides details of rhe widely. By 2014,there were an estimated 3-5 million kratom conclusions - consumers,and marketing and SEA export estimates suggest included,Anin'lai Studies confirm that chronic daily high that the present market is 15 million or more in the US.One mitragynine dosing can produce a level of dependence such federal survey estimated between 2-3 million kratom consumers, followedthat abrupt discontinuation is which might reflect its panel of respondents.The federal survey is However,the severity and duration of designed to track substance abuse and might underrepresent shorterweaker and produced by morphine,and the middle aged and older people with lower rates of recreational those.are not identical to . •duced by morphine-like opl'oids. substance use who might use kratom for other reasons. Ivitragynine alone and kra�oni tea preparations appeared effel in preventing and rellevIng opicil withdrawal with Does kratom contain dangerous substances? comparable efficacy to buiprenorphine,an FIDA-approved Like its botanical cousin coffee,kratom contains many medication •.. substances referred to as alkaloids,which tend to be somewhat alkaline and bitter in flavor.More than 40 alkaloids are identified in kratom to date,with most having little or no known pharmacological effect,or occurring at such low levels as to be of Surveys and clinical studies confirm that kratom withdrawal little cause for harm or benefit. However, as is the case with other can occur in some kratom consumers but is generally milder natural products,the naturally occurring mixture of substances as compared to opioid and other drug withdrawal syndromes likely contributes to the overall effects and natural variations in and generally self-manageable.Most kratom consumers do alkaloid composition may lead to varying pharmacological effects. not experience withdrawal and although it is more likely 12/5/2023 KratomUpdate The main ingredient currently thought to account for most In the absence of kratom regulation,some kratom makers of the effects reported by kratom consumers is boosted 7OHMG content far higher than that found in the native mitragynine,which does not have strong rewarding and plant material,and this is a potential safety concern.States addictive effects,nor respiratory depressant effects like passing kratom consumer protection act laws ensure that legally opioids and conventional stimulants. marketed kratom does not contain boosted mitragynine or The second most widely recognized substance is 7OHMG 7OHMG levels,contaminants,or other adulterants,thereby that has stronger opioid effects but occurs at levels that reducing public health risks.Additionally,dangerous substances are often nondetectable in fresh kratom leaves.However, like fentanyl and O-desmethyltramadol were found in adulterated 7OHMG is also a product of mitragynine metabolism and kratom products.Regulation is needed from FDA to ensure that its gradual elevation in the blood following oral all US consumers are protected from risky exposure to consumption may contribute to some of the effects of contaminated or adulterated products. kratom that are desired by consumers. Respiratory effects of kratom. It is well understood that kratom's respiratory effects are not like those of morphine-like opioids;however, research since 2018 support the conclusion that kratom Is not simply weaker than opioids with respect to respiratory depression.Specifically, mitragynine and other alkaloids in kratom act as partial agonists at oploid receptors,meaning that their maximal effects reach a ceiling beyond which higher doses produce little additional effect". This was demonstrated in several animal species(including cats,dogs,mice,and rats)with mitragynine doses increased to levels far beyond what is or can be consumed by even high intake chronic kratom consumers.The most recent study employed a sophisticated rodent model developed by FDA to compare a broad range of mitragynine doses to therapeutic and toxic oxycodone doses across blood gases and other parameters.Whereas oxycodone produced the signature dose-related plummeting blood oxygen levels and deaths,mitragynine produced no evidence of respiratory depression at any dose,and no life-threatening effects. Can you overdose on kratom? One of the most important guidelines to consider before naming Kratom acts as a partial p-opioid agonist that does not kratom or mitragynine as cause of death is to ensure that activate the p-arrestin 2 pathway involved in respiratory comprehensive toxicology testing is performed. In many cases depression.Thus,kratom is much less likely to contribute to in which kratom is found at the scene or in the decedent's overdose deaths than heroin,fentanyl,oxycodone or other home,and in some cases with mitragynine detected in a blood potent opioids.When mitragynine,the primary alkaloid in sample,investigators concluded it must have been involved in kratom,is identified in overdose cases,it is almost always the death. However, routine toxicology does not identify other found along with active central nervous system drugs with drugs that are increasingly known to cause overdose death, known lethal potential. Nevertheless,kratom consumers such as novel fentanyl related and other psychoactive should not assume that kratom is without risk,especially substances.Most laboratories do not include kratom or when combined with other drugs. mitragynine in their routine testing because of the lack of reports of kratom overdoses and deaths, necessitating The American Kratom Association recently published expensive analysis of autopsy specimens at reference guidelines on factors to consider prior to naming kratom or laboratories.Thus,only kratom testing is ordered and the mitragynine as cause of death.This was necessary because possible presence of other novel psychoactive substances is of the confusion following the FDA's announcement on not identified due to the additional cost that cannot be borne by February 6,2018,that kratom was seriously harmful,with an poorly resourced local and state forensic laboratories. opioid-like death risk.The FDA listed 44 deaths occurring in kratom consumers,but only 1 did not include other Centers for Disease Control scientists(2019)analyzed data respiratory depressing substances or other conditions that from the State Unintentional Drug Overdose Reporting System likely contributed to the deaths. For example,further (SUDORS)from 27 states over 18 months finding 152 or 0.56% investigation determined that the one kratom only case was of 27,338 overdose deaths mentioning kratom in their a motor vehicle fatality. postmortem toxicology reports. 12/5112023 Kratom Science Update However, kratom was listed as cause of death in 91 or 59.9% mitragynine exposures which varied widely from very low to very of these cases,despite only 7 or 4.6%having kratom only high levels. identified by toxicology.The authors stress that the presence of other drugs cannot be ruled out as contributing to cause of Recently,Papsun(2023)reviewed more than 5400 blood death.Eighty percent of decedents had a history of substance mitragynine postmortem kratom cases tested at NMS Labs over misuse.In cases when kratom was identified,65.1%of the last five years.Kratom identification in postmortem cases was ° 1.67-1.88%over the last 5 years.Mean and median blood fatalities also included fentanyl, 32.9/o heroin, benzodiazepines 29.4%,prescription opioids 19.7%and mitragynine concentrations were 360 and 120 ng/mL, ° respectively,with a range of 5.4-11,000 ng/mL Most cases cocaine 18.4/°. identified the presence of other drugs including fentanyl in 62%, Gershman(2019)recently investigated 15 kratom-related methamphetamine 19%,cocaine 10%and others in 2022 cases. deaths over 18 years and found 11 were multidrug deaths The authors concluded that"blood mitragynine concentrations of including opioids,and four were kratom only deaths and >1000 ng/mL are more often associated with severe adverse attributed by the coroners to kratom toxicity.Blood was events,up to and including death."However,there was no available for comprehensive toxicology testing in 3 cases and conclusion as to what dose of kratom or mitragynine alone might additional toxic drugs were identified in all of these cases.The be considered"lethal"or to carry a high risk of mortality.Although last case had no blood available for additional testing. kratom related deaths are low when compared to its widespread Mitragynine concentrations ranged from 16 to 4800 ng/mL. use,consumers should be aware of the potential dangers of Some of the kratom associated death cases did not test for combining multiple prescribed and recreational drugs with ' kratom but based the decision on crime scene investigation kratom. only,others had only a positive qualitative result confirming For •stances, including those • • more /1 000 annual drug overdose deathsin recent years, the lethal •• • .•ly well established in animals as the LD50 and typical pathological lethal effects, e.g., respiratory depression for opioids and sedatives, and cardiovascular events for stimulants, are well known For other substances such as caffeine,and marijuana's tetrahydrocannabinol (THC) and cannabidiol(CBD), deaths attributable to acute overdose are rare and the lethal dose is not established. A recent study compared the respiratory effects of up to 400 Although the lethal dose in humans remains unknown, mg/kg oral mitragynine to up to 150 mg/kg oral oxycodone in consumers should not take excessive kratom doses,should not rats according to the study design published by FDA. consume kratom with other CNS-active drugs and should Oxycodone significantly depressed oxygen saturation and consider their personal medical conditions. sedated the animals with two deaths at the higher doses. Regulation with balanced evidence-based warnings is in the Mitragynine did not significantly depress respiration or interest of personal and public health to minimize the risks of produce life-threatening effects,even at these exceedingly kratom without falsely equating it with"narcotics"or"opioids"and high doses.Thus,the LD50 was not able to be established thereby discouraging its contribution to harm reduction. for kratom. IIs kratom fueling the opioid overdose epidemic? The US has the world's most It also includes the Drug Abuse Warning Network(DAWN),which reported sophisticated and multi-pronged a variety of potential signals of emerging substance threats while kratom substance abuse and product safety use was rapidly increasing from the 1990s through pre-2012 reports,as monitoring network including the well as the"new"DAWN system that reported on 2021 data in its 2022 National Survey on Drug Use and report.None of these systems, nor more than 20,000 comments to the Health (NSDUH), Monitoring the Future DEQ,suggested that kratom contributed to the opioid epidemic. (MTF), Treatment Episodes Data Set, Kratom was also never listed in DEA's annual National Drug Threat and the DEA's National Forensic Assessment,though DE4 routinely monitors kratom as a"chemical of Laboratory Information System (NFLIS). concern."Despite over 10 years of monitoring,DEA has not listed kratom or mitragynine or 7OHMG as a national drug threat. Kratom12/5/12023 ••. Key scientific findings in the past five years: Multiple state of the art animal studies found that kratom This is consistent with human reports that kratom has low abuse potential.For example, mitragynine consumption helps to manage opioid withdrawal and produces weak rewarding effects as compared to reduce opioid craving. morphine and heroin.The authors of this fact sheet urge that as a precaution,consumers should monitor their Similarly,an intracranial brain self-stimulation study kratom consumption to reduce the risk of dependence suggested low rewarding effects of kratom alkaloids as development. compared to drugs of abuse. Surreys indicate that some people can become Several national internet surveys found that kratom use was dependent upon kratom;however, many of these people helpful in managing opioid withdrawal, reducing opioid were using kratom to abstain from opioids and/or other cravings,and achieving abstinence from opioids. substances.Disentangling prior substance use disorders from kratom use is not always clear.Most people who None of the national surveys relied upon by the FDA, report kratom dependence or withdrawal state that it is Centers for Disease Control(CDC),NIDA,and DEA to more readily self-manageable than dependence and determine if a substance poses an abuse-related threat to withdrawal from opioids and other drugs of abuse. public health suggested that kratom poses a known or imminent risk to public health.Consistent with this,the DEA Mitragynine treatment results in reduced opioid(e.g., never listed kratom as a threat to public health in its annual morphine and heroin)drug seeking and self- National Drug Threat Assessment reports.14 administration in animal models assessing the potential effectiveness of drug use disorder reduction and Safety studies in several animal species demonstrated that cessation.These findings are consistent with human even at extraordinarily high doses,mitragynine and kratom reports that kratom consumption reduces their opioid produced little evidence of respiratory depression or life- cravings and served as a path away from opioids. threatening effects in contrast to opioids such as morphine and oxycodone which produced substantial dose related In animals made physically dependent on morphine, decreases in respiration. kratom pretreatment reduced morphine withdrawal symptoms in several models for evaluating efficacy in the treatment of withdrawal. 2023 UPDATES: How kratom works,that is, its mechanisms of action, is Whereas 2%is the performance standard used presently in amongst the most active areas of research in the US and some states,it would seem ideal for FDA to develop an globally with new studies published in journals or evidence-based standard that might be somewhat higher or presented at scientific meetings seemingly every month. lower,and with guidance for accepted testing methods. Much of this progress is summarized in original research and review articles listed in the bibliography.A few key Whereas mitragynine is the primary or sole alkaloid present findings are included below. 0 in many marketed kratom products,it increasingly appears likely that a variety of other naturally occurring alkaloids Whereas 7OHMG is often discussed as a potentially contribute to the effects ascribed to kratom. dangerous kratom constituent,studies indicate that it is present at very low and often not detectable levels in fresh kratom leaf material.Thus,it is better thought of as 0 Although kratom use persists in the US with several million a mitragynine metabolite that gradually emerges in the consumers estimated,clear signals of substantial public bloodstream,likely contributing to some of the effects of health risk remain lacking,while the preponderance of kratom.Products that contain artificially high levels of evidence suggests that use of naturally derived kratom 7OHMG(e.g.,higher than 2%of the total alkaloid products is more typically associated with perceived health content)have likely been"spiked"with added 7OHMG. benefits. Regulatory oversight should prohibit such products. 12/5/2023 KratomUpdate GENERAL CONCLUSION: � The rapid progress in understanding the risks and benefits of kratom and its potential for therapeutic use and public health benefits over the past decade is a tribute to visionary funding from NIH and other organizations in the US and globally, as well as the dedication and care of hundreds of researchers worldwide. There clearly seems to be adequate scientific evidence to not only justify why regulation is warranted but also to guide regulatory efforts. For any regulation of food, dietary ingredients and pharmaceuticals, regulations need to be considered as an evolutionary process guided by emerging scientific evidence including laboratory and clinical studies, as well as real world surveillance to understand trends, patterns and emerging risks and benefits to health and well- being. Thus, the conclusion that more research is warranted should not be used as an excuse to delay regulatory implementation but rather a vital part of relevant and effective regulatory implementation and evolution. Through Pinney Associates, Drs. Henningfield and Huestis provide scientific and regulatory advising on new medicines, dietary supplements, cannabinoids, and tobacco/nicotine products for FDA regulation. This paid work includes leading the development and drafting of this kratom science facts summary for the American Kratom Association. Dr. Grundmann is a member of the advisory board of the Kratom Vendors Association and received an honorarium from the American Kratom Foundation for participation:in a scientific discussion forum about kratom dependence. Dr. Garcia-Romeo is a paid scientific advisor to ETHA Natural Botanicals and received a speaking honorarium from the American Kratom Foundation. 12/5/2023 Kratom Science Update 9 Annotated Bibliography Expert evaluations of kratom policy and regulation and Note: risks&public health United Nations Commission on Narcotic Drugs,WHO Expert Committee on Drug Dependence ncmmaryoltheWHatomco Cudingthattheee on Drug Dependence pre-review of kratom concluding that the Dependence(2021). evidence does not support initiation ofa fun review of Implementation of the international drug control treaties:changes in the scope of kratom for international drug scheduling considering its effects,safety,abuse related-risks and public health control of substances Summary of assessments,findings and recommendations of the factors 44th World Health Organization's(WHO)Expert Committee on Drug Dependence (ECDD),11-15 October 2021:Kratom,mitragynine,7-hydroxymitragynine. '\ htips.'Il w ,unodc.oVdocumenfs/wmmissions/CND/CND Sessions/CND_64ReconvenediECN72021_C �C RP12 V2108992 pdf. Assistant Secretary of Health Dr. Brett P. Giroir,Admiral This formal DHHSscheduling rescission letter (August 16,2018). summarizes review ofthe evidence for FDA's 2017 recommendation to schedule kratom and concluded that Letter from the Assistant Secretary of Health to the Administrator of the Drug FDA did not provide sufAcient evidence to support scheduling,and also failed to consider the adverse public Enforcement Administration to rescind previous support to permanently place health consequences of Scheduling and thereby banning mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled legal consumer access to kratom Substances Act 2018 -\ Available from:https://rmages go02.informamarkels comlWebrink-02PI,7b548e6d56-2ea44da4-9404- R 0348b56e9a88%7a dhilbn-8.16.2018-response-latter-6omashtadmyrroir.pol Gershman K,Timm K, Frank M, Lampi L,Melamed J, An important investigation of autopsy reports listing kratom Gerona R, Monte AA. only as cause of death and the importance of comprehensive toxicology to identify the presence of other Deaths in Colorado Attributed to Kratom. toxic drugs contributing to the death The range of N Engf J Med.2019 Jan 3:380(1):97-98. mdfagynine concentrations in kratom-related deaths includes low levels far below those reported in controlled kratom administration studies. Henningfield JE,Rodricks JV, Magnuson AM, Huestis MA. An exceedingly high dose of400mg7kg oral mitragynine did not significantly depress respiration or produce fife- Respiratory effects of oral mitragynine and oxycodone in a rodent model. threatening effects in rats.The LD50 was not established for kratom However,60 and 150 mg/kg oral oxycodone Psychopha—amlogy 2022 D-:239(12)3793-3804 significantly depressed oxygen saturation and sedated the animals resulting in two deaths 0 Olsen EO,O'Donnell J, Mattson CL,SchierJG,Wilson N. Center far Disease scientists analyzed data from the State Unintentional Drug Overdose Reporting System finding Notes from the Field:Unintentional Drug Overdose Deaths with Kratom Detected- that although kratom identifications In postmortem autopsy 27 States,July 2016-December 2017. cases only represented 0.56%of overdoses,d was reported as cause of death(kratom-involved)in 59.9%of MMWR Morb Modal Wkly Rep 2019 Apr 12;68(14):326-327 cases Potent opioids were also identified in these kratom cases,65.1%fentanyl,32.9%heroin and 19.7% prescription opiolds Afterrm iewing rrvfragynine mncentrahwis 61 more then 5400 blood Papsun D, Schroeder W, Brower J, Logan B. posfmx),farnkrswm cam over&aMWNveyean,,m„ragyninawas identified m 1.67-1.88%canes.with a wide range of concentrerions Forensic Implications of Kratom:Kratom Toxicity,Correlation with Mitragynine (5.4-11,000ngrmi.)Most cases idermoed the presence ofoffw drugs Concentrations,and Polypharmacy. includerg kr4enyl in 62%.mefhemphetamfne 1904.cocaine 10%and others The authors mnrJudad that'good mihagymne cawenfrations Curd Addict Rep 10,272-281(2023). of>1000 ng7mL are more often assoatafed with severe adverse evenfs. up to and including death-Although kratom related deaths are low when compared to its widespread use,cod m rs should be aware of the potential dangers of combining mwlrpfe prescribed and recreational drugs with kratom Kratom12/5/2023 • Prozialeck,W.,Avery, B., Boyer, E.,Grundmann,O., Note: Henningfield,J., Krueger A., McMahon, L., McCurdy, C., Leading krafom researchers discuss policy implications of Swogger,M.,Veltri,C., and Singh,D.(2019). state-of-the-art knowledge related tokratom'seffects, Kratom Policy:The challenge of balancing therapeutic potential with public safety. uses,risks,and real-world public health benefits and risks �j International Journal of Drug Policy.70:70-77. 0 Grundmann O,Garcia-Romeu A, McCurdy CR, Sharma A, This article addresses the fact that some manufactured Smith KE,Swogger MT,Weiss ST(2023). extracts have high concentrations of mftragynine and other substances and do not include labeling that Not all kratom is equal:The important distinction between native leaf and describes the concentrations,total content,or recommended serving sizes and the need for national extract products, regulation of such Addiction.2023 Oct 9.doi:10 1111/add.16366.Epub ahead of pdnt.PMID:3781"05 0 Swogger MT,Smith KE,Garcia-Romeu A, Grundmann O, AlMough there amno FDA approved uses for kratom, Veltri CA, Henningfield J, Busch LY(2022) which is the case for most dietary supplements,this expert opinion article provides practical information for Understanding kratom use:a guide for healthcare providers. consideration by health care professionals whose patients are consuming kratom Front Pharmacol 13 801855. Henningfield JE,Grundmann O, Babin JK, Fant RV,Wang This article compared estimates from FDA of deaths DW,Cone EJ(2019) associated with kratom consumption in comparison with deaths associated with nonmedical opioid use concluding Risk of death associated with kratom use compared to opioids. that the risk of death associated with kratom use is at least 1,000 times less than for opioids. Prev Med.128:105851 Henningfield JE,Wang DW, Huestis MA(2022) This article is a published version of an assessment of kratom abuse potential according to the 8-factor analysis Kratom abuse potential 2021:an updated eight factor analysis. required for permanent scheduling by the Controlled Substances Act It concludes that on the basis of all Front Phamacoi 12.775073. factors,including decades of surveillance in the US,and decades more globally,kratom does not warrant scheduling and,st fad,that scheduling kratom would carry adverse public health consequences This is consistent with the position of the WHO Expert Committee on Drug Dependence and the DHHS review led by Assistant Secretary Gimir. Kratorn reasonsfor use surveys Whereas there are several surveys that provide estimates of how many people use kratom with estimates ranging from about 2 to more than 15 million,those surveys provide no information about why people use kratom,or the consequence of their kratom use(See Henningfield JE,Grundm n O, Garcia-Romeu A, Swogger MT.We Need Better Estimates of Kratom Use Prevalence.Am J Prev Med. 201;62(1):132-133). The following surveys are focused Specifically,these surveys show that although there is some on why people use kratom and recreational use of kratom, most people use for reasons provide insights as to the risks and related to health and well-being including as approaches to benefits of kratonsumption. self-manage opioid and other drug withdrawal and to reduce 7 and discontinue opioid and other addictive drug use. 12/5/2023 Krato d2te Coe MA, Pillitteri JL,Sembower MA, Garcia-Romeu A, Cox DJ,Smith KE, Dunn Gerlach KK, Henningfield JE. KE, Griffiths RR. Kratom as a substitute for opioids:Results from an online survey. Kratom(Mitragyna speciosa):User demographics,use patterns, Drug Alcohol Depend.2019;202:24-32. and implications for the opioid epidemic. Drug Alcohol Depend.2020;208:107849. Grundmann O. 0 Smith KE, Rogers JM, Dunn KE,et al. Patterns of Kratom use and health impact in the US-Results from Searching for a Signal:Self-Reported Kratom Dose-Effect an online survey. Relationships Among a Sample of US Adults With Regular Kratom Drug Alcohol Depend 2017;176:63-70. Use Histories. Front Pharmacol.2022;13;765917. Smith KE, Rogers JM,Schriefer D, 0 Swogger MT,Walsh Z. Grundmann O. Kratom use and mental health:A systematic review. Therapeutic benefit with caveats?:Analyzing social media data to Drug Alcohol Depend.2018;183:134-40. understand the complexities of kratom use. Drug Alcohol Depend.2021;226:108879 Exploring the self-reported motivations of 0 Oliver Grundmann 1 2,Charles A Veltri 2, kratom( Mitragyna speciosa Korth.) use: a Diana Morcos 2, David Knightes 3rd 2, Kirsten cross-sectional investigation E Smith 3, Darshan Singh 4,Ornella Corazza 5, Eduardo Cinosi 5 6,Giovanni Martinotti 5 7, Grundmann et al.2022 Zach Walsh 8, Marc T Swogger 9Smith et al., (PMID: 35389321) 2023; and a few in 2022 (Feldman et al.,2023; Smith et al.,2023 • • • - • • - • • Behnood-Rod A,Chellian R, Wilson R, Hiranita T, Sharma A, Leon F,et al. • . - • • • • • _• • • Evaluation of the rewarding effects of • _ ••- • -• • - • • mitragynine and 7-hydroxymitragynine in an intracranial self-stimulation procedure in male and female rats. -• '•• - • _ • •• • • Drug Alcohol Depend.2020;215:108235. • - _ • - • "•• �' Hassan R, Pike See C, • • •-•• - Sreenivasan S, Mansor SM, . . Muller CP, Hassan Z. Mitragynine attenuates morphine withdrawal effects in rats-a comparison with methadone and buprenorphine. Mn Front Psychiatry.2020;11:411 Hemby SE,McIntosh S, Leon F,Cutler SJ, Yue K, Kopajtic TA, Katz JL. McCurdy CR. Abuse liability and therapeutic potential of the Mitragyna speciosa Abuse liability of mitragynine assessed with a self-administration (kratom)alkaloids mitragynine and 7-hydroxymitragynine. procedure in rats. e Addict Biol.2019;24(5):874-85 Psychopharmacology(Bert).2018;235(10):2823-9 Wilson LL,Harris HM, Eans SO, Brice-Tuff AC, Cirino TJ,Stacy HM,et a[ Lyophillzed kratom tea as a therapeutic option for opioid dependence. M Drug Alcohol Depend.2020;216:108310. Kratorn pharmacology studies help understand its effects that contribute toreasonsfor • safety Note:The following studies are representative of several dozen other studies published since 2018 that help understand the effects,and potential benefits and risks of kratom's constituents including mitragynine. At kratom doses far higher than those consumed by humans,respiratory depressant effects are substantially lower than opioids.This does not mean that kratom does not carry risks but rather that its overall risks appear much lower than those associated with opioids.Balanced regulation could help consumers minimize the risks of kratom use by banning medical claims,providing accurate labeling and warning labels,as is being implemented in states that passed kratom consumer protection act laws. Avery BA, Boddu SP, Sharma A, Furr EB, Chakraborty S, D[Berto JF, Faouzi A, Leon F,Cutler SJ,et al. Bernhard SM,Gutridge AM, Ramsey S,et al. Comparative pharmacokinetics of mitragynine after oral A novel mitragynine analog with low-efficacy mu opioid receptor administration of Mitragyna speciosa(kratom)leaf extracts in rats. agonism displays antinociception with attenuated adverse effects. M Plante Med.2019;85(4):340-6. J Med Chem 2021;64(18):13873-92 Hill R, Kruegel AC,Javitch JA, Lane JR, Kruegel AC, Grundmann O. Canals M. The medicinal chemistry and neuropharmacology of kratom:A (2022)The respiratory depressant effects of mitragynine are preliminary discussion of a promising medicinal plant and analysis limited by its conversion to 7-011 mitragynine. of its potential for abuse. SrJPharmacol 179(14):3875-3885 Q Neuropharmacology.2018;134(PtA):108-20. Macko E,Weisbach JA, Douglas B 0 Maxwell EA, King TI, Kamble SH, Raju KSR, Berthold EC, Leon F,et al. (1972)Some observations on the pharma logy of mitragynine[in Pharmacokinetics and safety of mitragynine in beagle dogs. cats,dogs and monkeys). T --, Ar0 WP&VM&0D ff The,198(1):145. _ Plante Med.2020;86(17):1278-85. 1 12/5/202.3 KratomUpdate 1 NIDA. Obeng S, Kamble SH,Reeves ME,Restrepo LF, Patel A, Behnke M,Chear NJ, 2022,March 25.Kratom.Retrieved from Ramanathan S,Sharma A, Leon F, Hiranita T,Avery BA, McMahon LR, McCurdy CR. https://nida.nih.gov/research-fopics/krafom on December 5,2023 Investigation of the Adrenergic and Opioid Binding Affinities, Metabolic Stability,Plasma Protein Binding Properties,and Functional Effects of Selected Indole-Based Kratom Alkaloids. J Mod Chem.2020 Jan 9:63(1):433439. Obeng S,Wilkerson JL, Leon F, Reeves ME, Sharma A, McCurdy CR. + Restrepo LF,Gamez-Jimenez LR,et al. Pharmacological comparison of mitragynine and 7- Assessing the therapeutic potential and toxicity of Mitragyna hydroxymitragynine: In vitro affinity and efficacy for mu-opioid speciosa in opioid use disorder. receptor and opioid-like behavioral effects in rats. Expert Opin Drug Metab Toxicol.2021;17(3):255-7. J Pharmacol Exp The,.2021:376(3):410-27. Vicknasingam B,Chooi WT, Rahim AA, Chakraborty S, DiBerto JF,Faouzi A, Ramachandram D,Singh D, Ramanathan S,et al. Bernhard,SM,Guttridge,AM, Kratom and pain tolerance:A randomized,placebo-controlled, Ramsey, S et al. double-blind study. .(2021).A Novel Mitragynine Analog with Low-Efficacy Mu Yale J Biol Mod 2020;93(2):229-38. Opioid Receptor Agonism Displays Antinociception with Attenuated Adverse Effects. J Med Chem.2021;64(18):13873-13892. McCurdy C,Grundmann O, McLaughlin J(2020)Kratom Resources.Department of Pharmacodynamics.College of Pharmacy,University of Florida. https//pd.pharmacy.u8.edu/n:search/kratom/Accessed 8 March 2022. Note: this is a living and evolving repository of factual scientific information that may be useful to policy makers,regulators,consumers, and other researchers. It is an example of what would ideally be provided by NIH and FDA. 1 AMM - � . • r Neither the US Food Drug and Cosmetic Act, nor the US CSA or the international drug control treaties define"therapeutic use" as being approved as drugs by FDA or the equivalent regulatory agencies in other countries. However that has become the de facto standard of the FDA, which therefore ignores self-reported beneficial use by dietary supplement consumers and states that they have no recognized therapeutic use, and thus, widespread use of kratom to stay off opioids was ignored as a benefit. The authors of this science update and the American Kratom Association agree that specific health claims should not be made by kratom marketers without supporting evidence, but neither should policy makers simply dismiss the benefits of kratom and the risks of removing licit kratom by millions of kratom consumers. Contributing to the misunderstanding that kratom carries opioid-like risks of overdose and addiction is a misunderstanding of potency and strength. Strength refers to the maximum effect that a substance can produce, whereas potency refers to how much of the substance it takes to produce a given effect.Thus, alcohol is strong and actually results in approximately 2,000 overdose deaths annually in the US, however, it is relatively low in potency among central nervous system active substances and requires the equivalent rapid consumption of a quart or more of high percentage (proof)alcohol to produce death, though for young people it may take much less as suggested by fraternity hazing related deaths every year in the US. At the other extreme is fentanyl which can produce extremely strong euphoriant effects in humans, reinforcing effects in animals, and lethal respiratory depressant effects at very low doses of just a few mg. Kratom's primary active alkaloid, mitragynine is both relatively weak and low in potency with respect to respiration as compared to morphine. In fact, it is a partial agonist with respect to respiratory depression, meaning that its maximal effects at all tested doses do not produce lethal respiratory depression. The mitragynine metabolite 7-hydroxymitragynine is more potent than morphine on the guinea pig ileum muscle twitching test but that test is not necessarily relevant to lethality, and 7-hydroxymitragynine, also appears to be a partial agonist with respect to its respiratory effects. DEA has included kratom on its list of"drugs and chemicals of concern", for the past decade,first listing it following reports of overdose deaths in Sweden among consumers of a kratom product that was later concluded to have been adulterated with lethal doses of O-desmethyltramadol. However, as mentioned in this science update, DEA never listed kratom as a threat to public health in its annual National Drug Threat Assessment reports. In fact, it has not listed kratom in its annual National Forensic Laboratory Reports since 2016, apparently, because the reports have remained low and not at the "threshold for reporting." Whether and when DEA will remove kratom or kratom alkaloids from its drugs and chemicals of concern list is not clear since researchers agree that kratom use and epidemiology should continue to be monitored, but unfortunately, this listing implies a higher level of concern than has been expressed by any other DEA action since it withdrew its scheduling proposal in 2016. 12/5/2023 Kratorn Science Update JACK BERGMAN COMMITTEE ON ARMED SERVICES 1ST DISTRICT,M;CHIGAN COMMITTEE ON VETERANS'AFFAIRS congr0g; of the aniteb 6tateo 10owe of Repregentatibeg Magbinaton,W 20515-2201 March 12,2024 Congressman Matt Salmon (Ret.) Chairman,American Kratom Association 13575 Heathcote Boulevard, Suite 320 Gainesville, VA 20155 Dear Matt: My purpose is writing today is to provide my perspective on the reports from state and local jurisdictions who are proposing bans on kratom, many of which are based on well-intentioned but misplaced concerns by law enforcement and public health officials. Simply put,these proposed bans will create far more harm than any potential benefit kratom critics believe will result from a ban. My specific concern is for the health and welfare of many of our nation's servicemembers and Veterans that I served with and others who returned from their service with injuries and chronic pain. Many of those Veterans have received treatments with dangerous opioids that lead to severe addictions and expose them to the unacceptable risk they will end up as another of the more than 80,000 opioid overdose deaths per year in the United States. One of the tools and resources many Veterans have used to quit their opioid dependence, manage pain, improve mood and focus, and get their lives back on track has been through controlled use of a pure,unmodified kratom product. For many, it has been a miracle solution keeping them from a downward spiral of addiction and destruction. I am certain you have seen during your time in Congress what I see clearly today. The common opponent in our effort to facilitate the recovery of millions of Veterans is the U.S. Food and Drug Administration(FDA). Three times in the last decade, the FDA has attempted to force kratom into Schedule 1 of the Controlled Substances Act, a drastic action that would essentially criminalize the use of the supplement nationwide and harm countless Americans who have benefited from kratom for decades. The FDA, which has a long-standing bias against any supplement that is not a pharmaceutical that can profit Big Pharma and their own budget, has pushed for kratom to be labelled a Controlled Substance by misstating the science, ignoring kratom's long history of safe use, and falsely claiming kratom has the same effects as classic opioids. In their campaign to get kratom reclassified as a dangerous drug, the FDA has relied on three false and thoroughly debunked objections to its widespread use: that kratom is unsafe,that it is highly addictive, and that it has no approved medical use. Even former HHS Assistant Secretary for Health Brett Giroir felt compelled to call out the FDA for relying on"disappointingly poor evidence and data and a failure to consider the overall public health"in coming to such a baseless conclusion. It is rare for a top-ranking HHS official to criticize the FDA for biased, shoddy work, but in this case the unsupported conclusions were so egregious that Giroir felt it W✓UMHeiICIi. GFF:(Y rRAVFRSE CITY OFWT 4% 0ININN OFFICE MANISTIOUL C*N f SF6 CANNOFI HOILE OII•'C!BLLK 13%DOUG:AS DR,STE 226 W 125 G AYf.,STE 0-119 7870%f Co Ro 442,STT E1 WASHINrror,,DC 2C-515 TnAVFReE C,rY,MI 49696 Gw'NN,MI 49841 MAMIS➢OUE,MI 49854 12021225-4735 (231)944-7633 (9061273-2227 1906)286-4191 necessary to publicly criticize them. Likewise, current HHS Secretary Xavier Becerra acknowledged substantial"knowledge gaps"regarding kratom and that"kratom-involved overdose deaths have occurred after use of adulterated kratom products or taking kratom with other substances." While the FDA continues to spread its propaganda about kratom, the Agency itself just concluded a human safety study on kratom that showed that kratom"appears to be well tolerated at all dose levels" (presented by the FDA at the 3rd Annual International Kratom Symposium in Orlando, Florida, February 2024). The study showed that two of the 40 participants experienced nausea after ingesting 12 grams of kratom in 24 capsules in a five minute period.No significant adverse events occurred. That study has now cleared the way for a Human Abuse Potential study to assess what level of dependence or addiction that kratom may cause, if any. That research will take another two years or more to complete. Equally significant is the FDA's refusal to comply with an order by a federal judge in the United States District Court for the Southern District of California to provide witnesses and documents on the FDA's position that kratom is dangerous. The judge called the hearing in a case the FDA itself initiated against a kratom importer. The U.S. Attorney stunningly informed the Court that the FDA"refused to provide us with witnesses or documents . . . [and] the reason they gave was that they have not yet made a determination regarding whether kratom is dangerous." Yet, the FDA continues to mislead state and local officials on the safety profile of kratom, including with false statements that remain on the FDA's website today. Any state or locality that proposes to criminalize the sale and consumption of kratom needs to look at the science on kratom, not the gaslighting the FDA continues to engage in. There is no doubt that kratom needs to be regulated to protect consumers from improperly manufactured or deliberately adulterated kratom products, and that is why there are eleven states who have taken that step, with many more currently considering state Kratom Consumer Protection Acts in their states. Senator Mike Lee(R-UT) and I are conservatives, and we have joined with our progressive colleagues, Senator Cory Booker(D-NJ) and Congressman Mark Pocan (D-WI), to lead a bipartisan effort to protect Veterans and the public with a federal Kratom Consumer Protection Act. Please let me know how I can provide additional assistance to you in your efforts as the Chair of the American Kratom Association in the effort to protect all consumers with responsible regulations on kratom. If you have any questions,please notify my staff, Amelia Burns at amelia.bums@mail.house.gov. Thank you for your prompt attention. Kind regards, QAgtir--ram+ Jack Bergman Member of Congress UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA UNITED STATES OF AMERICA, Case No. 3:23-cr-00I 79-TWR Plaintiff, MOTION FOR ISSUANCE OF V. SUBPOENA DIRECTING THE FDA TO PRODUCE DOCUMENTS FOR NINE2FIVE,LLC HE INSPECTION IN ADVANCE OF THE SEBASTIAN GUT RY(2), EVIDENTIARY HEARING ON Defendants. JANUARY 11, 2024 EXH I BIT B Subject: FW:Guthery From:Pierson,Melanie(USACAS)<Melanie_Pierson@usdom.gov> Sent:Friday,December 1,2023 9:40 AM To:Young,Andrew<Andrew.Ycune@btlaw.com> Cc:Orabona,Joseph(USACAS)<Jose h.Orabona usdo. ov> Subject:[EXTERNAL]Guthery Caution:This email originated from outside the Firm. We have been in contact with representatives of the FDA regarding the upcoming sentencing hearing regarding the dangers of kratom.They have refused to provide us with witnesses or documents to support our position,as well as witnesses and documents that might be inconsistent with our position. The reason they gave was that they have not yet made a determination regarding whether kratom is dangerous.We are prepared to withdraw our sentencing memorandum and refile,using supporting materials from independent experts and not the FDA,as we do not believe that the FDA is a part of the prosecution team in this case.If you disagree,please let us know immediately so we can file a motion with the court to resolve this issue in advance of the sentencing hearing. Respectfully, AUSA Melanie Pierson Filed December 6, 2023 Statement on the science of kratom products and their US regulation Kratom (Min-agyna speciosa Korth.), refers to a tree with a long use history in its native Malaysia, Thailand,Indonesia,and other parts of Southeast Asia.[1] Kratom has received increased attention in the United States since US consumers first began using kratom in the early 2000s for the self-treatment of a variety of health conditions, including pain and some psychiatric symptoms. Since this time,kratom products have proliferated and are used not only to address pain or as a substitute for licit and illicit substances with high-risk profiles,but also to improve general well-being, increase energy,mood,and productivity, as well as for recreation.[2] In its native Southeast Asia,kratom has been used by chewing freshly picked leaves or brewing tea immediately after leaf harvest.The first written reports of kratom use in scientific literature appeared over 150 years ago stating the traditional medicine use to alleviate pain, decrease fatigue/increase stamina, and self-treat other ailments.[3]To this day,fresh kratom leaf is widely used. More recently in Southeast Asia, the fresh leaf has been used to ameliorate withdrawal symptoms from a substance use disorder, most commonly related to opioid, alcohol, or stimulants.[4] In the US, primarily dried leaf material (not freshly harvested) is used in a number of preparations and products. The known science of kratom is centered on the presence of alkaloids(chemicals)which act on a variety of neurotransmitter systems to elicit a complex pharmacological profile. Mitragynine is the major alkaloid in kratom and because of this, it has been the subject of most scientific reports. There is a much smaller body of science around whole leaf kratom preparations and other individual alkaloids. Mitragynine acts on opioid,adrenergic,and serotonergic receptors,which is different than classical opioids, like morphine, that only act on opioid receptors.[5]As such,mitragynine is not a classical opioid, like morphine,but rather is unique in that it has partial agonist activity and relatively low abuse liability.To date, mitragynine and lyophilized kratom tea have not been shown to cause respiratory depression in animal models,which is a major concern of licit and illicit opioids consumed in the US.[6,7]The potential for mitragynine and kratom to serve as a medical blueprint for the treatment of substance use disorders has PAGE 1 been recognized by the National Institute on Drug Abuse.[2,8] Other kratom alkaloids exert diverse actions that may further explain the complex effects that kratom consumers report. The native kratom leaf contains varying amounts of alkaloids that usually are present in amounts of 24% by weight.The primary alkaloid in many leaf materials is mitragynine,which is present on a percent weight basis ranging from<1.0%but usually not exceeding 2.5%.[9,10] The other alkaloids are present in major and minor amounts with paynantheine,speciogynine, speciociliatine, and mitraciliatine,all of which do present with pharmacological activity,accounting for most of the remaining alkaloids. Mitragynine is metabolized in the human body to some degree into the active metabolite, 7- hydroxymitragynine.[l1]This 7-hydroxymitragynine metabolite has been shown to be associated with relatively greater abuse liability than its parent mitragynine,as it is more potent than mitragynine and 3- 22 times more potent than morphine at opioid receptors.[12-14] The pharmacology of 7- hydroxymitragynine appears to differ from mitragynine in that is only acts on opioid receptors,rather than multiple systems in the human body. It has been proposed that the amount of 7-hydroxymitragynine should be limited in products as it is found in very low levels in the native kratom leaf material and, indeed, many US products do not contain 7-hydroxymitragynine in detectable amounts. From a safety perspective, limiting the amount of both mitragynine, 7-hydroxymitragynine,and other alkaloids as has been done in most kratom-related state legislation,ensures that consumers are unlikely to experience adverse effects at commonly reported amounts of kratom ingestion. With a diverse kratom product marketplace in the US, it is important to distinguish between products comprised predominantly of native kratom leaf material,which contains at a maximum 2.5%mitragynine as part of a total of 4%of alkaloids by weight,and kratom extract products with enriched alkaloids. Extracts products that contain multiple times the amount of mitragynine and other kratom alkaloids than are present in the native leaf material may produce a higher risk profile of adverse effects than whole-leaf products although there is currently limited clinical evidence supporting this claim. Likewise,kratom products that are pre-mixed with other substances would confer a higher risk profile than kratom leaf PAGE 2 alone. Further, any semi-synthetic, isolated kratom alkaloid, and selective alkaloid rich fraction would, we believe,pose considerable risk in an unregulated product,and would no longer be considered as"kratom" in any meaningful sense of the term. Because native kratom leaf has a long use history in Southeast Asia, there are very few instances of major adverse effects reported,which is the basis for the differentiation between native leaf and kratom extract materials. In the years that kratom whole leaf and extract products have been sold in the US,there have been,to date, few clinical case reports of adverse effects.These include reports related to kratom-related morbidities,toxicities,mortalities,and those related to kratom physical dependence or substance use disorder.This is noteworthy given that US kratom consumers now number in the millions.[15-17] Of the cases that do exist,many are confounded by a variety of factors, including other health conditions and polysubstance exposure. Surveys,case reports,ecological momentary assessment,and other forms of self-report indicate that the primary use of kratom products among US consumers is for relieving pain,anxiety,or mood-related symptoms(and improving mood generally), increasing focus and energy, and for a sizable subset of consumers as a short-and long-term replacement for substances which they believed caused them problems,primarily opioids and alcohol, and to a lesser extent stimulants.[18-21] Like many psychoactive products(e.g.,caffeine),kratom products can be habit-forming as indicated by users who consume large quantities of kratom with greater frequency over an extended period of time. The severity of physical dependence is mild to moderate,and substance use disorder for kratom has been assessed as mild-moderate for those who meet criteria according to the Diagnostic and statistical Manual of Mental Disorders (DSM-5)criteria.[22] Note that a majority of kratom users do not develop a use disorder;those that use kratom regularly and develop physical dependence can manage this and their kratom consumption despite a lack of proper dosing instructions on most kratom product labels. Indeed, we have not seen clinically concerning hallmarks of addiction in the samples of consumers we and others have assessed.[23] PAGE 3 Because of the various kratom products on the market without Federal regulation or appropriate oversight of the US Food and Drug Administration(FDA), it is important to ensure consumers have access to kratom products that are adequately labeled to inform their consumption.As such, legislatures should require adequate labeling of kratom products according to the FDA and the US Federal Trade Commission(FTC)guidances for dietary supplements. Such labeling should include at a minimum: address and name of manufacturer or distributor, a list of all ingredients,the total amount of kratom material per serving,how many servings per container, an expiration or best before date,a statement about how products may be habit-forming with frequent or heavy use,a statement that consumers should consult a healthcare professional prior to kratom consumption,a statement that kratom use is not advised during pregnancy and lactation or by a person who is taking prescription medications. Sales of kratom products should be limited to consumers 18 years and older.The amount of mitragynine,7- hydroxymitragynine,and total alkaloids per serving should be included on the label as well as a statement that the product contains no semi-synthetic kratom-derived alkaloids. Lastly,the FDA has established guidance documents on proper labeling and good manufacturing practices for dietary supplements that can be adapted for kratom products. Good manufacturing practices(GMP)encompasses adequate documentation of sourcing of materials,adherence to established analytical principles,and organization of facilities and personnel to adhere to regulatory requirements.All kratom products should adhere to GMP. To conclude,we write this with the recognition that considerably more investment in scientific research is needed to better understand kratom, both as the naturally growing botanical and kratom-derived product formulations. Likewise, more research is needed on kratom's effects on humans. Our statement is based only on data to date. However, based on the currently available scientific and public health knowledge about kratom,we believe that US adults should have access to kratom products that are regulated, ideally along the lines we have noted above, and that investments are made by state legislatures not only in PAGE 4 passing kratom regulations,but enforcing them. Finally,this statement does not necessarily reflect the views of any institution that we work for. Respectfully, Oliver Grundmann,PhD,FCP Assistant Dean of Lifelong Learning Director&Clinical Professor Online Graduate Programs in Pharmaceutical Chemistry&Clinical Toxicology Department of Medicinal Chemistry,College of Pharmacy Department of Biobehavioral Nursing Science,College of Nursing University of Florida Phone:+1-352-273-7714 Email: grundmanAufl.edu Christopher R. McCurdy,PhD,FAAPS Associate Dean for Faculty Development Professor of Medicinal Chemistry The Frank A. Duckworth Eminent Scholar Chair Director,OF Translational Drug Development Core Department of Medicinal Chemistry College of Pharmacy University of Florida Office: (352)294-8691 Email: cmccurdy@cop.uEl.edu Abhisheak Sharma,PhD Assistant Professor of Pharmaceutics Co-Director,OF Translational Drug Development Core Department of Pharmaceutics University of Florida Phone:+1-662-715-1151,+1-352-294-8690 Email: asharmal@cop.ufl.edu Kirsten Smith,PhD Assistant Professor Behavioral Pharmacology Research Unit Department of Psychiatry and Behavioral Sciences School of Medicine Johns Hopkins University Cell: 865-418-8177 Office: 410-550-0035 Email: ksmit398 rc'h.edu PAGE 5 References 1. Brown PN, Lund JA, Murch SJ.A botanical,phytochemical and ethnomedicinal review of the genus Mitragyna korth: Implications for products sold as kratom. J Ethnopharmacol [Internet]. 2017/03/24. 2017;202:302-25.Available from: http://dx.doi.org/10.1016/j.jep.2017.03.020 2. Smith KE, Sharma A,Grundmann O, McCurdy CR. Kratom alkaloids:A blueprint?ACS Chem Neurosci. 2023;14(2):195-7. 3. Veltri C,Grundmann O. Current perspectives on the impact of Kratom use. Subst Abuse Rehabil [Internet]. 2019;10:23-3 1.Available from: https://www.ncbi.nlm.nih.gov/pubmed/31308789 4. Singh D, Narayanan S,Vicknasingam B, Prozialeck WC, Smith KE, Corazza O,et al.The Use of Kratoin(Mitragyna speciosa Korth.)Among People Who Co-use Heroin and Methamphetamine in Malaysia.J Addict Med[Internet]. 2022 Mar 1 [cited 2022 Oct 1];16(2):223-8.Available from: https://pubmed.ncbi.nlm.nih.gov/34001777/ 5. Karunakaran T,Zhuo NK,Zailan AA,Mian VJY, Bakar MHA. The Chemical and Pharmacological Properties of Mitragynine and Its Diastereomers:An Insight Review. Front Pharmacol. 2022; 6. Wilson LL, Harris HM,Eans SO, Brice-Tutt AC, Cirino TJ, Stacy HM,et al. Lyophilized Kratom Tea as a Therapeutic Option for Opioid Dependence. Drug Alcohol Depend [Internet].2020;216. Available from: https://www.ncbi.nlm.nih.gov/pubmed/33017752 7. Henningfield JE,Rodricks J V.,Magnuson AM, Huestis MA. Respiratory effects of oral mitragynine and oxycodone in a rodent model. Psychopharmacology(Berl) [Internet]. 2022 Dec 1 [cited 2023 Feb 17];239(12):3793-804.Available from: https://pubmed.ncbi.nim.nih.gov/36308562/ 8. NIDA. Kratom Research Topics National Institute on Drug Abyse. 2022. 9. Leksungnoen N,Andriyas T,Ngernsaengsaruay C,Uthairatsamee S,Racharak P,Sonjaroon W,et al.Variations in mitragynine content in the naturally growing kratom(Mitragyna speciosa) population of Thailand. Front Plant Sci.2022;13:1028547. 10. Sengnon N,Vonghirundecha P,Chaichan W,Juengwatanatrakul T, Onthong J,Kitprasong P, et al. Seasonal and geographic variation in alkaloid content of kratom(Mitragyna speciosa(Korth.) Havil.) from Thailand. Plants. 2023;12(4):949. 11, Kamble SH, Sharma A, King TI, Le6n F, McCurdy CR,Avery BA. Metabolite Profiling and Identification of Enzymes Responsible for the Metabolism of Mitragynine, the Major Alkaloid of Mitragyna speciosa(Kratom). Xenobiotica [Internet].2019;49(11).Available from: bttps://www.ncbi.nim.nih.gov/pubmed/30547698 12. Obeng S, Wilkerson JL,Le6n F, Reeves ME, Restrepo LF,Gamez-Jimenez LR,et al. Pharmacological Comparison of Mitragynine and 7-Hydroxymitragynine: In Vitro Affinity and Efficacy for µ-Opioid Receptor and Opioid-Like Behavioral Effects in Rats.J Pharmacol Exp Ther [Internet]. 202 1;376(3).Available from: https://www.ncbi.nlm.nih.gov/pubmed/33384303 13. Matsumoto K, Hatori Y,Murayama T,Tashima K,Wongseripipatana S,Misawa K,et al. Involvement of µ-opioid receptors in antinociception and inhibition of gastrointestinal transit PAGE 6 induced by 7-hydroxymitragynine, isolated from Thai herbal medicine Mitragyna speciosa. Eur J Pharmacol.2006;549(1-3):63-70. 14. Hiranita T, Sharma A,Oyola FL,Obeng S,Reeves ME, Restrepo LF,et al. Potential contribution of 7-hydroxymitragynine,a metabolite of the primary kratom(Mitragyna speciosa)alkaloid mitragynine,to the µ-opioid activity of mitragynine in rats.The FASEB journal.2020;34(S 1):1. 15. Palamar JJ. Kratom use is underestimated,but prevalence still appears to be low.Am J Prev Med. 2022;62(1):133-4. 16. Covvey JR,Vogel SM,Peckham AM, Evoy KE. Prevalence and characteristics of self-reported kratom use in a representative US general population sample. J Addict Dis [Internet].2020;38(4). Available from: https://www.ncbi.nlm.nih.gov/pubmed/32657217 17. Henningfield JE,Grundmann O, Garcia-Romeu A, Swogger MT.We need better estimates of kratom use prevalence.Am J Prev Med.2022;62(1):132-3. 18. Smith KE,Panlilio L V,Feldman JD,Grundmann O, Dunn KE,McCurdy CR,et al. Ecological Momentary Assessment of Self-Reported Kratom Use, Effects,and Motivations Among US Adults. JAMA Netw Open.2024;7(1):e2353401-c2353401. 19. Grundmann O. Patterns of Kratom use and health impact in the US—Results from an online survey. Drug Alcohol Depend.2017;176. 20. Coe MA, Pillitteri JL, Sembower MA, Gerlach KK, Henningfield JE. Kratom as a Substitute for Opioids: Results From an Online Survey. Drug Alcohol Depend[Internet]. 2019;202:24-32. Available from: https://www.ncbi.nlm.nih.gov/pubmed/31284119 21. Bath R, Bucholz T,Buros AF, Singh D, Smith KE,Veltri CA,et al. Self-reported Health Diagnoses and Demographic Correlates With Kratom Use: Results From an Online Survey.J Addict Med [Internet]. 2019;Available from: https://www.ncbi.nlm.nih.gov/pubmed/31567595 22, Smith KE, Dunn KE, Rogers JM, Garcia-Romeu A, Strickland JC,Epstein DH.Assessment of Kratom Use Disorder and Withdrawal Among an Online Convenience Sample of US Adults. J Addict Med. 2022; 23. Hill K,Grundmann O, Smith KE, Stanciu CN. Prevalence of Kratom Use Disorder among Kratom Consumers. J Addict Med.2023;10-1097. PAGE 7 � r 1,k3z-ft-j; rrM®+�� �' City Council Supplemental Meeting Packet CITY OF IOWA CITY November 4, 2024 Information submitted between distribution of the Supplemental Meeting Packet 1 on Friday and 3:00 pm on Monday. Late Handout(s) 10.b. ratom Ban - See correspondence form Laura Crossett. November 4,2024 City of Iowa City Item Number: 10.b. r 1 CITY OF IOWA CITY a � COUNCIL ACTION REPORT November 4, 2024 Kratom Ban - See correspondence form Laura Crossett. Attachments: Correspondence form Laura Crossett Ashley Platz , Z From: Laura Crossett <newrambler@gmail.com> Sent: Monday, November 4, 2024 2:50 PM Late Handouts Distributed To: *City Council Subject: Kratom ban 2q A (Date) RI5A **This email originated outside of the City of Iowa City email system. Please take extra care opening any links or attachments. ** Dear Council Members: I would come to speak to you in person this evening in favor of a kratom ban in Iowa City,which I understand you're voting on tonight, but I have been quite ill and don't want to spread my germs more than necessary. I am in favor of a ban on the sale of kratom in Iowa City because I believe it is a way to take a symbolic stand on a public health issue both by indicating the potential harms of the drug and by making it slightly harder to get. I know some of you are reluctant to legislate about a substance the FDA has made no move to regulate (though notably the DEA was on the verge of regulating it uite severe in 2016), and I am sympathetic to that reluctance, particularly given that the policing of drugs has disproportionately negatively affected people of color for decades. Many of you have also noted that a ban on sales in Iowa City will hardly make the substance hard to get—for instance, instead of going to the gas station a mile from my house, I could go to the liquor store in Coralville near where I take a weekly viola lesson. I also know, however,that legislation that make cigarettes harder to get and made more and more places off limits for smoking is correlated pretty strongly with a decrease in smoking, and so in that way even a small step starts to make a difference. But I also know that cities and states legislate about all sorts of things that the federal government does not.This country has no federal anti-discrimination law for LGBTQ people, but some states do. Iowa City manufactures and hands out Prides signs,which isn't even a form of legislation and has, one could argue, no practical effect at all—but certainly I notice a difference in communities that don't do such things. I am not a medical expert and I can't speak to precisely how kratom should be regulated or used. I do know, however, that it acts on opioid receptors and that you can buy it in multiple locations in my neighborhood, and that, as the FDA currently does not regulate it, there is no real guarantee of just what might be in any given kratom product you buy. I also knew Liz Wisnosky, a local woman who died due to circumstances related to her kratom use, and I knew her children, who now do not have a mother. I believe that banning the sale of kratom in Iowa City would be a symbolic and maybe even practical step in reducing harm, and perhaps even in preventing more such awful deaths. Thank you for your work and your consideration. Sincerely, Laura Crossett 1420 Yewell St. Iowa City, IA 52240 1 319-389-0449 Laura Crossett[she/her] newrambler.net since 1999 lauracrossett.com 2