House File 2133 H-8202 Amend House File 2133 as follows: 1 1. By striking everything after the enacting clause and 2 inserting: 3 < Section 1. NEW SECTION . 124F.1 Definitions. 4 As used in this chapter, unless the context otherwise 5 requires: 6 1. “Attractive to children” means a quality of a product 7 manufactured that is either: 8 a. In a shape that resembles a human, a cartoon character, 9 or an animal. 10 b. In a form that resembles an existing candy product that 11 is a widely distributed, branded food item. 12 2. “Department” means the department of health and human 13 services. 14 3. “Finished kratom product” means a kratom product that is 15 ready for sale to the end user. For purposes of registration, 16 a finished kratom product is differentiated by its ingredients, 17 not by its weight, volume, or size. 18 4. “Food establishment” means any establishment providing 19 or serving food directly to consumers that is regulated by the 20 department of inspection, appeals, and licensing and local 21 public health agencies. 22 5. “Kratom” means the plant, or any part of the plant, 23 Mitragyna speciosa. 24 6. “Kratom alkaloids” means the sum of all alkaloids 25 naturally occurring in the kratom plant and any semi-synthetic 26 derivatives of those alkaloids present in a kratom product 27 including but not limited to mitragynine, speciogynine, 28 speciociliatine, payantheine, and 7-hydroxymitragynine, as 29 determined through validated analytical testing. 30 7. “Kratom food establishment” means any food establishment 31 that sells finished kratom products. 32 8. “Kratom product” means a food product, food ingredient, 33 dietary ingredient, dietary supplement, or beverage intended 34 for human consumption that contains any part of the leaf of the 35 -1- HF 2133.3336 (1) 91 as/js 1/ 6 #1.

kratom plant and is manufactured as a powder, capsule, pill, or 1 other consumable form. 2 9. “Processor” means an entity that does any of the 3 following: 4 a. Refines kratom into input ingredients for the purpose of 5 manufacturing a finished kratom product. 6 b. Manufactures finished kratom products. 7 c. Packages finished kratom products for resale. 8 d. Serves as a warehouse or distributor of kratom products. 9 Sec. 2. NEW SECTION . 124F.2 Product requirements. 10 Finished kratom products sold to consumers at a retail 11 establishment, a convenience store, or a kava or kratom bar in 12 this state: 13 1. Shall be in one of the following delivery forms: 14 a. Dried leaf. 15 b. Powder. 16 c. Pill. 17 d. Liquid. 18 e. Capsule. 19 2. Shall possess a certificate of analysis that has been 20 submitted to the department as required under this chapter. 21 3. Shall be registered with the department. 22 4. Shall include directions for consumption of the kratom 23 product on the product’s label, including but not limited to 24 the following information: 25 a. A maximum dosage of one hundred milligrams of kratom 26 alkaloids per serving. 27 b. The number of servings per package. 28 c. The amount in milligrams of 7-hydroxymitragynine and 29 mitragynine per serving. 30 d. A warning advising consumers of the number of servings 31 that may be safely consumed in a twenty-four-hour period. 32 e. A warning prohibiting use by individuals who are under 33 twenty-one years of age. 34 f. A warning advising against use by individuals who are 35 -2- HF 2133.3336 (1) 91 as/js 2/ 6

pregnant or breast-feeding. 1 g. A warning advising the consumer to consult a health care 2 professional before use, that the product may be habit-forming, 3 and that the product may cause adverse health effects. 4 h. The following warning statement: 5 “These statements have not been evaluated by the Food and 6 Drug Administration. This product is not intended to diagnose, 7 treat, cure, or prevent any disease.” 8 i. The expiration date, best if used by date, or date of 9 manufacture. 10 j. The name and place of business of the registrant. 11 5. Shall comply with the packaging and labeling 12 requirements set forth in this chapter and the rules adopted 13 thereunder. 14 6. Shall not be attractive to children. 15 7. Shall be in a container that meets all of the following 16 conditions: 17 a. Is suitable to contain products for human consumption. 18 b. Is compliant with the federal child-resistant packaging 19 standards contained in 16 C.F.R. §1700.15 and 1700.20. 20 c. Contains a graduated measuring device, if applicable. 21 8. Shall be sold only to persons who are twenty-one years of 22 age or older and with proper age verification. 23 9. Shall not be served in a form that combines or mixes 24 finished kratom products with kava. 25 10. A person shall not manufacture, distribute, 26 sell, or offer for sale a kratom product that contains 27 7-hydroxymitragynine in a concentration that exceeds 28 twenty-five milligrams per serving. For the purposes of this 29 section, the concentration of 7-hydroxymitragynine shall be 30 determined by validated laboratory analysis. 31 Sec. 3. NEW SECTION . 124F.3 Manufacturing and distribution. 32 1. Kratom products shall be manufactured or distributed 33 in this state only by a processor who is subject to and in 34 compliance with all state laws and regulations applicable to 35 -3- HF 2133.3336 (1) 91 as/js 3/ 6

food processors. Kratom products shall not be manufactured or 1 distributed by a cottage food producer under section 137F.20. 2 2. A processor shall comply with current practices 3 contained in 21 C.F.R. pts. 111 and 117. 4 3. A processor shall maintain product liability insurance 5 with a minimum occurrence limit of three million dollars. 6 4. For each batch of a registered finished kratom product, 7 the processor shall retain and submit, upon request, a 8 certificate of analysis to the department from a laboratory 9 accredited pursuant to international organization for 10 standardization/international electrotechnical commission 11 standard 17025 or other comparable accreditation standard 12 required by the department. The processor shall not have 13 any direct or indirect financial or economic interest in the 14 laboratory or accrediting body. The processor shall maintain 15 the certificates of analysis for a minimum of one year after 16 the finished kratom product’s expiration date. The certificate 17 of analysis shall demonstrate that the finished kratom product 18 is in compliance with the concentration limits established by 19 statute or rule for the following: 20 a. Kratom alkaloids and kratom alkaloid metabolites. 21 b. Residual solvents. 22 c. Heavy metals including but not limited to cadmium, 23 arsenic, mercury, and lead. 24 d. Pesticides and any other substance limited by rule of the 25 department. 26 5. A finished kratom product served by a kratom food 27 establishment shall be registered with the department and 28 comply with the requirements of this chapter. A person shall 29 not serve kratom beverages combined with alcohol, drugs, or 30 other kratom products. 31 6. This chapter shall not apply to finished kratom products 32 processed or manufactured in this state and subsequently 33 shipped or transported out of this state for sale or use 34 outside of this state. 35 -4- HF 2133.3336 (1) 91 as/js 4/ 6

7. Finished kratom products produced in this state and 1 subsequently shipped or transported out of this state for sale 2 or use outside of this state: 3 a. Shall not be sold, shipped, or transported to a consumer 4 in this state, to a retail establishment in this state, or to a 5 person who sells or intends to sell such products to a consumer 6 in this state. 7 b. Shall be in a package with the following marking in a 8 bold font size of at least thirty-six points: 9 NOT FOR USE OR RETAIL SALE IN IOWA 10 c. Shall be physically separated from finished kratom 11 products that are, or are intended to be, sold or used in this 12 state. 13 Sec. 4. NEW SECTION . 124F.4 Adverse health events. 14 1. If a processor or the department receives notice of any 15 adverse health event suspected to be related to the processor’s 16 kratom product, the processor or the department shall submit an 17 adverse event report, as set out in the Federal Food, Drug, and 18 Cosmetic Act, 21 U.S.C. §379aa-1(b)(1), to the United States 19 food and drug administration. 20 2. If probable cause exists that a kratom product may 21 be adulterated, the department may require an independent 22 third-party test of the kratom product by a laboratory of the 23 department’s choice, and the processor shall pay the cost of 24 the test. If the processor does not make such payment to the 25 department within thirty days after receiving the invoice for 26 the testing fee, the department shall revoke the registration 27 for that product. 28 Sec. 5. NEW SECTION . 124F.5 Penalties. 29 1. A processor that manufactures, delivers, offers for 30 sale, distributes, or sells a finished kratom product that 31 violates section 124F.2 or 124F.3 shall be guilty of a serious 32 misdemeanor. 33 2. Kratom products possessed, manufactured, delivered, 34 offered for sale, distributed, or sold in violation of this 35 -5- HF 2133.3336 (1) 91 as/js 5/ 6

chapter by an entity regulated under this chapter may be 1 detained or embargoed and the entity in violation is subject to 2 all penalties and remedies that apply for a violation of this 3 chapter. The department shall not grant permission to remove 4 or use, except for disposal, detained or embargoed finished 5 kratom products that are attractive to children until the 6 finished kratom products comply with this chapter. 7 3. If a processor fails to provide the department with a 8 certificate of analysis within seven days after receiving a 9 request from the department or fails to immediately report an 10 adverse health event to the department as required by section 11 124F.4, the department may revoke the processor’s finished 12 kratom product registration. 13 4. A processor that manufactures, delivers, offers for 14 sale, distributes, or sells a kratom product that contains 15 any controlled substance or adulterants commits a serious 16 misdemeanor and may be subject to criminal penalties under 17 chapter 124. 18 5. A laboratory that fails to ensure the accuracy of its 19 certificates of analysis issued under this chapter is subject 20 to an administrative fine in an amount determined by the 21 department by rule. 22 Sec. 6. NEW SECTION . 124F.6 Rules. 23 The department shall adopt rules pursuant to chapter 17A 24 necessary to administer this chapter. 25 Sec. 7. NEW SECTION . 124F.7 Citation. 26 This chapter shall be known as and may be cited as the “Iowa 27 Kratom Consumer Protection Act” . > 28 2. Title page, by striking lines 1 and 2 and inserting < An 29 Act establishing the Iowa kratom consumer protection Act, and 30 providing penalties. > 31 ______________________________ GJERDE of Linn -6- HF 2133.3336 (1) 91 as/js 6/ 6 #2.