House File 2133 H-8168 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 service establishment” means any establishment 19 providing or serving food directly to consumers that is 20 regulated by the department and local public health agencies. 21 5. “Kratom” means the plant, or any part of the plant, 22 Mitragyna speciosa. 23 6. “Kratom food service establishment” means any food 24 service establishment that sells finished kratom products. 25 7. “Kratom product” means a food product, food ingredient, 26 dietary ingredient, dietary supplement, or beverage intended 27 for human consumption that contains any part of the leaf of the 28 kratom plant and is manufactured as a powder, capsule, pill, or 29 other consumable form. 30 8. “Processor” means an entity that does any of the 31 following: 32 a. Refines kratom into input ingredients for the purpose of 33 manufacturing a finished kratom product. 34 b. Manufactures finished kratom products. 35 -1- HF 2133.3220 (2) 91 as/js 1/ 6 #1.

c. Packages finished kratom products for resale. 1 Sec. 2. NEW SECTION . 124F.2 Product requirements. 2 Finished kratom products sold to consumers at a retail 3 establishment, a convenience store, or a kava or kratom bar in 4 this state: 5 1. Shall be in one of the following delivery forms: 6 a. Dried leaf. 7 b. Powder. 8 c. Pill. 9 d. Liquid. 10 e. Capsule. 11 2. Shall possess a certificate of analysis that has been 12 submitted to the department as required under this chapter. 13 3. Shall be registered with the department. 14 4. Shall include directions for consumption of the kratom 15 product on the product’s label, including but not limited to 16 the following information: 17 a. A maximum dosage of one hundred milligrams of kratom 18 alkaloids per serving. 19 b. The number of servings per package. 20 c. The amount in milligrams of 7-hydroxymitragynine and 21 mitragynine per serving. 22 d. A warning advising consumers of the number of servings 23 that may be safely consumed in a twenty-four-hour period. 24 e. A warning prohibiting use by individuals who are under 25 twenty-one years of age. 26 f. A warning advising against use by individuals who are 27 pregnant or breast-feeding. 28 g. A warning advising the consumer to consult a health care 29 professional before use, that the product may be habit-forming, 30 and that the product may cause adverse health effects. 31 h. The following warning statement: 32 “These statements have not been evaluated by the United 33 States Food and Drug Administration. This product is not 34 intended to diagnose, treat, cure, or prevent any disease.” 35 -2- HF 2133.3220 (2) 91 as/js 2/ 6

i. The expiration date. 1 j. The name and place of business of the registrant. 2 5. Shall comply with the packaging and labeling 3 requirements set forth in this chapter and the rules adopted 4 thereunder. 5 6. Shall not be attractive to children. 6 7. Shall be in a container that meets all of the following 7 conditions: 8 a. Is suitable to contain products for human consumption. 9 b. Is compliant with the federal Poison Prevention Packaging 10 Act of 1970, 15 U.S.C. §1471 et seq. 11 c. Contains a graduated measuring device, if applicable. 12 8. Shall not be adulterated including but not limited to by 13 containing metals, pesticides, or pathogens in excess of the 14 limits set by this chapter or department rule. 15 9. Shall be sold only in establishments that restrict entry 16 to persons who are twenty-one years of age or older and require 17 age verification. 18 10. Shall not be served in a form that combines or mixes 19 finished kratom products with psychoactive substances that 20 impact the central nervous system including but not limited to 21 alcohol, caffeine, kava, cannabinoids, and nicotine. 22 Sec. 3. NEW SECTION . 124F.3 Manufacturing and distribution. 23 1. Kratom products shall be manufactured or distributed 24 in this state only by a processor who is subject to and in 25 compliance with all state laws and regulations applicable to 26 food processors. Kratom products shall not be manufactured or 27 distributed by a cottage food producer under section 137F.20. 28 2. A processor that manufactures, processes, packs, or 29 offers for sale kratom, kratom products, or finished kratom 30 products shall be properly registered with the United States 31 food and drug administration. 32 3. A processor shall comply with current good manufacturing 33 practices contained in 21 C.F.R. pt. 210. 34 4. A processor shall maintain product liability insurance 35 -3- HF 2133.3220 (2) 91 as/js 3/ 6

with a minimum occurrence limit of three million dollars. 1 5. For each batch of a registered finished kratom product, 2 the processor shall retain and submit, upon request, a 3 certificate of analysis to the department from a laboratory 4 accredited pursuant to international organization for 5 standardization/international electrotechnical commission 6 standard 17025 or other compararble accreditation standard 7 required by the department. The processor shall not have 8 any direct or indirect financial or economic interest in the 9 laboratory or accrediting body. The processor shall maintain 10 the certificates of analysis for a minimum of one year after 11 the finished kratom product’s expiration date. The certificate 12 of analysis shall demonstrate that the finished kratom product 13 is in compliance with the concentration limits established by 14 statute or rule for the following: 15 a. Alkaloid and alkaloid metabolites. 16 b. Residual solvents. 17 c. Heavy metals including but not limited to cadmium, 18 arsenic, mercury, and lead. 19 d. Pesticides and any other substance limited by rule of the 20 department. 21 6. A finished kratom product served by a kratom food service 22 establishment shall be registered with the department and 23 comply with the requirements of this chapter. A person shall 24 not serve kratom beverages combined with alcohol, drugs, or 25 other kratom products. 26 7. This chapter shall not apply to finished kratom products 27 processed or manufactured in this state and subsequently 28 shipped or transported out of this state for sale or use 29 outside of this state. 30 8. Finished kratom products produced in this state and 31 subsequently shipped or transported out of this state for sale 32 or use outside of this state: 33 a. Shall not be sold, shipped, or transported to a consumer 34 in this state, to a retail establishment in this state, or to a 35 -4- HF 2133.3220 (2) 91 as/js 4/ 6

person who sells or intends to sell such products to a consumer 1 in this state. 2 b. Shall be in a package with the following marking in a 3 bold font size of at least thirty-six points: 4 NOT FOR USE OR RETAIL SALE IN IOWA 5 c. Shall be physically separated from finished kratom 6 products that are, or are intended to be, sold or used in this 7 state. 8 Sec. 4. NEW SECTION . 124F.4 Adverse health events. 9 1. If a processor or the department receives notice of any 10 adverse health event suspected to be related to the processor’s 11 kratom product, the processor or the department shall submit an 12 adverse event report, as set out in the Federal Food, Drug, and 13 Cosmetic Act, 21 U.S.C. §379aa-1(b)(1), to the United States 14 food and drug administration. 15 2. If probable cause exists that a kratom product may 16 be adulterated, the department may require an independent 17 third-party test of the kratom product by a laboratory of the 18 department’s choice, and the processor shall pay the cost of 19 the test. If the processor does not make such payment to the 20 department within thirty days after receiving the invoice for 21 the testing fee, the department shall revoke the registration 22 for that product. 23 Sec. 5. NEW SECTION . 124F.5 Penalties. 24 1. A processor that manufactures, delivers, offers for 25 sale, distributes, or sells a finished kratom product that 26 violates section 124F.2 or 124F.3 shall be guilty of a serious 27 misdemeanor. 28 2. Kratom products possessed, manufactured, delivered, 29 offered for sale, distributed, or sold in violation of this 30 chapter by an entity regulated under this chapter may be 31 detained or embargoed and the entity in violation is subject to 32 all penalties and remedies that apply for a violation of this 33 chapter. The department shall not grant permission to remove 34 or use, except for disposal, detained or embargoed finished 35 -5- HF 2133.3220 (2) 91 as/js 5/ 6

kratom products that are attractive to children until the 1 finished kratom products comply with this chapter. 2 3. If a processor fails to provide the department with a 3 certificate of analysis within seven days after receiving a 4 request from the department or fails to immediately report an 5 adverse health event to the department as required by section 6 124F.4, the department may revoke the processor’s finished 7 kratom product registration. 8 4. A processor that manufactures, delivers, offers for 9 sale, distributes, or sells a kratom product that contains 10 any controlled substance or adulterants commits a serious 11 misdemeanor and may be subject to criminal penalties under 12 chapter 124. 13 5. A laboratory that fails to ensure the accuracy of its 14 certificates of analysis issued under this chapter is subject 15 to an administrative fine in an amount determined by the 16 department by rule. 17 Sec. 6. NEW SECTION . 124F.6 Rules. 18 The department shall adopt rules pursuant to chapter 17A 19 necessary to administer this chapter. 20 Sec. 7. NEW SECTION . 124F.7 Citation. 21 This chapter shall be known as and may be cited as the “Iowa 22 Kratom Consumer Protection Act” . > 23 2. Title page, by striking lines 1 and 2 and inserting < An 24 Act establishing the Iowa kratom consumer protection Act, and 25 providing penalties. > 26 ______________________________ SORENSEN of Adair -6- HF 2133.3220 (2) 91 as/js 6/ 6 #2.