H.F. 612 Section 1. NEW SECTION . 124F.1 Definitions. 1 As used in this chapter: 2 1. “Attractive to children” means a kratom product that 3 is manufactured in the shape of cartoons or animals or is 4 manufactured or packaged in a form that bears any reasonable 5 resemblance to an existing candy product that is familiar to 6 the public as a widely distributed, branded food product, such 7 that a product could be mistaken for the branded product, 8 especially by children. 9 2. “Department” means the department of health and human 10 services. 11 3. “Independent testing laboratory” means a laboratory that 12 is accredited to standard ISO/IEC 17025 by an international 13 organization for standards-approved accrediting body. 14 4. “Kratom” means the plant Mitragyna speciosa or any part 15 of the plant, including all alkaloids present in the plant. 16 5. “Kratom extract” means a substance or compound obtained 17 by extraction of the Mitragyna speciosa leaf, intended for 18 ingestion, containing more than trace amounts of Mitragyna 19 speciosa and containing other alkaloids of the kratom plant, 20 but does not contain any controlled substances or levels of 21 residual solvents higher than is allowed in the United States 22 pharmacopeia 467. 23 6. “Kratom food service establishment” means a person 24 who sells kratom as a beverage prepared on site, or sells 25 prepackaged kratom beverages or finished kratom products, at a 26 food establishment as defined in section 137F.1. 27 7. “Kratom processor” means a person who manufactures, 28 distributes, maintains, or sells a kratom product or a person 29 who advertises, represents, or claims to sell, prepare, or 30 maintain a kratom product. 31 8. “Kratom product” means a finished article containing 32 any part of a leaf of the plant Mitragyna speciosa in fresh, 33 dehydrated, or dried form, or a kratom extract. 34 9. “Registrant” means a person or kratom processor that 35 -1- LSB 2242YH (9) 91 ss/ko 1/ 10

H.F. 612 sells, prepares, manufactures, distributes, or maintains kratom 1 products, or advertises, represents, or holds itself out as 2 selling, preparing, or maintaining kratom products. 3 10. “Retailer” means a person that sells, distributes, 4 advertises, represents, or holds itself out as selling kratom 5 products. 6 11. “Synthesized material” means an alkaloid or alkaloid 7 derivative that has been created by chemical synthesis or 8 biosynthetic means, including fermentation, recombinant 9 techniques, yeast-derived techniques, and enzymatic techniques, 10 rather than traditional food preparation techniques, such 11 as heating or extracting, that synthetically alters the 12 composition of any kratom alkaloid or constituent. 13 Sec. 2. NEW SECTION . 124F.2 Kratom product —— registration. 14 1. A person responsible for placing a kratom product into 15 commerce in the state shall register annually to offer the 16 kratom product for sale or distribution. The application for 17 registration shall include all of the following: 18 a. A certification from a qualified independent auditor 19 that the applicant meets or exceeds guidelines published by 20 the federal food and drug administration for current good 21 manufacturing practices for any facility that manufactures, 22 processes, packs, or holds a kratom product. 23 b. A current federal food and drug administration food 24 facility registration certificate for any kratom processor 25 facility that manufactures, processes, packs, or holds a kratom 26 product. 27 c. A statement that the applicant has a reasonable basis 28 that the product is safe for consumption under the conditions 29 of use set forth on the label and that the applicant assumes 30 responsibility and liability for any kratom product offered for 31 sale by the applicant. 32 d. A certificate of analysis from an independent testing 33 laboratory showing compliance with the requirements of this 34 chapter for residual solvents, 7-hydroxymitragynine content, 35 -2- LSB 2242YH (9) 91 ss/ko 2/ 10

H.F. 612 and heavy metal contaminants. 1 e. An application fee as determined by the board by rule. 2 2. An application for registration may include multiple 3 kratom products if the kratom products contain the same 4 ingredients sold in the same form but in a different container, 5 package, or volume. 6 3. The department shall create and maintain on the 7 department’s internet site a database of all kratom products 8 that are registered for sale in this state. 9 Sec. 3. NEW SECTION . 124F.3 Kratom product —— limitations. 10 1. A registrant shall not prepare, distribute, sell, 11 or expose for sale a kratom product containing a level 12 of 7-hydroxymitragynine in the alkaloid fraction that is 13 greater than two percent of the alkaloid composition of 14 the kratom product. A product that contains a level of 15 7-hydroxymitragynine greater than two percent shall not be 16 marketed as, labeled as, or contain any reference on the 17 product’s packaging, that it is a kratom product or state that 18 the product is derived from the alkaloid mitragynine. 19 2. A kratom processor, registrant, or retailer shall not 20 offer for sale a kratom product that contains any of the 21 following: 22 a. A poisonous or otherwise deleterious non-kratom 23 ingredient, including a controlled substance. 24 b. A dangerous psychoactive compound, including synthetic 25 cannabinoids, synthetic cathinones, or any other compound that 26 significantly alters the safety profile of the kratom product. 27 3. A kratom processor, registrant, or retailer shall not 28 offer for sale any of the following: 29 a. A kratom product that is combustible, intended to be used 30 for vaporization, or injectable. 31 b. A kratom product that is attractive to children. 32 c. A product containing kratom that is not a kratom product. 33 Sec. 4. NEW SECTION . 124F.4 Kratom product —— labeling. 34 A kratom product produced, manufactured, distributed, 35 -3- LSB 2242YH (9) 91 ss/ko 3/ 10

H.F. 612 offered, sold, or offered for sale shall include a label 1 that clearly and conspicuously provides all of the following 2 information on each retail package: 3 1. A statement against the use by individuals who are 4 under twenty-one years of age, who are pregnant, or who are 5 breastfeeding. 6 2. A recommendation to consult a health care professional 7 prior to use. 8 3. A statement that kratom may be habit forming. 9 4. The following statement: “These statements have not been 10 evaluated by the United States food and drug administration. 11 This product is not intended to diagnose, treat, cure, or 12 prevent any disease.” 13 5. The name and address for the place of business of the 14 registrant. 15 6. Directions for use that include all of the following: 16 a. A recommended amount of the kratom product per serving. 17 (1) For kratom products sold as capsules, gummies, or 18 prepackaged single-serving units, the recommended amount shall 19 be clearly described on the label. 20 (2) For kratom products sold as beverages, liquids, or 21 loose powders, a clear instruction or a mark on the package or 22 container that clearly informs the consumer of the recommended 23 serving size. 24 b. The number of servings that can be safely consumed in a 25 twenty-four-hour period. 26 c. A listing of the servings per container. 27 d. A listing of kratom alkaloids and other ingredients in 28 the product, including a quantitative not-to-exceed declaration 29 of the amount per serving of each of the following: 30 (1) Mitragynine. 31 (2) 7-hydroxymitragynine. 32 e. A kratom food service establishment that sells kratom as 33 a beverage prepared on site shall provide an equivalent label 34 in card form, or prominently display the required language in a 35 -4- LSB 2242YH (9) 91 ss/ko 4/ 10

H.F. 612 location next to the point-of-sale device to the customer, at 1 the time the beverage is purchased by the consumer. 2 f. A kratom product that contains psychoactive compounds 3 otherwise permitted by law must be clearly labeled with a full 4 disclosure of all active ingredients, the exact concentration 5 of each compound, and adequate warning statements about the 6 potential interactions and risks associated with the combined 7 use of these substances. 8 Sec. 5. NEW SECTION . 124F.5 Enforcement. 9 1. A person shall not sell or distribute a kratom product 10 that is not currently registered for sale in this state. 11 The department shall seize and destroy an unregistered 12 kratom product and the costs shall be assessed to the person 13 responsible for the availability of the kratom product in this 14 state. A kratom processor that sells or distributes a kratom 15 product that is not currently registered for sale in this state 16 is subject to the following penalties: 17 a. For the first sale or distribution of an unregistered 18 kratom product, ten thousand dollars, to be collected by the 19 department and deposited in the general fund of the state. 20 b. For the second sale or distribution of an unregistered 21 kratom product for which a fine was imposed pursuant to 22 paragraph “a” , fifteen thousand dollars, to be collected by the 23 department and deposited in the general fund of the state. 24 c. Upon the third sale or distribution of an unregistered 25 kratom product for which a fine was imposed pursuant to 26 paragraph “a” , the kratom processor shall be prohibited from 27 selling or distributing any kratom product in this state 28 for a period of two years following the third sale of the 29 unregistered kratom product. 30 2. A person shall not knowingly or willfully sell or 31 distribute a kratom product to a person under twenty-one years 32 of age. A person who violates this subsection shall be subject 33 to the following: 34 a. For a first offense, a simple misdemeanor. 35 -5- LSB 2242YH (9) 91 ss/ko 5/ 10

H.F. 612 b. For a second or subsequent offense within one year of the 1 date of the first offense, a serious misdemeanor. 2 3. A person shall not knowingly or willfully manufacture, 3 deliver, hold, offer for sale, distribute, or sell a kratom 4 product that contains any controlled substance. A person who 5 violates this subsection is guilty of a class “D” felony. 6 4. A person shall not knowingly or willfully manufacture, 7 deliver, hold, offer for sale, distribute, or sell a kratom 8 product that contains synthetic mitragynine, synthetic 9 7-hydroxymitragynine, or any other synthetically derived 10 compound of the plant Mitragyna speciosa. A person who 11 violates this subsection is guilty of a serious misdemeanor. 12 5. a. If the department has reason to believe that 13 a registered kratom product in this state violates the 14 requirements for registration under this chapter, the 15 department shall require the registrant to produce a current 16 certificate of analysis from an independent testing laboratory 17 showing compliance with the requirements for registration 18 under this chapter. If the registrant does not produce 19 a current certificate of analysis showing compliance with 20 the requirements for registration under this chapter within 21 a reasonable time period, the department shall revoke the 22 registration for the kratom product and immediately order the 23 stoppage of all sales of the kratom product. 24 b. If the department has reason to believe that the 25 independent testing laboratory used by a registrant has not 26 provided accurate results, the department shall submit the 27 kratom product for testing to an independent testing laboratory 28 of the department’s choice and the costs of the test shall be 29 assessed to the registrant. If the registrant fails to tender 30 payment within thirty calendar days of receipt of a request for 31 payment from the department, the department shall revoke the 32 registration for the kratom product and immediately order the 33 stoppage of all sales of the kratom product. 34 6. A registrant does not violate this section by 35 -6- LSB 2242YH (9) 91 ss/ko 6/ 10

H.F. 612 manufacturing, delivering, holding, offering for sale, 1 distributing, or selling a kratom product that contains 2 psychoactive compounds that has been reviewed and approved 3 by the department for safe consumption under clearly defined 4 conditions of use. 5 7. A retailer does not violate this section if the 6 retailer shows by a preponderance of the evidence that the 7 retailer relied in good faith upon the representations of a 8 manufacturer, packer, or kratom processor regarding a product 9 represented to be a kratom product. 10 Sec. 6. NEW SECTION . 124F.6 Rules. 11 The department shall adopt rules pursuant to chapter 17A for 12 the administration of this chapter. The rules shall include 13 all of the following: 14 1. The process for the registration of a kratom product by a 15 kratom processor or retailer. 16 2. The requirements for the enforcement of the prohibition 17 of the sale of a kratom product to a person under twenty-one 18 years of age. 19 3. Testing requirements for independent testing 20 laboratories that issue certificates of analysis for kratom 21 products. 22 4. Other rules as necessary for the implementation of this 23 chapter. 24 Sec. 7. NEW SECTION . 124F.7 Legislative intent. 25 It is the intent of the general assembly that this chapter be 26 liberally construed to ensure the safety of kratom products and 27 prevent the distribution of kratom products to minors. 28 EXPLANATION 29 The inclusion of this explanation does not constitute agreement with 30 the explanation’s substance by the members of the general assembly. 31 This bill relates to the regulation of kratom. The bill 32 requires a person responsible for placing a kratom product, 33 defined in the bill, into commerce in the state to annually 34 register that product for sale with the department of health 35 -7- LSB 2242YH (9) 91 ss/ko 7/ 10

H.F. 612 and human services (department). The bill requires an 1 application for registration to include a certification 2 that the product is manufactured, processed, and held in a 3 facility that complies with federal laws for good manufacturing 4 practices, a current federal food and drug administration 5 food facility registration certificate, a statement that the 6 applicant has a reasonable basis to believe that the kratom 7 product is safe, a certificate from an independent testing 8 laboratory showing compliance with the requirements of the 9 bill, and an application fee. The bill allows an application 10 for registration to include multiple kratom products if the 11 kratom products contain the same ingredients sold in the same 12 form but in a different container, package, or volume. The 13 bill requires the department to create and maintain a database 14 of all kratom products that are registered for sale in this 15 state. 16 The bill prohibits a kratom product from containing 17 certain adulterants. The bill prohibits a kratom processor, 18 registrant, or retailer from selling a kratom product that is 19 combustible, vaporizable, attractive to children, as defined in 20 the bill, or a product containing kratom that is not a kratom 21 product. 22 The bill requires a kratom product produced, manufactured, 23 distributed, offered, sold, or offered for sale in this state 24 to include a label that advises against use by individuals 25 who are under 21 years of age, who are pregnant, or who are 26 breastfeeding, recommends consultation with a health care 27 professional, states that kratom may be habit forming, states 28 that the efficacy of the product has not been evaluated by the 29 United States food and drug administration, includes the name 30 and address for the place of business of the registrant, and 31 includes directions for use. 32 The bill prohibits a person from selling or distributing a 33 kratom product that is not currently registered for sale in 34 this state. The bill requires the department to seize and 35 -8- LSB 2242YH (9) 91 ss/ko 8/ 10

H.F. 612 destroy an unregistered kratom product and to assess the costs 1 to the person responsible for the availability of the kratom 2 product in this state. The bill requires the department to 3 impose a fee for the first and second sale or distribution of a 4 particular unregistered kratom product and to prohibit a person 5 from selling or distributing kratom products for two years 6 following the third sale or distribution of an unregistered 7 kratom product. The bill prohibits a person from knowingly or 8 willfully selling or distributing a kratom product to a person 9 under 21 years of age. A person who violates this provision of 10 the bill for the first time is guilty of a simple misdemeanor. 11 A simple misdemeanor is punishable by confinement for no more 12 than 30 days and a fine of at least $105 but not more than 13 $855. A person who violates this provision of the bill a 14 second or subsequent time within one year of the first offense 15 is guilty of a serious misdemeanor. A serious misdemeanor is 16 punishable by confinement for no more than one year and a fine 17 of at least $430 but not more than $2,560. The bill prohibits 18 a person from knowingly or willfully manufacturing, delivering, 19 holding, offering for sale, distributing, or selling a kratom 20 product that contains a controlled substance. A person who 21 violates this provision of the bill is guilty of a class “D” 22 felony. A class “D” felony is punishable by confinement for 23 no more than five years and a fine of at least $1,025 but not 24 more than $10,245. The bill prohibits a person from knowingly 25 or willfully manufacturing, delivering, holding, offering 26 for sale, distributing, or selling a kratom product that 27 contains synthetically derived compounds of the plant Mitragyna 28 speciosa. A person who violates this provision of the bill is 29 guilty of a serious misdemeanor. 30 If the department has reason to believe that a registered 31 kratom product violates the requirements for registration, 32 the bill requires the department to require the registrant to 33 produce a current certificate of analysis from an independent 34 testing laboratory showing compliance with the requirements for 35 -9- LSB 2242YH (9) 91 ss/ko 9/ 10

H.F. 612 registration under the bill. If the registrant does not timely 1 produce a certificate showing compliance, the bill requires the 2 department to revoke the registration of the kratom product 3 and immediately order the stoppage of all sales of the kratom 4 product. If the department has reason to believe that the 5 independent testing laboratory used by a registrant has not 6 provided accurate results, the bill requires the department to 7 submit the kratom product for testing to an independent testing 8 laboratory of the department’s choice, with costs assessed to 9 the registrant. If the registrant fails to tender payment 10 within 30 calendar days of receipt of a request for payment 11 from the department, the bill requires the department to revoke 12 the registration of the kratom product and immediately order 13 the stoppage of all sales of the kratom product. The bill 14 exempts a retailer from punishment for a violation of the bill 15 if the retailer shows by a preponderance of the evidence that 16 the retailer relied in good faith upon the representations of a 17 manufacturer, packer, or kratom processor regarding a product 18 represented to be a kratom product. 19 The bill requires the department to adopt rules for the 20 implementation of the bill, including for the process of 21 registration of a kratom product, the requirements for 22 enforcing the prohibition on sale of kratom products to 23 persons under 21 years of age, the testing requirements for 24 independent testing laboratories, and other rules as necessary 25 for implementation of the bill. 26 The bill includes legislative intent language. 27 -10- LSB 2242YH (9) 91 ss/ko 10/ 10