HF 612 (LSB 2242YH (9) 91)

HOUSE FILE 612

BY  GOLDING and BARKER

A BILL FOR

An Act relating to the regulation of kratom, and making penalties applicable.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  NEW SECTION.  124F.1  Definitions.
   As used in this chapter:
   1.  “Attractive to children” means a kratom product that is manufactured in the shape of cartoons or animals or is manufactured or packaged in a form that bears any reasonable resemblance to an existing candy product that is familiar to the public as a widely distributed, branded food product, such that a product could be mistaken for the branded product, especially by children.
   2.  “Department” means the department of health and human services.
   3.  “Independent testing laboratory” means a laboratory that is accredited to standard ISO/IEC 17025 by an international organization for standards-approved accrediting body.
   4.  “Kratom” means the plant Mitragyna speciosa or any part of the plant, including all alkaloids present in the plant.
   5.  “Kratom extract” means a substance or compound obtained by extraction of the Mitragyna speciosa leaf, intended for ingestion, containing more than trace amounts of Mitragyna speciosa and containing other alkaloids of the kratom plant, but does not contain any controlled substances or levels of residual solvents higher than is allowed in the United States pharmacopeia 467.
   6.  “Kratom food service establishment” means a person who sells kratom as a beverage prepared on site, or sells prepackaged kratom beverages or finished kratom products, at a food establishment as defined in section 137F.1.
   7.  “Kratom processor” means a person who manufactures, distributes, maintains, or sells a kratom product or a person who advertises, represents, or claims to sell, prepare, or maintain a kratom product.
   8.  “Kratom product” means a finished article containing any part of a leaf of the plant Mitragyna speciosa in fresh, dehydrated, or dried form, or a kratom extract.
   9.  “Registrant” means a person or kratom processor that sells, prepares, manufactures, distributes, or maintains kratom products, or advertises, represents, or holds itself out as selling, preparing, or maintaining kratom products.
   10.  “Retailer” means a person that sells, distributes, advertises, represents, or holds itself out as selling kratom products.
   11.  “Synthesized material” means an alkaloid or alkaloid derivative that has been created by chemical synthesis or biosynthetic means, including fermentation, recombinant techniques, yeast-derived techniques, and enzymatic techniques, rather than traditional food preparation techniques, such as heating or extracting, that synthetically alters the composition of any kratom alkaloid or constituent.
    Sec. 2.  NEW SECTION.  124F.2  Kratom product —— registration.
   1.  A person responsible for placing a kratom product into commerce in the state shall register annually to offer the kratom product for sale or distribution. The application for registration shall include all of the following:
   a.  A certification from a qualified independent auditor that the applicant meets or exceeds guidelines published by the federal food and drug administration for current good manufacturing practices for any facility that manufactures, processes, packs, or holds a kratom product.
   b.  A current federal food and drug administration food facility registration certificate for any kratom processor facility that manufactures, processes, packs, or holds a kratom product.
   c.  A statement that the applicant has a reasonable basis that the product is safe for consumption under the conditions of use set forth on the label and that the applicant assumes responsibility and liability for any kratom product offered for sale by the applicant.
   d.  A certificate of analysis from an independent testing laboratory showing compliance with the requirements of this chapter for residual solvents, 7-hydroxymitragynine content, and heavy metal contaminants.
   e.  An application fee as determined by the board by rule.
   2.  An application for registration may include multiple kratom products if the kratom products contain the same ingredients sold in the same form but in a different container, package, or volume.
   3.  The department shall create and maintain on the department’s internet site a database of all kratom products that are registered for sale in this state.
    Sec. 3.  NEW SECTION.  124F.3  Kratom product —— limitations.
   1.  A registrant shall not prepare, distribute, sell, or expose for sale a kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than two percent of the alkaloid composition of the kratom product. A product that contains a level of 7-hydroxymitragynine greater than two percent shall not be marketed as, labeled as, or contain any reference on the product’s packaging, that it is a kratom product or state that the product is derived from the alkaloid mitragynine.
   2.  A kratom processor, registrant, or retailer shall not offer for sale a kratom product that contains any of the following:
   a.  A poisonous or otherwise deleterious non-kratom ingredient, including a controlled substance.
   b.  A dangerous psychoactive compound, including synthetic cannabinoids, synthetic cathinones, or any other compound that significantly alters the safety profile of the kratom product.
   3.  A kratom processor, registrant, or retailer shall not offer for sale any of the following:
   a.  A kratom product that is combustible, intended to be used for vaporization, or injectable.
   b.  A kratom product that is attractive to children.
   c.  A product containing kratom that is not a kratom product.
    Sec. 4.  NEW SECTION.  124F.4  Kratom product —— labeling.
   A kratom product produced, manufactured, distributed, offered, sold, or offered for sale shall include a label that clearly and conspicuously provides all of the following information on each retail package:
   1.  A statement against the use by individuals who are under twenty-one years of age, who are pregnant, or who are breastfeeding.
   2.  A recommendation to consult a health care professional prior to use.
   3.  A statement that kratom may be habit forming.
   4.  The following statement: “These statements have not been evaluated by the United States food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
   5.  The name and address for the place of business of the registrant.
   6.  Directions for use that include all of the following:
   a.  A recommended amount of the kratom product per serving.
   (1)  For kratom products sold as capsules, gummies, or prepackaged single-serving units, the recommended amount shall be clearly described on the label.
   (2)  For kratom products sold as beverages, liquids, or loose powders, a clear instruction or a mark on the package or container that clearly informs the consumer of the recommended serving size.
   b.  The number of servings that can be safely consumed in a twenty-four-hour period.
   c.  A listing of the servings per container.
   d.  A listing of kratom alkaloids and other ingredients in the product, including a quantitative not-to-exceed declaration of the amount per serving of each of the following:
   (1)  Mitragynine.
   (2)  7-hydroxymitragynine.
   e.  A kratom food service establishment that sells kratom as a beverage prepared on site shall provide an equivalent label in card form, or prominently display the required language in a location next to the point-of-sale device to the customer, at the time the beverage is purchased by the consumer.
   f.  A kratom product that contains psychoactive compounds otherwise permitted by law must be clearly labeled with a full disclosure of all active ingredients, the exact concentration of each compound, and adequate warning statements about the potential interactions and risks associated with the combined use of these substances.
    Sec. 5.  NEW SECTION.  124F.5  Enforcement.
   1.  A person shall not sell or distribute a kratom product that is not currently registered for sale in this state. The department shall seize and destroy an unregistered kratom product and the costs shall be assessed to the person responsible for the availability of the kratom product in this state. A kratom processor that sells or distributes a kratom product that is not currently registered for sale in this state is subject to the following penalties:
   a.  For the first sale or distribution of an unregistered kratom product, ten thousand dollars, to be collected by the department and deposited in the general fund of the state.
   b.  For the second sale or distribution of an unregistered kratom product for which a fine was imposed pursuant to paragraph “a”, fifteen thousand dollars, to be collected by the department and deposited in the general fund of the state.
   c.  Upon the third sale or distribution of an unregistered kratom product for which a fine was imposed pursuant to paragraph “a”, the kratom processor shall be prohibited from selling or distributing any kratom product in this state for a period of two years following the third sale of the unregistered kratom product.
   2.  A person shall not knowingly or willfully sell or distribute a kratom product to a person under twenty-one years of age. A person who violates this subsection shall be subject to the following:
   a.  For a first offense, a simple misdemeanor.
   b.  For a second or subsequent offense within one year of the date of the first offense, a serious misdemeanor.
   3.  A person shall not knowingly or willfully manufacture, deliver, hold, offer for sale, distribute, or sell a kratom product that contains any controlled substance. A person who violates this subsection is guilty of a class “D” felony.
   4.  A person shall not knowingly or willfully manufacture, deliver, hold, offer for sale, distribute, or sell a kratom product that contains synthetic mitragynine, synthetic 7-hydroxymitragynine, or any other synthetically derived compound of the plant Mitragyna speciosa. A person who violates this subsection is guilty of a serious misdemeanor.
   5.  a.  If the department has reason to believe that a registered kratom product in this state violates the requirements for registration under this chapter, the department shall require the registrant to produce a current certificate of analysis from an independent testing laboratory showing compliance with the requirements for registration under this chapter. If the registrant does not produce a current certificate of analysis showing compliance with the requirements for registration under this chapter within a reasonable time period, the department shall revoke the registration for the kratom product and immediately order the stoppage of all sales of the kratom product.
   b.  If the department has reason to believe that the independent testing laboratory used by a registrant has not provided accurate results, the department shall submit the kratom product for testing to an independent testing laboratory of the department’s choice and the costs of the test shall be assessed to the registrant. If the registrant fails to tender payment within thirty calendar days of receipt of a request for payment from the department, the department shall revoke the registration for the kratom product and immediately order the stoppage of all sales of the kratom product.
   6.  A registrant does not violate this section by manufacturing, delivering, holding, offering for sale, distributing, or selling a kratom product that contains psychoactive compounds that has been reviewed and approved by the department for safe consumption under clearly defined conditions of use.
   7.  A retailer does not violate this section if the retailer shows by a preponderance of the evidence that the retailer relied in good faith upon the representations of a manufacturer, packer, or kratom processor regarding a product represented to be a kratom product.
    Sec. 6.  NEW SECTION.  124F.6  Rules.
   The department shall adopt rules pursuant to chapter 17A for the administration of this chapter. The rules shall include all of the following:
   1.  The process for the registration of a kratom product by a kratom processor or retailer.
   2.  The requirements for the enforcement of the prohibition of the sale of a kratom product to a person under twenty-one years of age.
   3.  Testing requirements for independent testing laboratories that issue certificates of analysis for kratom products.
   4.  Other rules as necessary for the implementation of this chapter.
    Sec. 7.  NEW SECTION.  124F.7  Legislative intent.
   It is the intent of the general assembly that this chapter be liberally construed to ensure the safety of kratom products and prevent the distribution of kratom products to minors.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to the regulation of kratom. The bill requires a person responsible for placing a kratom product, defined in the bill, into commerce in the state to annually register that product for sale with the department of health and human services (department). The bill requires an application for registration to include a certification that the product is manufactured, processed, and held in a facility that complies with federal laws for good manufacturing practices, a current federal food and drug administration food facility registration certificate, a statement that the applicant has a reasonable basis to believe that the kratom product is safe, a certificate from an independent testing laboratory showing compliance with the requirements of the bill, and an application fee. The bill allows an application for registration to include multiple kratom products if the kratom products contain the same ingredients sold in the same form but in a different container, package, or volume. The bill requires the department to create and maintain a database of all kratom products that are registered for sale in this state.
   The bill prohibits a kratom product from containing certain adulterants. The bill prohibits a kratom processor, registrant, or retailer from selling a kratom product that is combustible, vaporizable, attractive to children, as defined in the bill, or a product containing kratom that is not a kratom product.
   The bill requires a kratom product produced, manufactured, distributed, offered, sold, or offered for sale in this state to include a label that advises against use by individuals who are under 21 years of age, who are pregnant, or who are breastfeeding, recommends consultation with a health care professional, states that kratom may be habit forming, states that the efficacy of the product has not been evaluated by the United States food and drug administration, includes the name and address for the place of business of the registrant, and includes directions for use.
   The bill prohibits a person from selling or distributing a kratom product that is not currently registered for sale in this state. The bill requires the department to seize and destroy an unregistered kratom product and to assess the costs to the person responsible for the availability of the kratom product in this state. The bill requires the department to impose a fee for the first and second sale or distribution of a particular unregistered kratom product and to prohibit a person from selling or distributing kratom products for two years following the third sale or distribution of an unregistered kratom product. The bill prohibits a person from knowingly or willfully selling or distributing a kratom product to a person under 21 years of age. A person who violates this provision of the bill for the first time is guilty of a simple misdemeanor. A simple misdemeanor is punishable by confinement for no more than 30 days and a fine of at least $105 but not more than $855. A person who violates this provision of the bill a second or subsequent time within one year of the first offense is guilty of a serious misdemeanor. A serious misdemeanor is punishable by confinement for no more than one year and a fine of at least $430 but not more than $2,560. The bill prohibits a person from knowingly or willfully manufacturing, delivering, holding, offering for sale, distributing, or selling a kratom product that contains a controlled substance. A person who violates this provision of the bill is guilty of a class “D” felony. A class “D” felony is punishable by confinement for no more than five years and a fine of at least $1,025 but not more than $10,245. The bill prohibits a person from knowingly or willfully manufacturing, delivering, holding, offering for sale, distributing, or selling a kratom product that contains synthetically derived compounds of the plant Mitragyna speciosa. A person who violates this provision of the bill is guilty of a serious misdemeanor.
   If the department has reason to believe that a registered kratom product violates the requirements for registration, the bill requires the department to require the registrant to produce a current certificate of analysis from an independent testing laboratory showing compliance with the requirements for registration under the bill. If the registrant does not timely produce a certificate showing compliance, the bill requires the department to revoke the registration of the kratom product and immediately order the stoppage of all sales of the kratom product. If the department has reason to believe that the independent testing laboratory used by a registrant has not provided accurate results, the bill requires the department to submit the kratom product for testing to an independent testing laboratory of the department’s choice, with costs assessed to the registrant. If the registrant fails to tender payment within 30 calendar days of receipt of a request for payment from the department, the bill requires the department to revoke the registration of the kratom product and immediately order the stoppage of all sales of the kratom product. The bill exempts a retailer from punishment for a violation of the bill if the retailer shows by a preponderance of the evidence that the retailer relied in good faith upon the representations of a manufacturer, packer, or kratom processor regarding a product represented to be a kratom product.
   The bill requires the department to adopt rules for the implementation of the bill, including for the process of registration of a kratom product, the requirements for enforcing the prohibition on sale of kratom products to persons under 21 years of age, the testing requirements for independent testing laboratories, and other rules as necessary for implementation of the bill.
   The bill includes legislative intent language.