H-8168

   Amend House File 2133 as follows:
   1.  By striking everything after the enacting clause and inserting: 
   <Section 1.  NEW SECTION.  124F.1  Definitions.
   As used in this chapter, unless the context otherwise requires:
   1.  “Attractive to children” means a quality of a product manufactured that is either:
   a.  In a shape that resembles a human, a cartoon character, or an animal.
   b.  In a form that resembles an existing candy product that is a widely distributed, branded food item.
   2.  “Department” means the department of health and human services.
   3.  “Finished kratom product” means a kratom product that is ready for sale to the end user. For purposes of registration, a finished kratom product is differentiated by its ingredients, not by its weight, volume, or size.
   4.  “Food service establishment” means any establishment providing or serving food directly to consumers that is regulated by the department and local public health agencies.
   5.  “Kratom” means the plant, or any part of the plant, Mitragyna speciosa.
   6.  “Kratom food service establishment” means any food service establishment that sells finished kratom products.
   7.  “Kratom product” means a food product, food ingredient, dietary ingredient, dietary supplement, or beverage intended for human consumption that contains any part of the leaf of the kratom plant and is manufactured as a powder, capsule, pill, or other consumable form.
   8.  “Processor” means an entity that does any of the following:
   a.  Refines kratom into input ingredients for the purpose of manufacturing a finished kratom product.
   b.  Manufactures finished kratom products.
   c.  Packages finished kratom products for resale.
   Sec. 2.  NEW SECTION.  124F.2  Product requirements.
   Finished kratom products sold to consumers at a retail establishment, a convenience store, or a kava or kratom bar in this state:
   1.  Shall be in one of the following delivery forms:
   a.  Dried leaf.
   b.  Powder.
   c.  Pill.
   d.  Liquid.
   e.  Capsule.
   2.  Shall possess a certificate of analysis that has been submitted to the department as required under this chapter.
   3.  Shall be registered with the department.
   4.  Shall include directions for consumption of the kratom product on the product’s label, including but not limited to the following information:
   a.  A maximum dosage of one hundred milligrams of kratom alkaloids per serving.
   b.  The number of servings per package.
   c.  The amount in milligrams of 7-hydroxymitragynine and mitragynine per serving.
   d.  A warning advising consumers of the number of servings that may be safely consumed in a twenty-four-hour period.
   e.  A warning prohibiting use by individuals who are under twenty-one years of age.
   f.  A warning advising against use by individuals who are pregnant or breast-feeding.
   g.  A warning advising the consumer to consult a health care professional before use, that the product may be habit-forming, and that the product may cause adverse health effects.
   h.  The following warning 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.”

   i.  The expiration date.
   j.  The name and place of business of the registrant.
   5.  Shall comply with the packaging and labeling requirements set forth in this chapter and the rules adopted thereunder.
   6.  Shall not be attractive to children.
   7.  Shall be in a container that meets all of the following conditions:
   a.  Is suitable to contain products for human consumption.
   b.  Is compliant with the federal Poison Prevention Packaging Act of 1970, 15 U.S.C. §1471 et seq.
   c.  Contains a graduated measuring device, if applicable.
   8.  Shall not be adulterated including but not limited to by containing metals, pesticides, or pathogens in excess of the limits set by this chapter or department rule.
   9.  Shall be sold only in establishments that restrict entry to persons who are twenty-one years of age or older and require age verification.
   10.  Shall not be served in a form that combines or mixes finished kratom products with psychoactive substances that impact the central nervous system including but not limited to alcohol, caffeine, kava, cannabinoids, and nicotine.
   Sec. 3.  NEW SECTION.  124F.3  Manufacturing and distribution.
   1.  Kratom products shall be manufactured or distributed in this state only by a processor who is subject to and in compliance with all state laws and regulations applicable to food processors. Kratom products shall not be manufactured or distributed by a cottage food producer under section 137F.20.
   2.  A processor that manufactures, processes, packs, or offers for sale kratom, kratom products, or finished kratom products shall be properly registered with the United States food and drug administration.
   3.  A processor shall comply with current good manufacturing practices contained in 21 C.F.R. pt. 210.
   4.  A processor shall maintain product liability insurance with a minimum occurrence limit of three million dollars.
   5.  For each batch of a registered finished kratom product, the processor shall retain and submit, upon request, a certificate of analysis to the department from a laboratory accredited pursuant to international organization for standardization/international electrotechnical commission standard 17025 or other compararble accreditation standard required by the department. The processor shall not have any direct or indirect financial or economic interest in the laboratory or accrediting body. The processor shall maintain the certificates of analysis for a minimum of one year after the finished kratom product’s expiration date. The certificate of analysis shall demonstrate that the finished kratom product is in compliance with the concentration limits established by statute or rule for the following:
   a.  Alkaloid and alkaloid metabolites.
   b.  Residual solvents.
   c.  Heavy metals including but not limited to cadmium, arsenic, mercury, and lead.
   d.  Pesticides and any other substance limited by rule of the department.
   6.  A finished kratom product served by a kratom food service establishment shall be registered with the department and comply with the requirements of this chapter. A person shall not serve kratom beverages combined with alcohol, drugs, or other kratom products.
   7.  This chapter shall not apply to finished kratom products processed or manufactured in this state and subsequently shipped or transported out of this state for sale or use outside of this state.
   8.  Finished kratom products produced in this state and subsequently shipped or transported out of this state for sale or use outside of this state:
   a.  Shall not be sold, shipped, or transported to a consumer in this state, to a retail establishment in this state, or to a person who sells or intends to sell such products to a consumer in this state.
   b.  Shall be in a package with the following marking in a bold font size of at least thirty-six points:

   NOT FOR USE OR RETAIL SALE IN IOWA

   c.  Shall be physically separated from finished kratom products that are, or are intended to be, sold or used in this state.
   Sec. 4.  NEW SECTION.  124F.4  Adverse health events.
   1.  If a processor or the department receives notice of any adverse health event suspected to be related to the processor’s kratom product, the processor or the department shall submit an adverse event report, as set out in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §379aa-1(b)(1), to the United States food and drug administration.
   2.  If probable cause exists that a kratom product may be adulterated, the department may require an independent third-party test of the kratom product by a laboratory of the department’s choice, and the processor shall pay the cost of the test. If the processor does not make such payment to the department within thirty days after receiving the invoice for the testing fee, the department shall revoke the registration for that product.
   Sec. 5.  NEW SECTION.  124F.5  Penalties.
   1.  A processor that manufactures, delivers, offers for sale, distributes, or sells a finished kratom product that violates section 124F.2 or 124F.3 shall be guilty of a serious misdemeanor.
   2.  Kratom products possessed, manufactured, delivered, offered for sale, distributed, or sold in violation of this chapter by an entity regulated under this chapter may be detained or embargoed and the entity in violation is subject to all penalties and remedies that apply for a violation of this chapter. The department shall not grant permission to remove or use, except for disposal, detained or embargoed finished kratom products that are attractive to children until the finished kratom products comply with this chapter.
   3.  If a processor fails to provide the department with a certificate of analysis within seven days after receiving a request from the department or fails to immediately report an adverse health event to the department as required by section 124F.4, the department may revoke the processor’s finished kratom product registration.
   4.  A processor that manufactures, delivers, offers for sale, distributes, or sells a kratom product that contains any controlled substance or adulterants commits a serious misdemeanor and may be subject to criminal penalties under chapter 124.
   5.  A laboratory that fails to ensure the accuracy of its certificates of analysis issued under this chapter is subject to an administrative fine in an amount determined by the department by rule.
   Sec. 6.  NEW SECTION.  124F.6  Rules.
   The department shall adopt rules pursuant to chapter 17A necessary to administer this chapter.
   Sec. 7.  NEW SECTION.  124F.7  Citation.
   This chapter shall be known as and may be cited as the “Iowa Kratom Consumer Protection Act”.>
   2.  Title page, by striking lines 1 and 2 and inserting <An Act establishing the Iowa kratom consumer protection Act, and providing penalties.>

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SORENSEN of Adair