SECTION 1. The General Laws, as appearing in the 2024 official edition, are hereby amended by inserting after Chapter 94 the following new chapter:

 Chapter 94J. Regulation of Kratom.

 Section 1. Definitions

 As used in this chapter the following words shall, unless the context clearly requires otherwise, have the following meanings:

 “Attractive to children”, kratom products manufactured in or featuring the shape, likeness, or otherwise bear resemblance to fictional characters, cartoons, or animals or is manufactured or packaged in a form that bears any reasonable resemblance to a candy product or branded food product such that a product could be mistaken for the branded product, especially by children.

 “Department”, the department of public health

 “Distributor”, a person that sells, prepares, distributes, or maintains kratom products, or advertises, represents, or otherwise holds itself out as selling, preparing, or maintaining kratom products.

 “Kratom”, the plant Mitragyna speciosa or any part of that plant, including all components present in the natural plant.

 “Kratom food service establishment”, means any person who sells kratom as a beverage prepared on-site, or sells pre-packaged kratom beverages or finished kratom products, at a licensed food service establishment.

 “Kratom product”, a food, dietary ingredient or beverage intended for human consumption which contains any part of the leaf of the plant Mitragyna speciosa or an extract of the Mitragyna speciosa leaf and is manufactured or served as a powder, capsule, pill, beverage, liquid, or other edible form.

 “Kratom extract”, a substance or compound obtained by extraction of the Mitragyna speciosa leaf, intended for ingestion, containing more than trace amounts of Mitragyna speciosa and contains other alkaloids of the kratom plant, which does not contain any controlled substances or levels of residual solvents higher than is allowed in the U.S. Pharmacopeia 467.

 “Registrant”, a person or processor that sells, prepares, manufactures, distributes, or maintains kratom products, or advertises, represents, or holds itself out as selling, preparing, or maintaining kratom products.

 “Retailer”, any person that sells, distributes, advertises, represents, or holds itself out as selling kratom products.

  "Synthesized material", an alkaloid or alkaloid derivative that has been created by chemical synthesis or biosynthetic means, including but not limited to; fermentation, recombinant techniques, yeast derived, enzymatic techniques, rather than traditional food preparation techniques, such as heating or extracting that synthetically alters the composition of any kratom alkaloid or constituent.

 Section 2. Kratom Product Limitations;

 (a) a registrant or retailer shall not prepare, distribute, sell, or expose for sale any of the following:

 (1) a product containing a concentration ratio greater than: (i) 150 milligrams of mitragynine per serving; (ii) 0.5 milligrams of 7-hydroxymitragynine per gram, or; (iii) greater than 1 milligram of 7-hydroxymitragynine per serving.

 (2) a kratom product that is adulterated with a poisonous or otherwise deleterious non-kratom ingredient, including, but not limited to, substances considered as “controlled substances” pursuant to section 1 of chapter 94C or applicable federal laws or substances that, when mixed or packed with kratom, affects the quality or strength of the kratom product to such a degree as to render the kratom product injurious to a consumer;

 (3) a kratom product that is adulterated with dangerous psychoactive compounds, which include, but are not limited to, natural or synthetic cannabinoids, synthetic cathinones, synthetic alkaloids, or other compounds that may significantly alter the safety profile of the kratom product;

 (4) is in any form that is combustible, intended to be used for vaporization, or injectable;

 (5) a kratom product that contains synthetic alkaloids, including synthetic mitragine, synthetic 7-hydroxymitragynine, or other synthetically derived alkaloids or kratom constituents.

 (6) a kratom product that contains levels of residual solvents higher than what is allowed under U.S. Pharmacopeia 467.

 (7) a kratom product that is attractive to children or contains symbolism, imagery, characters, branding, or other visual elements that could be considered to reasonably appeal to children, or

 (8) a product containing kratom or kratom by-products that does not fall into the definition of “kratom products” as provided in section 1 of this chapter.

 (b) no person, registrant, retailer, manufacturer, or other entity shall sell a kratom product intended for human ingestion without a label or fact sheet that clearly states: (i) the name and address of its manufacturer; (ii) a full list of ingredients; (iii) notice that the product has not been reviewed or approved as a medication by the FDA; and (iv) directions for the product's safe and effective use, including recommended serving size.

 (c) no person, registrant,  retailer, manufacturer, or other entity shall sell, offer to sell, make available for sale, gift, offer to gift, or otherwise provide or distribute a kratom product to any person under 21 years of age.

 (d) any registrant, retailer or other entity that violates subsection (a) or subsection (b) shall be subject to an administrative fine of not more than $500 for the first offense and $1,000 for subsequent offenses, provided, however, that a retailer does not violate subsection (a) or subsection (b) if they can show by a preponderance of the evidence that they relied in good faith upon the representations of a manufacturer, processor, packer or distributor of a kratom product or food represented to be a kratom product that such product was in compliance with this section.

 (e) a person, registrant, retailer, or other entity that willfully or knowingly violates subsection (c) shall be punished by a fine up to $10,000. A person, retailer, or other entity that recklessly or negligently violates subsection (c) shall be punished by a fine up to $5,000. A person, retailer, or other entity that otherwise violates subsection (c) shall be punished by a fine up to $1,000 for the first offense and up to $5,000 for subsequent offenses.

 (f) a registrant that is found to have willfully or knowingly violate subsections (a), (b), or (c) shall, consistent with the procedural requirements of Chapter 30A,

 Section 3. Registration

 (a) no person, retailer, or other entity shall engage in the sale, preparation for sale, or manufacturing of kratom products without first registering with the department. The department shall offer registration through an online portal.

 (b) the department may, in its discretion, impose a reasonable fee on prospective registrants prior to approval of any registration.

 (c) a registrant that is found to have willfully or knowingly violate subsections (a), (b), or (c) of section 2 of this chapter shall, consistent with the requirements of Chapter 30A, have their registration revoked by the department. A registrant that otherwise violates said subsections (a), (b), or (c) of section 2 of this chapter may, consistent with the requirements of chapter 30A, have their registration revoked by the department.

 Section 4. Rulemaking

 The department shall promulgate rules and regulations necessary to administer the provisions of this chapter, subject to the requirements of chapter 30A.

 SECTION 2. Notwithstanding any general or special law to the contrary, the Department of Public Health, in collaboration with the Department of Agricultural Resources, shall investigate, research, and make recommendations regarding the best practices for kratom regulation. Such recommendations shall include: (1) recommended legislative changes to effectively regulate kratom dosage, potency, laboratory testing, retailer registration and oversight of kratom sales, (2) the needed staffing necessary to effectively create a licensing and registration system for kratom retailers, manufacturers, and laboratory testing, and (3) any other best practices or legislative changes that the department deem necessary. The department shall publish its report and file with the clerks of the house and senate, the chairs of the joint committees on ways and means, public health, and mental health, substance use and recovery no later than January 1, 2030.