SB463

SECTION 1. Chapter 328, Hawaii Revised Statutes, is amended by adding a new part to be appropriately designated and to read as follows:

"Part . Hawaii Kratom consumer protection act

§328-A Short title. This part shall be known and may be cited as the Hawaii Kratom Consumer Protection Act.

§328-B Definitions. As used in this chapter:

"Attractive to children" means kratom products 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.

"Independent testing laboratory" means a laboratory accredited by a third-party accrediting body as a competent testing laboratory pursuant to standard 17025 of the International Organization for Standardization and International Electrotechnical Commission specialized system for worldwide standardization, commonly abbreviated as ISO/IEC 17025.

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

"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 contains other alkaloids of the kratom plant, which does not contain any controlled substances or levels of residual solvents greater than is allowed in the U.S. Pharmacopeia General Chapter 467.

"Kratom food service establishment" means a person who sells kratom as a beverage prepared on-site, or sells pre-packaged kratom beverages or finished kratom products, at a food service establishment licensed by the department.

"Kratom product" means a food, food ingredient, dietary ingredient, dietary supplement, or beverage intended for human consumption that 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.

"Synthesized material" means an alkaloid or alkaloid derivative that has been created by chemical synthesis or biosynthetic means, including fermentation, recombinant techniques, yeast derived, 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.

§328-C Kratom products; limitations. (a) No person shall sell, offer for sale, advertise, distribute, produce, or manufacture any of the following:

(1) A kratom product that contains:

(A) A level of 7-hydroxymitragynine in the alkaloid fraction that is more than two per cent of the alkaloid composition of the kratom product; provided that any product that contains a level of 7-hydroxymitragynine in the alkaloid fraction more than two per cent of the alkaloid composition cannot be marketed, labeled, or contain any reference on its packaging, that it is a kratom product or referenced that it is derived from the alkaloid mitragynine;

(B) Kratom extract and that contains levels of residual solvents greater than is allowed in the U.S. Pharmacopeia General Chapter 467; or

(C) Dangerous psychoactive compounds, including but not limited to synthetic cannabinoids or synthetic cathinones, or any other compound that significantly alters the safety profile of the kratom product;

(2) A kratom product that is adulterated;

(3) A kratom product produced or manufactured in a manner that is attractive to children;

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

(5) A product that contains any part of the leaf of the plant Mitragyna speciosa or an extract of the Mitragyna speciosa leaf and that does not conform to the definition of kratom product.

(b) For purpose of this section, a kratom product shall be deemed adulterated if:

(1) The kratom product contains a poisonous or otherwise deleterious non-kratom ingredient, including but not limited to substances listed as a controlled substance under federal law or chapter 329;

(2) The kratom product contains any synthesized material or alkaloids or other plant constituents that have been isolated or manipulated to artificially increase their potency through a method other than traditional food preparation techniques, unless the manufacturer has safety data to support the increased potency according to the conditions for use on the label in the populations the data supports; or

(3) A kratom product is combined with another compound that is known to inhibit key cytochrome P450 enzymes, including CYP3A4 and CYP2D6, unless such specific product mixtures are scientifically validated as safe under the intended conditions of use and are specifically permitted by the department by rules adopted pursuant to chapter 91.

§328-D Kratom product registration; required. (a) No person shall place a kratom product into commerce in the State unless the person has registered the kratom product with the department on a form prescribed by the department with a fee as provided under subsection (b) and the sworn certifications under subsection (d).

(b) The registration fee shall be determined by department by rule adopted pursuant to chapter 91. The fee shall be adjusted annually to cover all administrative costs for processing and administering the registration, including the necessary personnel and the publication and maintenance of a kratom registration webpage as provided in this section.

(c) A person registering a kratom product under section 328-C(b)(2) or (3) shall pay an additional fee determined by the department pursuant to chapter 91 based on the costs incurred to retain the services of qualified experts to review the safety data provided by the person to allow the department to conduct a review and make a final decision.

(d) Applications for registration shall include sworn certifications from the kratom product's producer or manufacturer of the following:

(1) The kratom product was manufactured, processed, or held in a facility that is in compliance with current good manufacturing practices that meet requirements of title 21 Code of Federal Regulations section 111;

(2) A statement that the producer or manufacturer has a reasonable basis that the product is safe for consumption under the conditions of use set forth on the label; provided that the person registering the kratom product shall assume responsibility and liability for the kratom product; and

(3) A certificate of analysis from a certified third-party independent testing laboratory showing compliance with the requirements of this chapter for residual solvents, 7-hydroxymitragynine content, contaminants, and synthesized materials.

(e) Products that contain identical kratom ingredients in identical kratom delivery forms shall be included in a single registration regardless of whether the containers, packages, or volumes are identical.

(f) Each registration shall expire on December 31 of each year. Before December 31 of each year, the person shall renew the registration on a form prescribed by the department with a fee as provided under subsection (b).

(g) The department shall publish and maintain a kratom registration page on the department's website listing all registered kratom products available to be sold, offered for sale, or distributed in the State.

§328-E Kratom products; labeling. A kratom product sold, offered for sale, advertised, distributed, produced, or manufactured in the State shall have 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 eighteen 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 the address for the place of business of the registrant; and

(6) Directions for use that includes the following:

(A) A recommended amount of the kratom product per serving that is:

(i) Clearly described on the label for product forms, such as capsules, gummies, prepackaged single serving units, and similar product forms; or

(ii) For beverages, liquids, or loose powders, a clear instruction or a mark on the package or container that clearly informs the consumer on the recommended serving size;

(B) A recommended number of servings that can be safely consumed in a twenty-four-hour period;

(D) A listing of kratom alkaloids and other ingredients in the product, including quantitative not to exceed declarations of the amount per serving of mitragynine and 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; and

(F) For any kratom product that contains psychoactive compounds otherwise permitted shall 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.

§328-F Enforcement. (a) Each kratom product without a valid registration shall be seized and destroyed, and the costs associated with the enforcement shall be assessed to the person selling, offering for sale, advertising, or distributing the kratom product.

(b) No person shall sell or offer for sale a kratom product intended to a person under eighteen years of age. A person who knowingly commits a second or subsequent violation of this subsection within one year after the initial violation shall be guilty of a misdemeanor.

(c) A person who knowingly sells, offers for sale, advertises, distributes, produces, or manufactures a kratom product containing any substance listed as a controlled substance under federal law or chapter 329 shall be guilty of a class C felony.

(d) A person who knowingly sells, offers for sale, advertises, distributes, produces, or manufactures a kratom product containing any synthesized material, including synthetic mitragynine, synthetic 7-hydroxymitragynine, or any other synthetically derived compound of the plant Mitragyna speciosa, or alkaloids or other plant shall constitute a violation of section 328-C(b)(2). A violation of this subsection shall result in the immediate seizure and destruction of the kratom products and may result in the penalties under section 328-29. Any person who, within five years of the instant offense, has convictions of two or more violations of this subsection shall be guilty of a class C felony.

(e) A person who violates section 328-C(b), except as provided under subsection (d), shall be subject to the penalties under section 328-29.

(f) Upon receipt of a violation report on any kratom product sold, offered for sale, advertised, distributed, produced, or manufactured, the department shall require the person to produce an updated and current certificate of analysis in a reasonable time frame from a certified third-party independent testing laboratory showing compliance with the requirements of this part for safe kratom products. If the person does not provide the certificate of analysis in the specified time frame, the registration for that product shall be revoked and a stop sale order shall be issued for products covered by the registration.

(g) If the department has a reasonable basis to require an independent third-party test of a registered kratom product by an independent testing laboratory of the department's choice, the person shall be required to submit payment for the test within a reasonable time frame. If the person does not tender payment to the department within thirty days of receipt of the invoice for the testing, the department shall revoke the registration for that product and a stop sale order shall be issued for products covered by the registration.

(h) No person shall be in violation of this part for any kratom product that has been reviewed and approved by the department for safe consumption in combination with psychoactive compounds under clearly defined conditions of use.

(i) No person shall be in violation of this part if it is shown by a preponderance of the evidence that the person relied in good faith upon the representations of a manufacturer, producer, or distributor of food represented to be a kratom product.

§328-G Rules. The department shall adopt rules pursuant to chapter 91 to effectuate this part. The rules shall provide:

(1) The process for a registration of a kratom product by a person;

(2) The requirements for enforcing the restriction on the sale of any kratom product to a person under the age of eighteen; and

(3) Proof of appropriate quality testing from an independent testing laboratory in the form of a certificate of analysis representing the product does not contain levels of residual solvents, biological contaminants or heavy metal contaminants that violates the standard for dietary supplement products.

§328-H Federal preemption. If at any time on or after the effective date of this part, the federal government or any department or agency thereof, including but not limited to the federal Drug Enforcement Administration or United States Food and Drug Administration, regulates 7-hydroxymitragynine, 7-hydroxymitragynine extracts, 7-hydroxymitragynine products, any other derivative of the plant Mitragyna speciosa, 7-hydroxymitragynine processors, or 7-hydroxymitragynine retailers, including the acceptance by the United States Food and Drug Administration of a new dietary ingredient notification, those federal regulations shall supersede and take precedence over any provision of this part and any administrative regulation promulgated thereunder to the contrary that is addressed by the federal action."

SECTION 2. In codifying the new sections added by section 1 of this Act, the revisor of statutes shall substitute appropriate section numbers for the letters used in designating the new sections in this Act.

SECTION 3. This Act does not affect rights and duties that matured, penalties that were incurred, and proceedings that were begun before its effective date.

SECTION 4. This Act shall take effect on January 1, 2026.

INTRODUCED BY:	_____________________________

THE SENATE	S.B. NO.	463
THIRTY-THIRD LEGISLATURE, 2025
STATE OF HAWAII