2023 -- H 5330

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2023

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A N   A C T

RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROTECTION ACT

     Introduced By: Representatives Edwards, and Kennedy

     Date Introduced: February 03, 2023

     Referred To: House Corporations

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby

amended by adding thereto the following chapter:

CHAPTER 28.12

KRATOM CONSUMER PROTECTION ACT

     21-28.12-1. Short title.

     This chapter shall be known and may be cited as the "Kratom Consumer Protection Act."

     21-28.12-2. Definitions.

     As used in this chapter:

     (1) “Department” means the department of health.

     (2) "Director" means the director of the department of health.

     (3) "Food" means a food, food product, food ingredient, dietary ingredient, dietary

supplement, or beverage for human consumption.

     (4) “Kratom extract” means a food product or dietary ingredient containing any part of the

leaf of the plant Mitragyna speciosa that has been extracted and concentrated in order to provide

more standardized dosing.

     (5) "Kratom product" means a food product or dietary ingredient containing any part of the

leaf of the plant Mitragyna speciosa or an extract of it, and is manufactured as a powder, capsule,

pill, beverage, or other edible form. All kratom products are foods.

     (6) "Processor" means a person that sells, prepares, manufactures, distributes, or maintains

kratom products, or advertises, represents, or holds itself out as selling, preparing, or maintaining

kratom products.

     (7) “Retailer” means any person that sells, distributes, advertises, represents, or holds itself

out as selling or maintaining kratom products.

     21-28.12-3. Kratom product limitations.

     A processor shall not prepare, distribute, sell, or expose for sale any of the following:

     (1) A kratom product that is adulterated with a dangerous non-kratom substance. A kratom

product is adulterated with a dangerous non-kratom substance if the kratom product is mixed or

packed with a non-kratom substance and that substance affects the quality or strength of the kratom

product to such a degree as to render the kratom product injurious to a consumer.

     (2) A kratom product that is contaminated with a dangerous non-kratom substance. A

kratom product is contaminated with a dangerous non-kratom substance if the kratom product

contains a poisonous or otherwise deleterious non-kratom ingredient, including, but not limited to,

the substances listed in § 21-28-2.08.

     (3) A kratom extract that contains levels of residual solvents higher than is allowed in the

U.S. Pharmacopeia 467.

     (4) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction

that is greater than two percent (2%) of the overall alkaloid composition of the product.

     (5) A kratom product containing any synthetic alkaloids including synthetic mitragynine,

synthetic 7-hydroxymitragynine, or any other synthetically derived compounds of the kratom plant.

     (6) A kratom product that does not provide adequate labeling directions necessary for safe

and effective use by consumers, including a recommended serving size.

     21-28.12-4. Age limits.

     A processor shall not distribute, sell, or expose for sale a kratom product to an individual

under eighteen (18) years of age.

     21-28.12-5. Kratom product registration.

     (a) A processor shall register annually any kratom product intended to be offered for sale

to an end consumer in Rhode Island that is in an approved kratom delivery form and pay a fee,

adjusted annually, to cover all administrative costs for processing and administering such

registrations. The registration shall include a certificate of analysis from a certified independent

third-party laboratory showing compliance with the requirements of this chapter for safe kratom

products.

     (b) Product non-compliance reports. Upon receipt of a violation report on any kratom

product offered for sale, the department shall require the processor to produce an updated and

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current certificate of analysis in a reasonable time frame from a certified independent third-party

laboratory showing compliance with the requirements of this chapter for safe kratom products. If

the processor does not provide the certificate of analysis in the specified time frame, the registration

for that product shall be revoked.

     (c) Adverse event reports. Upon receipt of any adverse event related to a registered kratom

product, the processor shall be required to submit a copy via certified mail to the department their

adverse event report that is required to be submitted to the U.S. Food and Drug Administration

(FDA) under Section 761 of the Federal Food Drug & Cosmetic Act (21 U.S.C. §379aa-1(b)(1)).

Any documented failure to report an adverse event to the department shall authorize the department

to revoke the product’s registration.

     (d) Third-party verification: If the department has a reasonable basis to require an

independent third-party test of a registered kratom product by a laboratory of the department’s

choice, the processor shall be required to submit payment for the test within a reasonable time

frame. If the processor does not tender payment to the department within thirty (30) days of receipt

of the invoice for the testing, the department shall revoke the registration for that product.

     21-28.12-6. Violations.

     (a) A processor that violates the provisions of § 21-28.12-3 shall be subject to an

administrative fine of not more than five hundred dollars ($500) for the first offense and not more

than one thousand dollars ($1,000) for a second or subsequent offense. Upon the request of a person

to whom an administrative fine is issued, the director shall conduct a hearing in accordance with

the procedures as set forth in chapter 35 of title 42 ("administrative procedures").

     (b) A retailer does not violate § 21-28.12-3 if it is shown by a preponderance of the

evidence that the retailer relied in good faith upon the representations of a manufacturer, processor,

packer, or distributor of food represented to be a kratom product.

     SECTION 2. This act shall take effect on September 1, 2023.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROTECTION ACT

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     This act would regulate the distribution of the product known as "kratom" and would ban

the adulteration of kratom with a dangerous non-kratom substance as to render the product injurious

to a consumer. This act would require that any kratom product shall contain adequate labeling

directions necessary for safe and effective use by consumers. Violations of this chapter would be

subject to administrative fines from five hundred dollars ($500) to one thousand dollars ($1,000).

     This act would take effect on September 1, 2023.

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