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S TATE OF RHODE IS LAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2023
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A N A C T
RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROT ECTION 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 1
amended by adding thereto the following chapter: 2
CHAPTER 28.12 3
KRATOM CONSUMER PROTECTION ACT 4
21-28.12-1. Short title. 5
This chapter shall be known and may be cited as the "Kratom Consumer Protection Act 6
(KCPA)." 7
21-28.12-2. Definitions. 8
As used in this chapter: 9
(1) "Director" means the director of the department of health. 10
(2) "Food" means a dietary ingredient. dietary supplement, botanical supplement, or 11
beverage for human consumption. 12
(3) "Kratom extract" means a dietary ingredient, dietary supplement, botanical supplement 13
or containing any part of the leaf of the plant Mitragyna speciosa that has been extracted and 14
concentrated in order to provide more standardized dosing 15
(4) "Kratom product" means a dietary ingredient, dietary supplement, botantical 16
supplement, or containing any part of the leaf of the plant Mitragyna speciosa or an extract of it; is 17
manufactured as a powder, capsule, pill, beverage. or other edible form: and all kratom products 18
are dietary ingredients, dietary supplements, or botanical supplements. 19
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(5) "Processor" means a person that sells, prepares, manufactures, distributes, or maintains 1
kratom products. 2
(6) "Retailer" means any person that sells, distributes, advertises, represents, or holds itself 3
out as selling or maintaining kratom products. 4
21-28.12-3. Kratom product limitations. 5
A processor shall not prepare, distribute, sell, or expose for sale any of the following: 6
(1) A kratom product that is adulterated with a dangerous non-kratom substance. A kratom 7
product is adulterated with a dangerous non-kratom substance if the kratom product is mixed or 8
packed with a non-kratom substance and that substance affects the quality or strength of the kratom 9
product to such a degree as to render the kratom product injurious to a consumer. 10
(2) A kratom product that is contaminated with a dangerous non-kratom substance. A 11
kratom product is contaminated with a dangerous non-kratom substance if the kratom product 12
contains a poisonous or otherwise deleterious non-kratom ingredient, including, but not limited to, 13
the substances listed in § 21-28-2.08. 14
(3) A kratom extract that contains levels of residual solvents higher than is allowed in the 15
U.S. Pharmacopeia 467. 16
(4) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction 17
that is greater than one percent (1%) of the overall alkaloid composition of the product. 18
(5) A kratom product containing any synthetic alkaloids including synthetic mitragynine, 19
synthetic 7-hydroxymitragynine, or any other synthetically derived compounds of the kratom plant. 20
(6) A kratom product that does not provide adequate labeling directions necessary for safe 21
and effective use by consumers, including a recommended serving size. 22
21-28.12-4. Age limits. 23
A processor shall not distribute, sell, or expose for sale a kratom product to an individual 24
under twenty-one (21) years of age. 25
21-28.12-5. Kratom product registration. 26
(a) A processor shall register annually any kratom product intended to be offered for sale 27
to an end consumer in Rhode Island that is in an approved kratom delivery form and pay a fee, 28
adjusted annually, to cover all administrative costs for processing and administering such 29
registrations. The registration shall include a certificate of analysis from a certified independent 30
third-party laboratory showing compliance with the KCPA requirements for safe kratom products. 31
(b) A retailer shall register annually to sell any kratom product sold in their establishment 32
and pay a fee (adjusted annually) to cover all administration costs for processing and administering 33
such registrations. A retailer shall not sell any kratom product that is not registered for sale as 34
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provided in subsection (a) of this section. 1
(c) Product non-compliance reports. Upon receipt of a violation report on any kratom 2
product offered for sale, the department shall require the processor to produce an updated and 3
current certificate of analysis in a reasonable time frame from a certified independent third-party 4
laboratory showing compliance with the KCPA requirements for safe kratom products. If the 5
processor does not provide the certificate of analysis in the specified time frame, the registration 6
for that product shall be revoked. 7
(d) Adverse event reports. Upon receipt of any adverse event related to a registered kratom 8
product, the processor shall be required to submit a copy via certified mail to the department of 9
their adverse event report that is required to be submitted to the U.S. Food and Drug Administration 10
(FDA) under Section 761 of the Federal Food Drug & Cosmetic Act. Any documented failure to 11
report an adverse event to the department shall authorize the department to revoke the product’s 12
registration. 13
(e) Third-party verification: If the department has a reasonable basis to require an 14
independent third-party test of a registered kratom product by a laboratory of the department’s 15
choice, the processor shall be required to submit payment for the test within a reasonable time 16
frame. If the processor does not tender payment to the department within thirty (30) days of receipt 17
of the invoice for the testing, the department shall revoke the registration for that product. 18
21-28.12-6. Violations. 19
(a) A processor or retailer that violates the provisions of § 21-28.12-3 shall be subject to 20
an administrative fine of not more than five hundred dollars ($500) for the first offense and not 21
more than one thousand dollars ($1,000) for a second or subsequent offense. Upon the request of a 22
person to whom an administrative fine is issued, the director shall conduct a hearing in accordance 23
with the procedures as set forth in chapter 35 of title 42 ("administrative procedures"). 24
(b) Upon receipt of a third violation pursuant to subsection (a) of this section, the 25
registration of the retailer shall be revoked and the retailer shall be prohibited from selling any 26
kratom product. 27
(c) A retailer does not violate § 21-28.12-3 if it is shown by a preponderance of the evidence 28
that the retailer relied in good faith upon the representations of a manufacturer, processor, packer, 29
or distributor of food represented to be a kratom product. 30
21-28.12-7. Taxation of kratom products. 31
A "kratom product" as defined in 21-28.12-2., is subject to sales and use tax, at the rates as 32
provided in §§ 44-18-18 and 44-18-20. 33
21-28.12-8. Removal of mitragynine and 7-hydroxymitragynine from notice of 34
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designation of controlled substances for mitragynine and hydroxymitragynine under 1
schedule I section 2.08 (g). 2
Upon enactment, mitragynine and 7-hydroxymitragynine shall be removed from § 21-28-3
2.08(g) of the Rhode Island Uniform Controlled Substances Act. 4
SECTION 2. This act shall take effect on January 1, 2024. 5
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EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROT ECTION ACT
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This act would regulate the distribution of the product known as "kratom" and would ban 1
the adulteration of kratom with a dangerous non-kratom substance as to render the product injurious 2
to a consumer. This act would require that any kratom product shall contain adequate labeling 3
directions necessary for safe and effective use by consumers. Violations of this chapter would be 4
subject to administrative fines from five hundred dollars ($500) to one thousand dollars ($1,000). 5
This act would take effect on January 1, 2024. 6
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