Rhode Island 2023 Regular Session

Rhode Island Senate Bill S0329 Compare Versions

Only one version of the bill is available at this time.

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5	5	2023 -- S 0329
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7	7	LC001960
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9	9	S TATE OF RHODE IS LAND
10	10	IN GENERAL ASSEMBLY
11	11	JANUARY SESSION, A.D. 2023
12	12	____________
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14	14	A N A C T
15	15	RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROTECTION ACT
16	16	Introduced By: Senators DiPalma, Miller, Euer, Acosta, and Gallo
17	17	Date Introduced: February 16, 2023
18	18	Referred To: Senate Judiciary
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21	21	It is enacted by the General Assembly as follows:
22	22	SECTION 1. Title 21 of the General Laws entitled "FOOD AND DRUGS" is hereby 1
23	23	amended by adding thereto the following chapter: 2
24	24	CHAPTER 28.12 3
25	25	KRATOM CONSUMER PROTECTION ACT 4
26	26	21-28.12-1. Short title. 5
27	27	This chapter shall be known and may be cited as the "Kratom Consumer Protection Act." 6
28	28	21-28.12-2. Definitions. 7
29	29	As used in this chapter: 8
30	30	(1) “Department” means the department of health. 9
31	31	(2) "Director" means the director of the department of health. 10
32	32	(3) "Food" means a food, food product, food ingredient, dietary ingredient, dietary 11
33	33	supplement, or beverage for human consumption. 12
34	34	(4) “Kratom extract” means a food product or dietary ingredient containing any part of the 13
35	35	leaf of the plant Mitragyna speciosa that has been extracted and concentrated in order to provide 14
36	36	more standardized dosing. 15
37	37	(5) "Kratom product" means a food product or dietary ingredient containing any part of the 16
38	38	leaf of the plant Mitragyna speciosa or an extract of it, and is manufactured as a powder, capsule, 17
39	39	pill, beverage, or other edible form. All kratom products are foods. 18
40	40	(6) "Processor" means a person that sells, prepares, manufactures, distributes, or maintains 19
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43	43	LC001960 - Page 2 of 4
44	44	kratom products, or advertises, represents, or holds itself out as selling, preparing, or maintaining 1
45	45	kratom products. 2
46	46	(7) “Retailer” means any person that sells, distributes, advertises, represents, or holds itself 3
47	47	out as selling or maintaining kratom products. 4
48	48	21-28.12-3. Kratom product limitations. 5
49	49	A processor shall not prepare, distribute, sell, or expose for sale any of the following: 6
50	50	(1) A kratom product that is adulterated with a dangerous non-kratom substance. A kratom 7
51	51	product is adulterated with a dangerous non-kratom substance if the kratom product is mixed or 8
52	52	packed with a non-kratom substance and that substance affects the quality or strength of the kratom 9
53	53	product to such a degree as to render the kratom product injurious to a consumer. 10
54	54	(2) A kratom product that is contaminated with a dangerous non-kratom substance. A 11
55	55	kratom product is contaminated with a dangerous non-kratom substance if the kratom product 12
56	56	contains a poisonous or otherwise deleterious non-kratom ingredient, including, but not limited to, 13
57	57	the substances listed in § 21-28-2.08. 14
58	58	(3) A kratom extract that contains levels of residual solvents higher than is allowed in the 15
59	59	U.S. Pharmacopeia 467. 16
60	60	(4) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction 17
61	61	that is greater than two percent (2%) of the overall alkaloid composition of the product. 18
62	62	(5) A kratom product containing any synthetic alkaloids including synthetic mitragynine, 19
63	63	synthetic 7-hydroxymitragynine, or any other synthetically derived compounds of the kratom plant. 20
64	64	(6) A kratom product that does not provide adequate labeling directions necessary for safe 21
65	65	and effective use by consumers, including a recommended serving size. 22
66	66	21-28.12-4. Age limits. 23
67	67	A processor shall not distribute, sell, or expose for sale a kratom product to an individual 24
68	68	under eighteen (18) years of age. 25
69	69	21-28.12-5. Kratom product registration. 26
70	70	(a) A processor shall register annually any kratom product intended to be offered for sale 27
71	71	to an end consumer in Rhode Island that is in an approved kratom delivery form and pay a fee, 28
72	72	adjusted annually, to cover all administrative costs for processing and administering such 29
73	73	registrations. The registration shall include a certificate of analysis from a certified independent 30
74	74	third-party laboratory showing compliance with the requirements of this chapter for safe kratom 31
75	75	products. 32
76	76	(b) Product non-compliance reports. Upon receipt of a violation report on any kratom 33
77	77	product offered for sale, the department shall require the processor to produce an updated and 34
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81	81	current certificate of analysis in a reasonable time frame from a certified independent third-party 1
82	82	laboratory showing compliance with the requirements of this chapter for safe kratom products. If 2
83	83	the processor does not provide the certificate of analysis in the specified time frame, the registration 3
84	84	for that product shall be revoked. 4
85	85	(c) Adverse event reports. Upon receipt of any adverse event related to a registered kratom 5
86	86	product, the processor shall be required to submit a copy via certified mail to the department their 6
87	87	adverse event report that is required to be submitted to the U.S. Food and Drug Administration 7
88	88	(FDA) under Section 761 of the Federal Food Drug & Cosmetic Act (21 U.S.C. §379aa-1(b)(1)). 8
89	89	Any documented failure to report an adverse event to the department shall authorize the department 9
90	90	to revoke the product’s registration. 10
91	91	(d) Third-party verification: If the department has a reasonable basis to require an 11
92	92	independent third-party test of a registered kratom product by a laboratory of the department’s 12
93	93	choice, the processor shall be required to submit payment for the test within a reasonable time 13
94	94	frame. If the processor does not tender payment to the department within thirty (30) days of receipt 14
95	95	of the invoice for the testing, the department shall revoke the registration for that product. 15
96	96	21-28.12-6. Violations. 16
97	97	(a) A processor that violates the provisions of § 21-28.12-3 shall be subject to an 17
98	98	administrative fine of not more than five hundred dollars ($500) for the first offense and not more 18
99	99	than one thousand dollars ($1,000) for a second or subsequent offense. Upon the request of a person 19
100	100	to whom an administrative fine is issued, the director shall conduct a hearing in accordance with 20
101	101	the procedures as set forth in chapter 35 of title 42 ("administrative procedures"). 21
102	102	(b) A retailer does not violate § 21-28.12-3 if it is shown by a preponderance of the 22
103	103	evidence that the retailer relied in good faith upon the representations of a manufacturer, processor, 23
104	104	packer, or distributor of food represented to be a kratom product. 24
105	105	SECTION 2. This act shall take effect on September 1, 2023. 25
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112	112	EXPLANATION
113	113	BY THE LEGISLATIVE COUNCIL
114	114	OF
115	115	A N A C T
116	116	RELATING TO FOOD AND DRUGS -- KRATOM CONSUMER PROT ECTION ACT
117	117	***
118	118	This act would regulate the distribution of the product known as "kratom" and would ban 1
119	119	the adulteration of kratom with a dangerous non-kratom substance as to render the product injurious 2
120	120	to a consumer. This act would require that any kratom product shall contain adequate labeling 3
121	121	directions necessary for safe and effective use by consumers. Violations of this chapter would be 4
122	122	subject to administrative fines from five hundred dollars ($500) to one thousand dollars ($1,000). 5
123	123	This act would take effect on September 1, 2023. 6
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