VT
Vermont House Bill H0416

Vermont 2025-2026 Regular Session

Vermont House Bill H0416 Compare Versions

Only one version of the bill is available at this time.
OldNewDifferences
11 BILL AS INTRODUCED H.416
22 2025 Page 1 of 10
33
44
55 VT LEG #381089 v.1
66 H.416 1
77 Introduced by Representatives Headrick of Burlington and Gregoire of 2
88 Fairfield 3
99 Referred to Committee on 4
1010 Date: 5
1111 Subject: Health; labeling of food, drugs, cosmetics, and hazardous substances; 6
1212 kratom 7
1313 Statement of purpose of bill as introduced: This bill proposes to require the 8
1414 Department of Health to develop and maintain a registry for kratom products 9
1515 prepared, manufactured, sold, distributed, or maintained in the State. It further 10
1616 proposes labeling requirements for kratom products prepared, sold, delivered, 11
1717 or maintained in the State and enforcement standards for violations of the 12
1818 proposed provisions. 13
1919 An act relating to the regulation of kratom products 14
2020 It is hereby enacted by the General Assembly of the State of Vermont: 15
2121 Sec. 1. SHORT TITLE 16
2222 This act may be cited as the “Kratom Consumer Protection Act.” 17
2323 Sec. 2. 18 V.S.A. chapter 82, subchapter 3 is added to read: 18
2424 Subchapter 3. Kratom Consumer Protection Act 19 BILL AS INTRODUCED H.416
2525 2025 Page 2 of 10
2626
2727
2828 VT LEG #381089 v.1
2929 § 4091. DEFINITIONS 1
3030 As used in this subchapter: 2
3131 (1) “Attractive to children” means the preparation, manufacturing, or 3
3232 packaging of a kratom product in a manner that bears any reasonable 4
3333 resemblance to an existing candy product or branded food product so as to be 5
3434 easily mistaken for the candy product or the branded product, especially by 6
3535 children. 7
3636 (2) “Department” means the Department of Health. 8
3737 (3) “Distributor” means a person that sells, distributes, or maintains 9
3838 kratom products in the State or a person who advertises, represents, or holds 10
3939 themselves out as selling, distributing, or maintaining kratom products in the 11
4040 State. 12
4141 (4) “Extract” means a substance or compound obtained by extraction of 13
4242 the leaf of the plant Mitragyna speciosa, intended for ingestion, which contains 14
4343 more than trace amounts of Mitragyna speciosa and other alkaloids of the plant 15
4444 and does not contain any controlled substances or levels of residual solvents 16
4545 higher than permitted by the U.S. Pharmacopeia 467. 17
4646 (5) “Independent laboratory testing” means a laboratory that is 18
4747 accredited by a third-party accrediting body as a competent testing laboratory 19
4848 pursuant to ISO/IEC 17025 of the International Organization for 20
4949 Standardization. 21 BILL AS INTRODUCED H.416
5050 2025 Page 3 of 10
5151
5252
5353 VT LEG #381089 v.1
5454 (6) “Kratom” means the plant Mitragyna speciosa or any part of the 1
5555 plant. 2
5656 (7) “Kratom food service establishment” means a food service 3
5757 establishment licensed pursuant to chapter 85 of this title that sells or 4
5858 distributes: 5
5959 (A) kratom as a beverage prepared on-site; or 6
6060 (B) a prepackaged kratom beverage or finished kratom product. 7
6161 (8) “Kratom product” or “product” means a finished article containing 8
6262 any part of the leaf of the plant Mitragyna speciosa in fresh, dehydrated, or 9
6363 dried form, or a kratom extract. 10
6464 (9) “Processor” means a person who prepares, manufactures, sells, or 11
6565 maintains kratom products in the State or a person who advertises, represents, 12
6666 or holds themselves out as preparing, manufacturing, selling, or maintaining 13
6767 kratom products in the State. 14
6868 (10) “Retailer” means a person who sells, distributes, advertises, or 15
6969 represents kratom products or a person who holds themself out as selling, 16
7070 distributing, advertising, or representing kratom products. 17
7171 (11) “Synthesized material” means an alkaloid, metabolite, or alkaloid 18
7272 derivative that has been created by chemical synthesis or biosynthetic means, 19
7373 including fermentation, recombinant techniques, yeast-derived, and enzymatic 20
7474 techniques, rather than traditional food preparation techniques, such as heating 21 BILL AS INTRODUCED H.416
7575 2025 Page 4 of 10
7676
7777
7878 VT LEG #381089 v.1
7979 or extracting, that synthetically alters the composition of any kratom alkaloid 1
8080 or constituent. 2
8181 § 4092. KRATOM PRODUCT PROHIBITIONS 3
8282 A processor or distributor shall not prepare, manufacture, sell, offer for sale, 4
8383 distribute, or maintain in the State any kratom product that: 5
8484 (1) contains or is adulterated with a dangerous non-kratom substance, 6
8585 including a poisonous or otherwise deleterious non-kratom ingredient or 7
8686 substance listed as a controlled substance under State or federal law; 8
8787 (2) is mixed with another compound that is known to inhibit key 9
8888 cytochrome P450 enzymes, including CYP3A4 or CYP2D6, or both, unless a 10
8989 specific mixture is scientifically validated safe under the intended conditions of 11
9090 use and are permitted by the Department by rule; 12
9191 (3) is a kratom extract product that contains levels of residual solvents 13
9292 exceeding those allowed in the U.S. Pharmacopeia; 14
9393 (4) contains synthesized material; 15
9494 (5) is in a form that is combustible, intended to be used for vaporization, 16
9595 or injectable; 17
9696 (6) is prepared, manufactured, or packaged in a manner that is attractive 18
9797 to children; and 19
9898 (7) is not registered on the Department’s registry pursuant to section 20
9999 4093 of this subchapter. 21 BILL AS INTRODUCED H.416
100100 2025 Page 5 of 10
101101
102102
103103 VT LEG #381089 v.1
104104 § 4093. KRATOM PRODUCT REGISTRATION 1
105105 (a) A processor or distributor shall register annually with the Department 2
106106 any kratom product that is in an approved kratom delivery form intended to be 3
107107 offered for sale or distributed to a consumer in the State. The registering 4
108108 processor or distributor shall pay a fee to the Department, subject to annual 5
109109 adjustment, to cover all administrative costs for processing and administering 6
110110 registrations and developing and maintaining a kratom product registry web 7
111111 page on the Department’s website. The processor or distributor’s registration 8
112112 application shall include: 9
113113 (1) sworn assurances from the processor or distributor that any facility 10
114114 in which the kratom product was prepared, manufactured, or maintained has a 11
115115 valid food facility registration with the U.S. Food and Drug Administration; 12
116116 (2) evidence demonstrating that the processor or distributor has a 13
117117 reasonable basis for believing the kratom product is safe for consumption 14
118118 under the conditions of use set forth on the product’s label; 15
119119 (3) a certificate of analysis from an independent testing laboratory 16
120120 showing compliance with the requirements for kratom products in accordance 17
121121 with this subchapter; and 18
122122 (4) sworn assurances that the processor or distributor has a reasonable 19
123123 basis for believing the kratom product complies with the prohibitions listed in 20
124124 section 4092 of this title. 21 BILL AS INTRODUCED H.416
125125 2025 Page 6 of 10
126126
127127
128128 VT LEG #381089 v.1
129129 (b) A kratom product containing the same kratom ingredients in the same 1
130130 approved kratom delivery form, but in a different container, package, or 2
131131 volume, shall be included in a single registration. 3
132132 (c) The Department shall publish and maintain a kratom registry page on its 4
133133 website listing all kratom products currently registered for sale in the State to 5
134134 enable retailers to verify whether a kratom product is permissible for sale or 6
135135 distribution to consumers. 7
136136 § 4094. KRATOM PRODUCT LABELING 8
137137 (a) Unless otherwise preempted under federal law, a kratom product 9
138138 prepared, manufactured, sold, delivered, offered for sale, or maintained in the 10
139139 State shall bear a conspicuous label on the packaging with the following: 11
140140 (1) a recommendation against the use of the kratom product by 12
141141 individuals under 21 years of age or who are pregnant or breastfeeding; 13
142142 (2) a recommendation that an individual consult with a health care 14
143143 professional prior to use; 15
144144 (3) a statement that kratom may be habit forming; 16
145145 (4) a statement in accordance with 21 C.F.R. § 101.93 that “These 17
146146 statements have not been evaluated by the Food and Drug Administration. 18
147147 This product is not intended to diagnose, treat, cure, or prevent disease.”; 19
148148 (5) the name and place of business of the processor or distributor 20
149149 registering the kratom product; and 21 BILL AS INTRODUCED H.416
150150 2025 Page 7 of 10
151151
152152
153153 VT LEG #381089 v.1
154154 (6) instructions for use of the kratom product, including; 1
155155 (A) the recommended amount of the kratom product per serving for 2
156156 the specific approved product form, including capsules, gummies, beverages, 3
157157 liquids, and loose powders; 4
158158 (B) the recommended number of servings that can be safely 5
159159 consumed in a 24-hour period; 6
160160 (C) a listing of servings per container; and 7
161161 (D) a listing of kratom alkaloids and other ingredients in the product, 8
162162 including quantities not to exceed declarations of the amount per serving for 9
163163 Mitragynine speciosa and 7-hydroxymitragynine. 10
164164 (b) A kratom food service establishment serving kratom as a beverage 11
165165 prepared on-site shall provide the information listed in subsection (a) of this 12
166166 section to the customer by supplying a written document directly to the 13
167167 customer or by prominently displaying the information near the point of sale 14
168168 device. 15
169169 (c) A kratom product containing a level of 7-hydrocymitragynine greater 16
170170 than the two percent limit shall not be marketed or labeled on its packaging as 17
171171 a kratom product or as a derivative of the alkaloid Mitragynine. 18
172172 § 4095. ENFORCEMENT 19
173173 (a)(1) No person shall knowingly sell, distribute, offer for sale, hold for 20
174174 sale, or give away a kratom product that is not registered with the Department. 21 BILL AS INTRODUCED H.416
175175 2025 Page 8 of 10
176176
177177
178178 VT LEG #381089 v.1
179179 (2) A person who violates this subsection shall: 1
180180 (A) be fined not more than $5,000.00 for each unregistered product; 2
181181 (B) be fined not more than $10,000.00 for a second or subsequent 3
182182 violation relating to the same product; and 4
183183 (C) be prohibited from selling a kratom product for a period of two 5
184184 years for a third or subsequent violation relating to the same product. 6
185185 (b)(1) No person shall knowingly sell kratom product intended for human 7
186186 ingestion to an individual 21 years of age or younger. 8
187187 (2) A person who violates this subsection shall: 9
188188 (A) be imprisoned not more than one year or fined not more than 10
189189 $1,000.00, or both, for a first offense; or 11
190190 (B) be imprisoned not more than two years or fined not more than 12
191191 $2,000.00, or both, for a second or subsequent offense. 13
192192 (c)(1) No person shall knowingly prepare, sell, deliver, offer for sale, hold 14
193193 for sale, or give away a kratom product that contains a controlled substance 15
194194 under the Controlled Substances Act, 21 U.S.C. §§ 801–904, or a regulated 16
195195 drug as defined in section 4201 of this title. 17
196196 (2) A person who knowingly violates this subsection shall be 18
197197 imprisoned not more than three years or fined not more than $3,000.00, or 19
198198 both. These penalties shall be in addition to any other provision in law. 20 BILL AS INTRODUCED H.416
199199 2025 Page 9 of 10
200200
201201
202202 VT LEG #381089 v.1
203203 (d)(1) No person shall knowingly prepare, sell, deliver, offer for sale, hold 1
204204 for sale, or give away a kratom product that contains synthetic mitragynine, 2
205205 synthetic 7-hydroxymitragynine, or any other synthetically derived compound 3
206206 of the plant Mitragyna speciosa. 4
207207 (2) A person who knowingly violates this subsection shall be 5
208208 imprisoned not more than two years or fined not more than $2,000.00, or both. 6
209209 These penalties shall be in addition to any other provision in law. 7
210210 (e) Upon receipt of a report of an alleged violation regarding any kratom 8
211211 product offered for sale, the Department shall require the registrant to produce 9
212212 an updated and current certificate of analysis in a reasonable time frame from a 10
213213 certified independent third-party laboratory showing compliance with the 11
214214 requirements of this subchapter for safe kratom products and include copies of 12
215215 all product labels. If the registrant does not provide the certificate of analysis 13
216216 in the specified time frame, the registration for that product shall be revoked 14
217217 and a stop sales order will be issued for products covered by this registration. 15
218218 (f) If the Department has a reasonable basis to require an independent third-16
219219 party test of a registered kratom product by a laboratory of the Department’s 17
220220 choice, the registrant shall be required to submit payment to the Department 18
221221 for the test within a reasonable time frame. If the registrant does not tender 19
222222 payment to the Department within 30 days following receipt of the invoice for 20 BILL AS INTRODUCED H.416
223223 2025 Page 10 of 10
224224
225225
226226 VT LEG #381089 v.1
227227 the testing, the Department shall revoke the registration for that product and a 1
228228 stop sales order will be issued for products covered by this registration. 2
229229 (g) A retailer that relied in good faith upon the representations of a 3
230230 processor or distributor of a kratom product shall not be in violation of this 4
231231 section. 5
232232 § 4096. RULEMAKING 6
233233 The Department shall adopt rules pursuant to 3 V.S.A. chapter 25 for the 7
234234 implementation of this subchapter, including: 8
235235 (1) a process registering a kratom product by a processor or distributor; 9
236236 (2) approved kratom product delivery forms; 10
237237 (3) approved extraction methods used in the preparation or 11
238238 manufacturing of kratom products; and 12
239239 (4) contents of a certificate of analysis from an ISO 17025 laboratory 13
240240 representing the product does not contain levels of residual solvents, biological 14
241241 contaminants, or heavy metal contaminants that meet the standard for dietary 15
242242 supplement products. 16
243243 Sec. 3. EFFECTIVE DATE 17
244244 This act shall take effect on July 1, 2025. 18