OK
Oklahoma House Bill HB3574

Oklahoma 2024 Regular Session

Oklahoma House Bill HB3574 Compare Versions

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30+April 11, 2024
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334 BILL NO. 3574 By: Pae of the House
435
536 and
637
738 Prieto of the Senate
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1443 An Act relating to public health and safety; amending
1544 63 O.S. 2021, Sections 1 -1432.2 and 1-1432.4, which
1645 relate to the Oklahoma Kr atom Consumer Protection
1746 Act; adding and modifying definitions; providing
1847 restrictions on the preparation, distribution, or
1948 sale of certain kratom products; and providing an
2049 effective date.
2150
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25-SUBJECT: Public health and safe ty
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2753 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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2954 SECTION 1. AMENDATORY 63 O.S. 2021, Section 1 -1432.2, is
3055 amended to read as follows:
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3256 Section 1-1432.2 As used in this act:
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3457 1. "Food" means a food, food product, food ingredient, dietary
3558 ingredient, dietary supplement or beverage for huma n consumption;
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3759 2. "Kratom leaf" means the leaf of the kratom plant, Mitragyna
3860 speciosa, in fresh or dehydrated or dried form that undergoes no
3961 post-harvest processing other than drying or size reduction by
4062 cutting, milling, or similar procedure, and may b e cleaned or
4163 sterilized using standard treatments applied to food ingredients,
4264 such as heat, steam, pressurization, or irradiation or other
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4392 standard treatments applied to food ingredients. The total alkaloid
4493 content of kratom leaf material used in the kra tom product shall not
4594 exceed three and one -half percent (3.5%) measured on a dried weight -
46-to-weight basis; ENR. H. B. NO. 3574 Page 2
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95+to-weight basis;
4896 3. "Kratom leaf extract" means the material obtained by
4997 extracting kratom using a solvent consisting of:
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5198 a. water, ethanol, or food -grade carbon dioxide (CO2), or
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5399 b. any other solvent allowed by federal or state
54100 regulation for use in manufacturing a food ingredient.
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56101 The extracted material shall contain mitragynine as the most
57102 abundant alkaloid, measured on a weight -to-weight basis, and at a
58103 level that is equal to or exceeds twice that of any other alkaloid
59104 present. The ratio of mitragynine to other alkaloids in the extract
60105 shall be equal to or greater than the ratio found in the starti ng
61106 material;
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63107 4. "Kratom product" means a food product or ingredient
64108 containing any part of the dietary supplement that consists of or
65109 contains kratom leaf of the plant Mitragyna speciosa or kratom leaf
66110 extract that does not contain any synthesized kratom alkaloids,
67111 other kratom constituents, or synthesized metabolites o f any kratom
68112 constituent in which the level of 7 -hydroxymitragynine, on a percent
69113 weight basis, is not greater than one percent (1%) of the amount of
70114 total kratom alkaloids, as confirmed wi th a high-performance liquid
71115 chromatography testing method. For pu rposes of this paragraph,
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72143 "synthesized" refers to substances produced using directed synthetic
73144 or biosynthetic chemistry, as opposed to traditional food
74145 preparation techniques such as heating or extracting ; and
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76146 3. 5. "Total kratom alkaloids" means the sum of mitragynine,
77147 speciociliatine, speciogynine, paynantheine, and 7 -
78148 hydroxymitragynine; and
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80149 6. "Vendor" means a person that sells, prepares or maintains
81150 kratom products or that advertises, represents or holds itself out
82151 as selling, preparing or maintainin g kratom products and includes a
83152 manufacturer, wholesaler, store, restaurant, hotel, catering
84153 facility, camp, bakery, delicatessen, supermarket, grocery store,
85154 convenience store, nursing home or food or drink company.
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87155 SECTION 2. AMENDATORY 63 O.S. 2021, Section 1 -1432.4, is
88156 amended to read as follows:
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90157 Section 1-1432.4 A. A vendor shall not prepare, distribute,
91-sell or expose for sale any of the f ollowing: ENR. H. B. NO. 3574 Page 3
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158+sell or expose for sale any of the following:
93159 1. A kratom product that is adulterated with a nonkratom
94160 substance. A does not meet the definition for a kratom product is
95161 adulterated with a nonkratom substance if the kratom product is
96162 mixed or packed with a nonkratom substance and that substance
97163 affects the quality or strength of the kratom product to such a
98164 degree as to render the kratom product injurious to a consumer
99165 pursuant to Section 1 -1432.2 of this title ;
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101193 2. A kratom product that is contaminated with a dangerous
102194 nonkratom substance. A kratom product is contaminated with a
103195 dangerous nonkratom substance if the kratom product contains a
104196 substance that is not safe for human consumption;
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106197 3. A kratom product containing a level of 7 -hydroxymitragynine
107198 in the alkaloid fraction that is greater than two one percent (2%)
108199 (1%) of the alkaloid composition of the product;
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110200 4. A kratom product containing any synthetic synthesized
111201 alkaloid including synthetic synthesized mitragynine, synthetic
112202 synthesized 7-hydroxymitragynine or any other synthetically derived
113203 synthesized compounds of the kratom plant; or
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115204 5. A kratom product contai ning any controlled substance listed
116205 in the Uniform Controlled Dangerous Substances Act, unless the
117206 product is compounded by a licensed pharmacist with the controlled
118207 substance dispensed in accordance with a valid prescription ; or
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120208 6. A kratom product cont aining a level of any residual solvent
121209 that was used in the manufacturing of the extract that exceeds the
122210 residual level specified for pharmaceutical products in the document
123211 "Q3C - Tables and List, Guidance for Industry, [June 2017] ICH
124212 Revision 3" issued by the United States Department of Health and
125213 Human Services, Food and Drug Administration .
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127214 B. Kratom products shall be accompanied by a label , or a quick
128215 response (QR) code on the product label linked to a website, bearing
129216 the following information prio r to its sale in this state:
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131244 1. A list of the ingredients, which shall include the common or
132245 usual name of each ingredient used in the manufacture of the
133246 product, listed in descending orde r of predominance;
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135247 2. That the sale or transfer of kratom to a per son under
136-eighteen (18) years of age is prohi bited; ENR. H. B. NO. 3574 Page 4
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248+eighteen (18) years of age is prohibited;
138249 3. The amount of total kratom alkaloids, mitragynine, and 7-
139250 hydroxymitragynine contained in the product;
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141251 4. The amount of total kratom alkaloids, mitragynine, and 7-
142252 hydroxymitragynine contained in packa ging for the product;
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144253 5. The name and the principal street address of the vendor or
145254 the person responsible for distributing the product;
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147255 6. The suggested Any federal food allergen labelin g
148256 requirements, if applicable, and clear and adequate directions fo r
149257 the consumption and safe and effective use of the such product,
150258 including the recommended serving size, the number of servings in
151259 the container, and the number of servings that can be safely
152260 consumed in a day. Provided, liquid kratom products shall be
153261 packaged in a retail container that has clear serving size markings
154262 and be subject to the following requirements:
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156263 a. products of less than eight (8) fluid ounces which
157264 contain more than thre e servings shall be accompanied
158265 by a calibrated measuring device, a nd
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160293 b. if such a product contains more than the eight (8)
161294 fluid ounces, the requirements specified in
162295 subparagraph a of this paragraph do not apply.
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164296 Provided further, packaging for powdered kratom products not in
165297 capsule form shall have a calibrated measur ing device included in
166298 the container; and
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168299 7. Any precautionary statements as to the safety and
169300 effectiveness of the product , including a warning that a consumer
170301 should consult a health care professional on questions about the use
171302 of kratom, that the produ ct may be habit-forming, and a statement
172303 that the kratom product is not intended to "diagnose, treat, cure,
173304 or prevent any disease"; and
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175305 8. A statement that a kratom product label is prohibited from
176306 making any therapeutic claims unless approved by the Uni ted States
177307 Food and Drug Administration .
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179308 C. A vendor may not distribute, sell or expose for sale a
180309 kratom product to an individual under eighteen (18) years of age.
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182310 D. Upon request by the State Department of Health, the vendor
183311 shall provide test results from a United States -based testing
184312 facility to confirm the items listed on the product label.
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186313 SECTION 3. This act shall become effective November 1, 2024.
187- ENR. H. B. NO. 3574 Page 6
188-Passed the House of Representati ves the 5th day of March, 2024.
189-
190-
191-
192-
193- Presiding Officer of the House
194- of Representatives
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198-Passed the Senate the 25th day of April, 2024.
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203- Presiding Officer of the Senate
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206-OFFICE OF THE GOVERNOR
207-Received by the Office of the Governor this _________ ___________
208-day of ___________________, 20_______, at _______ o'clock _______ M.
209-By: _________________________________
210-Approved by the Governor of the State of Oklahoma this _____ ____
211-day of ___________________, 20_______, at _______ o'clock _______ M.
212-
213-
214- _________________________________
215- Governor of the State of Oklahoma
216-
217-OFFICE OF THE SECRETARY OF STATE
218-Received by the Office of the Secretary of State this __________
219-day of ___________________, 20_______, at _______ o'clock _______ M.
220-By: _________________________________
221-
314+COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES
315+April 11, 2024 - DO PASS