Okla. Stat. tit. 63 § 1-1432.4

Current through Laws 2024, c. 453.

Section 1-1432.4 - Prohibited products - Labeling requirements - Distribution to minors prohibited - Test results

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

1. A kratom product that does not meet the definition for a kratom product pursuant to Section 1-1432.2 of this title;

2. A kratom product that is contaminated with a dangerous nonkratom substance. A kratom product is contaminated with a dangerous nonkratom substance if the kratom product contains a substance that is not safe for human consumption;

3. A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than one percent (1%) of the alkaloid composition of the product;

4. A kratom product containing any synthesized alkaloid including synthesized mitragynine, synthesized 7-hydroxymitragynine or any other synthesized compounds of the kratom plant;

5. A kratom product containing any controlled substance listed in the Uniform Controlled Dangerous Substances Act, unless the product is compounded by a licensed pharmacist with the controlled substance dispensed in accordance with a valid prescription; or

6. A kratom product containing a level of any residual solvent that was used in the manufacturing of the extract that exceeds the residual level specified for pharmaceutical products in the document "Q3C - Tables and List, Guidance for Industry, [June 2017] ICH Revision 3" issued by the United States Department of Health and Human Services, Food and Drug Administration.

B. Kratom products shall be accompanied by a label bearing the following information prior to its sale in this state:

1. A list of the ingredients, which shall include the common or usual name of each ingredient used in the manufacture of the product, listed in descending order of predominance;

2. That the sale or transfer of kratom to a person under eighteen (18) years of age is prohibited;

3. The amount of total kratom alkaloids, mitragynine, and 7-hydroxymitragynine contained in the product;

4. The amount of total kratom alkaloids, mitragynine, and 7-hydroxymitragynine contained in packaging for the product;

5. The name and the principal street address of the vendor or the person responsible for distributing the product;

6. Any federal food allergen labeling requirements, if applicable, and clear and adequate directions for the consumption and safe and effective use of such product, including the recommended serving size, the number of servings in the container, and the number of servings that can be safely consumed in a day. Provided, liquid kratom products shall be packaged in a retail container that has clear serving size markings and be subject to the following requirements:

a. products of less than eight (8) fluid ounces which contain more than three servings shall be accompanied by a calibrated measuring device, and

b. if such a product contains more than the eight (8) fluid ounces, the requirements specified in subparagraph a of this paragraph do not apply.

Provided further, packaging for powdered kratom products not in capsule form shall have a calibrated measuring device included in the container;

7. Any precautionary statements as to the safety and effectiveness of the product, including a warning that a consumer should consult a health care professional on questions about the use of kratom, that the product may be habit-forming, and a statement that the kratom product is not intended to "diagnose, treat, cure, or prevent any disease"; and

8. A statement that a kratom product label is prohibited from making any therapeutic claims unless approved by the United States Food and Drug Administration.

C. A vendor may not distribute, sell or expose for sale a kratom product to an individual under eighteen (18) years of age.

D. Upon request by the State Department of Health, the vendor shall provide test results from a United States-based testing facility to confirm the items listed on the product label.

Okla. Stat. tit. 63, § 1-1432.4

Amended by Laws 2024 , c. 278, s. 2, eff. 11/1/2024.

Added by Laws 2021 , c. 500, s. 4, eff. 11/1/2021.