Utah Admin. Code R70-580-6 - Label Requirements

(1) A kratom product that is marketed as conventional food as defined in Sections 4-5-102 and 4-45-102 shall be labeled pursuant to the labeling requirements of Section 4-5-201.

(2) A kratom product marketed as a dietary supplement as defined in Section 4-1-109 shall be labeled pursuant to the requirements of 21 CFR 101.36.

(3) The label shall contain the factual basis upon which the kratom processor represents the product as a kratom product by identifying kratom within the list of ingredients.

(4) The label shall identify each kratom product by a unique batch or lot number specifically linking each kratom product to a specific batch or a lot manufactured by the kratom processor.

(5) A kratom product shall not contain claims that the product is intended to diagnose, treat, cure, or prevent any medical condition or disease on the label or labeling.

(6) The label of each kratom product label shall include the following text pursuant to 21 CFR 101.93(c), prominently displayed:

"This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."

(7) A kratom product shall meet the standards in 21 U.S.C. 9, the Food Drug and Cosmetic Act, other applicable federal laws and regulations, and any applicable state laws and regulations relating to the labeling of food and cosmetics.

(8) If there is not sufficient room on the kratom product label, the kratom product shall display on the label a scannable bar code, QR code, or web address linked to a document containing the information required in Subsections R70-580-6(1) through R70-580-6(7).

(9) No information, illustration, or depiction that the processor knows or should know appeals to children shall appear on the label.

Notes

Utah Admin. Code R70-580-6

Adopted by Utah State Bulletin Number 2021-08, effective 4/2/2021 Amended by Utah State Bulletin Number 2023-06, effective 2/27/2023