CBD Product Safety and Standardization Act of 2021

To authorize the regulation of interstate commerce with respect to food containing cannabidiol derived from hemp, and for other purposes. 1. Short title This Act may be cited as the CBD Product Safety and Standardization Act of 2021 2. Regulation of interstate commerce with respect to food containing cannabidiol derived from hemp (a) Standards and regulations Chapter IV of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 342 et seq. 409A. Food containing cannabidiol derived from hemp (a) Standards The standards specified in this section for a food (other than a dietary supplement) containing cannabidiol derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946) are that the food— (1) is— (A) in conformity with a regulation issued pursuant to section 409(c)(1)(A); (B) the subject of a notice submitted to the Secretary under subpart E of part 170 of title 21, Code of Federal Regulations (or any successor regulations); or (C) generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use, within the meaning of section 201(s); and (2) complies with all other applicable requirements under, or pursuant to, this Act and the Fair Packaging and Labeling Act. (b) Regulations The Secretary shall issue, through notice and comment rulemaking pursuant to section 553 of title 5, United States Code, regulations specifying, with respect to a food containing cannabidiol derived from hemp— (1) a maximum amount of cannabidiol derived from hemp per serving; (2) labeling and packaging requirements; and (3) conditions of intended use, including any conditions specific to a food category described under subpart A of part 170 of title 21, Code of Federal Regulations (or any successor regulations). (c) Effective date The standards under this section shall apply beginning on the date of enactment of the CBD Product Safety and Standardization Act of 2021 . (b) Prohibited acts Section 301(ll) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 331(ll) (other than a food containing cannabidiol that meets the requirements specified in section 409A) made public (c) Conforming amendments (1) Adulteration Section 402 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 342 (j) If it is a food (other than a dietary supplement) that contains cannabidiol derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946), unless such food meets the requirements specified in section 409A. . (2) Misbranding Section 403 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 343 (z) If it is a food (other than a dietary supplement) that contains cannabidiol derived from hemp (as defined in section 297A of the Agricultural Marketing Act of 1946), unless the labeling of such food meets the requirements specified in or pursuant to section 409A. .

Summary: CBD Product Safety and Standardization Act of 2021 This bill requires the Food and Drug Administration (FDA) to regulate food containing cannabidiol (CBD) derived from hemp as a food additive. (The FDA has determined that food containing added CBD cannot be sold in interstate commerce.) Under this bill, in order to be sold, a food containing CBD derived from hemp must conform with current FDA requirements pertaining to food additives or be generally recognized as safe (GRAS). (Under current law, a food additive with the GRAS designation is not subject to FDA premarket review and approval requirements.) In addition, such a food must comply with all other relevant FDA and labeling requirements. Such a food shall be exempt from an existing provision that prohibits the sale of a food containing an additive that is (1) an FDA-approved drug or biological product, or (2) subject to certain clinical investigations. The FDA must issue regulations pertaining to such foods that specify (1) the maximum amount of CBD derived from hemp per serving, (2) labeling and packaging requirements, and (3) any conditions for intended use.