Companies interested in understanding more about the cultured cells, or with a desire to provide formal comments for submission to FSIS, are encouraged to contact our team. Cooley’s lawyers bring decades of experience helping agtech and foodtech companies navigate complex legal issues involving intellectual property; litigation; FDA regulatory; licensing, collaboration and M&A deals; and capital raises including venture financing and public and private capital markets.NotesSee Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. § 1451, et seq.)See Federal Meat Inspection Act (FMIA; 21 U.S.C. § 601 et. seq); Poultry Products Inspection Act (PPIA; 21 U.S.C. § 451,et seq.)21 U.S.C. §§ 601(n)(1) and 453(h)(1); 21 U.S.C. § 343(a).

Several regulations specifically address such products. (See: 27 CFR § 7.71.)FDA Requirements:The Food and Drug Administration (FDA) requires NA beverages that are not malt beverages under the FAA Act (beverage without malt and hops or an unfermented beverage) to be labeled in accordance with the Food, Drug, and Cosmetic Act (FD&C Act), Fair Packaging and Labeling Act (FPLA) 15 U.S.C. §§ 1451-1461, and the Nutrition Education and Labeling Act 21 U.S.C. §§ 343-350. (Clickherefor more information.)

[4] The MOU announced in March 2019 recognizes that each Agency has an important role in the oversight of human food derived from cell culture material. [5], [6] FDA derives its statutory authority from the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), and the Fair Packaging and Labeling Act (15 U.S.C. 1451, et seq.). Under these statutes, FDA is tasked with ensuring that food is not adulterated or misbranded by conducting inspections of manufacturing facilities and vehicles of transportation.

The Hatch bill does not contain an analogous provision. Under the authority of the Fair Packaging and Labeling Act (FPLA), 15 U.S.C. § 1451 et seq., the FDA already requires a list of ingredients for cosmetics marketed on a retail basis to consumers. 21 C.F.R. § 701.

The Fair Trade Commission (FTC) has amended the rules and regulations for consumer commodities’ labels promulgated under the Fair Packaging and Labeling Act, 15 U.S.C. § 1451 et seq., (FPLA) to: (1) allow the omission of street addresses from labels if they are listed in any readily accessible, well-known, widely published, and publicly available resource; (2) incorporate a more comprehensive metric conversion chart; (3) explicitly allow the use of exponents with customary inch/pound measurements; (4) delete outdated prohibitions on retail price sales representations; and (5) acknowledge the role of the weights-and-measures laws of individual states.The FPLA rules require consumer commodities to conspicuously state the name and place of business of the manufacturer, packer or distributor, including a complete street address. Previously, a label could omit the street address if the address was listed in a current city or telephone directory.

The appellate court failed to recognize that federal laws applicable to manufacturers of OTC products do not provide a mechanism similar to the CBE procedure that would permit a manufacturer to unilaterally change the warnings on product labeling crafted by the FDA.Under FDA’s regulations at 21 C.F.R. Part 330, OTC drug labeling “shall be stated in the exact language where exact language has been established and identified by quotation marks in an applicable OTC drug monograph regulation.” In addition, FDC Act § 751 (National Uniformity for Nonprescription Drugs) provides that in general “no State or political subdivision of a State may establish or continue in effect any requirement” for an OTC drug “that is different from or in addition to, or that is otherwise not identical with, a requirement under [the FDC Act], the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).” In addition to the Florida court reading Wyeth “so broadly as to preclude the assertion of implied conflict pre-emption based on impossibility under any circumstances,” McNeil notes that Wyeth has been misapplied by other courts in the OTC drug context.

Section 751 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 379r(a)) is an express preemption provision. Section 751r(a)) provides that “no State or political subdivision of a State may establish or continue in effect any requirement-- . . . (1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).” Currently, this provision operates to preempt States from imposing requirement related to the regulation of nonprescription drug products.

Section 751 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 379r(a)) is an express preemption provision. Section 751r(a)) provides that “no State or political subdivision of a State may establish or continue in effect any requirement-- . . . (1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).” Currently, this provision operates to preempt States from imposing requirement related to the regulation of nonprescription drug products.