The Food & Drug Administration is seeking public comments on its Center for Veterinary Medicine’s draft guidance entitled “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products.” That guidance seeks to ensure that the manufacture of such products meeting the definition of new animal drugs complies with the Federal Food, Drug, & Cosmetic Act. The guidance, specifically concerns product identification, safety, strength, purity, and quality. The comment period is open through November 22, 2021.
FDA Announces Guidance on Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products
FDA Proposes Procedures to Govern Import Tolerances of Animal Drugs in Food
The Food & Drug Administration has announced a final rule codifying procedures and food safety criteria for the establishment, amendment, or revocation of tolerances for residues of unapproved new animal drugs in animals who are imported for human consumption. These import tolerances provide a basis for the legal marketing of animal-derived food and would become effective January 19, 2022. The FDA is accepting comments regarding information collection issues through October 21, 2021.
Class Action Challenges MorningStar “Veggie” Product Labeling
A putative consumer class action has been filed in the U.S. District Court for the Northern District of California alleging that Kellogg Sales Company’s advertisement of its MorningStar brand “Veggie” products (including “Veggie Burgers” and “Veggie Dogs”) violates numerous California consumer protection laws. Plaintiffs allege that the “Veggie” labeling is false or misleading because it suggests that vegetables are the primary ingredients in such products when they instead are predominantly comprised of grain and oil. Plaintiffs are seeking a recall of Kellogg’s MorningStar products labeled in this manner, a corrective advertising campaign, disgorgement, and restitution.
USDA FSIS Responds to Two Petitions Relating to Labeling of Cultivated Meat
USDA’s Food Safety and Inspection Service has responded to Harvard Animal Law & Policy Program’s petition for FSIS to develop a labeling approach for “cell-based” meat and poultry products that respects First Amendment commercial speech protections by not requiring new standards of identity and not banning the use of common or usual meat or poultry terms or other product terms specified in current codified standards of identity. In its letter, FSIS “agrees that more information is necessary to develop new labeling requirements for these products,” stating that in response to the Harvard petition the agency filed an advance notice of proposed rulemaking (ANPR) on September 3, 2021, “to request comments pertaining to the labeling of meat and poultry products comprised of or containing cultured cells derived from animals subject to the Federal Meat Inspection Act or Poultry Products Inspection Act.” Conversely, FSIS has denied a February 9, 2018, petition by U.S. Cattlemen’s Association which urged the agency to exclude “cell-based” meat and plant-based meat substitutes from the definition of “beef” and “meat,” citing the FDA’s exclusive jurisdiction over plant-based products and the USDA’s September 3, 2021, ANPR regarding labeling of cultivated meat.
Legislation Would Expand Market for Non-Federally Inspected Meat
H.R. 5246, the ‘‘Expanding Markets for State-Inspected Meat Processors Act of 2021’’ would amend the Federal Meat Inspection Act in order to allow the interstate sale of meat that has been inspected by the respective state agency, rather than the U.S. Department of Agriculture. Until recently, Wyoming had no federally inspected animal agriculture facilities, precluding Wyoming-based producers from selling to out-of-state consumers. The bill has not yet been assigned to a committee. Reps. Liz Cheney and Carol Miller introduced the legislation as they did in 2020.
Congress Considers Country of Origin Labeling Requirements for Beef
S. 2716, the ‘American Beef Labeling Act of 2021’ would amend the Agriculture Marketing Act of 1946 to establish country of origin labeling requirements for beef products. The bill has been referred to the Senate Committee on Agriculture, Nutrition, and Forestry. Sens. John Thune, Jon Tester, Mike Rounds, and Cory Booker introduced the legislation.
FDA Re-Opens Comment Period on Environmental Impacts of Certain Sunscreens
The FDA has reopened the public comment period through September 23, 2021, on the environmental impacts of oxybenzone and octinoxate––ingredients found in some over-the-counter sunscreens that have been banned in Hawaii due to evidence of harm to coral reefs and other marine life. Public comments will assist the agency in the preparation of its Environmental Impact Statement and determinations about the future availability and labeling for sunscreens that contain these ingredients.
FSIS Solicits Comments to Guide Labeling of Cell-Cultured Meat and Poultry
The USDA’s Food Safety and Inspection Service has published an advanced notice of proposed rulemaking, soliciting comments to guide the agency’s future labeling requirements for cell-cultured animal products. The FSIS and FDA agreed in 2019 that both agencies will retain regulatory oversight of certain aspects of the production and distribution of products produced using animal cell culture technology, determining that FSIS will have authority over the labeling process. FSIS is accepting comments through November 2, 2021.
Texas Considers Requiring Cultivated Products be Labeled as “Cell-Cultured” or “Lab-Grown”
Texas House Bill 242 would amend the state Health and Safety Code to define terms such as meat, beef, pork, and poultry to specifically exclude any “cell-cultured, plant-based, or insect-based food product.” The bill would declare a plant-based meat analogue as misbranded if it does not prominently display a term such as “analogue,” “meatless,” or “plant-based” immediately before the name of the product and a cultivated meat product as misbranded if it does not prominently display the term “cell-cultured” or “lab-grown” immediately before the name of the product.
Miyoko’s Kitchen Wins Summary Judgment on Use of “Butter,” “Cruelty-Free” on Plant-Based Packaging
A federal judge has granted summary judgment to Miyoko’s Kitchen in the company’s challenge to a California state law restricting the use of terms and phrases such as “butter,” “cruelty-free,” and “lactose free” on plant-based products. The court relied heavily on a 2018 empirical study by Silke and Adam Feltz demonstrating that the vast majority of consumers were not misled by such labels. The court, however, granted summary judgment to the State regarding Miyoko’s use of “hormone free” on its vegan butter given that the product contains “naturally occurring plant hormones.”