OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few of the developments from December that should be highlighted. If you have any questions or would like more information, please do not hesitate to reach out to us.
U.S. Food and Drug Administration (FDA)
- On December 16, 2022, FDA announced that registration is now open for the February 9, 2023, virtual public meeting discussing FDA’s role in the Association of American Feed Control Officials (AAFCO) animal feed ingredient definition process. For those interested, OFW Law will be covering the meeting. Among other things, the meeting will include a discussion on how to improve FDA’s role in the AAFCO feed ingredient definition process.
- On December 20, 2022, FDA announced the availability of a Final Guidance on “Best Practices for Convening a GRAS Panel: Guidance for Industry” (“Guidance”). The Guidance provides best practices when assembling a panel of experts (“GRAS Panel”) to assess whether a substance intended to be used as or in human or animal food meets FDA’s generally recognized as safe (“GRAS”) standards under 21 C.F.R. Parts 170 and 570.
- On December 28, 2022, FDA issued its updated version (from the 2017 version) of the Model Food Code 2022. In addition, FDA provided a general summary of all of the changes made in the updated version of the Food Code. Two of the key updates are related to allergens. First, “Sesame” is now recognized as the 9th major allergen. Second, the Food Code calls for labeling/listing major food allergens for unpackaged foods and bulk foods dispensed by consumers. In addition, the Food Code specifically addresses food donations for the first time.
- Starting January 1, 2023, foods containing sesame will be subject to specific food allergen labeling and manufacturing requirements. Sesame is joining the list of major food allergens- along with milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans- under the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, which was signed into law April 23, 2021. FDA published a reminder to manufacturers about the effective date.
United States Department of Agriculture (USDA)
- On December 7, 2022, the USDA-Agricultural Marketing Service (AMS) published a new final rule, “Cattle Contracts Library Pilot Program.” The Final Rule establishes the Cattle Contracts Library pilot program. Under the Pilot Program, AMS will collect, maintain, and report aggregated information on packer contracts for the purchase of fed cattle from cattle producers. Larger beef packing operations will be required to supply contract information and marketing information to facilitate the Pilot Program.
- On December 20, 2022, USDA-Food Safety and Inspection Service (FSIS) announced January 1, 2026, as the uniform compliance date for new meat and poultry product labeling regulations published between January 1, 2023, and December 31, 2024.
- On December 23, 2023, USDA-FSIS published a Notice entitled “2023 Rate Changes for Basetime, Overtime, Holiday, Laboratory Services, and Export Application Fees.” The Notice announces the 2023 rates FSIS will charge meat and poultry establishments, egg products plants, and importers and exporters for providing voluntary, overtime, and holiday inspection and identification, certification, and laboratory services. Additionally, in the Notice, FSIS states that there will be no changes to the fee FSIS assesses exporters that apply for export certificates through the export component of the Public Health Information System (PHIS).
There are signs that, in the months to come, FDA will continue its reinvigorated interest in cannabis and cannabis-derivatives. Below are some important developments to be aware of:
- On November 21, 2022, FDA posted warning letters to five companies for illegally selling products containing cannabidiol (CBD) and other cannabinoids. The warning letters marked a departure from previous FDA enforcement in several respects:
- It has long been assumed that a CBD marketer could avoid enforcement if a product(s) did not make impermissible health claims. FDA took action against products that were not making health claims. Based on these warning letters, this is no longer the case as the FDA pursued the marketers solely because the products contained impermissible cannabinoids as ingredients.
- FDA also objected to numerous cannabinoid-containing product formats and presentations, such as gummies, because they are appealing to children.
- The renewal of the Farm Bill 2023 will certainly include a focus on hemp and hemp-derived cannabinoids like CBD and delta-8 tetrahydrocannabinol (THC). Though the 2018 Farm bill legalized hemp, the industry has not achieved the economic benefits hoped for, in part because FDA does not permit CBD in foods and dietary supplements. Lawmakers will likely seek to remove perceived FDA roadblocks and improve market opportunities for CBD.
- The building 2023 Farm Bill pressures coincide with FDA signaling that it will soon be taking significant action on cannabinoids. In addition to the November 2022 warning letters:
- In December 2022, FDA Chief Scientist Dr. Namandjé N. Bumpus said that “CBD science” is a top priority and that there are broad cross-agency initiatives underway, and that the public can expect updates from the agency in the near future. FDA closed out 2022 by previewing its cannabis activities for the Wall Street Journal here. For the first time, the agency made available, for an interview, its new senior advisor on cannabis, Mr. Norman Birenbaum. Mr. Birenbaum noted that the market was “widely unregulated” and that the agency had “growing and more intensifying short-term concerns” about intoxicating hemp-derived products.” FDA Principal Deputy Commission Janet Woodcock was also quoted as saying that “[g]iven what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance.”
If you have questions and/or would like help navigating this evolving area, please contact Tish Pahl (firstname.lastname@example.org) or Kyla Kaplan (email@example.com) for assistance.