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 November 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 November 1, 2022, FDA issued a proposed rule to amend the color additive regulations to increase fees (10 cents per round increased in color certification fees) for certification services.
- On November 15, 2022, FDA released an outline of the prevention strategy under development by the agency to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula. This prevention strategy is being developed following the large-scale recall of powdered infant formula earlier this year.
- On November 16, 2022, FDA sent five (5) warning letters to companies illegally selling products containing cannabidiol (CBD). The letters warned these companies to stop selling CBD-containing products that “people may confuse for traditional foods or beverages which may result in unintentional consumption of overconsumption of CBD.” Specific concerns were raised over the appeal of these products to children.
- On November 21, 2022, FDA published in the Federal Register the Final Rule on “Requirements for Additional Traceability Records for Certain Foods.” The Final Rule was promulgated pursuant to the Federal Food Safety Modernization Act and establishes additional recordkeeping requirements for persons who manufacture, process, pack, or hold certain foods the agency has designated for inclusion on the Food Traceability List under a new Subpart S to 21 C.F.R. Part 1. Foods not on the FTL and foods that do not contain foods on the FTL as an ingredient are not subject to the additional records requirements of Subpart S. Other exemptions may be available, and the Final Rule does not apply to foods under the exclusive jurisdiction of United States Department of Agriculture (USDA).
United States Department of Agriculture (USDA)
- On November 3, 2022, USDA Food Safety and Inspection Service (FSIS) hosted a virtual public meeting where the agency sought input on the “Proposed Regulatory Framework to Reduce Salmonella Illnesses Attributable to Poultry,” from a wide range of stakeholders. During the public meeting, pre-registered stakeholders had two (2) minutes each to comment on the four components. Then, the panelists had an opportunity to ask clarifying questions. There was also a brief opportunity for an open comment period where attendees were able to ask questions, receive answers, and provide comments. A recording and transcript of the Public Meeting can be found here. Comments on the Proposed Framework and the Public Meeting can be submitted on or before December 16, 2022.
- On November 18, 2022, USDA-FSIS published a Federal Register Notice, “Expansion of FSIS Shiga Toxin-Producing Escherichia coli (STEC) Testing to Additional Raw Beef Products” (the Notice). The Notice implements FSIS’ plans to expand routine sampling for non-O157 STEC, which was initially announced in a June 4, 2020, Federal Register Notice.
- On November 29, 2022, USDA Agricultural Marketing Service (AMS) announced a forty-five (45) day extension for the submission of comments and information on “Inclusive Competition and Market Integrity Under the Packers and Stockyards Act.” Comments are now due on January 17, 2023.
Other
- The COVID-19 Public Health Emergency (PHI) will remain in effect until at least January 11, 2023. This means that all food programs and exemptions functioning under the PHI will remain in effect until at least then. OFW Law would be happy to support in the transition once the PHI is no longer renewed.
