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 September 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 September 27, 2022, FDA released its “Activities for the Safety of Imported Produce,” which provides an update on what FDA is working on to advance the safety of imported produce into the U.S.
- On September 29, 2022, FDA published in the Federal Register the anticipated proposed rule on the “Definition of the Term ‘Healthy’.”. The proposed rule would update the definition for the implied nutrient content claim “healthy” in 21 C.F.R. § 101.65(d) to be consistent with current nutrition science and the Dietary Guidelines for Americans (“Dietary Guidelines”), as well as the updated Nutrition Facts label requirements. Comments are due by December 28, 2022.
- On September 30, 2022, FDA announced that the agency will continue to provide flexibility for infant formula manufacturers under certain conditions to stabilize supplies. Currently, manufacturers marketing their products in the U.S. under enforcement discretion would need to send a letter of intent to FDA to pursue compliance with all regulatory requirements by December 5, 2022.
- On September 30, 2022, FDA provided a reminder that “owners, operators, or agents in charge of domestic or foreign facilities engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA.” The registration and renewal period is open between October 1, 2022, and December 31, 2022. Renewal information can be submitted electronically through the FDA Industry System.
United States Department of Agriculture (USDA)
- On September 19, 2022, USDA’s Food Safety and Inspection Service (FSIS) hosted a secondary Revised Appendix A & B Guidelines webinar. As a reminder, back in December 2021, FSIS announced updates to the FSIS Cooking Guideline for Meat and Poultry Products (Revised Appendix A) and FSIS Stabilization Guideline for Meat and Poultry Products (Revised Appendix B). Similar to previous webinars, this webinar focused on FAQs, mandatory label features, accessing guidance documents on the FSIS website, and tips for using the label submission and approval system. All recordings and material are available here.
- On September 26, 2022, USDA’s Agricultural Marketing Service (AMS) released the proposed rule, “Inclusive Competition and Market Integrity Under the Packers and Stockyards Act.” The Proposed Rule applies to all livestock, meats, live poultry, etc. and would: (1) establish protections for producers and growers deemed a higher risk of unjust treatment; (2) identify retaliatory practices prohibited under the Packers and Stockyards Act (the P&S Act); (3) declare certain contracting practices unlawfully deceptive; and (40 establish recordkeeping requirements to document compliance with the Proposed Rule.
- During the last week of September, the Biden Administration released the “Biden-Harris Administration National Strategy on Hunger, Nutrition, and Health” and held a White House Conference on Hunger, Nutrition, and Health (The Conference). The Conference, which came fifty-three years after the last White House Conference on these subjects during the Nixon Administration, served as a platform for the Administration’s announcement of securing $8 billion in public- and private-sector commitments in support of the goal of ending hunger and increasing healthy eating and physical activity by 2030.
- On September 29-30, 2022, the Reagan-Udall Foundation (the Foundation), an independent partner organization of the FDA, hosted a “Public Meeting of the Independent Expert Panel” (Public Meeting) as part of its evaluation of FDA’s Human Foods Program. For the Public Meeting, the Foundation convened a food-focused Independent Expert Panel (the IEP) who heard from numerous moderators and panelists over six sessions. The agenda from the Public Meeting can be found here. The Foundation is accepting comments (via a Stakeholder Portal) until October 7, 2022. These comments, along with the input received at the Public Meeting, will be considered in the IEP’s report for FDA. The final report is due to FDA on December 6, 2022.