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 March that we took note of. 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 March 11, 2022, FDA issued Guidance on Enforcement Discretion Policies for Certain Federal Food Safety Modernization Act (FSMA) Regulations. This guidance is intended to inform stakeholders of FDA’s intent not to enforce certain provisions of the five rules that implement FSMA. These include: (1) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food, (2) Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Animal Food, (3) Foreign Supplier Verification Program (FSVP), (4) Produce Safety (PSR), and (5) Intentional Adulteration (IA).
- On March 22, 2022, FDA published a notice to stay the provisions of the yogurt standard of identity final rule. The final rule, published on June 11, 2021, amended the standard of identity for yogurt and revoked the definitions and standards of identity for low-fat yogurt and nonfat yogurt.
- On March 28, 2022, FDA, jointly with the Federal Trade Commission (FTC), sent several warning letters to companies selling cannabidiol (CBD) products using research studies to claim or imply misleadingly that their CBD and hemp products will cure, mitigate, treat, or prevent COVID-19. The warning letters can be found here. To date, FDA has not approved or authorized any drug containing CBD for the treatment or prevention of COVID-19 and therefore these products are deceptive and misleading to consumers.
United States Department of Agriculture (USDA)
- On March 30, 2022, the USDA published the Origin of Livestock (OOL) final rule for organic dairy. The new rule will be overseen by USDA’s National Organic Program and will, generally support dairy livestock operations that are in the process of transitioning to organic or starting a new organic program.
- USDA’s Animal Plant Health Inspection Service (APHIS) has confirmed the presence of highly pathogenic avian influenza (HPAI) in several more states including Massachusetts, Wyoming, North Carolina, Ohio, and North Dakota. While no human cases of these HPAI have been detected in the U.S., APHIS provides a number of resources for growers and producers who are dealing with HPAI. Those resources can be found here. Further, The Animal Health Protection Act authorizes APHIS to provide indemnity payments to producers for birds and eggs that must be depopulated during a disease response. APHIS also provides compensation for disposal activities and virus elimination activities. Additional information on biosecurity for backyard flocks can be found here.
- USDA continues to analyze the impact of Russia’s invasion of Ukraine on global agriculture and the food supply. Along with several press releases, the USDA factored in Russia’s recent military action in Ukraine in publishing the March 2022 World Agriculture Supply and Demand Estimates (WASDE) Report. The WASDE report is prepared and released monthly to provide annual forecasting for the supply and use of various commodities.
Environmental, Social, Governance (ESG) Disclosure/Reporting
- ESG reporting is coming to the United States and OFW Law is here to support food and agriculture companies in complying with any reporting requirements.
- ESG disclosures and claims are gaining popularity across industries as both consumers and investors are placing more value on ESG ideals, e.g., sustainability, diversity, climate and carbon emissions, waste, labor conditions, and ethical governance. On March 21, 2022, the Securities and Exchange Commission (SEC) announced a proposed rule on the ““Enhancement and Standardization of Climate-Related Disclosures for Investors” (SEC Climate Proposal), which would require a domestic or foreign SEC registrant to include certain climate-related information in registration statements and periodic reports (a summary of the proposal is below). The SEC Climate Proposal likely indicates that ESG requirements in the U.S. will likely expand in the near term, particularly for publicly traded companies regulated under the SEC.