Well Done

YOUR SOURCE ON FOOD LITIGATION AND REGULATION
FDA has consistently pursued its aim of encouraging US consumers to eat less salt. As we have previously written, FDA issued a Voluntary Sodium Reduction guidance in October 2021 to support the reduction of average sodium intake in Americans. Consistent with its intention to “continue the dialogue on sodium reduction,” FDA recently issued a proposed rule that would amend certain standards of identity (SOIs) to allow the use of salt substitutes in foods that list salt as a required or optional ingredient.
FDA recently announced it does not object to the use of certain qualified health claims regarding the relationship between the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease (CVD), provided that the qualified claim is appropriately worded so as not to mislead consumers.
Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified by US law, which are milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans. By law, those allergens must be listed separately from other ingredients on food labels. As discussed in a prior blog post, sesame is set to become the ninth major food allergen on January 1, 2023.
FDA issued a Voluntary Sodium Reduction guidance in October 2021, aimed to help Americans reduce average daily sodium intake over the next two and a half years. The guidance suggests voluntary sodium reduction targets for food manufacturers, restaurants, and food service operators for 163 categories of processed, packaged, and prepared foods.
The US Department of Agriculture (USDA) recently announced a new initiative that its Food Safety and Inspection Service (FSIS) plans to put in place to limit Salmonella in poultry plants to help reduce related illnesses.
FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance previously issued in September 2007 and revised in June 2008.
FDA recently entered into domestic mutual reliance (DMR) agreements with the states of California, Florida, Utah, and Wisconsin to help ensure the safety of domestic food production and distribution systems. FDA’s goal is to coordinate efforts with these states to help decrease human foodborne illness outbreaks, avoid duplication of regulatory oversight, and increase public health protection. Erik Mettler, assistant commissioner for partnerships and policy in FDA’s Office of Regulatory Affairs, noted that the agency is using these partnerships to “improve industry compliance with applicable food safety requirements.”
The US Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS) published a final rule on December 21, 2018, implementing the National Bioengineered Food Disclosure Standard (NBFDS). Beginning on January 1, 2022, the NBFDS will require manufacturers, importers, and retailers that package or sell food in bulk to disclose the presence of bioengineered food or food ingredients on product labels intended for retail sale.
Congress on August 3 introduced the Food Labeling Modernization Act of 2021 (H.R. 4917 or 2021 Bill), a bill that proposes to amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to improve requirements related to summary nutrient information found on food labels.

The Federal Trade Commission (FTC) recently issued a final rule that marks a major shift in the regulatory landscape for labeling that has already begun to impact other regulatory bodies—namely, the US Department of Agriculture (USDA). The FTC’s new rule adds teeth to its longtime policy to prevent deceptive “Made in USA” (MUSA) claims, codifies its informal 1997 Enforcement Policy Statement on U.S. Origin Claims, and enables it to seek civil penalties of up to $43,280 for each violation of the rule.