Last week, FDA issued a draft guidance that outlines the agency’s proposed approach for evaluating the public health importance of food allergens other than the eight major food allergens identified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.
YOUR SOURCE ON FOOD LITIGATION AND REGULATION
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.
On December 14, 2020, the US Food and Drug Administration (FDA) approved GalSafe pigs, which are genetically modified (GM) for use in food production and medical products. At the time, the agency noted in its Consumer Q&A that intentional genomic alterations (IGAs) in animals would be regulated by FDA to “ensure that it is safe for the animal, safe for anyone that consumes food from the animal, and that it is effective, i.e., it does what the developer claims it will do.” The agency also explained that IGAs would be “subject to premarket oversight whether they are intended to be used for food or to produce pharmaceuticals or other useful products” (emphasis added), with the US Department of Agriculture (USDA) being responsible for the labeling of food from GM animals.
US Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) introduced legislation on May 21 to ensure hemp-derived cannabidiol (CBD) is regulated by the US Food and Drug Administration (FDA) like other ingredients used in dietary supplements, foods, and beverages.