Well Done

On October 1, 2024, the US Food and Drug Administration (FDA) announced the implementation of its long-promised reorganization, with the establishment of the unified Human Foods Program (HFP). The HFP now oversees all FDA activities related to food safety and nutrition, organized in a single group working under the Deputy Commissioner of Human Foods.

The Association of American Feed Control Officials (AAFCO) and the US Food and Drug Administration (FDA) announced on August 2, 2024 that their long-standing Memorandum of Understanding (MOU) governing the development and review of definitions of animal feed ingredients will not be renewed once it expires on October 1, 2024. FDA described AAFCO and its relationship as “evolving” rather than “ending” and noted in a Letter to Stakeholders that FDA will continue to work closely with AAFCO and state authorities “to help ensure the safety of the animal food supply.”

The US Food and Drug Administration (FDA) issued final guidance titled Foods Derived from Plants Produced Using Genome Editing (Genome-Edited Plants Guidance), describing the agency’s approach for evaluating the safety of foods derived from genome-edited plant varieties. The Genome-Edited Plants Guidance also describes two voluntary processes for developers to inform and engage with FDA regarding the steps taken to ensure the safety of foods from their genome-edited plant varieties.

Rising alarm over microplastics as pollutants has sparked significant attention, stirring public concern and regulatory scrutiny. While there is both a lack of standardized methods for measuring microplastics and no scientific consensus about their potential health impacts, manufacturers are facing a surge of lawsuits asserting consumer protection claims based on the purported presence of microplastics in bottled water, and questions remain about the approach state and federal regulatory agencies might take to address the widespread use of plastic products in food production and storage.

The US Food and Drug Administration (FDA) recently announced in a letter of enforcement discretion its decision not to challenge certain qualified health claims regarding the consumption of yogurt and reduced risk of type two diabetes if the claims are not misleading and comply with other regulatory requirements.

In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s regulation of food products, FDA announced the selection of James Jones, a former Environmental Protection Agency official, to serve as the first Deputy Commissioner for HFP.

In a historic decision, the United States Department of Agriculture (USDA) has approved two companies, Upside Foods and GOOD Meat, to market lab-grown chicken in the United States. The final approval follows the US Food and Drug Administration’s (FDA’s) issuance of "no questions" responses to GOOD Meat and Upside Foods’ letters concluding that foods comprised of or containing cultured chicken cell material resulting from their proprietary production processes are as safe as comparable foods produced by other methods.

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.