The FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response have published a list of draft and final guidance topics that the agency intends to issue in the coming year. This is an update to the list that FDA published for the first time in the food space in June 2021.
The list includes guidance documents on several topics of significant interest to the food industry, including:
- Traditional Meat Alternatives. FDA plans to issue two draft guidance documents on traditional meat alternatives, an increasingly popular food category. One document will address the hotly debated naming of plant-based meat alternatives and another will address premarket consultations for cultured animal cell foods.
- Classifying Food as Ready-To-Eat or Not Ready-to-Eat. FDA plans to add an additional chapter to its in-progress draft guidance on the Hazard Analysis and Risk-Based Preventive Controls for Human Food requirements to help industry determine whether a food is considered ready-to-eat—an important distinction for food safety and Food Safety Modernization Act compliance.
- Foods Derived from Plants Produced Using Genome Editing. FDA supports innovation in plant biotechnology and has affirmed that bioengineered plants do not present different or greater safety concerns than traditional counterparts. FDA allows developers of genetically engineered plants to participate in voluntary pre-market consultation to ensure crop safety.
Although the guidance on new dietary ingredients has not yet been issued, it now will be accompanied by guidance on new dietary ingredient pre-market submission procedures and timeframes. Other items from FDA’s June 2021 list are still pending publication, including anticipated guidance on the labeling of plant-based milk alternatives, food allergens, lead and arsenic action levels in a range of food product categories, and best practices for convening a panel to evaluate whether a substance is “generally recognized as safe.” In addition to the Ready-To-Eat guidance noted above, FDA’s priority list also includes new chapters on allergen controls, process controls, and acidified foods to be added to its comprehensive guidance on the Hazard Analysis and Risk-Based Preventive Controls for Human Food requirements.
FDA’s Center for Veterinary Medicine also recently released a list of guidances under development, including an anticipated guidance on diversion or reconditioning of damaged, contaminated, or adulterated food for use as animal food.
FDA’s priority guidance list does not reflect the proposed and final rules FDA intends to issue in the coming year. Based on FDA’s Fall 2021 Regulatory Agenda and the current list of regulations under review at the White House’s Office of Information and Regulatory Affairs, publication of the proposed rule on the definition of “healthy” should be imminent and will likely be the first substantive food labeling proposal for this Administration.
Covington will continue to monitor closely developments on these and other issues of importance to the food industry. Even while FDA's guidances and rules are still forthcoming, Covington would be happy to share insights on how the agency is thinking about these key issues, based on our interactions with FDA to date.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
Back
