The U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (FDA’s CFSAN) and Office of Food Policy and Response (OFPR) have released an updated list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during 2022. The list focuses on Level 1 draft and final guidances.
Listed draft and final guidances address topics such as: questions and answers regarding allergens and labeling, foods derived from genetically modified plants, action levels for toxic elements in juice and food for young children, hazard analysis and risk-based preventive controls, imports, sprouts, industry-specific measures for microbiological contaminants, and labeling of plant-based alternatives.
Since the release of the original guidance agenda in January 2022, FDA has added Draft Guidance on Preparation of Premarket Submission for Food Contact Substances to the list. FDA has also issued a number of guidances related to food safety throughout the year that were previously on the list, including:
- Draft Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens
- Draft Guidance on Action Levels for Lead in Juice
- Guidance on Microbial Food Safety Hazards in the Production of Seed for Sprouting
- Guidance on Reconditioning Fish and Fishery Products by Segregation
- Draft Guidance on the Accredited Third-Party Certification Program: Questions and Answers
- Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and/or Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry
FDA intends to publish all draft and final guidances included on the list; however, the agency notes that changes in plans may arise. FDA may also issue additional guidances that are not on the list.
FDA provides several resources that stakeholders can reference to stay informed about industry guidances. Most proposed and final rules are on the “Unified Agenda of Regulatory and Deregulatory Actions,” which is published by the Office of Information and Regulatory Affairs in the Office of Management and Budget. The Unified Agenda is updated twice a year and reports planned actions by federal departments and agencies throughout the government. A list of FDA regulations and guidance documents that are under Administration review is also available on the Office of Management and Budget website.