On January 31, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) released a list of draft and final guidance topics that are a priority to complete during the next 12 months. The list is an update on the guidance agenda that the agency published in June 2021 and includes many of the same documents including:

• Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;

• Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;

• Best Practices for Convening a GRAS Panel: Guidance for Industry;

• 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; and

• Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry

Notably, the FDA expects to publish many of these guidance documents by January 2023, which is a 6-month extension from the original expected publication date of June 2022.

The FDA added the following guidance topics to be published by January 2023:

• Testing Methods for Asbestos in Cosmetic Products Containing Talc; Draft Guidance for Industry;

• New Dietary Ingredient (NDI) Notifications and Related Issues:  NDI Notification Procedures and Timeframes; Guidance for Industry;

• Premarket Consultation on Cultured Animal Cell Foods: Draft Guidance for Industry;

• Foods Derived from Plants Produced Using Genome Editing; Draft Guidance for Industry; and

• Labeling of Plant-Based Alternatives to Animal-Derived Foods; Draft Guidance for Industry

Public comments on the list, including suggestions for alternatives or recommendations on the topics FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA-2021-N-0553.