September 21, 2021

Volume XI, Number 264

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September 20, 2021

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FDA Releases List of Draft & Final Guidance Topics

On June 29, 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 covers food safety, allergens, food additives, and dietary supplements, among others, and includes the following guidance topics:

  • 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Importance of Food Allergens Other Than the Major Food Allergens Defined in the Federal Food, Drug, and Cosmetic Act; Draft Guidance for FDA Staff and Stakeholders;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Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notifications; Draft Guidance for Industry;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  • Labeling of Plant-based Milk Alternatives; Draft Guidance for Industry

The full list of guidance topics is available here. The list focuses on Level 1 draft and final guidances, which set forth the agency’s initial interpretations of new significant regulatory requirements, describe substantial changes in FDA’s earlier interpretation or policy, and deal with complex scientific or highly controversial issues.

The FDA anticipates publishing many of the documents by June 2022. In the future, the FDA intends to release the list of anticipated human food and cosmetic guidance topics at the beginning of each calendar year with updates scheduled for mid-year. Thus, FDA will update this list by the end of January 2022.

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.

© 2021 Keller and Heckman LLPNational Law Review, Volume XI, Number 181
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About this Author

Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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