June 30, 2022
Today, the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) and Office of Food Policy and Response (OFPR) 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 updates the guidance agenda released in January 2022 and focuses on Level 1 draft and final guidances.
Guidance topics that have been added to the agenda are the Draft Guidance on Insanitary Conditions at Tattoo Ink Manufacturing and Distribution Facilities, Guidance Policy regarding N-acetyl-L-cysteine, and the Draft Guidance on Preparation of Premarket Submission for Food Contact Substances.
Since the release of the agenda in January 2022, the FDA has issued the following guidances that were on the list:
- Draft Guidance on Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens
- Draft Guidance Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification
- Draft Guidance on Action Levels for Lead in Juice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- Draft Guidance on the Accredited Third-Party Certification Program: Questions and Answers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
The FDA is taking this action to provide continued transparency for stakeholders regarding foods program priorities. Guidance documents represent the FDA’s current thinking on a specific topic and the information can help stakeholders plan for potential changes that may impact their businesses and organizations. Guidance documents do not impose legally enforceable requirements.
Although the FDA's intent is to publish all draft and final guidance topics on the list, modifications in plans may be needed to support emerging issues and Administration priorities. We also may issue additional guidances that are not on the list.
Public comments on the list of human food and cosmetic guidance topics, including suggestions for alternatives or recommendations on the topics the FDA is considering, can be submitted to www.regulations.gov, using Docket ID: FDA - 2021-N-0553.
The FDA’s list of guidance topics is just one of several resources that the Foods Program routinely shares with stakeholders and partners to inform them of agency priorities. 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 government wide. A list of those FDA regulations and guidance documents under Administration review is available on the Office of Management and Budget website.
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