The FDA’s Center for Food Safety and Applied Nutrition and Office of Food Policy and Response has released a list of draft and final guidance topics that are a priority for the FDA Foods Program to complete during the next 12 months.
The agency anticipates it will publish many of these documents by January 2023. The list is an update on the guidance agenda released in June 2021 and focuses on the Level 1 draft and final guidances.
Level 1 guidances 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 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. They 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.
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 help inform them of agency priorities. Most proposed and final rules are tracked collectively and 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.
Here’s what’s on the list: