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During his first day in office, President Trump issued a flurry of executive orders, including a Regulatory Freeze Executive Order, effective January 20, 2025. The executive order titled “Regulatory Freeze Pending Review” mandates a halt on all rulemaking and new regulations across federal agencies, including the U.S. Food and Drug Administration (FDA), until they are reviewed and approved by agency heads appointed by President Trump. This regulatory freeze is not unprecedented and is similar to actions taken by previous incoming administrations.

Key Provisions of the Executive Order
The Regulatory Freeze Executive Order directs all federal agencies to do the following:

• No New Rules: Agencies are prohibited from proposing or issuing any new rules until they have been thoroughly reviewed and approved by a President-appointed agency head.
• Withdrawal of Unpublished Rules: Any rules that have been sent to the Office of the Federal Register (OFR) but not yet published must be withdrawn for review.
• Postponement of Effective Dates: Agencies are instructed to consider postponing for 60 days the effective dates of any rules that have been published but have not yet taken effect to allow for review regarding questions of fact, law, and policy that the rules may raise. During the 60-day postponement, agencies may open a comment period for public input and reevaluate pending petitions.

Impacts on the FDA
The FDA will be significantly affected by this regulatory freeze. The agency will need to review all pending rules to ensure they align with the new administration's policies. This review process could lead to modifications or cancellation of some regulations. Any new FDA regulations that were in the pipeline but not yet effective will be postponed. This could include food safety regulations related to the following:

• FDA revoking the use of Red No. 3 in food and ingested drugs.
• FDA proposed rule regarding Front-of-Package Nutrition Labeling.
• FDA final rule on the “Healthy” nutrient content claim which is not effective until February 25, 2025.
• FDA final rule on traceability (FSMA 204) which is not effective until January 2026.
• USDA Food Safety and Inspection Service proposed rule regarding Salmonella as an adulterant at certain levels in raw poultry.

Upon the new administration’s review, the rules will either move forward, be withdrawn, or be subject to additional rulemaking activities. According to the executive order, no further action needs to be taken for those rules that raise no substantial questions of fact, law, or policy.