USA: Regulatory Freeze on Pending Rules for Food Supplements 

On January 20th, the White House issued a regulatory freeze order. This order effectively suspends any rulemaking or similar regulatory activities until the new administration has had an opportunity to review the proposals from the previous administration. 
    The memorandum directed all executive departments and agencies to: 
        1. Refrain from proposing or issuing any rules in any manner, including submitting rules to the Office of the Federal Register, until a department or agency head appointed or designated by the President after noon on January 20, 2025, reviews and approves the rule. 
        2. Withdraw any rules that have been sent to the Federal Register but have not yet been published so they are reviewed and approved. 
        3. Postpone for 60 days the effective date for any rules that have been published in the Federal Register, or any regulations that have been issued in any manner but have yet not taken effect.
 
    Impact on Food Supplements 
    – FDA revoking the use of additive Red No. 3 in food and ingested drugs
    – FDA proposed rule regarding Front-of-Package Nutrition Labeling
    – FDA final rule on the nutrient content claim “Healthy” (because it is not effective until February 25, 2025)
    – FDA Food Traceability Rule FSMA 204 (because it is not effective until January 2026)
    – Proposed Dietary Supplements Access Act, allowing consumers to use their Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs) to purchase dietary supplements. 
    – Dietary Supplement Listing Act introduced in 2024
 
    It is important to note that the review of these rules does not necessarily mean they will be discarded or rejected.
 
We will keep you briefed as new information becomes available.
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