Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) issued a notice stating that FDA is delaying the effective date of its “healthy” final rule until April 28, 2025. The notice was signed by newly-confirmed HHS Secretary Robert F. Kennedy Jr., rather than an FDA official, as is more typical.
The “healthy” final rule, which Covington summarized in a recent client alert, establishes revised criteria for when foods can be labeled with the implied nutrient content claim “healthy.” The final rule was published on December 27, 2024 and originally had an effective date of February 25, 2025 and a compliance date of February 25, 2028. Today’s notice delays the rule’s effective date until April 28, 2025 but expressly indicates that it does not change the rule’s compliance date. This comes after FDA recently postponed a webinar on the “healthy” rule that was scheduled for February 20, 2025.
FDA is delaying the rule’s effective date pursuant to President Trump’s “regulatory freeze” memorandum, which ordered federal agencies to consider postponing for 60 days the effective date of any rules that had been published in the Federal Register but had not yet taken effect as of January 28, 2025. The memorandum instructed agencies to use this 60-day window to review such rules for “any questions of fact, law, and policy the rules may raise.” While today’s notice does not indicate whether FDA plans to make any changes to the “healthy” rule, it remains possible that the agency could do so after conducting this review.
As Covington noted in another recent client alert, the “healthy” rule could also be ripe for review under President Trump’s February 19, 2025 Executive Order on the Department of Government Efficiency Deregulatory Initiative, which instructs federal agencies to identify existing regulations that may merit recission or modification. Today’s notice, coupled with the administration’s broader deregulatory initiatives, could therefore present an opportunity for interested stakeholders to engage with HHS, FDA, and other administration officials on potential modifications to the “healthy” final rule.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.
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