FDA Delays Effective Date for Final Healthy Rule

Background

FDA issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling on December 19, 2024. The rule permits healthy claims for foods containing both 1) a certain quantity of food group equivalents (such as fruits, vegetables, whole grain, dairy, and protein foods) and 2) no more than specified amounts of added sugars, sodium, and saturated fat, referred to as nutrients to limit. Additionally, the rule allows certain foods to automatically qualify for the healthy claim, including individual foods or mixed foods comprised solely of one or more of foods encouraged by the Dietary Guidelines for Americans (i.e., vegetables, fruit, whole grains, fat-free and low-fat dairy, lean meat, seafood, eggs, beans, peas, lentils, nuts and seeds) as well as all non-carbonated and carbonated water, tea, and coffee with less than 5 calories per reference amount customarily consumed. Manufacturers are not required to comply with the rule until the compliance date of February 25, 2028. However, manufacturers can choose to comply earlier.

Although FDA is now delaying the final rule’s effective date of February 25, 2025 until April 28, 2025, the agency notes that the original February 25, 2028 compliance date remains “unchanged at this time.”

Justifications for Delayed Effective Date

FDA asserts that delaying the effective date is exempt from notice and comment procedures because the delay either constitutes a rule of procedure under 5 U.S.C. 553(b)(A) or, alternatively, is based on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). FDA further argues that public comment is impracticable, unnecessary, and contrary to the public interest, and that the delay is necessary to give agency officials the opportunity for review and consideration of the healthy rule, consistent with President Trump’s “Regulatory Freeze Pending Review” memorandum. Finally, the agency notes that “certain affected entities” would benefit from being informed as soon as possible of the final rule’s delayed effective date “in order to plan and adjust their implementation process accordingly.”

Under the Administrative Procedure Act the effective date is the date when the regulation becomes effective and is considered binding while the compliance date is the date when companies are expected to comply with the new requirements. We suspect the administration is delaying the effective date so it can have sufficient time to review the final regulation and assess whether its provisions are consistent with the administration’s priorities.

Next Steps

FDA did not specify what questions of fact, law, and policy it would consider during the delay period, but did reiterate that manufacturers can choose to comply with the updated “healthy” criteria earlier than the February 25, 2028 compliance date.

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The delayed effective date is notable as the first action related to rulemaking taken by FDA after Robert F. Kennedy, Jr.’s confirmation as Secretary of the Department of Health and Human Services and the creation of the Make America Healthy Again Commission.³ We will monitor any action FDA may take with respect to the definition of “healthy.”

Please do not hesitate to contact us if you have any questions. 

Authored by Veronica Colas and Chigozie Akah.