FDA Postpones the Effective Date of the Final Rule on the Definition of ‘Healthy’ Until April 28, 2025

In line with the Regulatory Freeze Pending Review memorandum issued by the President on January 20, 2025, the U.S. Food and Drug Administration (FDA) has delayed the effective date of the final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy,’” until April 28, 2025.

The FDA originally published this final rule in the Federal Register on December 27, 2024, with an intended effective date of February 25, 2025. However, following the Presidential directive (90 FR 8249, January 28, 2025), which urged federal agencies to postpone the implementation of pending regulations for 60 days, the FDA extended the effective date to April 28, 2025. This extension allows for additional review regarding factual, legal, and policy considerations surrounding the rule.

The rule updates the criteria for using the term “healthy” as an implied nutrient content claim on food labeling. It aims to help consumers identify foods that align with current dietary guidelines. The primary changes include:

• Revised standards for when “healthy” and related terms (e.g., “healthful,” “healthily,” “healthier”) can be used in food labeling.
• A new framework based on food groups and nutrient limits (NTL) to determine eligibility for the “healthy” claim.
• Definition of food groups in alignment with the Dietary Guidelines for Americans, 2020-2025, including vegetables, fruits, dairy, grains, protein foods, and oils.
• Food Group Equivalents (FGEs) to establish the minimum qualifying amounts of food from each group based on nutritional content.
• Nutrient limitations for added sugars, saturated fat, and sodium, based on a percentage of the Daily Value (DV).
• Automatic qualification for certain whole foods (e.g., fruits, vegetables, whole grains, low-fat dairy, lean proteins) with no added ingredients.
• Automatic qualification for water, tea, and coffee with less than 5 calories per serving.
• Record-keeping requirements for foods using the “healthy” claim when the FGE is not evident from the product label. These records must be retained for at least two years and be made available for FDA inspection upon request.

With the postponement, food manufacturers and stakeholders have additional time to assess compliance requirements and prepare for the regulatory changes. The FDA remains committed to implementing science-based labeling regulations that support public health while ensuring transparency and accuracy in food marketing.

Stay updated with the latest FDA announcements to ensure compliance with evolving food labeling regulations.

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