Article
Regulatory Compliance

US FDA Delays Definition of Healthy

Recent US federal action will delay the implementation of FDA's definition for “healthy” until April 28, 2025.

In December 2024, the U.S. Food and Drug Administration (FDA) finalized a rule that updated the nutritional requirements a food must meet to use the term “healthy on its packaging. The rule was published with an effective date of February 25, 2025. In January, President Trump issued a memorandum entitled “Regulatory Freeze Pending Review” which freezes new rules until a department or agency head appointed or designated by the President reviews and approves the rule. The freeze also directs agencies to postpone the effective date for any new rules that were published in the Federal Register but have not yet taken effect for the purpose of review.

The recent action means that the FDA definition for “healthy” will be delayed until April 28, 2025. Among other requirements, the final rule identifies limits on added sugars, saturated fats, and sodium for foods that are labeled as healthy. Some foods such as flavored yogurts and sweetened cereals that previously carried the healthy label will no longer qualify for this claim under the new definition. The current understanding of this definition could evolve further with the appointment of Robert F. Kennedy, Jr. as Secretary of Health and Human Services.

The “healthy” claim was last defined in the 1990s, and it was focused solely on nutrients based on the science available at that time. The current awareness of dietary patterns and concerns about added sugar, fat, and sodium will help inform the new definition.

About the Author

Julie Holt is a subject matter expert in the areas of food and beverage, additives and regulatory strategy. Ms. Holt’s expertise includes the beverage industry, with current consulting support across multiple beverage categories.

Holt has more than 25+ years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, prior to joining FoodChain ID. As a consultant, she supported several food and beverage clients including a Fortune 50 company. Holt has provided global regulatory knowledge covering more than 200 countries. Her consulting efforts have supported global regulatory needs, R&D projects, sustainability goals and innovation initiatives.

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