FDA's Definition of "Healthy" … Updated Just in Time for New Year's Resolutions
After years of talk, the U.S. Food and Drug Administration in mid-December 2024 at last finalized an updated definition of the implied nutrient content claim "healthy." The original definition of "healthy" dates back to the early 1990s, and a lot has changed since then.
The updated definition takes a more holistic approach to the term, rather than focusing exclusively on levels of specific nutrients. This means, in part, that certain foods that did not qualify under the original criteria but that are understood to be part of a healthy diet—e.g., avocados, salmon, nuts—are more likely to qualify as "healthy" now.
When FDA first defined "healthy" in 1994, we concluded that 'the fundamental purpose of a "healthy" claim is to highlight those foods that, based on their nutrient levels, are particularly useful in constructing a diet that conforms to current dietary guidelines.' … The current Dietary Guidelines, 2020-2025 focuses on the importance of a healthy dietary pattern as a whole and its role in promoting health, reducing risk of chronic diseases, and meeting nutrient needs.
The updated definition brings forward the categorization of food products into the categories used in the Dietary Guidelines: vegetables, fruits, grains, fat free or low-fat dairy, and proteins (e.g., lean meat, seafood, eggs, beans, peas, lentils, nuts, and seeds). To bear a "healthy" claim, the food must be present in a certain amount and must fall below limits on certain undesirable nutrients, i.e., added sugar, sodium, and saturated fat, with certain exceptions.
Further, consistent with the proposed rule, the updated definition of "healthy" now uses types and amounts of "food group equivalents" as criteria and specifies six scenarios of food group equivalents that may bear a "healthy" claim. The nutrient disclosure requirements for general nutrient content claims (e.g., "see nutrition facts for [fat, saturated fat, cholesterol, sodium] content") do not apply to foods that meet the criteria for a "healthy" claim. Under the updated definition, all water, tea, and coffee products with less than 5 calories per reference amount customarily consumed and per labeled serving may bear the term "healthy."
The compliance date for this updated definition is February 25, 2028. Given that FDA promulgated this rule in the final days of the Biden Administration, it could be subject to repeal under the Congressional Review Act.