FDA finalizes updated "healthy" nutrient content claim; manufacturers get until Feb. 2028 to comply

The U.S. Food and Drug Administration finalized an updated definition of the voluntary "healthy" nutrient content claim that uses a food'group based approach and new limits for nutrients to limit, agency officials said during a webinar hosted for National Women's Health Week.

"The updated criteria accomplish a new framework and uses a food group based approach along with nutrients," Vincent DeJesus, a presenter from FDA's Human Foods Program, said. Under the final rule, a product must contain a meaningful amount of at least one recommended food group (for example vegetables, fruits, dairy or protein) and must not exceed set limits for saturated fat, sodium and added sugars to bear the voluntary "healthy" claim.

Why it matters: the change is intended to align the label claim with current nutrition science and federal dietary guidance, making the claim a quicker signal of foods that can help build healthier dietary patterns. Agency presenters said that the change should also discourage highly processed products that are high in added sugar, sodium or saturated fat from carrying the claim.

What changed: the new rule replaces the older nutrient'only thresholds with a combined test that requires both (1) a minimum food group equivalent (FGE) per product category and (2) maximum limits for saturated fat, sodium and added sugars expressed as percent of the Daily Value (DV). The rule applies different FGE minimums and nutrient limits depending on whether a product is an individual food, a mixed product, a main dish or a meal; limits for nutrients to limit increase stepwise from mixed products to meals.

Examples and exemptions: agency officials said some foods that previously could not bear the claim under the older nutrient rules may now qualify (they cited eggs, olive oil and certain fish). Conversely, many highly processed cereals, sugary yogurts and snack foods that lack meaningful amounts of recommended food groups or are high in added sugars, sodium or saturated fat will generally not qualify. FDA expanded an exemption so that certain single'ingredient foods and foods recommended by the Dietary Guidelines (for example plain brown rice, unsalted nuts, frozen vegetables without added ingredients) automatically qualify without meeting the FGE/nutrient tests; water and very low'calorie coffee and tea are also covered by exemptions.

Small'size handling: for products with a reference amount customarily consumed (RACC) under 50 grams, FDA explained that FGE and nutrient limits are calculated on a 50'gram basis rather than the smaller RACC so small, nutrient'dense items are not unfairly excluded.

Rulemaking and timeline: FDA published the final rule after a public comment period in which it received more than 400 comments and a marketplace review that shaped the final criteria, agency officials said. The final rule has an effective date in April 2025 and a compliance date in February 2028 to give manufacturers time to assess recipes, ingredient lists and labeling.

Cautions and limits: presenters emphasized the claim is voluntary and limited in scope: it is intended to signal foods that can be part of a healthy dietary pattern, not to serve as a seal of overall product healthiness. The agency also noted that FDA'evaluated individual substance'disease relationships when authorizing health claims (for example, the agency'issued a qualified health claim for cranberry products and recurrent urinary tract infection with limited evidence), but that the updated "healthy" claim is a distinct nutrient content claim focused on food groups and nutrients to limit.

Next steps for industry and consumers: manufacturers that currently use the "healthy" claim or plan to do so should evaluate whether individual products meet the updated FGE and nutrient limits and adjust formulations or labeling as needed before the February 2028 compliance date, the agency said. FDA pointed listeners to enforcement discretion letters, model claim language and guidance documents available on the agency website for details.

"How manufacturers should prepare will depend on how individual manufacturers are using the healthy claim now," DeJesus said. "Each manufacturer needs to look at their existing foods and potential food products and determine if use of the claim is possible."