The FDA has announced its long-awaited Rule governing when the term “healthy” can be used as an implied nutrient content claim on food labels.

The FDA has regulated healthy claims since 1994, and while it has updated various guidelines relating to nutrition facts labels, serving sizes, and the Daily Value (DV) of certain individual nutrients, its definition of “healthy” lagged behind. The agency began this rulemaking in 2016, when it published a request for information and comments on the “healthy” claim. Then, in September of 2022, the FDA issued a proposed rule to amend the definition of “healthy” to ensure that foods bearing the claim are foods that may help consumers maintain healthy dietary practices, consistent with current nutrition science and federal dietary guidance. The final Rule takes into account the over 400 comments submitted to the FDA on its 2022 proposal.

The final rule includes a number of updated provisions. certain foods that previously qualified for a “healthy” claim no longer will, including fortified white bread, highly sweetened yogurt, and highly sweetened cereal.

While the full text of the Rule bears careful reading, to summarize, the Rule:

1. Establishes parameters for use of the term “healthy” and its derivative terms -- “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”;
2. Establishes a framework based on food groups and nutrients to limit for the “healthy” claim;
3. Requires that, to bear a “healthy” claim, individual food products, mixed products, main dishes, and meals must meet certain food group equivalents and specific limits for added sugars, saturated fat, and sodium based on a percentage of the DV for these nutrients;
4. Provides that certain foods encouraged by the Dietary Guidelines -- vegetables; fruits; whole grains; fat-free and low-fat dairy; lean meats, seafood, eggs, beans, peas, lentils, nuts and seeds – automatically qualify as “healthy” because of their nutrient profile and positive contribution to an overall healthy diet; and
5. Provides that all water, tea, and coffee with less than 5 calories per serving automatically qualify for the “healthy” claim.

The Rule will go into effect on February 25, 2025; businesses will then have three years – until February 25, 2028 – to comply. The FDA has indicated that it intends to provide additional resources, including guidance documents, FAQs, web updates and online webinars to help manufacturers with their compliance obligations.