FDA finalized a new definition of the nutrient content claim “healthy” in a rule published in the Federal Register on December 19, 2024. The rule took effect April 28, 2025 (delayed slightly from an original February 25, 2025 effective date under a government-wide regulatory freeze), and any “healthy” claim on your label has until February 25, 2028 to meet the new criteria. As of September 2026, FDA has not announced any extension to that 2028 compliance date (Federal Register, FDA).
What changed
The old “healthy” definition, in place since the 1990s, was built almost entirely around individual nutrient limits (total fat, saturated fat, cholesterol, sodium) with little regard for what kind of food was carrying the claim. That let some highly processed, low-fat products qualify while foods like nuts, salmon, and olive oil didn’t, because their fat content tripped the old thresholds even though nutrition science had moved on.
The new rule flips the emphasis toward food groups and overall dietary pattern, matching the approach in the current Dietary Guidelines for Americans. To use “healthy” on a label now, per FDA’s own materials, a food generally has to do both of the following:
- Contain a meaningful amount of a food group the Dietary Guidelines recommend eating more of (fruits, vegetables, whole grains, protein foods, or dairy, fat-free or low-fat), with the specific amount varying by food category.
- Stay within limits on three nutrients research links to diet-related chronic disease: added sugars, sodium, and saturated fat. Limits are set as a percentage of Daily Value and vary by food category rather than being one flat number for every product (FDA).
A few food categories, including raw fruits and vegetables and certain water products, are treated as automatically meeting the criteria without the food-group or nutrient math, consistent with how FDA has long handled naturally healthy staples.
Who this affects, and examples FDA has pointed to
If you use the word “healthy”, or implied versions of it, as a nutrient content claim on your label, check your product against the new criteria before the 2028 deadline. FDA has highlighted some concrete before-and-after examples in its own consumer materials:
- Now eligible for the first time: nuts and seeds, olive oil and other oils, higher-fat fish like salmon, eggs, and water, all previously excluded under the old fat-based thresholds despite being nutrient-dense.
- No longer eligible: some fortified white bread, highly sweetened yogurt, and highly sweetened cereal: products that could meet the old fat/sodium/cholesterol limits but fall short on added sugars or whole-grain/food-group content under the new rule (FDA consumer update).
This is one specific claim, not a change to the Nutrition Facts panel itself. The panel’s mandatory nutrients, rounding, and %DV calculations under 21 CFR 101.9 are unaffected. It only touches whether a product can legally carry the word “healthy” (or close variants) as a marketing claim.
What to do about it
If your label currently uses “healthy” as a claim, or you’re considering adding it, the practical steps are the same either way: check your product’s actual food-group content and its added sugars, sodium, and saturated fat against the category-specific limits in the final rule, and don’t assume a product that qualified under the old definition still does. The sweetened-yogurt and fortified-bread examples above are exactly the kind of product that can fall out of eligibility. FDA describes what the rule requires; whether your product meets it is a determination you make (or bring to a food-labeling attorney or consultant if the numbers are close).
A nutrient content claim like “healthy” is separate from, but related to, the small business nutrient content claim rules covered in our exemption guide, since making any nutrient content claim voids that exemption regardless of whether the claim itself is accurate. When you build a label with NutriLabels, our builder flags nutrient content claims like “healthy,” “low sodium,” or “good source of” for review so you notice when a claim needs a closer look, rather than letting it slide onto a label unexamined.
Checking a “healthy” claim well before the 2028 date means your next print run carries a claim you have already measured against the new criteria. Enter your recipe, then see your label: free with no card required, you see your calories, the claims you qualify for, your allergen line and the nutrient to watch, and every other value and %DV stays hidden until you unlock it. $29 unlocks every other nutrient value and %DV, every FDA format your product qualifies for, the ingredient statement and allergen declaration, ready to print. Start your label, or reach us on our contact page if you want a second set of eyes on a claim.
Last checked: September 15, 2026
Sources
- https://www.federalregister.gov/documents/2025/02/25/2025-03118/food-labeling-nutrient-content-claims-definition-of-term-healthy
- https://www.fda.gov/food/hfp-constituent-updates/fda-finalizes-updated-healthy-nutrient-content-claim
- https://www.fda.gov/consumers/consumer-updates/fresh-take-what-healthy-means-food-packages
- https://www.fda.gov/food/nutrition-food-labeling-and-critical-foods/use-healthy-claim-food-labeling