"Healthy" is a nutrient content claim under 21 CFR 101.65(d). Using it on a food or supplement label requires meeting specific nutrient criteria. The old definition, finalized in 1994, reflected nutrition science from that era — it focused primarily on total fat, saturated fat, cholesterol, sodium, and minimum nutrient requirements. The December 2024 final rule modernized those thresholds significantly, and some products that couldn't use "healthy" before now can, while others that could use it may no longer qualify.
What Changed: The Old vs. New Framework
The 1994 "healthy" definition focused on limiting total fat (≤3g for most foods) and cholesterol. Under that framework, foods like nuts, avocados, and salmon — which are high in fat but nutritionally beneficial — couldn't be called "healthy." Meanwhile, fat-free products loaded with sugar could qualify.
The December 2024 rule restructured the definition around:
Food group equivalents: Products must contain a meaningful amount of a food group consistent with the Dietary Guidelines (fruits, vegetables, grains, dairy, protein foods)
Nutrient limits: Caps on sodium, added sugars, and saturated fat — with thresholds calibrated by food category
No total fat limit: Beneficial unsaturated fats are no longer disqualifying
The New Nutrient Thresholds
The December 2024 final rule establishes thresholds by food category. For dietary supplements and most packaged food products, the key limits per serving are:
Added sugars: ≤10% of Daily Value (≤2.5g per serving)
Sodium: ≤10% of Daily Value (≤230mg per serving)
Saturated fat: ≤10% of Daily Value (≤2g per serving)
Products must also contain at least a certain percentage of the Daily Value for one of a defined set of beneficial nutrients (vitamin D, calcium, iron, potassium, dietary fiber, or a food group equivalent) to demonstrate positive nutritional value — not just absence of negatives.
Who Can Now Use "Healthy" That Couldn't Before
Under the new definition:
Nuts and nut-based products: No longer disqualified by fat content if sodium and added sugar thresholds are met
Salmon and fatty fish: High in beneficial omega-3s, can now qualify if sodium is managed
Avocado-based products: Avocado oil and avocado-containing supplements that meet other thresholds can now use "healthy"
Whole grain products: Benefit from the food group component requirement
Who May Have Lost "Healthy" Status
High-sodium products: Many products that previously met the total fat test now fail on the tightened sodium threshold
Added sugar-heavy products: Products with sugar as a primary ingredient or sweetener may fail the ≤2.5g added sugar per serving limit
Fat-free but nutrient-poor products: Fat-free products without meaningful nutrition from food groups or key nutrients may fail the positive nutrient requirement
"Healthy" in Marketing vs. on Labels
The FDA's "healthy" definition governs the use of the word "healthy" as an implied nutrient content claim — meaning it applies when the claim characterizes the nutritional content of the food. Using "healthy" in contexts like "live a healthy lifestyle" or "healthy habits" as general marketing language may not trigger the nutrient content claim requirement, but FDA evaluates context. In the context of supplement or food marketing, "a healthy choice" or "healthy product" adjacent to the product name will be treated as a nutrient content claim.
FTC also applies scrutiny to "healthy" claims in advertising under its substantiation standard. The FDA final rule doesn't automatically determine FTC compliance, but it provides the most defensible benchmark for substantiation.
Transition Period
FDA's December 2024 final rule included a compliance date giving manufacturers time to update labels. Brands using "healthy" on existing labels under the old standard should have a clear timeline for updating to the new definition — or discontinuing the claim if the product no longer qualifies under the new thresholds.
"Healthy" is a defined legal term — not a general aspiration
Truli audits "healthy" claims on labels and marketing materials against the December 2024 final rule thresholds — flagging products that use the term without meeting the new nutrient criteria for added sugars, sodium, saturated fat, and beneficial nutrient content.
A note from Truli: Truli is not a law firm, and this article does not constitute or contain legal advice or create an attorney-client relationship. When determining your obligations and compliance with respect to relevant laws and regulations, you should consult a licensed attorney.
