The answer is legally complicated since the Food and Drug Administration (“FDA”) has defined the term “healthy” to apply to foods, not dietary supplements. On the other hand, in some circumstances, certain types of oils — like olive oil — are now eligible to use the “healthy” label. Thus, if your supplement is an oil or other food-like consumable, your supplement might be able to make the “healthy” claim. This is an evolving area of law.

That being said, while it might be possible to use the “healthy” label, it is probably better to make defensible “health benefits” claims instead. Use of labels like “healthy” and FDA approval of health claims for dietary supplements is a confusing legal labyrinth, and you will need experienced FDA Approval Lawyers to help. Call us here at Revision Legal for more information. Here is more information on the use of the “healthy” label and recent changes made by the FDA.

The FDA recently changed/updated the criteria for lawful use of the “healthy” label on foods (and, potentially, other food-like products). Under the old definition (from 1994), the “healthy” label required that the food product be limited in fats, saturated fats, cholesterol, and salt/sodium, and also had to provide 10% of the recommended daily amounts of vitamin A or C, calcium, iron, protein, or fiber. In practice, this was a relatively easy standard to meet. As an example, many heavily sugared cereals were able to meet this standard since such foods were/are low in fats and provided a good daily dose of fiber.

As stated in an FDA fact sheet here, the new definition of “healthy” requires that a food product:

1. Contain a certain amount of food from at least one of the food groups or subgroups (such as fruit, vegetables, grains, fat-free and low-fat dairy, and protein foods) recommended by the Dietary Guidelines for Americans, and

2. Meet specific limits for added sugars, saturated fat, and sodium

Among other significant changes is the addition of limits on added sugars and the abolition of quotas for things like vitamins, various minerals, protein, etc.

Examples listed that will automatically qualify for the new “healthy” labeling claim include anything that is “nutrient-dense” and that has nothing added other than water. These include unadulterated versions of:

• Vegetables and fruits — even “high fat” fruits like avocados
• Water
• Whole grains
• Fat-free and low-fat dairy
• Lean game meat
• Seafood — including higher-fat fish like salmon
• Eggs
• Beans, peas, and lentils
• Nuts and seeds
• Olive and some other types of oil

As noted, if you produce and market supplements, your supplement might be eligible to use the “healthy” label. Given the new definition, a supplement that is, for example, ground or dried vegetables (and nothing else) might qualify. In the alternative, it may be better, if possible, to make a “health claim” or “disease claim,” which are claims that explicitly link a supplement to the amelioration or prevention of a disease or health-related condition.

The Three Categories of Lawful Supplement Claims

Federal law draws a sharp distinction between three types of claims that dietary supplement manufacturers can make: health claims, structure/function claims, and nutrient content claims. Each category has different legal requirements, and mixing up the rules is one of the most common compliance mistakes that supplement companies make.

Health Claims

A “health claim” describes a relationship between a food substance and a disease or health-related condition — for example, “calcium reduces the risk of osteoporosis.” Under 21 U.S.C. § 343(r) and implementing FDA regulations at 21 C.F.R. Part 101, health claims for dietary supplements must be pre-authorized by the FDA and backed by “significant scientific agreement.” The authorization process is rigorous. Unauthorized health claims on supplement labels are deemed misbranding under the Federal Food, Drug, and Cosmetic Act (“FDCA”), which can trigger warning letters, injunctions, seizures, and civil penalties.

Structure/Function Claims

A “structure/function claim” describes the role of a nutrient or ingredient in maintaining the normal structure or function of the body — for example, “vitamin D supports bone health.” These claims do not require FDA pre-authorization, but they do carry important obligations under 21 C.F.R. § 101.93. Specifically, the manufacturer must (1) have substantiation that the claim is truthful and not misleading, (2) notify the FDA within 30 days of first marketing the product with the claim, and (3) include the mandatory disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”

Nutrient Content Claims

Nutrient content claims characterize the level of a nutrient in a supplement — for example, “high in vitamin C” or “excellent source of fiber.” The FDA has defined specific criteria for these terms at 21 C.F.R. Part 101, Subpart D. Using terms like “high,” “excellent source,” or “more” without meeting the criteria is a labeling violation.

The FTC’s Parallel Role in Supplement Advertising

The FDA regulates supplement labeling; the Federal Trade Commission (“FTC”) regulates supplement advertising. In practice, these two regimes are nearly identical in substance — the FTC requires that advertising claims be truthful, non-deceptive, and supported by competent and reliable scientific evidence. See FTC Policy Statement on Deception (1983) and FTC Policy Statement Regarding Advertising Substantiation (1984). The FTC has authority under 15 U.S.C. § 45 (Section 5 of the FTC Act) to pursue civil penalties and injunctive relief against companies whose supplement ads make unsubstantiated claims. The FTC’s “Dietary Supplements: An Advertising Guide for Industry” is the primary enforcement roadmap and should be treated as binding guidance.

Disease Claims: The Bright-Line That Converts a Supplement Into a Drug

Perhaps the most consequential legal rule in supplement marketing is the disease claim rule. Any claim that a supplement is intended to diagnose, cure, mitigate, treat, or prevent a disease — a “disease claim” under 21 C.F.R. § 101.93(g)(2) — transforms the supplement into an unapproved drug under the FDCA. The practical result: a company selling a “supplement” with a disease claim is selling an illegal, unapproved drug, regardless of what the product is actually called. The FDA takes disease claims seriously. In recent years, the agency has issued hundreds of warning letters to supplement companies for disease claims, particularly for products marketed as treatments for diabetes, cancer, COVID-19, and cardiovascular conditions.

Practical Compliance Steps for Supplement Marketers

• Conduct a pre-launch label and advertising review. Every claim — including claims made on websites, social media, and by paid influencers — should be reviewed against the FDA and FTC frameworks before going live.
• Build a substantiation file. For every structure/function claim, assemble and retain the scientific studies, expert opinions, and other evidence that support the claim.
• Use the required disclaimer. Structure/function claims require the FDA disclaimer, and it must appear prominently and conspicuously.
• File the 30-day notification. For structure/function claims, the FDA notification is a legal requirement, not an optional best practice.
• Train your marketing team. Many violations occur because marketing staff do not understand the bright line between structure/function claims and disease claims.
• Monitor social media. If influencers are making claims about your supplement, those claims are legally attributable to your company under FTC guidance.

Enforcement Trends and Penalties

FDA enforcement actions against supplement companies have accelerated significantly. Common triggers include claims related to weight loss, sexual performance, cognitive enhancement, and immunity. Civil monetary penalties under the FDCA can reach tens of thousands of dollars per violation per day. The FTC has also levied multi-million dollar judgments against supplement companies under its Section 5 authority. In egregious cases involving false disease claims, the Department of Justice has pursued criminal charges.

Contact Revision Legal

If you have questions about food and beverage law, the experienced attorneys at Revision Legal can help. We represent businesses, entrepreneurs, and individuals across the country. Contact us through the form on this page, visit our food and beverage law practice page, or call us at (855) 473-8474.