How to Market Dietary Supplements Without Getting in Trouble with FDA

Marketing dietary supplements requires navigating a complex regulatory framework. The FDA does not approve dietary supplements before they reach market, but it closely regulates the claims companies make about their products. Understanding the boundaries of permissible claims is essential to avoiding Warning Letters, injunctions, and enforcement action.

What Claims Can Dietary Supplement Companies Legally Make?

Dietary supplement companies may make three types of claims under FDA regulations: (1) Structure/function claims, which describe how a nutrient or ingredient affects normal body structure or function (e.g., “calcium builds strong bones”); (2) Nutrient content claims, which characterize the level of a nutrient in the product; and (3) Health claims that describe a relationship between a food substance and a disease or health condition, which require FDA authorization. Disease claims—stating that a product treats, cures, or prevents a disease—are prohibited for dietary supplements and will cause the product to be regulated as an unapproved drug.

What Is the Difference Between a Structure/Function Claim and a Disease Claim?

The line between a permissible structure/function claim and a prohibited disease claim can be subtle. A structure/function claim refers to the product’s effect on a normal body structure or function. A disease claim implies that the product treats, mitigates, cures, or prevents a disease. For example, “supports cardiovascular health” is generally a structure/function claim, while “reduces the risk of heart disease” is a disease claim requiring FDA authorization. Context matters: website testimonials, surrounding marketing language, and even the product name can convert an otherwise permissible claim into a disease claim.

What Disclosure Is Required When Making Structure/Function Claims?

When a dietary supplement label includes a structure/function claim, the manufacturer must: (1) include a disclaimer stating “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.”; (2) notify FDA within 30 days of first marketing the product with the claim; and (3) have substantiation that the claim is truthful and not misleading. The disclaimer must appear prominently and conspicuously on the label.

How Does FDA Enforce Supplement Claim Violations?

FDA monitors dietary supplement marketing through label review, website monitoring, and consumer complaints. When FDA identifies impermissible claims, its primary enforcement tools include: Warning Letters requiring corrective action; seizures of misbranded or adulterated products; injunctions against continued violations; and referral to the Department of Justice for criminal prosecution in egregious cases. FTC also has jurisdiction over advertising claims and frequently coordinates with FDA on enforcement actions against supplement companies.

What Should a Dietary Supplement Company Do Before Launching a New Product?

Before launching a dietary supplement, companies should: (1) review all label and marketing copy with qualified regulatory counsel to identify any disease claims or unsubstantiated claims; (2) ensure substantiation files are in place for any structure/function claims; (3) verify the product meets cGMP requirements under 21 CFR Part 111; (4) confirm that any ingredients are lawfully marketed as dietary supplements (including new dietary ingredient notification requirements under DSHEA if applicable); and (5) file the required 30-day notification with FDA if structure/function claims are included on the label.

This content is for educational purposes only and does not constitute legal advice. Contact Capote Law Firm to discuss your dietary supplement compliance needs.