The Four Types of Permissible Claims: A Practical Guide

The FDA and FTC jointly regulate claims made about dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA), 21 U.S.C. § 321 et seq., and Section 5 of the FTC Act, 15 U.S.C. § 45. There are four categories of permissible claims, each with different substantiation and disclosure requirements.

1. Structure/Function Claims

Structure/function claims describe the role of a nutrient or ingredient as it affects the normal structure or function of the human body (e.g., ‘Calcium builds strong bones’). These claims are permitted without pre-approval under DSHEA § 6, 21 U.S.C. § 343(r)(6), provided the manufacturer: (1) has substantiation that the claim is truthful and not misleading, (2) notifies the FDA within 30 days of first marketing the product with such a claim, and (3) prominently displays 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.’

2. Nutrient Content Claims

Nutrient content claims characterize the level of a nutrient in a food or supplement (e.g., ‘High in fiber,’ ‘Sugar-free’). These claims are strictly regulated under 21 C.F.R. Part 101. The specific nutrient levels required to support each claim are defined by regulation — for example, ‘High in’ requires 20% or more of the Daily Value per serving. Using a claim that does not meet the regulatory threshold is a misbranding violation.

3. Authorized Health Claims

Authorized health claims describe a relationship between a food substance and a disease or health condition (e.g., ‘Diets low in sodium may reduce the risk of high blood pressure’). They require FDA authorization through the rulemaking process and must be supported by significant scientific agreement (SSA). As of 2024, the FDA has authorized claims relating to calcium and osteoporosis (21 C.F.R. § 101.72), dietary fat and cancer (21 C.F.R. § 101.73), and dietary saturated fat and coronary heart disease (21 C.F.R. § 101.75), among others.

4. Qualified Health Claims

Qualified health claims are authorized by the FDA for relationships supported by credible scientific evidence that does not rise to the level required for an authorized health claim. The FDA requires that such claims be accompanied by an appropriate disclaimer reflecting the weight of the evidence.

Substantiation: The FTC Standard

While the FDA regulates labeling claims, the FTC regulates advertising claims in all other media — including websites, social media, television, and print. The FTC requires that advertising claims about dietary supplements be supported by ‘competent and reliable scientific evidence’ — generally meaning randomized controlled trials (RCTs) conducted on humans using the actual product or a comparable formulation at the dose used in the supplement being sold.

In vitro studies, animal studies, and observational data are typically insufficient to meet the FTC substantiation standard for disease-risk reduction claims. The FTC’s enforcement actions in this space — including the landmark case FTC v. Pom Wonderful LLC, No. 9344 (FTC 2013) — make clear that the agency will pursue marketers who make efficacy claims unsupported by adequate clinical evidence.

Social Media and Influencer Marketing of Supplements

Supplement brands that use social media influencers are subject to the same substantiation requirements that apply to direct advertising. A brand is liable for claims made by its paid influencers — it cannot avoid liability by arguing the influencer acted independently.

• Influencer contracts should include explicit provisions limiting the influencer to approved, substantiated claim language.
• The brand should maintain a written advertising review process and retain copies of all approved materials.
• Influencer agreements should require prior written approval of any post before publication.
• Any testimonials used in advertising must be substantiated — the advertiser cannot use a single consumer’s extraordinary result to imply that result is typical.

New Dietary Ingredients (NDIs): Pre-Market Notification

If your supplement contains a ‘new dietary ingredient’ — an ingredient not marketed in the United States in a dietary supplement before October 15, 1994 — you must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before introducing the product to market, under DSHEA § 8, 21 U.S.C. § 350b. The notification must include the basis for concluding that the ingredient will reasonably be expected to be safe. Failure to submit a required NDIN renders the supplement adulterated under the FDCA.

Revision Legal’s FDA and FTC compliance attorneys advise supplement brands on claim substantiation, labeling review, influencer marketing compliance, and response to FDA warning letters and FTC civil investigative demands. Contact us at revisionlegal.com/contact or visit our Internet Law practice page.

The general rule is that no type of “health claim” or “disease claim” can be made on a dietary supplement unless that claim has been authorized by the Federal Food and Drug Administration (“FDA”). There are several options for obtaining this authorization if a health claim is desired. There are also some strategies for avoiding health claims.

What are “health claims,” and how to avoid them?

As the FDA defines it here, a “health claim” on a dietary supplement explicitly links two essential things a substance (like a food, component, or ingredient) and a disease or health-related condition. For a more detailed and legalistic definition, see FDA regulations at 21 CFR § 101.14.

Avoiding a “health claim” is a matter of eliminating one of those essential elements. If either is missing or there is no linkage asserted, then there is no “health claim.” Note that a health claim can be explicit or implicit. For example, using symbols to make an unauthorized health claim is not allowed. An example might be using a symbol or picture recognized as a heart and linking it to a symbol of your supplement.

Methods of obtaining FDA authorizations for “health claims”

There are several methods of finding or obtaining FDA authorization for “health claims.”

The first is to do sufficient research on the FDA regulations to locate an already-issued regulation. Over the years, the FDA has issued extensive regulations under the Nutrition Labeling and Education Act (“NLEA”) and other authorizing legislation. For example, the linkage between calcium supplements and bone density has been well established. As such, the FDA has a regulation that authorizes a health claim for foods containing calcium and calcium supplements. If an FDA regulation already exists related to your supplement and a health claim, then that health claim can safely be made.

Note, however, that the claim made on the label and in advertising/marketing MUST comply with the regulations. As can be seen in the regulation linked above, certain words must be contained on the label, and any limiting or qualifying language related to the health claim must be prominently displayed.

Alternatively, a petition can be filed asking for authorization pursuant to the NLEA. This can be done by providing scientific evidence that substantiates the linkage between the substance/ingredient and the medical condition.

Depending on the scientific substantiation, another option for obtaining FDA authorization is to file a notification with the FDA pursuant to the Food and Drug Administration Modernization Act. The scientific substantiation must come in the form of an “authoritative statement” from the National Academy of Sciences or a scientific body of the U.S. government. If an authoritative statement of this sort is available, then — instead of a petition — a health claim notification can be submitted to the FDA. This can be used for making a health claim on labels and in marketing 120 days after the notification is submitted unless the FDA issues a denial/refusal.

Finally, there is also the possibility of obtaining authorization for what is called a “qualified health claim.” As described in the link above, petitions can be filed with the FDA to authorize health claims where the scientific evidence falls below what is required for issuing a regulation or for notifications allowed under the Modernization Act. Generally, the FDA will allow a “qualified health claim” if the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers.

Contact The FDA Health Claim Attorneys at Revision Legal

For more information, contact the experienced FDA Health Claim Lawyers at Revision Legal. You can contact us through the form on this page or call (855) 473-8474.