Structure/Function Claims: What Supplement Brands Can and Cannot Say

What Structure/Function Claims Are

The Dietary Supplement Health and Education Act (DSHEA) of 1994 allows supplement manufacturers to make claims about how a nutrient or ingredient affects the normal structure or function of the human body. These are called structure/function claims.

Structure/function claims describe an effect on normal body processes. They cannot claim to diagnose, treat, cure, mitigate, or prevent any disease. The moment a claim crosses that line, the product is legally classified as an unapproved new drug under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)(B)). The one exception is an FDA-authorized health claim the product qualifies for (21 CFR 101.93(f)).

DSHEA set special requirements for structure/function claims and for two related types of supplement labeling claim. All three carry the same three obligations below: substantiation, the 30-day notification, and the disclaimer.

• ✓Structure/function claims describe the role of a nutrient in affecting the body's normal structure or function, as in "Calcium builds strong bones". They may instead characterize the documented mechanism by which it acts, as in "Fiber maintains bowel regularity". Both forms are one claim type, not two.
• ✓General well-being claims describe general well-being from consuming a nutrient or dietary ingredient, as in "Promotes a general sense of well-being".
• ✓Nutrient deficiency disease claims describe a benefit related to a classical deficiency disease, such as vitamin C and scurvy. These are allowed only if the label also says how widespread that disease is in the United States.

Claims That Pass vs Claims That Fail

The difference between a legal structure/function claim and an illegal disease claim is often just a few words. These examples show where the line falls across common supplement categories.

The 30-Day FDA Notification Rule

DSHEA requires that you notify the FDA within 30 days of first marketing a dietary supplement with a structure/function claim. This applies to every product with any structure/function claim on the label.

What the Notification Includes

• ✓The text of the structure/function claim
• ✓The name of the dietary ingredient or supplement that is the subject of the claim, if the claim's text does not name it
• ✓The name of the dietary supplement product, including its brand name
• ✓The name and address of the manufacturer, packer, or distributor
• ✓The signature of a responsible person, certifying that the information is complete and accurate and that the firm has substantiation that the claim is truthful and not misleading

The Required Disclaimer

Every product with a structure/function claim must display this disclaimer on the label:

The disclaimer must appear in boldface type in a size no smaller than one-sixteenth of an inch (21 CFR 101.93(e)). Under 101.93(d), it must appear on each panel or page where a structure/function statement appears, placed adjacent to the statement with no intervening material or linked to it with a symbol such as an asterisk (set off in a box if not adjacent). In a December 11, 2025 letter to industry, FDA said it is likely to propose amending the each-panel requirement and, meanwhile, intends to exercise enforcement discretion on it. FDA does not extend that discretion to putting the disclaimer on the label and linking it to each claim, or to the other requirements of 21 CFR 101.93. Enforcement discretion does not change the regulation's text, so confirm any relabeling decision with regulatory counsel. For more on label requirements, see our packaging and label compliance guide.

FTC Advertising Standards

Under the FDA-FTC liaison agreement, the FDA has primary responsibility for claims in labeling, including the package, product inserts, and other promotional materials available at the point of sale. The Federal Trade Commission (FTC) has primary responsibility for claims in all forms of advertising, which its guidance says includes internet content, social media, and influencer marketing. The agreement does not stop the FTC from acting on claims in labeling too.

The FTC standard for health claims is "competent and reliable scientific evidence," which the FTC defines as tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function, and that are generally accepted in the profession to yield accurate and reliable results (FTC Health Products Compliance Guidance, 2022). As a general matter, the guidance says health benefit claims need randomized, controlled human clinical trials (RCTs). "We believe it works" or "our customers say it works" does not meet this standard.

What the FTC Watches For

• Unsubstantiated efficacy claims. Any claim about what your product does must be supported by evidence. "Clinically proven" requires actual clinical trials.
• Misleading testimonials. Customer testimonials are treated as claims, and the brand needs substantiation for the experience they depict. If a testimonial shows results that are not typical, a "results not typical" disclaimer is not enough: FTC guidance calls for clearly and conspicuously disclosing the results consumers can generally expect.
• Influencer and endorser liability. Both the brand and the influencer can be liable for false or misleading claims. FTC staff have sent warning letters to individual influencers, including 12 health influencers in November 2023 over paid posts that did not adequately disclose the payment.
• "Made in USA" claims. A product labeled "Made in USA" needs its final assembly or processing and all significant processing done in the United States, and all or virtually all of its ingredients made and sourced there (16 CFR 323.2). Imported ingredients can disqualify the claim.
• Before/after representations. Before and after photos or stories must be truthful, and if the depicted outcome is more dramatic than users can generally expect, the ad should clearly and conspicuously disclose the results a typical consumer can expect.

In April 2023 the FTC sent notices of penalty offenses to approximately 670 companies marketing OTC drugs, homeopathic products, dietary supplements, or functional foods, putting them on notice that they could face civil penalties if they cannot substantiate their product claims. The Endorsement Guides (16 CFR Part 255), which the FTC updated in June 2023, say that endorsers, not just advertisers, may be liable for statements they make in an endorsement.

Common Claims Mistakes

Most claims violations are not intentional. Brand owners write marketing copy that sounds reasonable but crosses a legal line they did not know existed.

• Using disease names anywhere on the label or website. A statement that your product has an effect on diabetes, cancer, Alzheimer's, arthritis, or any other named disease is a disease claim, whether it says so explicitly or implicitly (21 CFR 101.93(g)(2)). Even phrases like "helps with blood sugar issues" can trigger enforcement if they imply a disease connection.
• Copying competitor claims without verification. Your competitor may be making illegal claims that haven't been enforced yet. Copying their language does not make it legal. It makes two brands out of compliance instead of one.
• Relying on the DSHEA disclaimer as a defense. The disclaimer ("not intended to diagnose, treat, cure, or prevent any disease") does not make a disease claim legal. If the claim itself is a disease claim, the disclaimer does not fix it.
• Ignoring social media content. Everything your brand posts, every influencer endorsement, and every customer testimonial you share is subject to FTC scrutiny. Social media is advertising, not casual conversation.
• Using clinical study language without clinical studies. "Clinically proven," "scientifically tested," and "doctor recommended" all create specific evidentiary obligations. If you don't have the evidence, don't use the language.
• Not filing the 30-day FDA notification. This is a straightforward administrative requirement, and missing it is an avoidable compliance gap.

Building a Claims Review Process

Experienced brand owners don't leave claims compliance to chance. They build a review process that catches problems before they reach consumers or regulators.

• ✓Have a regulatory attorney review all label claims before production. This typically costs $1,500 to $5,000 per product (an Inventory Ready estimate, not a published survey figure).
• ✓Create a claims library: a document listing every approved claim, the evidence supporting it, and the exact language approved by your regulatory attorney.
• ✓Train everyone who writes marketing copy (including social media managers and freelancers) on the difference between structure/function claims and disease claims.
• ✓Review all customer testimonials before sharing them. Testimonials that describe disease-related outcomes ("cured my arthritis") cannot be used.
• ✓Monitor influencer content if you have endorsement relationships. You can be liable for misleading or unsubstantiated statements your endorsers make about your product (16 CFR 255.1(d)).
• ✓Keep a file of the scientific evidence supporting each claim. If the FTC asks, you need to produce this evidence. Having it organized beforehand matters.

For a broader view of compliance risks beyond claims, see our supplement compliance risks guide. For the current regulatory environment, see our 2026 regulatory landscape overview.