Overpromising and the Limits of Disclaimers
What the FDA disclaimer on supplements means, why US regulators say disclaimers and words like promising or preliminary do not fix overstated health claims, and how to read them.
Content last updated . This page has not been medically reviewed.
What the supplement disclaimer is
For dietary supplements, US law requires a disclaimer when a label makes a structure/function claim or certain other claims. The FDA explains that the statement is required by law when a manufacturer makes such a claim. [1] The regulation text (21 CFR 101.93) gives the wording: "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] The FDA says the second part is there because only a drug can legally make a claim to diagnose, treat, cure or prevent a disease. [1]What it does not mean: the FDA does not approve dietary supplements or their labeling. [1] So the disclaimer is not a sign of review. The FDA says such claims are not approved by FDA and do not require FDA evaluation before use in labeling. [1] The FTC adds that compliance with the disclaimer provisions does not constitute FDA authorization, and advertisers should not imply the FDA approved a claim on that basis. [3]
What the FTC says disclaimers cannot do
The FTC's Health Products Compliance Guidance (staff business guidance, December 2022) is not law and offers no safe harbor. [3] It says its principles apply to health-related products generally, including diagnostic tests and health apps. [3] On disclaimers it states:- The disclaimer required on supplement labels or a similar statement "won’t cure an otherwise deceptive ad." [3]
- In its example, an ad claimed an herbal supplement treats diabetes without adequate substantiation. Including the disclaimer did not negate the explicit claim, so the ad was deceptive. [3]
- Attempts to disclaim dramatic results with statements like "Results not typical" do not cure the deception in testimonials. [3]
- In its example of an insomnia app advertised with customer testimonials, the testimonials did not constitute substantiation; the advertiser needed scientific evidence. [3]
Why "promising," "preliminary" and "may" are not safe hedges
For emerging science the FTC says it is very difficult to adequately qualify a claim based on limited and still-emerging science. [3] Vague terms are inadequate: it is not enough to say a product "may" have a benefit or "helps." [3] Consumers are likely to read modifiers such as "promising," "preliminary," "initial" or "pilot" as positive attributes rather than as warnings about the state of the science. [3]This matters for emerging wellness science because early lab and small-study findings are often described with exactly these words. See research hype and press releases and claim check: "clinically proven".
"Registered," "listed" and "trial" are not approval
The FDA says patients are told a product is registered with the FDA, or are pointed to clinicaltrials.gov, to suggest compliance. It adds that a firm having registered and listed its product does not mean the product is legally marketed. [8] See claim check: "FDA registered" vs approved.A reading checklist
| What you see | What to ask |
|---|---|
| "Not evaluated by the FDA" | Is there any human evidence for this claim at all? The disclaimer is not evidence. [1] |
| "Promising," "preliminary," "may help" | Who was studied, how many, what outcome? Do not read these words as positive. [3] |
| Testimonials | The FTC says they are not a substitute for scientific evidence of effectiveness. [3] |
| "Registered" or "listed" | Is it approved for this use? [8] |
| A guarantee of success | The UK government advises that an advert guaranteeing complete success should raise concerns. [9] |
| Disease claims on a cosmetic | Disease-type claims can make it a drug in FDA's view. [4] |
For supplement rules see how supplements are regulated, and for judging safety statements see evaluating safety claims.
Frequently asked questions
Does "not evaluated by the FDA" mean the product is safe?
No. The FDA says the disclaimer informs consumers that the FDA has not evaluated the claim. [1] It says nothing about safety or effectiveness.
Can a disclaimer protect a company from a false claim?
FTC staff say the supplement disclaimer or similar statements will not cure an otherwise deceptive ad. [3] The guidance is not itself law, and each case depends on its facts. [3]
Are words like "promising" or "preliminary" honest hedges?
The FTC says consumers are likely to read them as positive attributes, and vague qualifiers are inadequate. [3]
Are cosmetics with "regenerative" claims regulated like drugs?
The FDA says intended use decides it, and a claim to regenerate cells can make a product a drug. [4]
Does the FDA approve dietary supplements?
The FDA says it does not approve dietary supplements or their labeling. [1]
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Wording can change a product's legal category
A May 2025 FDA warning letter to Supreme Rejuvenation, LLC, shows how this works for exosome products. The company's website mixed hedged wording ("Emerging research suggests that exosomes may play a role in cellular signaling") with stronger claims such as that exosomes "have shown incredible efficacy in various studies." [5] The FDA wrote that the products were unapproved new drugs. [5] A warning letter is the FDA's position, not a court finding. In a May 2026 letter to Blue Horizon International, LLC, the FDA likewise said the products it described were drugs as defined in the Federal Food, Drug, and Cosmetic Act. [6] There are currently no FDA-approved exosome products. [7] See stem cell cosmetic claims.
References
- U.S. Food and Drug Administration. Questions and Answers on Dietary Supplements (content current as of August 27, 2026). Read 2026-10-22.
- U.S. Electronic Code of Federal Regulations. 21 CFR 101.93, Certain types of statements for dietary supplements (current text). Read 2026-10-22.
- U.S. Federal Trade Commission staff. Health Products Compliance Guidance (December 2022; PDF read). Read 2026-10-22.
- U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) (content current as of September 11, 2024). Read 2026-10-22.
- U.S. Food and Drug Administration. Warning Letter to Supreme Rejuvenation, LLC, CBER 25-700749 (May 5, 2025). Read 2026-10-22.
- U.S. Food and Drug Administration. Warning Letter to Blue Horizon International, LLC, CBER 26-728085 (May 26, 2026). Read 2026-10-22.
- U.S. Food and Drug Administration. Public Safety Notification on Exosome Products (December 6, 2019). Read 2026-10-22.
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies (posted June 3, 2021; content current as of April 8, 2024). Read 2026-10-22.
- UK Government (Foreign, Commonwealth and Development Office) Travel Aware campaign. Surgery abroad, cut out the risk (undated campaign page). Read 2026-10-22.