How to Read Health Product Marketing Claims
How to read wellness and device marketing: what US rules say about wellness claims, "FDA registered" versus cleared, "clinically proven", testimonials and "natural".
Content last updated . This page has not been medically reviewed.
Wellness claims versus medical claims (US devices)
The FDA's general wellness guidance for low-risk devices was issued January 6, 2026 and supersedes the 2019 version. [1] Its examples of general wellness claims include claims to promote sleep management, such as to track sleep trends. [1] For certain non-invasive products that estimate readings such as blood pressure, oxygen saturation, glucose or heart rate variability, the guidance lists conditions for the wellness category. They include that the outputs are not intended for the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition, and that they do not include values that mimic those used clinically unless validated. [1]What this means for readers: a product sold for "wellness" is not being claimed to diagnose or treat anything. Its numbers are estimates for general use. If a product starts to suggest you take medical action on the number, ask whether it has been cleared for that purpose. See how to evaluate a health device claim.
"Clinically proven", "tested" and "backed by science"
These phrases have no single meaning on a product page. Under US advertising law, claims about health benefits or safety require substantiation in the form of competent and reliable scientific evidence, described by the Federal Trade Commission as tests, analyses, research, or studies conducted and evaluated in an objective manner by experts. [5] Questions to ask:- Which study? Is it named and can you find it? See how to find validation studies and regulatory records.
- Who was in it? People like you, or animals, cells or a few volunteers? See reading early-stage research.
- What was measured? A lab marker, a device reading, or how people feel and function?
- Who paid and who ran it? A company study is not automatically wrong, but it is not independent.
- Does the result match the claim? A study of one ingredient or one narrow task may not support a broad promise.
Common red flags
The FDA lists tip-offs for health fraud. Being suspicious of products that claim to cure a wide range of diseases is one. [6] Others:- Personal testimonials. Success stories are easy to make up and are not a substitute for scientific evidence. [6]
- Quick fixes. Few diseases or conditions can be treated quickly, even with legitimate products. [6]
- "All natural". These terms do not necessarily equate to safety. [6]
- "Secret ingredient", "guaranteed results", "miracle". [6]
The FDA describes health fraud scams as products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. [7] It also describes an indirect risk when a product keeps someone away from proven, sometimes essential, medical treatment. [8]
Not every exaggerated ad is fraud, and a red flag is a reason to check, not proof.
Reading the fine print
| Marketing says | Ask |
|---|---|
| "Supports healthy sleep" | Supports in what way, shown by what? |
| "Clinical-grade" | Compared with what, in whom? "Grade" is not a regulatory category we verified. |
| "Detects" or "predicts" | Detects what, in whom, and how often is it wrong? See claim check: wearables detect illness before symptoms. |
| "Accuracy of 95%" | Accuracy of what measure, which device version, which people? |
| "Used by experts" | Is there any study of results? |
Where to check
Look for scientific journal articles that support the claim and the expertise of the person posting it. [9] For supplement and therapy claims see how to evaluate a supplement formula and how to evaluate a therapy claim.Evidence labels used here
Marketing claim means a statement made to sell a product that has not been shown by independent evidence. Established means supported by consistent, good-quality research. Regulatory wording above comes from the cited US pages and may change.Frequently asked questions
Does "FDA registered" mean the FDA approved it?
No. Registration provides the FDA with the location of device establishments and the devices made there. [2]
What does FDA cleared mean?
Usually a 510(k): the maker showed substantial equivalence to a legally marketed device. [3] It applies to a specific intended use.
Is "clinically proven" regulated?
Health claims need competent and reliable scientific evidence under the FTC's guidance. [5] That does not tell you how strong a given claim is, so ask for the study.
Are testimonials evidence?
No. They are easy to make up and are not a substitute for scientific evidence. [6]
Is a "natural" product safer?
Not necessarily. [6]
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.
Registered, cleared, approved: not the same
- "FDA registered" is about the company and product being listed. Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. [2] It is not a statement that the FDA has judged how well the device works.
- "FDA cleared" usually refers to a 510(k). Submitters must compare their device to similar legally marketed devices and support their substantial equivalence claims. [3] Clearance applies to a specific function and intended use, not to every feature or wellness claim on the box.
- Supplements are different again. Structure/function claims are not pre-approved by the FDA; the manufacturer must have substantiation that the claim is truthful and not misleading. [4] The label must state that the FDA has not evaluated the claim. [4]
References
- U.S. Food and Drug Administration. General Wellness: Policy for Low Risk Devices. Guidance for Industry and FDA Staff (issued January 6, 2026). Read 2026-10-22.
- U.S. Food and Drug Administration. Device Registration and Listing. (content current as of 2025-09-30). Read 2026-10-22.
- U.S. Food and Drug Administration. Premarket Notification 510(k). (content current as of 2024-08-22). Read 2026-10-22.
- U.S. Food and Drug Administration. Structure/Function Claims. (content current as of 2024-03-28). Read 2026-10-22.
- Federal Trade Commission. Health Products Compliance Guidance. Read 2026-10-22.
- U.S. Food and Drug Administration. 6 Tip-offs to Rip-offs: Don't Fall for Health Fraud Scams. (content current as of 2021-03-04). Read 2026-10-22.
- U.S. Food and Drug Administration. Health Fraud Scams. (content current as of 2026-07-22). Read 2026-10-22.
- U.S. Food and Drug Administration. How to Spot Health Fraud. (content current as of 2018-03-08). Read 2026-10-22.
- National Center for Complementary and Integrative Health. How To Know if Health Information on Social Media Is Accurate. Read 2026-10-22.