Most wellness products are sold under rules that let them say a lot without proving much. Once you know those rules, the marketing gets much easier to read.
The evidence in brief
- Dietary supplements don’t need FDA approval before they’re sold. The manufacturer is responsible for making sure they’re safe and correctly labeled.
- A supplement can claim to ‘support’ a body function without FDA review, as long as it carries a standard disclaimer, but it can’t claim to treat or cure a disease.
- ‘FDA registered’ only means a company is registered with the agency. It doesn’t mean anyone reviewed the product.
- Independent seals such as USP Verified or NSF Certified check what’s in the bottle, not whether the product works.
- You can report side effects to the FDA and misleading ads to the Federal Trade Commission.
Wellness marketing has its own vocabulary: supports, boosts, clinically studied, FDA registered, doctor formulated. Some of those phrases are regulated, some aren’t, and a few are chosen because they sound more official than they are. This is the reference we use ourselves when we read a label or an ad.
Supplements: sold first, checked later
Under the Dietary Supplement Health and Education Act of 1994, supplements are regulated as a category of food, not as drugs. In practice that means:
- Companies don’t have to show a supplement works before selling it.
- They’re responsible for its safety. The FDA generally steps in after a product is on the market, for example when reports of harm come in.
- Manufacturers must follow good manufacturing practices, but the FDA doesn’t test every product.
Three kinds of label claims
| Claim type | Example | Who checks it |
|---|---|---|
| Structure/function | “Supports healthy joints” | Not approved by the FDA; the label must carry the disclaimer below |
| Health claim | “Adequate calcium throughout life may reduce the risk of osteoporosis” | Authorized by the FDA based on scientific evidence, with set wording |
| Disease claim | “Treats arthritis” | Not allowed on supplements; only approved drugs can make it |
Any structure/function claim must come with this sentence:
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.
It’s easy to skim past. Read it as the label telling you that nobody at the FDA has checked whether the claim is true.
Registered, cleared, approved
- “FDA registered.” Companies that make foods, drugs and medical devices register their facilities with the FDA. Registration isn’t a review or an endorsement of any product.
- “FDA cleared.” Many moderate-risk medical devices, from some light therapy masks to over-the-counter glucose sensors, reach the market this way. The company showed the device is substantially equivalent to one already on the market, for a specific use.
- “FDA approved.” Drugs and high-risk devices go through approval, which requires evidence of safety and effectiveness.
An FDA logo on a product or its ads is itself a warning sign. The agency doesn’t allow its logo to be used to suggest endorsement.
What testing seals tell you
Because the FDA doesn’t test supplements before sale, some companies pay independent organizations to do it. Seals such as USP Verified and NSF Certified generally mean the product contains the listed ingredients in the stated amounts and isn’t contaminated with specified harmful substances. NSF Certified for Sport also screens for substances banned in sports.
What a seal doesn’t tell you is whether the product works, or whether it’s right for you.
Ads and influencers
The Federal Trade Commission oversees advertising. Health claims in ads must be backed by competent and reliable scientific evidence, which for health benefits generally means good-quality studies in people. Influencers who are paid, or who receive free products, must clearly disclose that connection. A post without a disclosure doesn’t mean there’s no deal.
Red flags
- It promises to cure or prevent a serious disease.
- It claims to work for everything.
- The evidence is testimonials and before-and-after photos.
- It’s “clinically studied,” but only one ingredient was studied, at a different dose.
- It uses words like secret, breakthrough or what doctors won’t tell you.
- It’s sold for weight loss, sexual performance or bodybuilding. The FDA has found hidden prescription drugs in hundreds of products in these categories.
Try it gently
Before starting a supplement, show the bottle to a pharmacist. They can check it against your medicines in a few minutes, usually at no cost.
Where to look things up and report problems
- NIH Office of Dietary Supplements: fact sheets on vitamins, minerals and many herbs.
- National Center for Complementary and Integrative Health: plain-language research summaries on herbs and practices.
- MedlinePlus: information on medicines and supplements from the National Library of Medicine.
- FDA Safety Reporting Portal or MedWatch: to report a side effect from a supplement, cosmetic or device.
- ReportFraud.ftc.gov: to report misleading advertising.
We’ve applied these questions to collagen supplements, ashwagandha, red light devices and detox products.
Asked and answered
If a big pharmacy chain sells it, hasn’t someone checked it?
Not necessarily. Stores decide what to stock, but supplements aren’t reviewed by the FDA before sale, wherever they’re sold.
What does ‘clinically proven’ mean?
It isn’t a regulated phrase. Ask which study, how many people, for how long, who paid for it, and whether it tested this product or just one ingredient.
Is ‘natural’ safer?
No. Many potent drugs and poisons come from plants, and natural products can interact with medicines or harm the liver.
This guide is general information, not medical advice. Check with your doctor or pharmacist before starting a supplement, device or treatment, especially if you’re pregnant, take medicines or have a health condition.