| Product type | Reviewed before sale? | What the label may claim | Who must hold the proof |
|---|---|---|---|
| Prescription drug | Full review Yes, full FDA review before sale | Can name a disease it treats | Manufacturer, proven to FDA before launch |
| Medical device, PMA route | Approved Yes, this is FDA "approval" | Can name a disease it treats | Manufacturer, proven to FDA before launch |
| Medical device, 510(k) route | Cleared Similarity only, called FDA "clearance" | Claims tied to the older device it copies | Manufacturer, versus a predicate device |
| General wellness device | No review No FDA review | General wellbeing only, no disease claims | Manufacturer, no filing required |
| Dietary supplement | No approval No FDA approval before sale | Structure/function claims only, with a disclaimer | Manufacturer, and nobody checks first |
Long-form explainers that every individual check links back to.
FDA cleared, FDA approved and FDA registered mean three completely different things, and most wellness devices on sale carry none of them.
The FDA handles supplement labels and safety, the FTC handles advertising, and neither agency reviews or approves the claim on the bottle…
"Third-party tested" is an unregulated marketing phrase where the brand chooses the lab and the batch, and it is not the same…
Nobody checks whether a supplement works before it goes on sale, so here is the six-step method for checking it yourself before…
Each one takes a single claim you have seen on a label or in an ad and follows it back to whatever evidence exists.
No. Under DSHEA, a dietary supplement does not need FDA approval before it goes on sale. The manufacturer is responsible for making sure the product is safe and the label is truthful. The FDA acts mainly after a product is already on the market.
Approved means the FDA reviewed evidence that the product is safe and effective for its stated use. Cleared means the FDA agreed the device is substantially equivalent to one already on the market. Cleared is a lower bar, and marketing often blurs the two.
It is not a defined regulatory term with a fixed threshold. Under FTC rules an advertiser must hold competent and reliable scientific evidence for the claim before making it, but no agency signs off on the phrase in advance.
It tells you the product contains the ingredients on the label at the stated amounts, is free of specified contaminants, and was made under good manufacturing practices. It does not tell you the ingredient works for the benefit being advertised.
Because a structure/function claim triggers a required disclaimer stating the claim has not been evaluated by the FDA and the product is not intended to diagnose, treat, cure or prevent any disease. It is a legal condition of making the claim.
No. This site explains how health products are marketed, regulated and tested, and what the published research shows. It is general consumer information, not medical advice, and it is not a substitute for a licensed clinician who knows your history.
Erin Delaney writes and reviews everything here. Every page carries a byline and a last-reviewed date.
Claims are checked against the FDA, the FTC, the NIH Office of Dietary Supplements, USP and NSF, and the published literature. Never against another blog.
Market Truth is not a government agency, a clinic, or a supplement or device company, and takes no payment or copy approval from the brands it covers.
How we research sets out what counts as evidence here, and how we correct a page when we get something wrong.