"FDA approved" is one of the most misused phrases in online retail. In the United States the FDA approves some kinds of products and does not approve many others, so for most things sold on Shopify the claim is false. This guide explains what the phrase means and when to leave it off the page. This is general information, not legal advice.
What the FDA approves and what it does not
FDA approval is a specific premarket review for specific product types. The FDA's own consumer guidance lists which products go through it.
| Product type | What the FDA says |
|---|---|
| New drugs and biologics | Must be FDA approved before they are marketed, with rare exceptions |
| High-risk (Class III) medical devices | Generally require approval of a premarket approval application |
| Moderate-risk (Class II) medical devices | Usually cleared, not approved, by showing substantial equivalence to an existing device |
| Cosmetics | Products, ingredients and labeling do not require FDA approval, apart from color additives |
| Dietary supplements | The FDA does not approve dietary supplements for safety and effectiveness |
| Food | The FDA does not approve food products, though certain ingredients need approval |
Registered, cleared and approved are different
These three words are often used as if they meant the same thing. They do not, and swapping one for another makes the claim untrue.
- Approved: The FDA reviewed and approved that specific product
- Cleared: A device was shown to be substantially equivalent to one already legally marketed
- Registered: The facility is on file with the FDA. The FDA states that registration of an establishment does not denote approval of the establishment
Phrases to remove
If your product is in a category the FDA does not approve, any wording that suggests approval is a problem. The FTC's health products guidance also says advertisers should not mischaracterize the extent to which a product or claim has been reviewed.
- ❌ "FDA approved" on a supplement, cosmetic or food
- ❌ "FDA approved facility" or "made in an FDA approved lab"
- ❌ "FDA registered" used as a quality or safety claim
- ❌ "FDA approved ingredients" as a blanket statement
- ❌ "FDA certified"
Do not use the FDA logo
The FDA's name and logo policy says they are not for use by the private sector or on private sector materials without written FDA authorization. The policy states that unauthorized use may violate federal law and lead to civil or criminal liability. Check your product images, badges and footer for it.
When you can say it
Use the phrase when it is literally true of the exact product you sell, and describe the status in the FDA's own terms.
- ✅ A drug or device that holds its own FDA approval
- ✅ "FDA cleared" for a device that went through clearance, if you have the record
- ❌ Borrowing the status of an ingredient, a supplier or a similar product
If you resell, ask the manufacturer for the documentation before you repeat the claim. For related rules, see cosmetic vs drug claims.
Doing this at scale
ContentGuard scans product descriptions and classifies each claim as safe, risky or prohibited against a rule profile you choose, such as US Dietary Supplement or US Cosmetics/OTC Drug. It cites the governing FDA or FTC rule and proposes a rewrite you can apply in one click. It is a screening tool, not a substitute for legal review. See ContentGuard.