Appearance, not treatment
Cosmetic
No premarket approval — but a drug claim reclassifies it as a drug, whatever the label says.
No patient needed
- 1What it is
- 2Who makes it
- 3Fit for your practice
- 4Products
- 5Build your order
What it is
Regulated under the cosmetic provisions of the FD&C Act. Cosmetics need no FDA premarket approval, but they also may not make drug claims — the moment a product is presented as treating, preventing or altering a body function, it is regulated as a drug regardless of the label.
Patient named before it is madeNo