Is Melatonin Approved by the FDA?

Melatonin is not approved by the FDA for any use. Melatonin falls under the FDA’s Dietary Health and Education Act as a dietary supplement. The FDA is not authorized to review the safety or effectiveness of dietary supplements like melatonin before they are marketed.

However, manufacturers must notify FDA about new ingredients prior to marketing. The FDA will only review (not approve) the ingredient for safety, but not effectiveness. If a manufacturer makes an unproven health claim or if the supplement is found to be unsafe the FDA can remove the OTC from the market.

Avoid buying dietary supplements from the Internet and from online pharmacies whose authenticity you cannot verify. It is important to remember that an OTC label that says “natural” melatonin supplement does not always mean it’s “safe” for consumption. Formulations that are United States Pharmacopeial (USP) Convention Verified can be considered most reliable in this regard; the label “USP” is found on the outside of the bottle. For example, all Nature Made melatonin products are verified by the USP.

摘自

https://www.drugs.com/melatonin.html