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FDA Warning Letter Explorer
FDA warning letter · Drugs

Supergoop!

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Thus, even if your product was in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “Supergoop! PLAY SPF 50 BODY MOUSSE” is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.128
  • 21 CFR 207