Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1“Naturasil Molluscum Treatment Kit” is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 2“Naturasil Molluscum Treatment Kit” includes non-homeopathic ingredients that, although listed as “inactive ingredients,” are considered active ingredients under 21 C.F.R. 201.66(b)(2) because they are promoted with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.66(b)(2)