Nature’s Innovation, Inc.

Selected passages from the FDA letter

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

Passage 1

Your “Naturasil Molluscum Treatment Kit” and “Natural Shingles” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

Your “Naturasil Molluscum Treatment Kit” and “Natural Shingles” products are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).

Passage 3

No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products.

Passage 4

Your above-mentioned drugs include 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 on your website in various places with claims to diagnose, cure, mitigate, treat, or prevent disease, or to affect the structure or any function of the body.