GeroNova Research 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 products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. § 331(d) and 355(a)].

Passage 2

Your CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your CARNITINE PLUS Vegcaps, GeroNova Beauté Infinie Elixir, R-Lipoic Acid Vegcaps 300 mg, and R-Lipoic Acid Vegcaps 100 mg products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].