Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Despite statements on your product labeling marketing your products, “FOR RESEARCH ONLY” and “NOT FOR HUMAN USE,” evidence obtained from your product labeling, including your website establishes that your products are intended to be drugs for human use.
Passage 2Your products marketed as SARMs are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the above-described conditions prescribed, recommended, or suggested in their labeling.
Passage 3No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.128