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 Use Only,” and “not intended for human consumption, medical use, or veterinary use,” evidence obtained from your website establishes that your products are intended to be drugs for human use.
Passage 2No 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