Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on our review of your website and social media website, your product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is an article other than food intended to affect the structure or any function of the human body.