Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1The claims on your website and social media website establish that your product is an unapproved new drug sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
Passage 2your “B12 VITAMINVAPE” product is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because it is intended for use in the cure, mitigation, treatment, or prevention of disease and/ or intended to affect the structure or any function of the body.
Passage 3Your “B12 VITAMINVAPE” product is not generally recognized as safe and effective for the above referenced uses and, therefore, is a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 4We note that you market your “B12 VITAMINVAPE” product with a Nutrition Facts label, but your product does not meet the definition of “food” under section 201(f) of the FD&C Act, 21 U.S.C. 321(f).