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 establish that “Skincell Advanced” and “Skincell” are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2Based on our review of your website, “Skincell Advanced” and “Skincell” are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Passage 3“Skincell Advanced” and “Skincell” are not generally recognized as safe and effective for their above referenced uses and therefore are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 4The introduction or delivery for introduction into interstate commerce of these products without an approved application violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).