Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your 7-OH products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d).
Passage 2Examples of claims observed on your website that establish the intended use of your above products as drugs include, but may not be limited to, the following:
Passage 3Your 7-OH products are not generally recognized as safe and effective for the above referenced uses and, therefore, are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 4dietary supplements containing 7-OH as a dietary ingredient are adulterated under section 402(f)(1)(B) of the FD&C Act, 21 U.S.C. 342(f)(1)(B), because 7-OH is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.