Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” 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 2your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products 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“The Wait For Tianaa is Over . . . LET US TAKE YOU THERE . . . Tianaa is a proprietary blend of Natural Herbs and Nootropics created to deliver the unparalleled pick up, clarity, relaxation, and relief”
Passage 4Your “Tianaa Red,” “Tianaa White,” and “Tianaa Green” products are not generally recognized as safe and effective (GRASE) 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).