Hydroxie, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample 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 2

your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets, Hydroxie 30mg 7-OH Tablets, Hydroxie 15mg 7-OH Sublingual Strips, Hydroxie Red 15mg Sublingual Strips, Hydroxie 7-OH Shots, Hydroxie Red Shots, Hydroxie Free Sample, and Hydroxie Red Free Sample 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). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).