What happened
Original notice title
Hydroxie, LLC MARCS-CMS 709661, June 25, 2025
From the archived source record
As described below, 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). FDA has also determined that your Hydroxie 7-OH Drink Mix product, offered in various flavors, is marketed to contain 7-OH, and therefore is adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because it bears or contains an unsafe food additive. FDA has observed a proliferation of products containing 7-OH, and has serious concerns about products containing 7-OH. The concerns include the following: 1) 7-OH products have not been evaluated by FDA for safe use; 2) FDA has received adverse event reports associated with 7-OH containing products; and 3) 7-OH has been reported to have opioid-like effects. Unapproved New Drugs Based on our review of your website, www.hydroxie.com, and social media account, www.instagram.com/enjoyhydroxie/, 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 drugs as defined by 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. This activity leads to its unique effects. . ..
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- d4bc937fa1a2
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →