What happened
Original notice title
7Tabz Retail, LLC MARCS-CMS 709546, June 25, 2025
From the archived source record
This letter is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the internet address www.pop7tabz.com in May 2025 and has observed that your website offers various products marketed to contain 7-hydroxymitragynine (7-OH) including, 7Tabz 7-OH (15mg and 30mg) and 7Tabz 7-Hydroxy+Pseudo (20 mg) (hereinafter “your 7-OH products”).” 1 As described below, your 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). Unapproved New Drugs Based on our review of your website, www.pop7tabz.com, your 7-OH 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. Be advised, however, that dietary 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. In fact, as noted above, available information on the use of 7-OH in products raises serious safety concerns. The introduction or delivery for introduction into interstate commerce of an adulterated dietary supplement is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.
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
- 6ec8a2e71ccb
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 →