FDA WARNING_LETTER - 7Tabz Retail, LLC - July 15, 2025

The FDA issued a warning letter to Pop7Tabz, located at 5525 Johns Road, Tampa, FL, regarding their marketing of products containing 7-hydroxymitragynine (7-OH) on their website, www.pop7tabz.com. The inspection, conducted in May 2025, identified that the company"s products, including 7Tabz 7-OH (15mg and 30mg) and 7Tabz 7-Hydroxy+Pseudo (20mg), are being marketed as unapproved new drugs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The FDA"s concerns include the lack of evaluation for safe use of 7-OH products, reports of adverse events, and the opioid-like effects of 7-OH, a potent mu-opioid agonist. Additionally, the agency noted that the products might appeal to children due to their packaging and labeling. The FDA also highlighted that these products were previously marketed as dietary supplements, which is not permissible as 7-OH is considered a new dietary ingredient without adequate safety information, rendering such supplements adulterated under section 402(f)(1)(B) of the FD&C Act.

Pop7Tabz is required to address these violations by providing a written response within fifteen working days, detailing corrective actions taken and plans to prevent future violations. Failure to comply may lead to legal actions, including product seizure and injunctions. The company must ensure compliance with all federal laws and FDA regulations.