FDA WARNING_LETTER - Hydroxie, LLC - May 31, 2025

The FDA issued a warning letter to Hydroxie, located at 306 W El Norte Pkwy, Escondido, CA, following a review of their website and Instagram account in May 2025. The FDA identified that Hydroxie markets products containing 7-hydroxymitragynine (7-OH), including Hydroxie 15mg 7-OH Tablets and Hydroxie Red 15mg Tablets, as unapproved new drugs. These products are being sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as they are not recognized as safe and effective for their intended uses, which include claims of mental clarity, energy enhancement, and pain relief.

Additionally, Hydroxie"s 7-OH Drink Mix is considered adulterated under section 402(a)(2)(C)(i) of the FD&C Act because it contains an unsafe food additive. The FDA has not evaluated these products for safety, and there have been adverse event reports linked to 7-OH, which is noted for having opioid-like effects.

The FDA requires Hydroxie to cease the introduction of these products into interstate commerce until they obtain the necessary approvals. Hydroxie must address these violations promptly to comply with the FD&C Act and avoid further regulatory actions. The company is urged to review the FDA"s regulations and ensure that all marketed products meet safety and efficacy standards.