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Hydroxie, LLC was cited for marketing multiple unapproved new drug products containing 7-hydroxymitragynine (7-OH), including tablets, sublingual strips, and shots, in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company also marketed a 7-OH Drink Mix product that was determined to be adulterated due to containing an unsafe food additive. The FDA expressed serious concerns about the safety of 7-OH products generally, noting that they have not been evaluated for safe use and that the agency has received adverse event reports associated with these products.