Royal Diamond Imports, Inc. Warning Letter Details

Summary

Royal Diamond Imports, Inc. was cited for marketing unapproved new drugs and misbranded products, including Roxy Instamix Complex Alkaloid Drink Mix and various ROXY 7-OH tablets containing 7-hydroxymitragynine (7-OH). The company failed to obtain FDA approval for 7-OH as a food additive and did not establish that the ingredient was generally recognized as safe (GRAS), rendering the drink mix adulterated under the Federal Food, Drug, and Cosmetic Act. The FDA identified serious safety concerns including lack of safety evaluation data for 7-OH, adverse event reports associated with these products, and evidence of opioid-like effects, as part of broader concerns about the proliferation of 7-OH-containing products in interstate commerce.