White Label Leaf, LLC/Flying Monkey US, LLC Warning Letter Details

Summary

White Label Leaf, LLC/Flying Monkey US, LLC was cited for marketing Delta-8 THC-containing gummies (Mango Tango Gummies, Heavy Hitter Blend Mango Gummies, and Heavy Hitter Blend Blueberry Gummies) that the FDA determined were adulterated under the Federal Food, Drug, and Cosmetic Act because they contained unsafe food additives. The company violated the Act by introducing these unapproved, psychoactive cannabinoid products into interstate commerce through their website without FDA authorization or safety evaluation. The FDA expressed broader concerns that Delta-8 THC products have not been evaluated for safe use, have generated adverse event reports, and pose public health risks through unsafe manufacturing processes and potentially deceptive marketing practices.