Duoc Thao Tre Xanh, LLC Warning Letter Details

Summary

Duoc Thao Tre Xanh, LLC was cited for marketing unapproved new drugs and misbranded products through their website, including Ganoderma Lucidum Red Reishi Mushroom, Papaya Leaf Extract, Immune Health, and Fucoidan, with disease claims that violated the Food, Drug, and Cosmetic Act. The company made explicit therapeutic claims on their website stating the products could cure, treat, or prevent diseases including cancer, diabetes, hepatitis, HIV infection, and leukemia, thereby establishing the products as drugs requiring FDA approval rather than dietary supplements. These marketing claims violated section 201(g)(1)(B) of the Act by positioning the products for use in the cure, mitigation, treatment, or prevention of disease without proper FDA authorization.