FDA WARNING_LETTER - Tatra Herb Company - February 07, 2011

On June 1, 2011, the FDA issued a Warning Letter to Tatra Herb Company following an inspection from February 5-7, 2011, and a review of their website in May 2011. The inspection covered their tea and botanical herb manufacturing, repacking, and distribution facility.

The FDA determined that several products, including Pau d’Arco (Taheebo), St. Johnswort, Burdock, Goldenseal, Capsicum Powder (Cayenne), Licorice, and Alfalfa Herb, were promoted with therapeutic claims (e.g., for AIDS, cancer, diabetes, depression) that classify them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act). These products are not generally recognized as safe and effective for their claimed uses and lack FDA approval. Furthermore, these products are misbranded under section 502(f)(1) of the Act because they are intended for conditions not amenable to self-diagnosis and lack adequate directions for layperson use.

Additionally, several dietary supplement products were found to be misbranded under section 403 of the Act. Violations included failure to bear nutrition labeling ("Supplement Facts" panel) as required by 21 CFR 101.36, failure to identify the products as "dietary supplement