FDA WARNING_LETTER - Ten Tea - January 17, 2011

The FDA conducted an inspection of Ten Tea's facility from December 2010 to January 2011, followed by a review of product labels and the company website in April 2011. The agency determined that Ten Tea's Green Tea, Dragon Well Green Tea, Ginseng Green Tea, Pu-Erh Tea, White Tea, and Kung Ding Cha products are promoted with therapeutic claims, such as reducing blood pressure, decreasing cancer risk, and lowering cholesterol. These claims cause the products to be unapproved new drugs under sections 201(g)(1)(B) and 201(P) of the Federal Food, Drug, and Cosmetic Act, as they are not generally recognized as safe and effective for these uses and lack prior FDA approval (505(a)). Furthermore, the product labeling fails to bear adequate directions for their intended uses, leading to misbranding under sections 502(t)(1) and 502(f)(1). An unauthorized health claim regarding reduced risk of heart attacks, stroke, and cancer also causes misbranding under section 403(r)(1)(B), as it is not an authorized health claim. The introduction of these misbranded drugs into interstate commerce violates section 301(a) of the Act. Ten Tea must take prompt action to correct these violations and prevent recurrence. A written response detailing corrective steps and documentation is required within fifteen working days. Failure to comply may result in enforcement actions, including product seizure and injunctions.