FDA WARNING_LETTER - Ten Ren Tea Company of San Francisco, Ltd - December 30, 2010

The FDA conducted an inspection of Ten Ren Tea Company of San Francisco's manufacturing and repacking facility from December 20-30, 2010. The inspection, along with a review of product labels for Ten Ren's Green Tea, Dragon Well Green Tea, and Ginseng Green Tea, and the company's website (www.tenren.com) in April 2011, revealed several violations.

The FDA determined that the aforementioned tea products are promoted with therapeutic claims, such as reducing blood pressure, decreasing the risk of heart attacks, stroke, and cancer, and reducing cholesterol. These claims cause the products to be considered drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)], as they are intended for the cure, mitigation, treatment, or prevention of disease.

Since these products are not generally recognized as safe and effective for these uses, they are deemed "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and cannot be legally marketed without prior FDA approval. Furthermore, the product labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act [2