FDA WARNING_LETTER - Diaspora Tea & Herb Co., LLC - January 31, 2011

The FDA issued a Warning Letter to Diaspora Tea & Herb Co., LLC, following a January 2011 review of their website, http://www.rishi-tea.com/store/index.php. The FDA determined that several products, including Oolong Tea, Ginger, Green Oolong Tea, 100% Premium Tealeaf Powder, and Pu-erh Tea, were promoted with therapeutic claims, classifying them as unapproved new drugs under section 201(g)(1)(B) and 201(p) of the Federal Food, Drug and Cosmetic Act (the Act). Examples of these claims include ginger preventing colds/flus, tea antioxidants preventing cancer and lowering cholesterol, and Pu-erh Tea reducing cholesterol and arterial plaque. Marketing these "new drugs" without FDA approval violates section 505(a) of the Act.

Additionally, products like Yerba Maté, White Tea, and Super Green Tea were found to be misbranded under section 403(r)(1)(A) of the Act due to unauthorized nutrient content claims. The company used "high" and "rich in" claims for nutrients without established Daily Values (DV), such as "rich in Tea Polyphenols" for Pu-erh Tea. Furthermore, "antioxidant" claims failed to comply with 21 CFR 101.54(g), either by not naming the specific nutrients