Ten Ren Tea Company of San Francisco, Ltd – FDA Warning Letter, Mar 23, 2015

On July 31, 2015, the FDA issued a Warning Letter to Ten Ren Tea Company of San Francisco, Ltd., following an inspection from March 3-23, 2015. The inspection and subsequent label review revealed serious violations of the Federal Food, Drug and Cosmetic Act.

The primary violation is that Ten Ren Chrysanthemum Tea and Hibiscus Spice Tea are adulterated under Section 402(a)(2)(C)(i) of the Act because they contain "Stevia leaf, tea bag cut," an unapproved food additive under Section 409. Stevia leaf is not authorized by a food additive regulation, nor is it generally recognized as safe (GRAS) for use in conventional foods. The FDA cited safety concerns regarding whole-leaf Stevia or crude extracts, including potential effects on blood sugar, reproductive, cardiovascular, and renal systems.

Additionally, Ten Ren Chamomile Tea, Relaxing Tea, Chrysanthemum Tea, and Hibiscus Spice Tea are misbranded under Section 403(f). Their labels contain foreign language information but do not present all required label information in both English and the foreign language, violating 21 CFR 101.15(c)(2). Specific misbranding issues include the omission of the zip code in the place of business statement (21 CFR 101.5(d)) and the name/place of business and ingredient statements not being