FDA Warns Ten Ren Tea for Disease Claims

SAN FRANCISCOTeas from Ten Ren Tea Company of San Francisco are promoted as intended for use in the cure, mitigation, treatment or prevention of disease and are therefore unapproved drugs, according to a warning letter FDA sent to the companys CEO Henry K. Lii. FDA called out product claims on packaging and at the companys website regarding Ten Ren's Green Tea, Dragon Well Green Tea and Ginseng Green Tea.

FDA took issue with several claims, including:

The claim that tea decreases the risk for heart attacks, stroke and cancer has not been authorized by FDA. In February 2011, FDA authorized one qualified health claim for green tea: Drinking green tea may reduce the risk of breast or prostate cancer. FDA does not agree that green tea may reduce that risk because there is very little scientific evidence for the claim." However, the claim on Ten Rens website is not consistent with this qualified health claim.

The agency conducted an inspection on Dec. 20, 2010 through Dec. 30, 2010 of Ten Rens manufacturing and repacking facility located at in South San Francisco and collected labels as well as reviewed the companys website in April 2011.  Based on its review of labels and website, FDA said claims violated section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. Further, FDA said the product labeling fails to bear adequate directions for the products intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

FDA added these products are not GRAS (generally recognized as safe) and effective for the promoted uses and, therefore, the products are new drugs" as defined by section 201(p) of the Act [21 U.S.C. § 321(p)]. Further, because Ten Ren's Green Tea, Dragon Well Green Tea and Ginseng Green Tea are being offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use these products safely for their intended uses. Thus, the product labeling fails to bear adequate directions for the products intended uses, causing the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].  The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act, [21 U.S.C. §§ 331(a)].