No Health Claim for Green Tea

FDA has denied approval of a qualified health claim for green tea and reduced risk of cardiovascular disease (CVD) as petitioned by Stanley M. Tarka of AAC Consulting Group, Rockville, MD, on behalf of Ito En, Ltd. and Ito En (North America), Inc., Brooklyn, NY.

On June 9, 2005, the petitioner requested approval of the following claim: "Daily consumption of at least 5 fluid ounces (150 mL) of green tea as a source of catechins may reduce a number of risk factors associated with cardiovascular disease. FDA has determined that the evidence is supportive, but not conclusive, for this claim. (Green tea provides 125 mg catechins per serving when brewed from tea and 125 mg catechins as a pre-prepared beverage.)"

FDA used studies on the effects of consuming green tea or green-tea extract on the incidence of coronary events, cardiovascular death, coronary artery disease, atherosclerosis, and coronary heart disease, as well as related factors, such as high blood pressure, blood (serum or plasma) total cholesterol, and blood low-density lipoprotein cholesterol levels, to evaluate the claim. The petitioner cited 105 publications to substantiate the relationship, and FDA included two additional studies. FDA determined that no credible scientific evidence exists to support qualified health claims about consumption of green tea or green tea extract and a reduction of a number of risk factors associated with CVD.

"Although Ito En considers it unfortunate that the green tea health claim petition has been rejected by the FDA, the company will continue its research on green tea," says Rona Tison, vice president of corporate relations, Ito En (North America). "Ito En looks forward to working with FDA to identify research supporting green tea and a specific benefit to human health."

FDA's letter of denial can be found at http://www.cfsan.fda.gov/~dms/qhcgtea2.html.