FDA Nixes Health Claim For Green Tea

Last year, the Ito En company petitioned the U.S. Food and Drug Administration to approve a health claim for green tea, which would have stated that green tea "may reduce a number of risk factors associated with cardiovascular disease." FDA denied the claim last week, concluding that "there is no credible evidence to support a relationship between consumption of green tea or green tea extract and a reduced risk" of cardiovascular disease. In reaching this conclusion, the agency reviewed in depth over 30 scientific studies on green tea and cardiovascular risk. While several observational studies supported the notion that green tea can be cardiac healthy, FDA noted that the randomized clinical trials with green tea or green tea extract failed to confirm such a relationship. FDA's reply to Ito En is quite comprehensive, and includes both a list of references and a full description of the agency's policies and its reasoning in reaching this conclusion. You can read the whole opinion here.