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Lack of 'Credible' Evidence to Back up Claim, Agency Says

May 10, 2006 -- The FDA has rejected a company's petition to claim that green tea may reduce risk factors linked to cardiovascular disease (CVD).

The petition was submitted to the FDA in June 2005 by the Japan-based company Ito En, Ltd. and its U.S. branch, which market green tea.

The company's claim would have stated, in part, that chemicals called catechins in green tea "may reduce a number of risk factors associated with cardiovascular disease."

The FDA nixed that claim after reviewing scientific studies on green tea.

The FDA's bottom line: "There is no credible scientific evidence to support qualified health claims about consumption of green tea or green tea extract and reduction of a number of risk factors associated with CVD."

Mixed Results

The FDA reviewed observational studies, in which participants weren't assigned to drink green tea, and interventional studies, in which some participants were asked to drink green tea or consume extracts of green tea.

Those studies had mixed results, so the FDA deemed the data "not credible to support the relationship between consumption of green tea or green tea extract and a reduced risk of CVD."

Those comments were made in an 18-page letter by the FDA's Barbara Schneeman, PhD. She directs the Office of Nutritional Products, Labeling, and Dietary Supplements at the FDA's Center for Food Safety and Applied Nutrition. The letter was sent to a Maryland consulting company listed on the tea company's petition.

In rejecting the proposed claim, the FDA doesn't suggest that green tea is unhealthy. Instead, the FDA's letter argues that science hasn't proven that drinking green tea cuts CVD risk.

In July 2005, the FDA rejected another company's petition to claim that green tea fights cancer.

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