FDA Rejects Health Claim for Green Tea, CVD

WASHINGTON--The Food and Drug Administration (FDA) denied a petition that would have granted a qualified health claim for the relationship between green tea consumption and reduced risk for cardiovascular disease (CVD). While the petition, filed last year by AAC Consulting Group for Ito En (North America), cited 105 publications for substantiation, FDA only used 11 studies that it considered appropriate to the health claim process.

In its letter denying the petition, Barbara O. Schneeman, Ph.D., concluded: "Based on FDA's consideration of the scientific evidence and other information submitted with your petition, and other pertinent scientific evidence and information, FDA concludes that there is no credible evidence to support qualified health claims for green tea or green tea extract and a reduction of a number of risk factors associated with CVD."

FDA noted health claims are designed to characterize the relationship between a particular substance and a reduction in risk of contracting a particular disease. In examining scientific evidence, the agency focuses its review on human intervention and observational studies; other types of data such as animal and in vitro work cannot by themselves support a health claim relationship. As such, after winnowing down the submitted references and then assessing the conclusions of the appropriate studies, FDA concluded there is no credible evidence supporting a relationship between green tea consumption and a reduced risk of CVD. In its letter, FDA also noted it rejected the use of a qualifying disclaimer that could have run with the health claim, as it determined it would not rectify the "unsubstantiated" claim.

Ito En (North America) released a statement in response to FDA's decision; Rona Tison, vice president of corporate relations, stated: "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. Ito En looks forward to working with FDA to identify research supporting green tea and a specific benefit to human health. Like many fruits and vegetables, green tea contains important antioxidants, which research has shown, can play a significant role in an individual's well-being."