FDA Rejects Health Claim for Green Tea, CVD 27223

FDA Rejects Health Claim for Green Tea, CVD

WASHINGTONThe Food and Drug Administration (FDA) denied a petitionthat would have granted a qualified health claim for the relationship betweengreen tea consumption and reduced risk for cardiovascular disease (CVD). Whilethe petition, filed last year by AAC Consulting Group for Ito En (NorthAmerica), cited 105 publications for substantiation, FDA only used 11 studiesthat it considered appropriate to the health claim process.

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

FDA noted health claims are designed to characterize the relationship betweena particular substance and a reduction in risk of contracting a particulardisease. In examining scientific evidence, the agency focuses its review onhuman intervention and observational studies; other types of data such as animaland in vitro work cannot by themselves support a health claim relationship. Assuch, after winnowing down the submitted references and then assessing theconclusions of the appropriate studies, FDA concluded there is no credibleevidence supporting a relationship between green tea consumption and a reducedrisk of CVD. In its letter, FDA also noted it rejected the use of a qualifyingdisclaimer that could have run with the health claim, as it determined it wouldnot rectify the unsubstantiated claim.

Ito En (North America) released a statement in response to FDAs decision;Rona Tison, vice president of corporate relations, stated: Although Ito En considers it unfortunate that the green tea health claimpetition has been rejected by the FDA, the company will continue its research ongreen tea. Ito En looks forward to working with FDA to identify researchsupporting green tea and a specific benefit to human health. Like many fruitsand vegetables, green tea contains important antioxidants, which research hasshown, can play a significant role in an individuals well-being.