F.D.A. rejects heart health claim for green tea
May 11, 2006
by Eric Schroeder
WASHINGTON — Less than a year after it concluded that green tea is "highly unlikely" to reduce the risk of breast cancer, the Food and Drug Administration on Tuesday rejected a petition that sought to allow health claims on green tea touting the beverage’s heart health benefits.
The F.D.A.’s decision followed the review of 105 articles and other publications submitted as part of the petition. But despite the review, the F.D.A. said it could not find any credible scientific evidence suggesting drinking green tea reduces the risk of heart disease.
The petition, filed in June 2005 by Ito En Ltd., a Japanese company that bills itself as the largest green tea company, and its U.S. subsidiary, Ito En (North America) Inc., stated:
"Daily consumption of at least 5 fluid ounces of green tea as a source of catechins may reduce a number of risk factors associated with cardiovascular disease. F.D.A. 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)."
But the F.D.A. said it found no credible scientific evidence to allow the claim, and decided not to add any disclaimers or qualifying language to validate it, either.
"We considered but rejected use of a disclaimer or qualifying language to accompany the proposed claim for consumption of green tea or green tea extract and a reduction of a number of risk factors associated with C.V.D. (cardiovascular disease)," Barbara O. Schneeman, director of the F.D.A.’s Office of Nutritional Products, Labeling and Dietary Supplements, wrote in a May 9 letter denying the petition. "We concluded that neither a disclaimer nor qualifying language would suffice to prevent consumer deception in these instances, where there is no credible evidence to support the claim. Adding a disclaimer or incorporating qualifying language that effectively characterizes the claim as baseless is not a viable regulatory alternative because neither the disclaimer not the qualifying language can rectify the message conveyed by the unsubstantiated claim."