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FDA Denies Health Claims For Green Tea |
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May 11, 2006
In response to a petition from tea importer Ito En, the FDA declined to authorize a qualified health claim characterizing the relationship between the consumption of green tea and a reduction of a number of risk factors associated with cardiovascular disease for use in the labeling of conventional foods and dietary supplements. In a lengthy letter to the petitioner, Barbara Schneeman, Director of the FDA's Office of Nutritional Products, Labeling, and Dietary Supplements, said the information in the petition "does not change FDA's ultimate conclusion that the petition should be denied for lack of credible evidence." "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 cardiovascular disease," Schneeman said. "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," she said. "Adding a disclaimer or incorporating qualifying language that effectively characterizes the claim as baseless is not a viable regulatory alternative because neither the disclaimer nor the qualifying language can rectify the message conveyed by the unsubstantiated claim." Schneeman's letter cited the agency's review of 105 articles and other publications submitted as part of the petition but said they failed to make the case for green tea's health benefits. found nothing to support claims of the drink's health benefits. Ito En, a Japanese company, filed its petition with the FDA in June 2005, seeking permission to make the claim. Report Your Experience
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