Qualified Health Claim Linking Green Tea To CVD Reduction Denied By FDA
This article was originally published in The Tan Sheet
"No credible evidence" exists to approve a qualified health claim linking green tea or green tea extract to a reduction of risk factors associated with cardiovascular disease, FDA states in a letter of denial to green tea marketer Ito En May 9
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A qualified health claim petition submitted on behalf of the beverage company Ito En requests FDA approval of the statement: "Daily consumption of at least 5 fluid ounces of green tea may reduce a number of risk factors associated with cardiovascular disease." The petition, filed by AAC Consulting Group, also applies to dietary supplements containing the ingredient. The agency says it is collecting comments on the petition through Sept. 26 and will notify the firm of its final decision no later than March 10, 2006. FDA recently allowed qualified statements linking green tea to cancer prevention (1"The Tan Sheet" July 11, 2005, p. 12). Infant formula claim: A petition filed by Nestlé USA June 17 requests a qualified health claim supporting "the ability of 100% Whey Protein Partially Hydrolyzed, when used in infant formula, to reduce the risk associated with standard intact cow's milk formulas"...
FDA emphasizes the negative in its specified wording for qualified health claims that may link green tea with prevention of breast and prostate cancers