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FDA Calls Heart Health Claims 'Supportive'
Adapted from Nutra-Ingredients USA, May 12, 2006.
The evidence that green tea could benefit heart health are "supportive" but not "conclusive," said the FDA, leaving the door open to backing such health claims in the future.
Green tea is a rich source of catechins, compounds suggested to play a beneficial role in reducing the risk of various diseases, including Alzheimer's, certain cancers, cardiovascular and oral health, with some, namely epigallocatechin gallate (EGCG), now emerging as particularly powerful.
Last year the FDA adopted a conservative approach toward claims that green tea could protect against certain types of cancer, and has followed this with similar conclusions about supposed benefits for heart health.
"The 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," said the FDA letter.
The FDA letter was in response to a petition file in June 2005 by a major Japanese tea company and its U.S. subsidiary, seeking FDA support for their claim that that five ounces (150 mL) or more of green tea every day could reduce the risk of cardiovascular disease (CVD).
But Barbara Schneeman, Ph.D. director of the Office of Nutritional Products, Labeling, and Dietary Supplements, rejected the claim, saying: "FDA has determined that the evidence is supportive, but not conclusive, for this claim." Dr. Schneeman noted, "Green tea provides 125 mg catechins per serving when brewed from tea and 125 mg catechins as a pre-prepared beverage."
The FDA's acknowledgement that the current scientific evidence is 'supportive' rather than 'conclusive' is seen as a significant recognition of the growing number of peer-reviewed scientific studies demonstrating specific health benefits of teas in general, and green teas and the antioxidant EGCG in particular.
For example, in 1994 the Journal of the National Cancer Institute published the results of an epidemiological study indicating that drinking green tea reduced the risk of esophageal cancer in Chinese men and women by nearly sixty percent. In another example, University of Purdue researchers recently concluded that the compound EGCG found in in green tea inhibits the growth of cancer cells.
Additionally, the FDA did not close the door on reversing the claim in the future, stating "scientific information is subject to change, as are consumer consumption patterns. FDA intends to evaluate new information that becomes available to determine whether it necessitates a change in this decision. For example, scientific evidence may become available that will support the use of a qualified health claim or that will support significant scientific agreement."
It is not known if this decision by FDA will significantly affect sales, particularly with the statement that the evidence is "supportive, but not conclusive."
The Tea Association of the USA has predicted that the US market will continue to grow. Packaged Facts, a division of MarketResearch.com, put the domestic market for tea and ready-to-drink tea at $6.8 billion in 2005, a 9.4 percent increase over last year. By 2010 it projects that it will reach $10 billion.
Seventy-two percent of overall sales are accounted for by ready-to-drink bottled and canned ice teas, but loose tea and tea pouches come second with 20 percent of sales. Within this category green tea is the most dynamic variety and is demonstrating a rapid increase in market sales.
The association predicts that the ready-to-drink tea market will continue to grow by 10 to 12 percent annually.