Market Updates

FDA Issues Warning for Supplement Ingredient and Evaluates Claims Surrounding Green Tea and Cancer

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By: Sean Moloughney

Editor, Nutraceuticals World

FDA is warning consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide-a drug that could have serious, life-threatening consequences in some people. Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. FDA said consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. The product is sold as part of a shrink-wrapped two-bottle set. One of the 90 capsule bottles is labeled Liqiang 4 Dietary Supplement Capsules, the other bottle is promoted as a “bonus pack” of Liqiang 1. At this time, FDA says it is evaluating Liquang 1 and other versions of this line of products to determine their composition and safety. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the U.S. in herbal stores and through mail order by Bugle International, Northridge, CA. The FDA learned of the potential problem through an anonymous consumer complaint and followed up with testing that revealed the presence of glyburide in this product.

In other developments, under FDA’s “Consumer Health for Better Nutrition Initiative,” the agency is announcing the results of a review of qualified health claims that green tea may reduce the risk of certain types of cancer. Based on a systematic evaluation of the available scientific data, FDA intends to consider exercising its enforcement discretion for the following qualified health claims for breast and prostate cancer:

“Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer”; and

“One weak and limited study does not show that drinking green tea reduces the risk of prostate cancer, but another weak and limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of prostate cancer.”

The FDA also concluded that existing evidence does not support qualified health claims for green tea consumption and a reduced risk of any other type of cancer.

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