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The Food and Drug Administration (FDA) announced today that NBTY, Inc., of Bohemia, N.Y., has completed its voluntary destruction of approximately 90,000 units of Royal Tongan Limu, a dietary supplement promoted to treat various diseases like cancer, arthritis, and Attention Deficit Disorder (ADD). The destruction of the product, witnessed by FDA Chicago District, occurred October 13 - 17, 2003, at a landfill in Desoto, Ill. It involved approximately $2,700,000 worth of product. Royal Tongan Limu was distributed by Dynamic Essentials, a subsidiary of NBTY located in Lake Mary, Fla. Dynamic Essentials has ceased operation, and no longer promotes or sells the products on its website.
"Getting rid of these bogus products, from a company that was giving false information about health benefits to consumers, underscores the message from FDA to those who would mislead consumers about their health," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "We will not tolerate companies that raise false hopes for preventing and treating illnesses, when there are more scientifically proven steps than ever before that consumers can take to improve their health."
FDA determined the product was being promoted for treatment and mitigation of various diseases after evaluating unsubstantiated therapeutic claims on the company's website. The firm was initially warned with an FDA "cyber letter" in 2002 informing them that claims on their website caused their products to be in violation of the law.
Among the unsubstantiated therapeutic claims observed on the website included "Limu Moui may make cancer cells pop (self-destruct) and stop cell division." Other claims include "Limu Moui lubricates joints to make them more flexible and thereby eliminating pain of arthritis, etc." FDA determined these unapproved drug claims violate the Federal Food, Drug and Cosmetic Act.
Subsequently, in 2003, FDA followed up with an investigation at the firm's New York and Florida locations that prompted the decision of the firm to voluntarily cease the operations of Dynamic Essentials, Inc., and destroy the product.
Today's action demonstrates FDA's continued activities in monitoring the marketplace to ensure that products marketed as dietary supplements are labeled properly and that claims made for these types of products are not false or misleading.
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