Potentially dangerous products banned for use in supplements in 2004
SILVER SPRING, Md., Dec. 6, 2011 /PRNewswire-USNewswire/ -- At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements.
The seizure took place in Rancho Dominguez, Calif. Through this action, FDA removed more than $70,000 worth of these potentially dangerous dietary supplement ingredients from the market.
Judge Gary A. Feess of the Central District of California issued a warrant for the seizure of more than 4,000 pounds of raw material – Cissus quadrangularis and Cassia angustifolia extracts – containing the ephedrine alkaloids.
"Working in close coordination with our federal colleagues in U.S. Customs and Border Protection, Immigration and Customs Enforcement and the Drug Enforcement Administration, the FDA helped identify and remove these potentially dangerous products from the marketplace," said Dara A. Corrigan, associate commissioner for regulatory affairs. "We will continue to take enforcement action that prevents potentially harmful products from reaching consumers and endangering their health."
Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Prior to 2004, dietary supplements containing ephedrine alkaloids had been extensively promoted for aiding weight control and boosting sports performance and energy. But available data showed little evidence of the compound's effectiveness except for modest, short-term weight loss without any clear health benefit, while confirming that the substance raised blood pressure and otherwise stressed the circulatory system. These effects were linked to significant adverse health outcomes, including heart attack, stroke and death.
FDA's chemical analysis confirmed the presence of these alkaloids in the shipment, but the shipping drums carried no labels indicating that the material contained the banned ephedrine alkaloids.
For more information:
Overview of Dietary Supplements
FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products (2004)
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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SOURCE U.S. Food and Drug Administration