Ephedra – FDA seizes supplements – 6 December 2005

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FDA Press Release

This listserv covers mainly Class I (life-threatening) recalls. A complete listing of recalls can be found in the FDA Enforcement Report at: http://www.fda.gov/opacom/Enforce.html

FOR IMMEDIATE RELEASE
P05-94
December 6, 2005

Media Inquiries:
Catherine McDermott, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Acts to Seize Ephedra-Containing Dietary Supplements
At the request of the U.S. Food and Drug Administration (FDA), the U.S. Attorney’s Office for the Eastern District of Texas and the U.S. Attorney’s Office for the District of Oregon filed Complaints for Forfeiture against Nature’s Treat Energy Plus #1, a dietary supplement that contains ephedra, an herbal source of ephedrine alkaloids. The supplement is distributed by Nature’s Treat, Inc., Gainesville, Texas and ACD Distributing, LLC, of Eugene, Oregon.

“FDA will do all we can to protect Americans from potentially dangerous dietary supplements,” said Andrew von Eschenbach, MD, Acting FDA Commissioner. “We will continue to warn consumers to avoid consumption of dietary supplements containing ephedrine alkaloids.”

Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in 2004 declaring that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. According to the product’s label, the recommended daily dose of Energy Plus #1 contains 46.8 mg of ephedrine alkaloids.

U.S. Marshals seized 2634 bottles (120 capsules per bottle) of Nature’s Treat Energy Plus #1 (lot numbers 205108 and 205109) from Nature’s Treat, Inc., Gainesville, Texas. Also seized were 363 bottles of the same lot numbers from ACD Distributing. The seized products have a total retail value of approximately $150,000.