Editor's Note: That ephedra-containing products are making their way back into the marketplace is evidenced by this voluntary recall by a dietary supplement reseller and distributor, Brand New Energy. The Food and Drug Administration (FDA) sampled EphBurn 25 and found it to contain ephedrine alkaloids. This recall shows that FDA is testing suspect products and that those distributing such products will be asked to voluntarily recall them. The Federal Food, Drug, and Cosmetic Act is a strict liability statute, and distributing an unlawful product is a crime, even if not known to be unlawful at the time.
U.S. Food and Drug Administration
August 30, 2012
Brand New Energy Announces Voluntary Recall of Dietary Supplement EphBurn 25 Due to Possible Health Risk
Brand New Energy ("BNE"), dietary supplement re-sale distributor, is recalling all lot codes of EphBurn 25. The recall was initiated on August 28, 2012, after notification by the Food and Drug Administration (FDA) to a third-party retailer which purchased EphBurn 25 that one lot of EphBurn 25 was sampled by the FDA and found to contain ephedrine alkaloids, making it an unapproved drug.
Ephedrine is commonly used as a stimulant, appetite suppressant, concentration aid, and decongestant, and it has been used to help aid in weight loss. The ephedrine alkaloids work mainly by increasing the activity of noradrenaline on adrenergic receptors. A number of adverse effects associated with ephedrine alkaloid-containing dietary supplements have been reported to the FDA. These include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, and psychosis and memory loss. More serious effects have also been reported, including heart attack, stroke, seizure and death. There have been no reports of adverse events associated with this recalled product. ...
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