Ephedra Ban

Ephedra was a popular herbal remedy for weight loss and sports performance enhancement in the United States up until it was banned in 2006 by the Food and Drug Administration (FDA). Here is a brief history of ephedra regulation:

1997: The FDA proposed a ruling that would ban supplements containing 8 mg or more of ephedrine alkaloids from being sold and would also require stricter labeling of ephedra supplements.

Members of the supplement industry created a public relations group to oppose the changes.

2000: The FDA withdrew the proposed changes and restrictions. A review published in the New England Journal of Medicine, however, reported a number of cases of severe side effects resulting from ephedra use.

2001: Minnesota Vikings football player Korey Stringer died as a result of heatstroke. Ephedra use was considered to be a possible cause in his death.

2003: A report was prepared by the non-profit think tank the RAND Corporation for the Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services. Their ephedra study reviewed clinical trials and adverse events reported to the FDA and to a manufacturer, Metabolife. The report said that a number of serious adverse events were "strongly tied to ephedra use within 24 hours without other plausible explanations", including three deaths, two heart attacks, two strokes, one seizure and three psychiatric incidents.

Ephedra has been linked to other adverse events and deaths, but the estimates vary greatly.

A study published in the medical journal Annals of Internal Medicine in 2003 found that products containing ephedra accounted for 64% of all adverse reactions to herbs reported in the United States in 2001, even though ephedra sales made up less than 1% of herbal supplement sales in the United States.

On February 17, 2003, 23-year-old Baltimore Orioles pitcher Steve Bechler died of heatstroke in Fort Lauderdale, Florida, after collapsing the day before during a workout at Fort Lauderdale Stadium. The local medical examiner reportedly said that the ephedra Bechler had been taking to lose weight may have contributed to his death.

Bechler's highly publicized death is believed to have been a key factor in the FDA's announcement on December 30, 2003 that it was planning to ban dietary supplements with ephedra because of the health risks.

The FDA also issued a consumer alert, advising consumers to stop buying and using ephedra. Although ephedra dropped sharply, 14% of people using non-prescription weight loss supplements in the United States continued to take ephedra or products containing ephedrine.

2004: On February 6, 2004, the FDA issues their final rule banning the sale of all dietary supplements containing ephedra in the United States, saying that they posed an "unreasonable risk of illness or injury".

The rule became effective 60 days after it was issued.

2005: On April 14, 2005, Judge Tena Campbell of the Federal District Court in Utah overturns the FDA's universal ban on ephedra products as a result of a suit brought by the supplement manufacturer Nutraceutical Corporation, which marketed a lower-dose ephedra product.

The judge ruled that the FDA had come to their decision by doing a risk-benefit analysis, considered inappropriate for supplements under a 1994 law (called the Dietary Supplement Health and Education Act (DSHEA)). Also the DSHEA required dose-specific findings to justify a ban and that the FDA had insufficient evidence to conclude that products with 10 mg or less a day of ephedrine alkaloids posed a risk. As a result, products with 10 mg or less of ephedra alkaloids were allowed back on the market.

2006: On August 17, 2006, a federal appeals court upheld the FDA ban on ephedra, overturning the 2005 ruling that allowed the sale of products containing 10 mg or less of ephedra.

The court ruled that the 133,000 page administrative record, which included 19,000 adverse events reports, compiled by the FDA was sufficent to support the inital finding that supplements containing ephedrine alkaloids at any dose posed an unreasonable risk of illness and injury and that the risk-benefit analysis was required.

The FDA stated that no dose of dietary supplements containing ephedrine alkaloids was safe and that the sale of these products in the United States was illegal and subject to enforcement action.

Up until this ruling, many herbal supplement companies marketed low-dose ephedra products containing 10 mg or less of ephedra alkaloids.

2007: Nutraceutical Corporation filed a petition for rehearing in front of the tenth circuit of the US Court of Appeals, however the United States Supreme Court declined to hear the petition.

Disclaimer: The information contained on this site is intended for educational purposes only and is not a substitute for advice, diagnosis or treatment by a licensed physician. It is not meant to cover all possible precautions, drug interactions, circumstances or adverse effects. You should seek prompt medical care for any health issues and consult your doctor before using alternative medicine or making a change to your regimen.

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