US Federal Judge Reverses Ban on Deadly Diet Supplement

Money Talks Yet Once Again. With 2003 estimated sales in excess of $1.2 Billion US Dollars, a dietary supplement purported to be responsible for numerous deaths, is now back on the market.
The FDA, following concerns raised by the medical community, over the deaths of several athletic individuals using the supplement, not just “couch potatoes” gallantly attempting to return to a more active and fit lifestyle, passed motion to ban the “diet miracle” fat burner. The 2003 death of 23-year-old Baltimore Orioles pitcher Steve Bechler, resulted in a slew of negative publicity that lead to declining sales of diet and sports supplements containing the compound Ephedrine.
Ephedrine is a widely used alkaloid of Ma Huang (Ephedra Sinica, Botanical Family Ephedraceae) an ancient Chinese herbal stimulant. Known use of this family of herbs, dates back over 5,000 years. Ancient Chinese physicians prescribed ephedra tea and pills for the common cold, coughs, asthma, headaches, and hay fever. Ephedra comforts asthma and bronchitis patients by acting as a bronchial dilator. In recent years, the powerful stimulant, due to it’s proven ability to supercharge human metabolic rate, found it’s way onto the diet supplement bandwagon as the “Most Powerful Natural Fat Burner”. It was on this stage, it’s risk potential came to light.
Based on data collected from several poison control centers, a group of California based researchers had claimed the compound to be the most dangerous herbal product on the market. Because it is an herb, it was not subject to regulations governing pharmaceutical drugs and could be sold over-the-counter. This is still the case today.
The government's decision to ban the supplement, actually came late in 2003. According to the Public Citizen's Health Research Group in Washington, D.C., More than 150 deaths have been linked to the use of the compound in recent years. Tommy Thompson,
Health and Human Services Secretary at the time, said the government had enough evidence to confirm the supplement was so powerful it quite readily caused heart attacks. Thompson announced a "Consumer Alert" warning against the use of all products containing the herb in any form, further stating the agency had notified manufacturers of its intent to publish a final rule banning the sale of supplements containing the compound. The ban followed the government review of more than 16,000 reports of adverse events, Thompson said. The actual ban was issued in February 2004. The American Heart Association touted the ban, “a Victory for the health of Americans”. In a speech prepared in anticipation of this favorable court decision, Dr.Augustus Grant, then the acting president of the AHA, stated “It sends a clear message to consumers either using or considering the use of these products, who may be unaware of the potential risks… While they may believe they are doing something good for their health, in truth they could be putting themselves at serious risk.”
In the typical grandiose style of US capitalism at it’s finest, the powerful lobbyist groups representing the interests of the diet and supplement industries, flexed their muscles and went to battle.
One of the largest manufacturers of Ephedra based supplements, Metabolife International Inc., was quick to "respectfully" disagreed with the FDA's decision. The company stated that the FDA would be unable it to meet the burden of proving that ephedra products, when taken in accordance with their label directions for proper use, present a significant or unreasonable risk, as they lacked the data and information to prove such allegations. Two other major players, Nutraceutical Corp. and Solray Inc., followed through with a full scale legal challenge.
April 14, 2005, federal judge Tena Campbell of the Utah federal district court reversed the year old FDA ban , citing the agency’s inability to prove that any specific dosage of the controversial weight-loss drug ephedra was dangerous, and sent the matter back to the agency for further evaluation.
"A negative inference is different from the affirmative proof required..." Campbell wrote in her opinion. "There is not sufficient evidence in the administrative record to establish that the risks identified by the FDA are associated with the intake of low dose EDS."

*For more interesting information on Ephedra, visit http://www.ephedra.nu/uk_botanical1.html


DocStuey will soon be publishing a full scale article on the pros and cons of Ephedra use.

Doc Stuey


For more facts about deadly supplements in the news, see this recent article title
"New Study, Proof That Vitamin E Kills"?


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Copyright (H.Brett) 2005