How Did Concerns Over Ephedra Diet Pills Begin?
Initial concerns over Ephedra began in 1994 with adverse events mainly tied to one product that was extensively marketed in Texas, Formula One. This product was believed to contain ephedra, but investigations by state and federal authorities revealed that there was considerable uncertainty about the formulation of the product, and the manufacturer was sued by Texas. Once this product was reformulated pursuant to a consent decree with Texas, reports of adverse events from Formula One virtually disappeared.
During the Formula One investigations, both Texas and FDA widely publicized concerns that Ephedra products in general could cause serious adverse events including seizures, heart attacks, strokes and death. This publicity had a predictable result similar to past experiences with other foods, such as aspartame, that have been unfairly branded as causing health problems. Scared consumers and health professionals began reporting a whole range of health problems to FDA and state officials that were “associated with” Ephedra, meaning that there was evidence of Ephedra consumption but no other causal connection to these dietary supplement products. These “events” included deaths caused by drunk driving, birth control failures, and even murders.
Careful scientific review has shown that the vast majority of the events have no connection to Ephedra consumption, but arose from preexisting conditions or were the result of other causes. A former FDA toxicologist and other experts have confirmed through valid scientific analysis of FDA’s adverse event reports that these reports support the safe use of Ephedra when appropriately consumed according to current national standards. Nonetheless, FDA, rather than examining the events to see if they could be scientifically connected to Ephedra, simply released the raw number of events and deaths with assertions that FDA was “concerned” about product safety.
The end result is that FDA has attempted to stigmatize Ephedra, through publicity of its “concern” and the raw numbers of events collected, as part of an effort to advance the agency’s scientifically unsupportable position that most uses of Ephedra should be banned, including the most common use as an aid to weight loss. FDA’s press releases and related news programs were the direct cause of many if not most of the reports FDA received, as charts of the dates for the reports to FDA have shown. The conclusion of objective experts is that Ephedra is another safe dietary supplement when used as directed.
Suggested Reading:
