Ephedra, a plant-based stimulant also known as Ma Huang, was a common ingredient in dietary supplements during the 1990s and early 2000s. It has been used in Chinese medicine for centuries to treat conditions like colds and congestion. In the United States, supplements containing ephedra were marketed to aid weight loss and boost athletic performance, gaining considerable popularity before safety concerns prompted regulatory review.
Adverse Health Effects and Documented Risks
The health risks of ephedra are linked to its active chemical compounds, ephedrine alkaloids. These stimulants directly affect the central nervous system, increasing heart rate and elevating blood pressure to potentially dangerous levels. This stimulation occurs because ephedrine alkaloids mimic adrenaline, a hormone that triggers the body’s “fight or flight” response and places strain on the cardiovascular system.
Even when taken at recommended doses, ephedra was linked to serious health events like heart attack, stroke, seizures, and sudden death. These adverse effects were not limited to individuals with pre-existing health conditions but were also observed in young, healthy people. The evidence showed that the potential for harm was substantial, leading to a re-evaluation of its safety.
The combination of ephedrine alkaloids with caffeine, a common formulation in weight-loss products, amplified these risks. While this combination could produce a modest short-term effect on weight loss, this benefit was determined to be insufficient to justify the health dangers it posed.
The Path to Prohibition
Concerns at the U.S. Food and Drug Administration (FDA) grew in the late 1990s as the agency received an increasing number of Adverse Event Reports (AERs) linked to ephedra use. By 2002, more than 1,000 health-related problems had been reported, detailing serious cardiovascular and neurological events. This created a body of evidence that the supplements posed an unreasonable risk to public health.
An initial FDA attempt in 1997 to regulate dosage and require warning labels was withdrawn in 2000 after challenges regarding the evidence for specific dosage limits. As AERs continued to accumulate, advocacy groups like Public Citizen petitioned the FDA in 2001 to ban all ephedra-containing products.
A turning point occurred in February 2003 with the death of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles. His death from heatstroke was linked to an ephedra supplement, drawing media scrutiny and public outcry. This event amplified pressure on regulatory bodies, and Major League Baseball banned the substance, following a similar prohibition by the National Football League in 2001 after the death of player Korey Stringer.
The FDA’s Final Ruling
The mounting evidence and public pressure led the FDA to announce its intention to prohibit the sale of dietary supplements containing ephedrine alkaloids on December 30, 2003. The agency stated the products posed an unacceptable health risk, and a final rule on April 12, 2004, officially banned their sale in the United States.
The ban was targeted at dietary supplements and did not extend to all products with compounds from the ephedra plant. It did not apply to traditional Chinese medicine remedies from licensed practitioners or certain over-the-counter medications like asthma remedies containing synthesized ephedrine or pseudoephedrine. These medications are regulated separately as drugs.
Manufacturers of ephedra supplements challenged the FDA’s ban in court, but the ruling was upheld. In 2006, the U.S. Court of Appeals for the Tenth Circuit affirmed the ban, concluding the FDA’s record supported the finding of an unreasonable risk. A final appeal to the Supreme Court was declined in 2007, solidifying the prohibition.