While health problems resulting from ephedra had been known for years, public concern over the herbal supplement did not peak until an incident in Clearwater, Fla., on Feb. 17, 2003. That was the day Steve Bechler, a pitcher for the Baltimore Orioles, died following a spring training workout.
Afterward, authorities found a bottle in Bechler's locker that contained ephedra-spiked diet pills. The substance, an ancient Chinese herb (ma huang) that is a powerful natural stimulant, contributed "significantly" to Bechler's death due to complications of heatstroke, said a physician who conducted toxicology tests on the 23-year-old athlete's body.
Ephedra, an adrenaline-like stimulant, can have dangerous effects on the heart. It has been linked to high blood pressure, irregular heart beat, insomnia, dizziness, tremors, nervousness, headaches, heart attack and stroke. (Bechler's temperature hit 108 degrees before his death.)
Less than two months after the incident, the American Heart Association urged the federal government to ban sales of ephedra, widely used in the United States to help people lose weight and enhance athletic performance. At year's end, the U.S. Food and Drug Administration took action, issuing a consumer alert (below) on ephedra's safety and announcing a proposed rule that would effectively prohibit the sale of supplements containing ephedra.
" ... We're sending a strong and unambiguous signal about the safety of dietary supplement products containing ephedrine alkaloids," said U.S. Health and Human Services Secretary Tommy Thompson. "Consumers should stop buying and using ephedra products right away, and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective."
But ephedra had already claimed a great many victims. Since it was an herbal supplement and not a drug, ephedra was never subject to pre-market testing or FDA approval. But concerns grew at the agency after it started receiving negative reports, at least 140 reports of ephedra-related illnesses or death from 1997 to 1999. By mid-2000, at least 75 lawsuits had been filed across the country over ephedra, according to a report by The Washington Post, with a number resulting in multi-million dollar settlements.
Ephedra products - hundreds or more marketed as diet pills and workout boosters - have been sold by at least 62 different companies under a variety of names, such as Metabolife 356, Ripped Fuel, Ultimate Orange and Hydroxycut. A number of products have already been voluntarily recalled, but many ephedra products continue to be advertised and sold.
The diet supplement is listed on ingredient labels in a number of ways, including, but not limited to, ephedra, ephedra extract, ephedra herb powder, ma huang, epitonin, ephedrine, Chinese ephedra, Mormon tea, and herbal ecstasy.
A number of incidents involving ephedra use have been highly publicized. In 1996, a college student was found dead in a Florida hotel room during spring break after taking a product called Ultimate Xphoria, while a 15-year-old girl died during soccer practice in April 2000. Lawsuits were filed and settlements reached in both cases.
Kline & Specter, PC, with more than experienced attorneys, several of whom are also highly regarded doctors, has handled Ephedra cases and is one of the nation's leading law firms with the ability to litigate pharmaceutical lawsuits.
The following is the text of the U.S. Department of Health and Human Services News Release dated Dec. 30, 2003:
FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra
Consumers Advised to Stop Using Ephedra Products Immediately
HHS Secretary Tommy G. Thompson today announced that the Food and Drug Administration (FDA) has issued a consumer alert on the safety of dietary supplements containing ephedra and has notified manufacturers of its intent to publish a final rule on dietary supplements containing ephedrine alkaloids. The rule will state that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of dietary supplements containing ephedrine alkaloids when it becomes effective, 60 days following publication.
"FDA will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason," Secretary Thompson said. "Today's action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now."
"We are taking action today to notify Americans about the unreasonable risk of ephedra as currently marketed in dietary supplements," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Our action is based on diligent and thorough work by the agency as required by the challenging legal standard in the dietary supplement law. We worked hard to obtain and review all the available evidence about the risks and benefits of ephedra, including its pharmacology, studies of ephedra's safety and effectiveness, adverse event reports, and reviews by independent experts."
"By issuing these letters today, we're sending a strong and unambiguous signal about the safety of dietary supplement products containing ephedrine alkaloids. Consumers should stop buying and using ephedra products right away, and FDA will make sure consumers are protected by removing these products from the market as soon as the rule becomes effective."
According to the Federal Food, Drug, and Cosmetic Act, a dietary supplement product is adulterated if it or a dietary ingredient within it presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use. Under the Dietary Supplement Health and Education Act of 1994, the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed.
Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted for use to aid weight loss, enhance sports performance, and increase energy.
FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA's evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks. Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes.
FDA's notification reflects the agency's recent comprehensive evaluation of the science as well as a public comment period intended to cap years of debate about the risks and safety of ephedra in dietary supplements. In 1997, FDA first proposed a rule on dietary supplements containing ephedra including requiring a warning statement on these products. FDA modified this proposed rule in 2000, and last February the agency announced a series of comprehensive actions designed to protect Americans from the potentially serious risks of dietary supplements containing ephedra. To solicit comments on new evidence about ephedra as well as on a proposed warning statement, last February's actions included publishing a Federal Register notice outlining FDA's concerns and reopening the comment period.
Following publication of this notice, FDA received and reviewed tens of thousands of comments. The agency has also reviewed a comprehensive RAND Corporation report on the data on ephedra and a series of adverse event reports that it was unable to obtain more quickly because under the Dietary Supplement Health and Education Act such adverse event reports are not required to be submitted to FDA.
"We are going to issue a rule that clarifies and applies a legal standard that has never been used before. Using the challenging standard provided under the law, we have done all we can to make sure our regulatory action will succeed," said Dr. McClellan.
FDA has sent 62 letters to firms marketing dietary supplements containing ephedra and ephedrine alkaloids alerting them of this future rule.
While working on the forthcoming rule, FDA has been actively protecting the public health through a series of high-profile enforcement actions aimed at addressing the public health danger. Dietary supplement enforcement actions include inspections that resulted in voluntary compliance, voluntary recalls, warning letters, seizures and injunctions, criminal enforcement and joint enforcement actions with the Federal Trade Commission and the Department of Justice. In conjunction with FDA's actions to date, classes of ephedra products have already been removed from the market (for example, many products marketed for enhancing sports performance), the demand for ephedra products has declined significantly, and many companies have already ceased marketing.