Related topics: •  Special Report: Ephedra Supplements -- Bad Business? Part 1 •  Special Report: Herbal Diet Pills

Editor's note: On Dec. 30, 2003, U. Health and Human Services Secretary Tommy G. Thompson announced that the government planned to ban the sale of pills containing ephedra in early 2004, and he urged consumers to stop taking the herbal stimulant immediately. The ban took effect on April 12, 2004. Several years of court battles followed, but ultimately the ban was left intact. Thompson's action to ban ephedra came after years of criticism from consumers and researchers who have documented cases of heart attacks, high blood pressure, and strokes associated with ephedra. While products like the sports drink Extreme Ripped Force no longer contain ephedra, some supplement manufacturers have replaced it with bitter orange, a substance that may carry the same risks as ephedra. Our award-winning, two-part series below published in 2000 was one of the early articles alerting readers to the dangers of ephedra.

You can walk into many gyms in San Francisco and buy a fruity sports drink containing ma huang, kola nut, or guarana, thinking that you're getting a tasty herbal concoction. In drugstores, supermarkets, and nutrition centers you can pick up a bottle of pills with these same ingredients. But ma huang is another term for ephedra, which contains a stimulant scientists have linked to a host of injuries and, in rare cases, death. Guarana and kola nut, for their part, are both natural sources of caffeine. What's more, if taking ephedra alone is risky, combining it with caffeine may be riskier still, according to medical experts.

And if you thought the drink you were enjoying had been tested for safety by a government agency, you'd be mistaken -- the FDA doesn't require that manufacturers run clinical tests on herbal substances for safety. Unlike prescription and over-the-counter drugs, dietary supplements can be placed on the market and sold without undergoing government approval or safety testing. And the agency can exercise only limited regulatory power until it receives reports of injuries or deaths.

So when consumers buy ephedra-filled sports drinks or pills like Ripped Fuel, Extreme Ripped Force, Inferno, BURN IT UP! Herbal Blend, Ephedra White Cross, or Herbal Fire Formula 2 Blowout, it's strictly buyer beware. Don't assume that an ephedra supplement -- or any dietary supplement -- is safe or that it meets government standards just because it appears on your grocer's or vitamin store's shelves.

The active ingredient in ephedra is ephedrine, a stimulant that's a chemical cousin of amphetamine. Ephedrine is found in many decongestants and in Chinese medicines, and experts say that these medicines are safe when taken as directed.

But now ephedra is found in the trendy sports drinks and energy pills flooding gyms, supermarkets, pharmacies, and health-food stores across the country. Consumers are using the supplements to drop pounds, increase stamina during workouts, and even to lift more weight; others take it as a legal alternative to speed.

"Most of the people I know take it for the energy or 'high' feeling they get," says 27-year-old "Cathy"* of San Francisco. "They usually take it if they're planning on having a late night out, and then they usually take more than one at a time."

But all this may come at a price. While millions of people do use the supplements without incident, ephedrine can cause irregular heartbeat, tremors, seizures, and soaring blood pressure, sometimes leading to stroke and heart attack. Analyzing reports of injuries and death from ephedra supplements reported to federal health agencies, Neal Benowitz and Christine Haller of the University of California at San Francisco's Department of Clinical Pharmacology warn that the supplements are unsafe -- even if taken as directed.

"Because of the severity of the [injuries], and in particular the occurrence of these events in young, otherwise healthy individuals," the authors wrote, "we conclude that ephedrine-containing herbal supplements, as currently used, present a significant public health concern."

An independent study by Dr. Amanda Gruber, associate chief of the substance abuse division in the Biological Psychiatry Laboratory at McLean Hospital, found that people may even become physically dependent on the substance. Indeed, some users talk frankly about their difficulty in "kicking" the pills. "One of my problems is that from the very short time that I have been taking [ephedra supplements], I want to take them all the time," writes 18-year-old Lauren on the Web site nutritionalsupplements.com; its bulletin boards see a lively amount of ephedra discussion, with some users singing its praises and others recounting adverse reactions. "When I am on them, I am in a great mood. I get so many things done when I work out. I could work out for hours on end. But when I'm off, I'm tired and cranky."

Wes Siegner, Jr., legal counsel and spokesman for the Ephedra Education Council, a trade group representing ephedra manufacturers, contends that studies on ephedrine addiction are not well-documented, and the reported problems are not common enough to represent a widespread health risk.

"It's possible to be addicted to ephedrine but it's a rare occurrence," he says. "It's not a significant public health issue."

Interestingly, the amounts of this active ingredient in capsules containing ephedra may vary not only from company to company, but from bottle to bottle of the same brand. In a study published in the May 15, 2000 issue of American Journal of Health-System Pharmacists, Dr. Bill Gurley criticizes the manufacturing practices of many companies producing ephedra supplements.

Gurley analyzed 20 commercially available supplements (19 in pill form, one in liquid form), 11 of which contained "stacked" stimulants (ephedra in combination with caffeine, synephrine, or other stimulants). His investigation turned up widespread discrepancies in the amount of ephedra in each batch and the amounts listed on the product labels -- the amounts of the active ingredient varied from miniscule percentages to more than one and a half times what was promised on the label. His investigation led him to conclude there is an "apparent lack of interest in product quality by many nutraceutical manufacturers."

Gurley's report also concludes that labeling on these products is often misleading -- and even if the consumer could make sense of the label, he might not realize that he was getting too much or too little of the product. Gurley says that the kind of discrepancies he uncovered "would likely result in a product being misbranded and ultimately recalled by the manufacturer," if dietary supplements were regulated as strictly as drugs are.

But they aren't. So an unwary consumer downing an energy pill before working out may be playing a game of supplement roulette -- ingesting the equivalent of one and a half doses in a single swallow and putting himself at higher risk of a dangerous reaction.

The American Herbal Products Association, a trade association that represents the herbal product manufacturers, sharply criticized Gurley's study and attempted to delay its publication. Officials contend the study overstated the risk associated with the product and said it would confuse consumers about the safety of ephedra products. There are more adverse reactions to analgesics, they point out, than to ephedra.

But even if the amounts listed on the label are correct, consumers following the directions on many packages may still be putting themselves at risk. The cautionary labels on many ephedra supplements recommend a maximum dosage of no more than 100 milligrams in a 24 hour period. The FDA's original proposal -- now withdrawn pending further study -- advised that in one day, consumers should take no more than 24 milligrams.

Six supplement makers have recently taken steps to strengthen warning labels on their ephedra products, including Metabolife, which was hit with a lawsuit last year charging that it failed to warn consumers of serious health problems such as seizures, brain damage, and stroke. Metabolife labels now advise consumers to consult a doctor before taking the weight-loss pills if they suffer from high blood pressure, diabetes, thyroid disorder, depression or any psychiatric disorder, recurrent headaches, seizure disorder, and a host of other medical conditions.

With all the health problems associated with ephedra, why doesn't the government take further action? Experts say the FDA's hands are tied. In the early 1990s, the government made an abortive attempt to put tighter controls on the herbal supplement industry. The multibillion dollar vitamin and supplement lobby fought back, claiming that stricter regulation would harm the industry and drive many companies out of business. Subsequently, the federal Dietary Supplement Health and Education Act (DSHEA) of 1994, permitted manufacturers to put their products on the market without safety testing or FDA approval. Not surprisingly, the market has taken on a Wild West feel as supermarkets, gyms, health-food stores, and drugstores have been flooded with a dizzying array of supplements.

The act also put the burden of proving a supplement is hazardous squarely on the FDA -- an uphill battle for the agency. The FDA tried to slap restrictions on ephedra supplements in 1997 after receiving hundreds of reports from consumers claiming to have had adverse reactions after taking the stimulant. The agency proposed labeling that warned consumers to take no more than 24 milligrams of ephedra in a day, and that they should take it regularly for no longer than a week. However, the FDA's proposal met with strong opposition from the supplement industry, which dismissed the reports as anecdotal. After an unfavorable report from the General Accounting Office (the investigative branch of Congress), which concluded that the FDA had not properly documented reports of ephedra-related injury and death, the agency ultimately withdrew its proposal.

But with the latest FDA report on ephedra's hazards, the agency may have more success in linking these supplements to serious health problems. Testimony from doctors, pharmacists, pharmacologists, and other researchers backs up the agency's contention that ephedra supplements (particularly those "stacked" with caffeine) are potentially dangerous -- especially if used daily over a period of months and in large quantities.

In fact in February 2003, the secretary of health and human services announced that the FDA would begin to formulate new warning labels for ephedra. The warnings will likely caution against the following: combining ephedra with caffeine or other stimulants, taking ephedra if you are pregnant or nursing, and taking it after strenuous exercise. People under the age 18 will probably also be cautioned against taking ephedra.

Perhaps no one is as aware of the potential dangers of ephedra supplements as Barb Michal. In 1997 her 24-year-old son, Kristopher, who was taking synthetic ephedrine pills, died of a heart attack at work. When an autopsy turned up ephedrine as the only suspect substance in his system, Michal began researching the pills on the Web, which led her to the FDA's files of hundreds of reports of injuries -- and some deaths -- allegedly linked to ephedra. This sparked a crusade that led her to found HEAT (Halt Ephedrine Abuse Today), a non-profit Michigan corporation. She now lives in California, where she works as a paralegal with attorney John Tiedt, who takes on many ephedra-related cases. "Mothers Against Drunk Driving (MADD) started with one grieving mother," says Michal. "If HEAT has to get as big as MADD, I'm prepared to take it that far."

She and other activists are aware that challenging certain supplement makers carries its own set of risks. Metabolife International, for example, has sued journalists who have reported on the safety of its weight-loss pills containing ephedrine. The courts recently threw out a suit against Hearst-Argyle television for a show about the possible dangers of Metabolife pills. In a decision dismissing all claims against the defendants, the court ruled that Metabolife's data on ephedrine was unreliable and its lawsuit was designed to chill the exercise of free speech.

On August 15, 2002, the U.S. Justice Department announced that it had opened a criminal investigation into whether Metabolife, the top manufacturer of products containing the herbal stimulant ephedra, lied about its safety. The next day, Metabolife disclosed that it had withheld 13,000 health-related consumer complaints from federal regulators for more than four years.

The power of the industry giants, the FDA's setbacks in regulating ephedra, and the rampant popularity of herbal supplements in general, have created an uphill battle for activists like Michal and Tiedt. "The playing field is by no means level. Our hands are tied, and meanwhile the manufacturers conduct no safety tests -- the industry has nothing to show safety," Michal says. "They are marketing legal speed to an unknowing public."

Tiedt, who maintains the HEAT site and has taken on some ephedra-related lawsuits, says, "We're receiving more and more complaints... it's almost an epidemic."

Some ephedra manufacturers acknowledge that ephedra is used by some as a "street drug alternative," and back regulations that warn against marketing ephedra as a "euphoric" narcotic. They contend that the use of ephedra has grown dramatically in recent years. Last year, for example, 3 billion doses were consumed, and sales increased 76 percent over the previous year, according to the Ephedra Education Council. Sold primarily as a weight loss and energy product, ephedra carries few health risks, but many are misled by the warnings from the FDA, Siegner of the ephedra trade group says.

Meanwhile, in the absence of strong federal regulation, some ephedra users talking on nutritionalsupplements.com's bulletin boards are struggling to piece things together for themselves. "I used [an ephedra supplement], and believe me when I tell you it's dangerous," asserts one user. "I only used it for three days as instructed and I felt worse and worse every day. The first day, I felt a slight stomach-ache. So I rested for a day. The next time I felt nausea and more stomach-ache. The third time I took [it], I got signs of anxiety and extreme nervousness. Nothing else in my life caused this stress... I threw away the pills."

In her post entitled "It's Two in the Morning and I Just Cleaned My Entire House Because Ripped Fuel Won't Let Me Sleep," 18-year-old Lauren writes, "It is 2 in the morning. I have to get up and go to work tomorrow. I just cleaned my house and I mean really cleaned. It smells like cleanser and I am so very very awake right now, but I am starting to get a really bad headache. And I get them all the time."

Michal receives three or four e-mails a day about ephedra supplements through the HEAT site, and she says nearly half of them deal with addiction and dependence, in addition to many reports of injury. As head of Pharmacists' Planning Service, Fred Mayer helped design a bill to restrict ephedra products in California. "We've definitely got to get some warning labels on these products to protect people," he says. "Better yet, we should make them available by prescription only. That would stop the abuse."

Slowly, Michal's message may be picking up steam. "We get people checking out the products before they start taking ephedrine, and thanking us for telling them the [facts]," she says. Gruber agrees that better regulation is necessary, but also believes that consumer education is the crucial piece in ending irresponsible use. That way, the next time you scan your drugstore's shelves or your gym's cooler, you'll know exactly what you're picking up -- and its potential for harm.

-- Benj Vardigan is a senior editor for Consumer Health Interactive and the winner of an Outstanding Young Journalist award from the Northern California chapter of the Society of Professional Journalists. Executive Editor Diana Hembree contributed to this report.

•These names have been changed.

For a more in-depth look at some of the studies mentioned above -- and for more responses from manufacturers, gyms, and nutrition centers -- check out Part I of this series.

Further Resources

If you've experienced an adverse reaction of any sort, it's important to report it. You can call the Food and Drug Administration hotline at (888) 463-6332.

References

First published July 19, 2000
Last updated January 16, 2008
Copyright © 2000 Consumer Health Interactive

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