Herbal Industry Cover-Up
What some herb and supplement companies don't want you to know. Our special report.
By Diana Hembree CONSUMER HEALTH INTERACTIVE Editor's note: The U. S. Food and Drug Administration banned the sale of supplements containing ephedra on April 12, 2004. One year later, a federal judge in Utah lifted the ban in that state. While the FDA appeals the Utah ruling, dietary supplements containing ephedra and ephedrine alkaloids continue to turn up on the market, and the FDA continues to investigate and seize these products. In the early 1990s June Grell began drinking an herbal tea to help her lose weight. After drinking Super Dieters Tea faithfully for several months, the athletic 37-year-old died suddenly in her sleep at her home in San Rafael, California -- a death that several physicians would later blame on the diet tea. What Grell didn't know was that the tea's active ingredient -- senna -- was a laxative whose long-term use, toxicologists say, can cause an electrolyte imbalance so serious it can lead to arrhythmia and heart failure. Despite senna's dangers, the tea's label didn't mention any possible side effects, or even that senna was a laxative. Calling the tea a "refreshing low-calorie beverage," the label warned only that it shouldn't be used during pregnancy. In the ten years since June Grell's death, her husband, a trial attorney, has waged an exhausting campaign against dangerous herbal products. Besides lobbying successfully for a warning label on all herbal supplements sold in California that contain laxatives and stimulants, he sued the diet tea's manufacturer, Laci Le Beau. But like some other vocal critics of hazardous herbal products, Grell soon found himself on the other side of a lawsuit. After Grell talked with reporters about his wife's death, manufacturer Laci Le Beau slapped him with a $5 million libel lawsuit, charging that by alleging its product was unsafe Grell had "willfully, maliciously, oppressively, with a callous and intentional disregard...subjected the plaintiff to unjust hardship." Grell had stumbled onto the seamy side of an industry that many people associate with pure, natural ingredients. The federal government doesn't require that the ingredients in any herbal product be tested for effectiveness, much less safety -- and some are far from pure or safe. More than 180 deaths have been linked to herbs and supplements over the last few years, according to the Food and Drug Administration, which oversees dietary supplements. "The problem is that there's no government regulation of supplements at all," says Frederick Mayer, a California pharmacist who belongs to the Dietary Supplement Safety Committee, an ad hoc group calling for tighter scrutiny of alternative medicines. "People are dying and it's time that something be done about it." And although many herbalists agree that the industry needs better oversight, some supplement makers have fought all attempts to regulate the industry. Over the past decade several manufacturers have tried to silence critics with six-figure harassment suits. Others have thrown away customer complaints, concealed adverse reactions to herbal products, and threatened to sue federal regulators trying to protect consumers from dangerous products. Dubious behavior by individual herb and supplement companies includes: | • | Destroying records of adverse reactions to products. In a deposition with a Laci Le Beau company official, Grell asked whether the company had received complaints about Super Dieters Tea. CEO Frederick Stine replied that it had, and that company policy was to respond to the complaints and then throw them away.
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| • | Marketing products that contain prescription drugs, including controlled substances. In 2006, the FDA warned consumers against using two dietary supplements manufactured in Brazil and marketed to U.S. consumers over the Internet: Emagrece Sim (the Brazilian Diet Pill) and Herbathin. These products were found to contain fluoxetine HCI, the active ingredient in Prozac, and chlordiazepoxide HCI, the active ingredient in Librium, which may be habit forming and impair the ability to drive. Both also contain Fenproporex, a stimulant not approved for sale in the U.S. that converts to amphetamine in the body.
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| • | Failing to report adverse reactions to products. In 1993 E'ola International began manufacturing a diet supplement that contained synthetic ephedrine, a stimulant that has been linked to hundreds of reports of adverse reactions, including soaring blood pressure, tremors, stroke, and even death, according to the FDA. The company received 3,500 complaints of adverse reactions from consumers, including reports of anxiety, headache, and racing heart, but never reported any of them to the FDA or any other agency, according to Fred Osborne Rogers, E'ola's compliance coordinator. (Although supplement makers are not required to report adverse reactions to the FDA, the company could have availed itself of the agency's voluntary reporting program.)
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| • | Filing harassment suits against critics. Metabolife International, which formerly made a weight-loss product containing ephedrine, has sued journalists who've reported on the safety of its ephedrine-based diet pills.
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| • | Threatening to sue federal regulators. More than ten years ago -- five years before he entered the diet supplement industry -- Michael J. Ellis was arrested for running a methamphetamine lab and convicted of using a telephone to further a drug deal, according to the Washington Post. In 1995 he started Metabolife International and is now president of a supplements industry coalition that threatened to sue federal regulators seeking restrictions on ephedrine for safety reasons.
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| • | Withholding product complaints from the government. On August 15, 2002, the Justice Department launched a criminal investigation of Metabolife to determine whether the herbal diet pill manufacturer lied about ephedra's safety. The next day, Metabolife disclosed that it had withheld thousands of consumer complaints about ephedra products from U.S. regulators for years. The company said that the 13,000 health-related complaints were not released because they hadn't been analyzed properly. The explanation angered U.S. Food and Drug Administration officials, who had sought access to the documents since 1997.
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| • | Grand Jury Indictment. On July 22, 2004 the US Department of Justice announced that a southern California Grand Jury returned an eight-count indictment against Metabolife and its founder, Michael J. Ellis. The indictment included charges against Ellis and Metabolife for making “false, fictitious, and fraudulent representations to the Food and Drug Administration,” as well as “corruptly endeavoring to influence, obstruct, and impede proceedings” in the regulation of dietary supplements containing ephedra.
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| • | Tax evasion. In September 2006, a federal judge sentenced William Bradley -- one of three owners of Metabolife -- to six months in prison and two years probation for tax evasion. According to the government, Bradley evaded taxes using a variety of schemes, including diverting corporate profits from Metabolife and using a charitable foundation to conceal his income. Bradley admitted the charges in a plea agreement and paid the Internal Revenue Service $6 million in back taxes, penalties, and interest.
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Despite such hazards, those looking to the federal government to protect unwitting consumers from dubious diet pills and other unsafe supplements have been sorely disappointed. Among other things, the FDA has decided to let makers of vitamins, herbs, and other dietary supplements market products for "natural conditions" such as memory loss without proving they are safe or effective. On their part, supplement makers point out that herbs cause far fewer problems than prescription drugs, which kill an estimated 100,000 people each year. Others say that the industry will voluntarily put warning labels on risky products. Rob McCaleb, president of the Herb Research Foundation, holds up ephedra as an example: "Some feel that the use of fast-acting stimulants and diet pills is contrary to the principles of those committed to healthful lifestyles, proper nutrition, and exercise." Meanwhile, Christopher Grell continues to push for federal warnings on stimulant and laxative teas. The company that made the diet tea his wife drank has recently been sold to Natrol, a publicly traded company. The libel lawsuit against Grell is still pending, even though the dangers of senna are hardly in dispute: prominent herbalists have warned against long-term use of senna, and reports of four deaths of women in their 20s and 30s who used diet teas are on file at the FDA. Among them was Debbie Helferey, a 20-year-old resident of central Florida, who died of sudden cardiac arrest. She had been drinking the tea to lose weight, according to a lawsuit filed by Grell. A medical examiner's death certificate lists Super Dieters Tea as a cause of death. -- Diana Hembree is the executive editor of Consumer Health Interactive.
References
FDA Warns Consumers About Brazilian Diet Pills Found to Contain Active Drug Ingredients. FDA News. U.s. Food and Drug Administration. January 13, 2006.
FDA Acts to Seize Ephedra-containing Dietary Supplements. FDA News, December 6, 2005.
FDA Requests Seizure of More Dietary Supplements Containing Ephedrine Alkaloids. January 12, 2006.
Benowitz, Neal L. "Review of Adverse Reaction Reports Involving Ephedrine-Containing Herbal Products." Submitted to U.S. Food and Drug Administration, January 17, 2000.
Gruber, Amanda J. "Ephedrine Abuse Among 36 Female Weightlifters." American Journal on Addictions: Vol. 7, Number 4, Fall 1998, pp. 256-261. Woosley, Raymond L. "Summary of Analysis of Adverse Events Reports for Dietary Supplements Containing Ephedrine Alkaloids." August 18, 1999. King DS, et al. Effect of oral androstenedione on serum testosterone and adaptations to resistance training in young men: a randomized controlled trial. JAMA 1999 Jun, 281:2020.
Questions and Answers about FDA's Actions on Ephedra Dietary Supplements. Dec. 30, 2003. Food and Drug Administration. http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html
Letter to companies marketing ephedra dietary supplements. Food and Drug Administration. http://www.fda.gov/oc/initiatives/ephedra/december2003/warningltr.html
Mayo Clinic. Ephedra (Ephedra sinica)/Ma huang. September 2005. http://www.mayoclinic.com/health/ephedra/NS_patient-ephedra
Food and Drug Administration. News Release Summary -- July 22, 2004. http://www.fda.gov/bbs/topics/news/2004/doj72204.html
Department of Justice. News Release Summary -- September 21, 2006. http://www.usdoj.gov/usao/cas/press/cas60921-Bradley.pdf
Reviewed by Forrest Batz, Pharm.D., an assistant clinical professor at UCSF's school of pharmacy and a consultant in natural medicines based in Santa Rosa, California.
Our reviewers are members of Consumer Health Interactive's medical advisory board.
To learn more about our writers and editors, click here.
First published December 14, 2001
Last updated September 14, 2007
Copyright © 2001 Consumer Health Interactive
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