Ephedra Products under Attack
in United States and Canada

Stephen Barrett, M.D

Ephedra is a general term that refers to several species of herbs that contain the chemical ephedrine, also referred to as ma huang. Ephedra is effective as a nasal decongestant and can be legally marketed for this purpose if the recommended dosage is not too high. Government agencies in the United States and Canada are attempting to protect consumers against misleading claims and dangerous reactions associated with these products; and many lawsuits involving ephedra or ephedrine have been filed by ephedra victims. Hundreds of ephedra products are marketed as "energy boosters" and/or "thermogenic" diet aids, even though no published clinical trials substantiate that they are safe or effective for these purposes. These products outnumber the conventional prescription and nonprescription ephedra products that are FDA-approved as decongestants [1].

U.S. Actions

In February 2001, a jury awarded $13.3 million to an Alaskan woman who suffered a debilitating stroke after taking a weight-loss product containing ephedrine. The Superior Court jury in Anchorage ordered E'OLA International of St. George, Utah and its executives to pay Rosalie Talbert $1.3 million in compensatory damages and $12 million in punitive damages because of "outrageous" behavior in the sales of its "AMP II Pro" drops The jury found E'OLA liable for (a) creating an unsafe product; (b) misrepresenting it as "all natural" when it contained synthetic ephedrine in addition to herbal ephedra; and (c) for being negligent in failing to change the product despite government warnings that it could cause serious illness, including stroke. This was the first such case to come to trial. Between 1994 and mid-1999, supplement companies settled nearly three dozen personal-injury and wrongful-death lawsuits involving ephedra or ephedrine. Many more suits are pending [2]. As a result, the cost of insurance for companies marketing ephedra products has risen drmatically [3].

In October 2001, at the FDA's request,U.S. Marshals seized about $140,000 bottles of "AMP II Pro drops" valued at $2.8 million along with bulk ephedrine hydrochloride (HCl) used in their manufacture from E'OLA and its contract manufacturer, Nature's Energy, Inc., of Pleasant Grove, Utah. The drops had been marketed as a "dietary supplement" but labeled for use against obesity. The FDA maintains that because ephedrine is approved as a drug, it cannot be marketed as a "dietary supplement" and that dietary supplements cannot be marketed to treat obesity (which the agency classifies as a disease). According to San Francisco Attorney Christopher Grell, who represents plaintiffs in personal injury and wrongful death lawsuits against E'OLA, the company had received more than 3,500 complaints about side effects but did not report any problem to the FDA. Such lawsuits plus sising insurance rates connected with several deaths are making it risky to market ephedra products [4].

Canadian Actions

In June 2001, Health Canada advised against products containing ephedra, in combination with caffeine and other stimulants, for purposes of weight loss, body building or increased energy [5]. At that time, 60 adverse events associated with such products had been reported in Canada. Since then, a product that combined large doses of ephedrine with caffeine has been reported as a contributing factor in one death in Canada. Similar problems have been reported in larger numbers in the United States.

In January 2002, Health Canada asked manufacturers, distributors and importers to stop selling ephedra-containing products marketed for appetite suppression, weight loss promotion, "metabolic enhancement," increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects. The agency acted after concluding that such products can cause strokes, heart attacks, heart rate irregularities, seizures, psychosis and death [6]. A customs lookout has also been issued to try to prevent importation of these products into Canada.

Canadian law requires products marketed with health claims to be labeled with a Drug Identification Number (DIN). This recall deals with products that are marketed without government approval and includes:

Health Canada advises Canadians to stop using these products and to return them to their points of sale. People suffering from heart conditions, high blood pressure and diabetes are particularly at risk. The agency intends to continue to monitor reports of adverse events associated with ephedra/ephedrine and will take further action if necessary. A survey will be undertaken within 6 months to determine whether these products are still being marketed. Noncompliant products will be ordered removed from the shelves. Consumers who see such products on the shelves can complain to their regional Health Canada office:

Atlantic Region (Halifax): Annette Daley, (902) 426-5350
Manitoba and Saskatchewan (Winnipeg): Robert Scales, (204) 983-5453
Quebec (Longueil): Alain Bérubé, (450) 646-1353, ext. 232\
Western (Burnaby): Dennis Shelley, (604) 666-3704
Ontario (Scarborough): Jean-Marc Charron, (416) 973-1466

For Additional Information

References

  1. Gurley BJ and others. Content versus label claims in ephedra-containing dietary supplements. American Journal of Health-System Pharmacists 57:963-969, 2000.
  2. Gugliotta GR. Woman wins $13.3 million against dietary company. Washington Post, Feb 8, 2001.
  3. Evans D. Herbalife, Other Ephedra Marketers Face Soaring Insurance Rates. Bloomberg LLP, April 11, 2002.
  4. US Marshals seize unapproved drug in FDA case. FDA Talk Paper T01-53, Oct 31, 2001.
  5. Advisory not to use products containing Ephedra or ephedrine, Health Canada Advisory 2001-67, June 14, 2001.
  6. Health Canada requests recall of certain products containing Ephedra/ephedrine. Health Canada Advisory 2002-01, Jan 9, 2002.

This article was revised on April 12, 2002.

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