Ephedra Products Raise Questions
April 11, 2003
Go to any drug store and look at the impulse buy section. Go to any health store and look for the energy products. The vitamin aisle in any large grocery store, kiosks at the mall. It seems everywhere one looks, they are selling products containing ephedra, usually as weight-loss or body building aids. The names of the products themselves make promises: "Diet Fuel," "Ripped Fuel", "Kwik Burn", "MetaboLITE," "Turbo Charge," "Ultra Diet Pep," And the products are backed by powerful promotional support, including by the Ephedra Education Council whose website -- ephedrafacts.com -- boasts that "ephedra is safe when taken as directed" and "ephedra is useful." 1
But is it? Ephedra, which also goes by the name ma huang, contains the active ingredient ephedrine. Ephedrine affects the cardiovascular system by increasing blood pressure and heart rate. It is also a central nervous system stimulant. Ephedrine is a close chemical relative of amphetamine or "speed." And it poses some of the same risks as "speed." According to a December 2000 article in the New England Journal of Medicine Journal, 43 serious adverse reactions that were “definitely or probably” related to ephedra supplements had been reported to FDA. Many of these reactions were serious, including heart attacks, seizures and stokes. Ten of these events caused the death of the consumer, and 13 resulted in permanent impairment. 2 Indeed, according to an article in the March 2003 issue of Annals of Internal Medicine, ephedra containing products, even though they total less than 1% of total herbal product sales, account for 64% of the herbal product related reports of adverse reactions. 3 This alarming rate of adverse events led the authors to call for restrictions and/or a ban on the sale of the products. 4
In addition, several studies suggest that ephedra might be addictive, meaning that users may need ever increasing dosage to get the desired effect and have difficulty quitting use. 5 Also, consumers may experience the severe changes of behavior such as paranoia and sudden aggression found among users of amphetamine. 6 Product danger can be increased by "stacking," a practice by which manufacturers combine ephedra with caffeine or other stimulants.
Those who manufacture and sell ephedra products contend they are safe. But others disagree. The American Medical Association has twice asked the FDA to remove ephedra products from the market. 7 In January 1997, Health Canada, the Canadian version of FDA, asked for a recall for all products with an ephedra dose unit of more than 8 mg. and those products that combined ephedra and other stimulants. FDA is proposing its stringent warning, the so-called "Black Box," which will, if enacted, highlight that "serious adverse reactions, including death, have been reported after using ephedra." 8 Ephedra use has been banned by NCAA, the NFL and the International Olympic Committee. 9
Despite this growing recognition of ephedra's dangers, the products remain on the market and are widely used. According to FDA, 12 million person consumed ephedra in 1999. Why doesn't the government do more to restrict ephedra use? There is a gap in the regulatory power. Most ephedra products are "botanicals," thus are considered dietary supplements, not drugs. This distinction is critical because, although the ephedra products have drug-like action (the advertised purpose for many is identical to that of the weight-loss drugs fen-phen and Meridia), and drug-like side-effects, they are not subject to drug-like regulation. Under the Dietary Supplement Health and Education Act of 1994, the FDA's powers over dietary supplements are extremely limited. While FDA may require drug manufacturers to prove a new drug is safe and effective before it can be marketed, FDA power over supplements are primarily "post-market" in nature. FDA has no power to screen supplements for safety prior to the product's marketing. FDA cannot take even post-market regulatory action unless it proves that a supplement poses a "significant or unreasonable risk of injury." 10 The burden is on FDA to prove that a supplement is hazardous and that regulation is appropriate. Indeed, when FDA attempted to limit ephedra dosage in 1997, doubts that it had met this burden led to FDA withdrawal from ephedra regulation. 11 Hopefully, FDA's new label initiative will not meet the same fate.
But for many, any new restrictions will be too late. As described above, serious injuries, including deaths, have occurred. In this country, when regulatory structures are insufficient to protect the public, the civil justice system steps up to compensate injured persons and deter unsafe products. Thus, persons allegedly injured by ephedra products have begun to seek compensation in the courts. Persons who suspect they have been harmed should contact attorneys to protect their rights. A list of products listed on the internet as containing ephedra is found below. The authors can be contacted at glwilson@rkmc.com or tdsutton@rkmc.com, or by calling Robins, Kaplan Miller & Ciresi L.L.P.
Products Containing Ephedra according to Holistic OnLine, developed and maintained by International Cyber Business Services, Inc.
Product Name Manufacturer
| Adipokinex | Syntrax |
| Allergy Season Tea | The Yogi Tea Co. |
| Breathe Easy | Traditional Medicinals |
| Breathe Deep Tea | The Yogi Tea Co. |
| Clenbutrx | Vital Pharmaceuticals, Inc. |
| Chinese Ephedra | Frontiers |
| Chinese Ma Huang | Gaia Herbs, Inc. |
| Diet Fuel | TwinLab |
| Diet Pep | Natural Balance, Inc. |
| Diurlean | ISS Research |
| Dymetadrine Extreme | AST Sports Science |
| EPH 833 | AST Sports Science |
| Ephedra Ma Huang | Solaray, Inc. |
| Extreme Ripped Force | American Bodybuilding Products |
| Extreme Ripped Force the Bar | American Bodybuilding Products |
| Extreme Thermic Blast | MD Labs |
| Extreme Thermic Blast Caps | MD Labs |
| GH Fuel | TwinLab |
| Herba Fuel | TwinLab |
| Hydroxycut | MuscleTech Research and Development |
| Kwik Burn | Labrada Bodybuilding Nutrition, Inc. |
| Liqui-Drenoline | ProLab Nutrition |
| Ma Huang | Herb Pharm |
| Ma Huang | Herbs of Light |
| MD6 | Biotest |
| Metabogenx | AlphaOmega Marketing |
| MetaboLift | TwinLab |
| MetaboLITE | Elation Therapy |
| Performance Orange | ProLab Nutrition |
| Ripped Force | American Bodybuilding Products |
| Ripped Fuel | TwinLab |
| Ripped Fuel | TwinLab |
| Ripped to the Max | Science Foods |
| Sinus Clear | Ridgecrest Herbals, Inc. |
| Super Diet Max for Men | Natural Max, Inc. |
| Super Diet Max Super Strength | Natural Max, Inc. |
| Stocked | ProLab Nutrition |
| Thermadrene | SportsPharm |
| Thermicore | Met-RX |
| Thermo Burn Stack | Lucent labs |
| Thermo Diet for Women | Futurebiotics |
| Thermogen | Optimum Nutrition |
| Thermogen Ephedra Herbal Tea | Life Extension Foundation |
| Thermogenic Enhancing Capsules | Life Extension Foundation |
| Thermogenics Plus | Silver Sage Mother Nature, PhD |
| ThermoSlim Tea | Hobe' Labs, Inc. |
| ThermoSpeed | Worldwide Sport Nutritional Supplements, Inc. |
| ThermoSpeed Bar | Worldwide Sport Nutritional Supplements, Inc. |
| Thin Tab 100 | Health and Nutrition Systems International, Inc. |
| Turbo Charge | Natural Balance, Inc. |
| Ultimate Orange | Next Nutrition, Inc. |
| Ultra Diet Pep | Natural Balance, Inc. |
| Thermo-Tek | IronTek Advanced Performance Nutrition |
| Vasopro | Mega Pro International |
| Xenadrine RFA-1 | Cytodyne Technologies |
Related Links