TKO Sports Nutrition

How is Ephedra Legal?

On April 14th 2005 a Utah state court judge declared the current FDA control of Ephedra (Ma Huang) as a drug is wrong.  The FDA has a limited amount of time in which to file an appeal to the ruling.  If the appeal is filed, and granted, the FDA could propose a restriction and/or limitation on the sale of Ephedra.  One thing is for sure, the FDA will not be able to write there own restrictions, as done before.  They would have to present a proposal that would then be voted on through the house and senate.  

As it stands, the future availability of ephedra in the United States is unknown.  The FDA did make a brief statement stating that they would allow the sale of 10mg or less of Ephedra alkaloids per capsule.  This would be only a recommendation because currently, the FDA has no legal control over the herb. 

Industry Studies on Ephedra 

In December of 2000, the council on Responsible Nutrition in connection with Cantox Health Sciences International, published a report entitled "Safety Assessment and Determination of a Tolerable Upper Limit For Ephedra" (Cantox Report).  The Cantox Report reviewed nine randomized, double blind, placebo controlled studies each of which were at least of eight weeks in duration.  Each of the studies monitored heart rate, blood pressure, adverse events, and other related tolerability parameters.  In particular, one study revealed that cardiac arrythmias did not occur in subjects given 90 milligrams of ephedrine alkaloids per day verses placebo.  The Cantox Report determined that the "lowest observed adverse effect level" is 150 milligrams of ephedrine alkaloids per day.  Thus, the lowest observed adverse effect level is 50% higher than the maximum daily dose of ephedrine alkaloids recommended by the dietary supplement industry which is 100mg per day.

The Harvard/Columbia Study:  Herbal Ephedra/Caffiene for Weight Loss: A Six Month Safety and Efficacy Trial.

This study examined the long-term safety and efficacy for weight loss of an herbal supplement containing Ma Huang and Kola Nut (30mg ephedrine alkaloids, three times per day).  It was a six month randomized, double-blind placebo controlled trial, the results of which were published in the May 2002 issue of the International Journal of Obesity.  After six months, "the tested product produces no adverse events and minimal side effects that are consistant with the known mechanism and action of Ephedrine and caffiene".

Safety Versus Other Drugs

The safety of ephedra containing dietary supplements is undisputable.  In fact, ephedra is the least of America's concerns.  For example, in 2000 alone, the American Association of Poison Control Centers received 16,649 calls regarding exposure, or potential exposure to aspirin, and 56,731 calls regarding exposure, or potential exposure to acetaminophen (Tylenol).  After collecting all information the poison control center determined that of the adverse events in the year 2000, at least 5,946 adverse events (including 52 deaths) were plausibly related to aspirin and at least 9,960 adverse events (including 99 deaths) were plausibly related to acetaminophen.

Ephedra and it's use for Weight Loss

With regard to dietary supplements used to support wight loss objectives, it should be emphasized that the Surgeon General has indicated that over-weight  and obeseity have reached epidemic proportions.  An estimated 61% of the U.S. adults are over-weight or obese.  Over-weight and obesity continue to be the second leading cause of preventable death, ofter smoking, resulting in an estimated 300,000 deaths per year at a direct cost (direct and inderect) that exceeds $100 billion per year.  Accordingly the Surgeon General indicated that both the prevention and treatment of over-weight and obesity and thier associated health problems are important public health goals.  Ephedrine and caffiene have been studied extensively and here are some of the amazing results:

• 300% decrease in stored fat verses placebo
• 29% greater weight loss verses Redux (a leading prescription diet drug)
• 600% increase in total weight loss
• 42% reduction in body fat in a specified time period
• 19% loss of total body weight
• 76.9% increase of the metabolic rate without exercise