“Fear. Fear attracts the fearful. The strong. The weak. The innocent. The corrupt. Fear. Fear is my ally.” - Darth Maul- The Phantom Menace

This famous quote by the evil sith Darth Maul in Star Wars may have well been the tactic used by the FDA when they banned the sale of ephedra in April of 2004. The FDA stated that the supplement presents an unreasonable risk to public safety, as it increases the chances of illness or injury. But one year later in April 2005, a federal judge in Utah overruled the ban. After examining the literature, the Court determined that it had not proved that a daily dosage of 10 milligrams or less of ephedra alkaloids present a significant risk of illness or injury.

In the journal of Archives of Toxicology this month 79: 330-340 (2005), listed was a research study entitled, “Short-term and long-term in vivo exposure to an ephedra and caffeine-containing metabolic nutrition system does not induce cardio toxicity in B6C3F1 mice.” Of course you won't read about it in any of the major newspapers. The study looked at mice for one year, and its primary purpose was to compare normal and high dosages (dosages ranging from 1 to 10 times the human dose) of the supplement and examine the affect on the heart (1). The two groups were as follows: one group received a multi-nutrient system containing vitamins, minerals, omega-3 fatty acids, and phytochemical extracts of citrus, ephedrine, guarana, ginko, green tea, and octium. The control group received nothing. The animals given thermogenic stack consumed more food and were leaner and more active compared to control mice.

Results of the study concluded that after one year of using the caffeine/ephedrine supplement, neither the low dose (1X) nor high dose (10X) produced any adverse cardiovascular effects in the mice. In addition, at the end of the study (although there were fluctuations in cardio-sensitive enzyme activity), no major changes in CK (leakage enzyme present in high concentrations in the heart), LDH (enzyme found in heart, lungs, and blood), and AST (enzyme found in heart and liver) enzymes indicative of cardiovascular damage was observed.

The above study demonstrates that when used in moderation and for prolonged periods of time in healthy animals, ephedra is non-toxic even at high dosages. Another important consideration of the study was that as the dosage of caffeine and ephedrine were increased, so were all the other ingredients in the formula (i.e. vitamins, minerals, omega-3 fatty acids, and phytochemical extracts of ginko, green tea, and octium). This may have produced a cardio-protective affect. This is one of many studies reporting that ephedrine is a safe drug for healthy individuals.

For example, Greenway et al. (2) documented that caffeine and ephedrine has a long history of safe, non-prescription use. The adverse events accompanying acute dosing are mild and transient. Adverse events with caffeine and ephedrine reach and remain at placebo levels after 4–12 weeks of continuous treatment. Dr. Greenway an obesity expert also concluded that, “The benefits of caffeine and ephedrine in treating obesity appear to outweigh the small associated risks.” In addition, ephedrine and caffeine have been prescribed to almost 10 million people in Denmark as an aid to weight loss (4).

This is contrary to what the FDA has the general public believing, that a single dose of ephedrine and caffeine is going to cause a person to go into sudden cardiac arrest! This is a typical national news headline that appeared a short time ago, “Ephedrine and unheralded sudden cardiac death.” The study involved giving dogs a single dose of an over the counter ephedrine supplement. The dogs were separated into two groups: healthy dogs and dogs representing animal models of ischemic heart disease. In ischemic heart disease the blood supply to the heart becomes constricted causing damage to the heart muscle. The ischemic heart diseased dogs had surgical blockages placed in their arteries to their hearts to mimic cardiovascular disease. When ephedrine was given to healthy animals it did not raise their heart rates, either at rest or during exercise. Of the 15 dogs with a heart block given ephedrine, nine had increased ventricular arrhythmias (a dangerous and wild beating of the heart) and four had ventricular fibrillation (an extreme arrhythmia where the heart can no longer pump). One of the four animals with VF could not be resuscitated (3).