Ephedra Back on the Market

Your favorite fat burner, ephedra, is back on the market and flying off the shelves (if you can find it). Research has shown that ephedra helps promote the loss of fat while helping spare lean muscle tissue through a process called thermogenesis. There are many research reports showing that caffeine can help burn calories by stimulating thermogenesis, a process that helps the body generate energy during digestion, but not enough to result in significant weight loss. That is why it is usually added to ephedra products. In addition to burning calories, caffeine is a diuretic that increases the amount of urine a person excretes and can therefore help people temporarily rid themselves of excess water weight. Experts caution that while caffeine can be helpful, many caffeinated products are full of calories. They can also speed up a person’s heart rate, increase blood pressure, interrupt sleep and lead to nervousness or irritability.

Most of you have plenty of questions regarding Ephedra

On April 13, 2005, a federal court in Salt Lake City [U.S. District Court for the District of Utah, Central Division] issued its decision on a legal challenge to FDA's 2004 Final Rule banning all ephedrine-alkaloid dietary supplements. Judge Tena Campbell's decision made two key points:

It held that the analysis used by FDA was incorrect and improper. FDA's analysis weighed risks against benefits. The Dietary Supplement Health and Education Act (DSHEA), however, requires a straightforward risk assessment. The court held that requiring supplement companies to demonstrate a benefit as a pre-condition to marketing violated DSHEA by shifting the burden from FDA to industry.

It held that FDA didn't have adequate scientific evidence to find that a daily dose of 10 mg. or less of ephedrine alkaloids presented a "significant or unreasonable risk of illness or injury" [under 21 U.S.C. § 342(f)(1)(A)]. The court effectively held that it's improper to ban all ephedra supplements because FDA lacks data to determine what dosage might be safe.


The case isn't necessarily over yet. FDA is appealing, and the 10th Circuit Court of Appeals might reverse the district court's ruling. Meanwhile, FDA may seek a stay to block renewed ephedra sales while the matter is pending.