The FDA is expected to regulate products containing ephedrine.
The U.S. Food and Drug Administration (FDA) has proposed stringent limits on the manufacturing and marketing of ephedrine-based dietary supplements.
Ephedrine is the principle alkaloid found in the herb ephedra (Ephedra spp.), also known as ma-huang. Today, most of the ephedrine contained in commercial products is synthetically produced.
Ephedrine is often associated with weight-loss and body-building products, but it is also an effective and potent constituent used in the treatment of asthma and allergies. However, ephedrine can increase the heart rate and may cause heart palpitations, among other reactions, so products must be used with care. Manufacturers and consumers had until August 18 to file comments on the proposed regulations. The FDA is expected to issue final regulations in early 1998.
The June 1997 proposal is the FDA’s first regulatory initiative under the Dietary Supplement Health Education Act of 1994 (DSHEA). The FDA has received more than 600 reports of adverse reactions to ephedrine since DSHEA passed. The regulations would require that manufacturers sharply reduce the ephedrine content of most products and require ephedrine-containing products to carry warning labels stating that taking more than the recommended dose may be fatal.
According to news reports, the FDA intends to ban the marketing of any capsules containing more than 8 mg of ephedrine and would limit the maximum recommended intake to 24 mg a day. Several manufacturers have already voluntarily reduced the ephedrine content to 12 mg per capsule and the daily maximum intake to 50 mg. The FDA also intends to prohibit manufacturers from suggesting people use ephedrine products for more than seven days. That would impact manufacturers of weight-loss and body-building products containing ephedrine because it takes weeks of use to see such benefits.
Dietary supplement manufacturers aren’t required to prove the safety and effectiveness of their products before marketing them, so that’s why the FDA didn’t act until it received reports of adverse reactions. Some states, prompted by reports of health hazards connected to ephedrine, have banned some types of ephedrine products. One student from Long Island died last year after taking an energy product that contained ephedrine and that promised to deliver a “natural high”.
In Traditional Chinese Medicine, ma-huang is used to promote perspiration and as a diuretic; it is prescribed for bad colds, dry fevers, joint pain, coughing, shortness of breath, and ankle swelling. It has been used for more than 2,000 years to treat bronchial asthma and coughing and wheezing.
—Herbs for Health Staff