Capsules: New Regulations on Ephedrine

The FDA is expected to regulate products containing ephedrine.

| September/October 1997

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”.

Subscribe today and save 58%

Subscribe to Mother Earth Living !

Mother Earth LivingWelcome to Mother Earth Living, the authority on green lifestyle and design. Each issue of Mother Earth Living features advice to create naturally healthy and nontoxic homes for yourself and your loved ones. With Mother Earth Living by your side, you’ll discover all the best and latest information you want on choosing natural remedies and practicing preventive medicine; cooking with a nutritious and whole-food focus; creating a nontoxic home; and gardening for food, wellness and enjoyment. Subscribe to Mother Earth Living today to get inspired on the art of living wisely and living well.

Save Money & a Few Trees!

Pay now with a credit card and take advantage of our earth-friendly automatic renewal savings plan. You’ll save an additional $5 and get six issues of Mother Earth Living for just $19.95! (Offer valid only in the U.S.)

Or, choose Bill Me and pay just $24.95.

Facebook Pinterest Instagram YouTube Twitter

Free Product Information Classifieds