FDA Proposes Limits on Natural Stimulant

The Food and Drug Administration moved Monday to limit dosages of the active ingredient in many dietary supplements and to ban marketing of such products as long-term ways to lose weight or to build muscles.

The proposals came in response to at least 17 deaths and 800 reports of illness associated with the stimulant ephedrine alkaloid, an amphetamine-like compound.

The proposed regulations would limit the amount of ephedrine alkaloids that can be contained in the supplements. Specifically, the agency would prohibit all ephedrine products from containing 8 milligrams or more per dose.

Many supplements would also be required to bear warnings that too much of the product can cause death, the FDA said.

The agency previously had issued warnings that the supplements--used by some as alternatives to street drugs such as “ecstasy”--can produce a variety of adverse health effects, including headaches, high blood pressure, insomnia, heart attacks and strokes.

“Consumers should be aware that, just because a product is labeled ‘natural’ or from an herbal source, it is not guaranteed to be safe,” said Dr. Michael Friedman of the FDA.

Ephedrine alkaloids also have been used in traditional herbal medicine to combat cold and chest ailments, a practice that the FDA would permit in the short term under the new proposal.

However, the FDA proposals would require label statements on ephedrine alkaloid products that instruct consumers not to use them for more than seven days and would prohibit claims for uses requiring long-term intake, such as weight loss or body-building.

This measure, the FDA said, “is based on the fact that long-term intake of ephedrine alkaloids increases the likelihood of serious adverse effects.”

The proposals are not nearly as tough as state laws passed last year in Florida and New York. These laws ban all ephedrine alkaloid products. They were enacted after the death of a 20-year-old who had taken Ultimate Xphoria, one of the products the FDA considers an alternative to street forms of ecstasy.

The FDA proposals will become final in August, after a period set aside for public comment.

Makers of ephedrine-alkaloid products indicated that they may object to the FDA proposals.

Norris Preston-Rakin, chief executive officer of Global World Media Corp. of Venice, Calif., which manufactures Herbal Ecstasy, said ephedrine alkaloid is safe and asserted that the FDA had not researched the issue properly.

“Ephedrine is not dangerous,” he said. “If you take too much of anything, it’s not good.”

David Mitchell, vice president of Lotus Brands in Wisconsin, said the FDA has unfairly targeted the natural products industry. Mitchell added that the maker of Ultimate Xphoria is an exception in a normally careful industry.

“Our industry tries to be responsible and self-regulating, but unfortunately, there was at least one company . . . which seems to have acted irresponsibly,” he said.

According to a 1994 law, the FDA cannot ban a dietary supplement unless the product poses a health risk. Based on reports of illnesses, scientific literature and public comments, the agency decided to declare ephedrine alkaloids hazardous in large or continued dosages.