Ephedra falls under FDA jurisdiction - natural stimulant

Vegetarian Times, Sept, 1997 by Cristin Marandino

In a move that has been at least three years in the making, the Food and Drug Administration (FDA) has proposed strict regulation of products containing the amphetamine-like ephedrine alkaloid, a natural stimulant derived from the herb ma huang, part of the herbal family Ephedra. The FDA's proposal comes in the wake of 17 deaths and approximately 800 illnesses that are being attributed to the herbal stimulant. Ephedrine is most commonly marketed as an energy booster and is often incorporated into weight-loss and body-building supplement products. But it has also been irresponsibly touted by some "cowboy companies" as a legal alternative to the street drug ecstasy. The proposed regulation, however, affects conservative supplement manufacturers and renegade companies alike.

With marketing campaigns targeting everyone from athletes to pudgy home-bodies, and labels sporting such claims as "For the maximum preservation of lean body mass," "Fast acting energy" and "Maximizes metabolism, fat loss, energy," the market for ephedrine has become quite a profitable one. And although the supplement industry has voluntarily imposed warning labels on these products, laws governing their manufacture and use were few. Not anymore.

Although the Dietary Supplements Health and Education Act (DSHEA) of 1994 prohibits the FDA from regulating dietary supplements, if one in particular poses "a significant or unreasonable risk of illness or injury" the FDA is within its authority to implement regulation. As of press time, the FDA was accepting public comment regarding the proposal and said all input would be carefully considered when the final guidelines are penned in early 1998.

Currently, the FDA is calling for the following restrictions in its regulation:

* The amount of ephedrine in any product containing the alkaloid will be limited to 8 milligrams (mg.) per dose, with a maximum daily dosage of 24 mg.

* The duration of use for products containing ephedrine will be limited to seven days.

* Products claiming energy enhancement will be required to carry this warning: "Taking more than the recommended serving may result in heart attacks, seizures or death."

* The use of other botanical sources of caffeine (kola extract, for one) in conjunction with ephedrine will be prohibited because the combined effect increases the stimulation to the heart and nervous system.

* The only companies that will not be affected by these regulations are the manufacturers of pharmaceutical over-the-counter cold and flu medications (such as Sudafed) that contain ephedrine and the less potent pseudoephedrine. The alkaloids are FDA-approved for use as decongestants and bronchodilators.

According to Mark Blumenthal, executive director of the American Botanical Council based in Austin, Texas, the ephedrine controversy has actually had a positive impact on the sometimes adversarial relationship between the FDA and herb industry. "The FDA is willing to listen to the industry and work with them, says Blumenthal.

"Most people in the industry will be concerned with the 8/24 issue [8 mg. per dose, 24 mg. maximum daily dosage], the seven day issue and the caffeine issue," says Blumenthal.

FDA limitations could, in effect, take ephedrine-based products out of the weight-loss and body-building market. Restrictions on the maximum daily dosage as well as the duration of use make it impossible to market the products as weight-loss or body-building aids, as it would take weeks of significant, continual use to produce visible results. With top supplement companies selling an estimated $15 to $30 million worth of ephedrine-based products, manufacturers will likely fight to save this lucrative business.

While many in the supplement industry might prefer that the FDA stick its nose in someone else's business, the FDA says it has significant cause for concern. Since 1994, the FDA reports that it has received and investigated claims of ephedrine-related side effects that range from insomnia and high blood pressure to strokes and death. "Consumers should be aware that just because a product is labeled `natural' or comes from an herbal source it is not guaranteed to be safe," says Michael Freidman, M.D., deputy commissioner of the FDA. "The effects of ephedrine alkaloids are potentially powerful ones."

Some within the industry appear to be more annoyed than concerned with the FDA's proposal. Says Dave Mastroianni, senior vice president of research and development at Weider Nutrition, Salt lake City, "We don't mess around. We're being punished for the poor marketing techniques of just a few cowboy companies that are out there. We are very conservative in our claims and provide strong warning labels on all of our products."

Arthur Whitemore, an FDA spokesperson, says the agency serves as a watchdog and notifies companies like the ones Mastroianni is referring to that their claims are illegal and must be changed or the products must be pulled. What changed the "watchdog" agency into an "attackdog" was the death of a 20-year-old college student who died last year from taking Ultimate Xphoria, which promised a "natural high." Several states, including Ohio, Texas, Florida and New York, reacted by either banning or limiting the sale of products containing ephedrine. The ensuing controversy prompted the FDA to act.