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Ephedra � Getting the Story Straight
by Wes Siegner

When it comes to dietary supplements, it's hard to tell fact from fiction. From issues of government regulation to consumer benefits, myths prevail over reality and sensationalism rules the day. Speculative opinions seem to prevail over research and accepted scientific standards.

No sector of the supplement industry knows this better than those who produce Ephedra products. Dietary supplements containing herbal Ephedra, have become a lightening rod for critics of the entire supplement industry. The Food and Drug Administration has targeted Ephedra in its effort to gain greater control over all supplements. As a result, the market for supplements has been undercut by increasing public confusion about safety and efficacy. Clearing the air about Ephedra's safety is now critical to restoring public confidence in all supplements.

The best place to start is with the facts:

No serious scientific research---absolutely none--- shows Ephedra consumption causes dangerous side effects when it is used as directed, by healthy consumers. In fact, existing data---from consumption patterns to clinical research---all point to the exact opposite: Ephedra is safe and effective when used properly, as it is by an estimated 12-17 million consumers.
The only indication of possible side effects comes from a relatively small number of adverse event reports, which even critics concede do not provide valid scientific evidence that Ephedra is the cause. Nationally recognized scientists and the General Accounting Office, the U.S. government's watchdog agency, have done research on these reports and concluded that the data is without scientific merit.
Ephedra manufacturers have urged the FDA to mandate consumer labeling and manufacturing safeguards to reduce the risk of consumer misuse. The FDA has never responded. Nonetheless, the industry has succeeded at self-regulation through state laws mandating science-based serving limits and informative warning labels.

With obesity reaching epidemic levels in our nation, weight-loss products like Ephedra have never been more valued by consumers or needed more to combat the public health costs associated with weight-related health problems. It is clearly time to speak out about the FDA's failure to act responsibly toward Ephedra, and other supplements.

Like it or not, all supplement executives have a stake in the Ephedra controversy. Its outcome is likely to affect sales and regulation of the entire industry. With this in mind, the following is a primer for industry executives on the facts about Ephedra.

Fact #1 � Science Supports The Safety Of Ephedra

Scientific studies confirm that Ephedra products are safe and beneficial when used as part of an overall weight-loss program. In particular, a six-month study by researchers at Harvard and Columbia Universities on Ephedra/caffeine products concluded that the products were safe and produced significant weight loss. When reporting on Ephedra, the media often relies upon anecdotal adverse event reports (AERs) to raise unfounded alarm. Medical and scientific experts have reviewed the AERs compiled by the FDA and have affirmed that they do not provide sufficient evidence to link the adverse event to Ephedra. The General Accounting Office investigators reached the same conclusion in their report to Congress.

Moreover, these reviews make it clear that the very few adverse events that appear to be causally related to ephedra consumption are the result of misuse of Ephedra products. Like any over-the-counter health care product � aspirin or allergy medicine, for instance � Ephedra's safety is assured when it is taken according to directions on the label. Many food and health-care products, such aspirin can be harmful to certain individuals when improperly used. Considering how many billions of servings of Ephedra products are consumed every year, the frequency of adverse effects reports is relatively normal compared to other products.

Fact #2 � Ephedra Is Beneficial For Weight-Loss

Each year, 12 to17 million Americans safely use Ephedra weight-loss products, consuming approximately 3 billion servings. These numbers and well-designed and controlled scientific studies validate that Ephedra can be a beneficial tool for weight loss, and weight loss is critical to improving the overall health of Americans. The Surgeon General recently reported that nearly two out of three American adults are overweight or obese, and that number is increasing. Obesity, according to the Surgeon General, should be classified as a disease that can cause heart disease, strokes, cancer and diabetes. Ephedra is one of the few safe and effective weapons in America's fight against excess weight.

Fact #3 � With Inaction By FDA, Industry Standards and State Laws Guide Consumers

The Ephedra industry recommends a serving level of up to 25 mg of Ephedra per serving, and no more than 100 mg per day. While responsible Ephedra manufacturers recommend these levels on labels, which is in compliance with laws passed in several states, the industry has pushed the FDA to adopt serving limits as well as standard warnings as the national standard, mandating informative labels. Responsible industry members already have extensive warnings on their labels. They warn consumers with preexisting conditions � such as heart disease, thyroid disease, diabetes, and high blood pressure not to take the product or to consult a health care professional before doing so. The industry recommends against use by minors and opposes using promotions and claims like "Herbal Ecstasy" that can lead to abuse.

Whether its Ephedra or aspirin, instructing consumers to carefully read the label for proper use is critical. Ephedra products should be consumed with the same degree of care given to any over-the-counter health care product.

Fact #4 � The Industry Promotes Responsible Regulation By The FDA

Contrary to claims by critics, the industry has urged responsible regulation of Ephedra products. Myths regarding the industry's opposition to regulation are likely the result of the FDA's June, 1997 attempt to regulate Ephedra off the market by proposing severe serving limits and by proposing to prohibit weight loss and other claims. The industry opposed FDA's proposal � not because it believed that products should be unregulated � but because the FDA based its claims on unscientific, and unsubstantiated AERs. After reviewing the AERs, the General Accounting Office and medical experts issued reports and affirmed that the AERs contained virtually no scientific evidence, prompting the FDA to withdraw its proposed regulations.

Good manufacturing practices have existed within the industry for years. As part of the food processing community, the industry's manufacturing practices include testing raw materials, testing finished products, retaining samples and maintaining detailed records of every step in the manufacturing process. The industry has lobbied the FDA to implement regulations adopting the industry good manufacturing processes. This would allow the FDA to weed out the bad apples and thus, ensure that all manufacturers are offering the same quality to consumers.

Fact #5 � No Athlete Should Use Ephedra Sports Supplements to Gain a Competitive Edge

Recent media coverage portrays Ephedra supplements as a tool for athletes to gain a quick competitive edge. The industry strongly discourages this use and recommends that athletes, in particular, heed warning labels before using any Ephedra product. No athlete in a competitive environment should take any product for the sole purpose of attempting to temporarily overcome his or her normal physical limitations. No parent, trainer or coach should permit minors to take ephedra unless directed to do so by a healthcare professional. Trainers and coaches should communicate these messages to those whom they supervise. Regardless of whether or not someone is taking an Ephedra product, it is always recommended that an individual consult a health care professional before beginning an exercise program.

Shredding the fiction about Ephedra products is critical to the whole dietary supplement industry. Today, Ephedra is the victim of a misinformation campaign -- tomorrow, it could lead to the unfair treatment of other dietary supplements.