Dr. Greg Nigh and Dr. Greg Eckel

December 2003

Submitted Editorial

The FDA announced recently that it will ban the sale of ephedra, also known in Chinese medicine as ma huang. This herb has been used in several weight loss supplements, and has been linked with 155 deaths. Unfortunately, the FDA has responded to ephedra's potential dangers in exactly the wrong way.

Ma huang is used with caution in Chinese medicine. It is recognized as a powerful herb, to be used only in short durations, in limited amounts, and for very specific conditions. As with any medicinal product - natural or synthetic - there is a therapeutic dosage and use for ephedra. The health issue is not that ephedra is dangerous, but that it is misused. For example, no one with knowledge about ephedra's therapeutic importance would use it for either weight loss or enhancement of physical performance.

By comparison, acetaminophen, the drug contained in Tylenol, is responsible for 56,000 emergency room visits, 26,000 hospitalizations, and 450 deaths annually in the United States. However, no one would suggest that acetaminophen should be taken off the over-the-counter market. Here again, the problem is not use, but misuse.

Paracelsus, a physician living over 400 years ago and often called the "Grandfather of Pharmacology,” wisely observed that “the dose is the poison.” This is just as true for ephedra or other natural product as it is with any medication. The important question about any medicinal product is not “Is it safe?” but “What is its therapeutic dosage?” If there is no therapeutic dose, then it isn't a medicinal product.

If natural products are mistaken by the public as weak or “safe at any dose,” the problem is not with the product, but with information and education. Every over-the-counter medication warns of the risks of overdose, and clearly specifies what amount not to exceed in 24 hours. Such warnings clearly do not prevent misuse, but they provide users with enough information to make informed decisions.

Rather than taking a valuable and useful natural product away from everyone, the FDA should require makers of retail natural products to provide consumers with information about therapeutic dosages, toxicities and dangers of overdose. Further, there are some individuals who should not take products such as ephedra at all.

Both naturopathic physicians and licensed practitioners of Chinese medicine receive several hundred hours of advanced training in the therapeutic uses of herbs such as ephedra. Product information provided by retail manufacturers should inform consumers about when to consult a health care professional trained in the use of herbal remedies.

This is precisely the type of warning found in conventional over-the-counter medications. Consumers, not the FDA, should be responsible for appropriate use of herbs and supplements and, likewise, should understand the consequences of product abuse.

Tens of millions of Americans chose to support their health with supplements and natural products. Millions of these will also visit licensed alternative health care professionals who are extensively trained in the safe and effective use of those products for a wide range of conditions. Taking a therapeutic tool out of everyone's hands is in no one's best interest.