HERB SAFETY

Since March 2000, a series of articles in the mass media have launched an attack on herbal remedies. In the article written by Aaron McCormick, published in the Sunday, March 12, 2000 San Francisco Examiner and San Francisco Chronicle, horror stories were given. An article that the Record reprinted from the Washington Post on March 19, 2000 with the title “Health concerns grow as herbal supplements boom.” also excoriated dietary supplements for safety reasons.

Both March articles pointed out the mishandling and mislabeling of herb products might lead to life-threatening damages. The lack of regulation by the Food and Drug Administration (FDA) for herbs on the one hand, coupled with manufacturers vying for the big market potential for botanical medicine on the other have indeed created a hazardous situation for consumers.

State officials from the California Department of Health who were contacted about the safety of herbal products offered only one piece of undated document which, I surmise, was done around 1996. It is the Compendium of Asian Patent Medicines, authored by Richard Ko, Ph.D., a pharmacologist, and Alice Au, Ph.D. and published by the California Department of Health Services. This is a valuable piece of document and we at PCMC Herb Center refer to it to rule out unsafe products. However, such testing and documentation are unfortunately too few and too far in-between to guide the consumers.

In the absence of FDA regulation for herbal remedies manufactured in and outside of the United States, no medical claims are allowed and hence no indications/counterindications and dosage are required on the labels. As they are considered food, all that is required on the label would be food contents such as the amount of sodium, fat, and sugar. To cite an extreme case, I have seen labels where all the items are marked 0 “zero,” rendering a zero information content as well. The consumer should rightfully ask what he/she is paying for and ingesting.

FDA regulation for herbal remedies would take too long and would be too costly. When applying the same standards as synthetic drugs, it would drive up the cost and throw out too many time-proven herbal remedies before anyone would carry the burden and cost of proving something that cannot be patented. At its best, regulation would weed out the dangerous products.

Most likely, it would stifle domestic manufacturing and stop the import of patent herbal remedies from Asia altogether. At its worst, it would turn the herbal and nutritional supplement industry over to the pharmaceutical industry, allowing the latter to dictate the terms and to harvest the field, a $5 billion a year business in the U.S., growing at 18% annual rate.

The Sunday, June 4, 2000 San Francisco Chronicle ran an article by Dr. Henry I. Miller, a senior research fellow at Stanford University’s Hoover Institution who served with the Food and Drug Administration (FDA) from 1979 to 1994. There he called for health and safety standards for herbal remedy and self-monitoring in the industry.

Miller’s suggestion makes good sense. The industry should set up a cooperative, guiding council to do its own regulating. It can draw on the expertise of, say, members of the American Botanical Council and bestow upon them the power to form a governing body. The American Botanical Council can also expand its mission to educate the public about herbal remedies, once they are removed from the two extreme ends of the FDA jurisdiction, food on one end and drug on the other, and granted its proper place in the spectrum.

People are less likely to get into trouble when they are better informed. If the information on the labels were clear and accurate, the danger of self-administering and overdosing on herbs such as ephedra, garlic, ginko, goldenseal, hawthorne, licorice root, aloe, arnica, black cohosh, feverfew, ginger, ginseng and nettle as reported by the Cleveland Clinic will be greatly diminished.

Before the ideal governing and regulating body is formed in the herbal industry, the best we can to is to constantly monitor the literature for any harmful content or side effects from the herbal products. We agree with Miller that voluntary, self-regulation is the most effective way to ensure consumer safety. It amounts to no more, and no less, than professional ethics.

At PCMC, we have always consulted Ko and Au’s Compendium of Asian Patent Medicines and have systematically ruled out stocking any of the products that have been contaminated. Like Dr. Richard Ko, we still believe most imported herbs and medicines are safe and beneficial. The best we can do to protect our patients is (1) to keep abreast of information from monitoring agencies in the U.S. and abroad, (2) to buy from reputable importers, and (3) to carefully check the bulk herbs that we order. Unfortunately, there is no easy way for us to test for contamination or adulteration. We would urge our State agencies to conduct tests more frequently for consumer protection.

Ephedra (mahuang) is never sold over the counter at PCMC Herb Center, though our licensed acupuncturists and herbalists may prescribe mahuang in herbal formulas for respiratory conditions. Our weight control tea, Bojenmi Tea, does not contain any ephedra.

It is common sense that Panex Ginseng should not be taken by people with hypertension. At PCMC, we have published educational material so that our consumers of “dietary supplements” are informed of the incompatibility of certain herbs with certain conditions.

As far as western herbs are concerned, St. John’s Wort, a mood modifier, should never be taken together with MAO inhibitors. We warn our patients about that in the newsletter as well as verbally. The Washington Post article mentioned that “abuse of the bodybuilding supplement gamma-hydroxybutyrate (GHB) and similar substances has resulted in death of young athletes;” but, thanks again to the careful scrutiny and judgment of our medical director, Yi-po Anthony Wu, M.D., M.P.H., PCMC Herb Center does not even carry the GHB related supplements.