The use of herbs and herbal products has become broadly accepted. Consumer surveys consistently find that nearly half of all Americans now use herbs. (1)
The decision to use herbs for their health promoting value is, as with all health decisions, a personal one. There are, however, many good reasons to consider herbal products as complements to your own health care. The best reason, however, may be the fact that herbs and herbal products provide real health benefits Most herbs are available in the form of “herbal supplements.” These products are found in the form of teas, tablets, capsules, liquid extracts, and others. We now have ready access to products that bring the herbal traditions from all over the world in a variety of convenient forms. In addition, scientific inquiries continue to develop our knowledge of the benefits of plants, and often validate the observations made over the past centuries.
In spite of this widespread acceptance of herbal products in individual self-care choices, misconceptions exist as to the regulation, safety and effectiveness of herbal products.
“Are Herbal Supplement Products safe?”
Plants that enjoy broad culinary and therapeutic usage are generally safe. We can flavor our food with any number of herbs to make a meal more flavorful. We can appreciate a delicious cup of peppermint leaf or ginger root tea, or benefit from the soothing properties of marshmallow root or the bark of slippery elm. We can take an herbal supplement containing dandelion root or saw palmetto berries, or any number of the other herbs. Although allergies and reactions have been recorded for a few herbs that are widely used in foods and supplements, such individual concerns are also seen with many foods, and do not diminish the safety profile of the many herbs that are generally recognized as safe.
Federal law requires that every food product, including herbal supplements, is free of “adulteration” and is not “misbranded.” This legal language translates into a requirement that all foods and supplements have a reasonable expectation of safety when offered for sale and when used as directed. So manufacturers of soups, cereals, and supplements all have an obligation to sell only safely made and properly labeled goods, and can find their products subject to seizure should they fail to do so. In addition, manufacturers of herbal products are specifically required to limit their ingredients to either those that were already in the market prior to passage of landmark legislation in 1994 or those that a company can convincingly show, by providing information to the Food and Drug Administration, to be safe.
There are so few credible reports of unexpected side effects due to herbal products that most experts consider problems with herbal products to be of only minor or occasional concern. Norman Farnsworth, Director of the World Health Organization Collaborating Centre for Traditional Medicine and Research Professor of Pharmacognosy at the University of Chicago at Illinois, is generally considered to be one of the most respected experts on the scientific research of botanical medicines. In an article written on the subject of herbal safety,(1) Dr. Farnsworth concluded, “…side effects or toxic reactions associated with herbal medicines in any form are rare. In fact, of all classes of substances reported to cause toxicities of sufficient magnitude to be reported in the United States, plants are the least problematic.” This is not to say that every herbal ingredient that is sold as an ingredient in a supplement is appropriate for every consumer or in any quantity. Responsible and informed use by consumers is essential to ensure that herbal products maintain their established safety profile. Accurate product labeling must provide consumers with all information that is material to the use of the product, and such disclosure is required by Federal law.(2)
“Are Herbal Supplements Effective?”
In the last several decades, there has been a resurgence of research in the clinical efficacy of herbs. The results of such studies often verify that the empirical observations of the past centuries were accurate. But can a consumer have confidence in the claims made for the products that are available in the market? To begin with, Federal labeling law and regulations for supplements limit allowable claims to those for which a manufacturer “has substantiation that such statement is truthful and not misleading.”(3) The manufacturer therefore has a legal burden to assure that the claim that is made for their products has scientific evidence to back it up. Because there is a greater acceptance of herbal therapies by conventional physicians in Europe, a significant body of clinical data supporting the use of herbs has been developed there. More recently, a number of U.S. companies have designed clinical studies for their branded products. It is estimated that there are over 1,000 clinical trials now being undertaken in the U.S. to increase our knowledge about herbs. The National Institutes of Health has even set up a center with a special focus on “alternative” medicine, and is now concentrating much of its resources on the study of herbal products.
1. Bennett, J. and CM Brown. 2000. Use of Herbal Remedies by Patients in a Health Maintenance Organization. Journal of the American Pharmaceutical Association 40(3):353-358.
2. Federal Food, Drug & Cosmetic Act, Section 201(n).
3. The Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Congress