Walking into the vitamin aisle of any pharmacy, chain discount store, or even our local grocery store, we will find them: herbal remedies or supplements, such as St. John’s Wort, Echinacea, Ginkgo and many more. Each preparation claims to help one ailment or another using the “natural action” of herbs. Herbal, vitamins, and mineral supplements are all considered dietary supplements by the Food and Drug Administration (FDA); we would typically take vitamins and minerals believing that they will improve our health.
The difference with the use of herbal preparations is that we would take them to address specific ailments. Clinical studies have proved some herbal supplements safe and effective and that some are really dangerous.
The effectiveness of many others still has not been established. Many physicians will not endorse or embrace every herbal remedy available because some may actually compromise our health; however, a growing number of them are working to better understand herbal therapies so that they can help us make informed decisions about our health care.
A recent study found that many people who choose herbal therapy rely predominantly on their family and friends for information. But if we do choose to take herbal preparations, we should to our family doctor first.
Limited regulation and control of herbal preparations: since Congress passed the “Dietary Supplement Health and Education Act of 1994,” there has been an overall lack of quality control for dietary supplements, including herbs. In 1993, the FDA proposed regulations that would require companies to prove their products actually did what they claimed.
However, to prove efficacy and safety, companies would have to conduct expensive clinical studies on each and every herbal compound they wanted to put on the market. Companies would not make the investment unless they thought they could recover it and make a profit. And because herbs, particularly those that have been used for many years, would be difficult to patent, that profit would be hard to come by.
So, the industry fought back with a grassroots letter-writing campaign: users of herbal products contacted their representatives to tell them that they wanted continued access to herbal remedies. In the end, Congress passed the 1994 Act, which actually limited the control over products labeled “dietary supplement.” This Act stated that manufacturers do not have to prove safety or efficacy of a product before they put it on the market.
With the new law, Congress acknowledged that consumers believe supplements provide health benefits and that they want greater latitude in deciding if the herbs will help them. As a result, herbal products and supplements are not subject to the same rigorous standards as are drugs.
Herbs can be marketed with limited proof of effectiveness or safety; vendors can make health claims about products based on their own review and interpretation of studies without FDA authorization. However, the FDA can pull a product off the market if it is proved dangerous.
The U.S. Pharmacopeia (USP), an independent medical research group, announced in November 2001 a new dietary supplement verification program. As part of the program, the USP will allow its certification mark to appear on supplement labels that, after periodic testing, contain accurate doses, are manufactured appropriately and truly contain the ingredients they claim. However, we should be very cautious, because the USP mark does not guarantee that the supplement works as promised or that it is safe to take.
As part of the 1994 law, dietary supplements must have information that includes the name of the herb, net quantity of contents, their ingredients, and their amount. Also, they must show this disclaimer: “This product has not been evaluated by the FDA and is not intended to diagnose, treat, cure, or prevent any disease.”
Herbal supplements containers must also show directions for use, serving size, amount of active ingredients, and other ingredients such as amino acids (for which no daily value has been established). Also, the name and the address of manufacturer, packer, or distributor.
Manufacturers typically refer to herbal products by their common name and the part of the plant used to make the supplement, such as root, stem, or leaf. If the common name is not listed in the “American Herbal Products Association” list of “Herbs of Commerce,” the Latin name is used.
By Charlene M. Jackson, MD