The Dietary Supplement Health and Education Act of 1994 (DSHEA)
For a synthetic drug to become available by prescription, it must undergo rigorous pre-market scrutiny by the United States Food and Drug Administration (FDA). Similarly, foods must meet manufacturing standards before they are deemed safe to eat. Herbal remedies have always presented a problem for the FDA. Should they be classified as foods or a drugs? Until 1994, the FDA pretty much resolved this dilemma by treating herbal products as food additives. The manufacturers refrained (for the most part) from making any medical claims about their products. And, if the FDA felt that an herbal product was unsafe, it could pull the product from the market and subject it to further testing.
In 1993, the FDA decided that herbal manufacturers would soon have to provide more scientific data about their products because more and more people were taking them. This decision was met with opposition. Members of Congress were bombarded with complaints from health food storeowners, herbal medicine manufacturers, and the supplement-taking public.
The outcome of this upheaval was the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation essentially declared that any herb, vitamin, mineral, or other botanical product (other than tobacco) that was marketed as a dietary supplement was exempt from regulation by the FDA. The maker must simply provide “reasonable assurance” that no ingredient “presents a significant or unreasonable risk of illness or injury.” Herb manufacturers still couldn’t claim that their products prevented, treated, or cured disease, but they were allowed to make one claim that they had never before been allowed to make—they could advertise that their products “supported the structure or function” of various organs in the body. But in order to make such a claim, they had to include on the label the following disclaimer: This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
While there are still some rules about what can go on product labels, the FDA has no jurisdiction over what is written in books, said on videos, or written on the Internet. As a result, claims about cures, and about the treatment, and prevention of disease have proliferated. It is now totally up to the consumer to evaluate the validity of these claims.
How DSHEA Affects Consumers
Due to this law, no proof of safety or effectiveness of an herbal product needs to be submitted to any governmental regulatory agency before becoming available to the public. This means that side effects and toxic reactions caused by herbs or herbal products may get discovered only after they have happened to consumers who have purchased the product. Moreover, there is no regulatory process mandating that adverse reactions to herbs be reported to the public or to any governmental entity. For example, the manufacturer of Metabolife, the popular herbal weight loss remedy which contains the potentially lethal combination of ephedra and caffeine withheld from the public more than 14,000 adverse reactions, including 80 fatal or near-fatal incidents, which were reported to them by consumers of their product. However, under DSHEA the manufacturer had a legal right to do so. Therefore, the toxicity associated with herbal remedies is most likely greatly underestimated. ( In contrast, serious adverse reactions to prescription drugs must be made public and typically the drug is promptly pulled from the market). The Congressional Research Service reports that according to their analysis, many people believe that “any product that appears in pill form has been reviewed for safety by the FDA.” Thus, many people who use herbal remedies incorrectly assume that these products are regulated by the FDA for safety and efficacy.
How DSHEA Affects the Labeling of Herbs
Although claims that an herbal product prevents, treats, or cures disease are not permitted to appear on a product label, claims can be made about the effect of the remedy on an organs structure or function. For instance, the label on a bottle of milk thistle can claim that the product “may support the liver” or “may inhibit factors responsible for liver damage,” but it cannot state that it cures or prevents liver disease. However, though a label cannot make such blunt claims, other advertising venues are not prohibited from making them. This leads to confusion over exactly what claims manufacturers are making about their products. Also, since the labeling of herbs is unregulated, they may often lack crucial information—such as the exact ingredients and the amount and potency of the ingredients. Some herbal remedies contain only one ingredient, whereas other remedies contain a mixture of ingredients. Consumers should research the quality and efficacy of any herbs or herbal products which they intend to use and shouldn’t rely solely on the manufacturers’ claims.
All contents of this article are Copyright © Melissa Palmer, MD
Melissa Palmer, MD is the author of " Dr. Melissa Palmer's Guide of Hepatitis and Liver Disease". (Published 2004. Penguin Putnam).
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