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Does the Government Insure Safety?

The government regulates herbal medicines in the same way that it regulates food and nutritional supplements, but herbal products do not undergo the same strict research requirements as prescription drugs or over- the- counter medications (like aspirin). Whole plants cannot be patented (meaning that no one manufacture has exclusive rights to an herb) and therefore, non-pharmaceutical companies that produce herbal products are not obligated to do the same safety research that the Food and Drug Administration (FDA) requires for prescriptions or over-the- counter medications. If the FDA has reason to suspect that an herb is unsafe, then the agency may require it be removed from the market. By law, however, the FDA cannot require testing of all herbal products before they are put on the shelf.

Currently, there is an inconsistency in safety guidelines for manufacturing, labeling, promotion of health claims, and potency and purity of compounding. Herbal medicines cannot gain patent rights and, as such, they are not termed "drugs." The Food and Drug Administration (FDA) can "suggest" but cannot require the herbal industry to provide scientific data to its consumers.

The Dietary Supplement Health and Education Act of 1994 places the burden of product safety assurance on the manufacturer. The FDA still assumes the responsibility for proving that a product is unsafe, not the manufacturer, and only if the FDA has reason to suspect that an herb is unsafe can it require that a product be removed from the market. By law, however, the FDA cannot require the testing of all herbal products before they are available to consumers.

Because of continued concerns regarding safety and health claims practices, on April 29, 1998, the FDA put forth the "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body." Specifically, these regulations state that "under the proposal, dietary supplements that expressly or implicitly claim to diagnose, treat, prevent, or cure a disease continue to be regarded as drugs and have to meet the safety and effectiveness standards for drugs under the Food, Drug, and Cosmetic Act." Disease is defined as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system...of the body that is manifested by a characteristic set of one or more signs or symptoms...."

Implicit in this new definition would be acceptance of the claim, "promotes vascular health" but rejection of the assertion, "decreases blood pressure." Many herbal product manufacturers, therefore, add information to their product advertisements or labeling that indicates that their product " is not intended to diagnose, treat, cure or prevent any disease," and thus is not subject to FDA drug regulations. At this point in time, herbal supplements will continue to be examined by the FDA under similar guidelines as the food industry.


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Date of Last Update: 07/27/12