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Dietary Supplement and Health Education Act

As a result of the 1994 Dietary Supplement and Health Education Act (DSHEA), the herbal marketplace is entirely unregulated. Herbal products don't have to be proven safe or effective to be sold, and there is no guarantee that the herbal product is what it says it is on the label.

While prescription and over-the-counter drugs and food additives must meet the Food and Drug Administration's (FDA) safety and effectiveness requirements, herbs that are marketed with medical claims bypass these regulations. Herbal products can go to market with no testing for efficacy, thus skipping the years-long process that drugs must undergo. The FDA is also prohibited from taking an herb off the market unless the agency can prove that using the herb will create a medical problem. Unfortunately, this law places the burden of proof of an herb's safety on the over-taxed FDA rather than on the companies profiting from the sale of the herb.

FDA approval is not required for package or marketing claims, so herbal manufacturers can put unsupported health claims on their labels. While the label does have to say that claims have not been reviewed or approved by the FDA, this caution is usually in small print. Lastly, supplements do not have to be manufactured according to any standards. Since herbs are not regulated as drugs, no legal standard exists for their processing, harvesting, or packaging. In many cases contents and potency are not accurately listed on the label.

For More Information

bulletThe FDA Guide to Supplements. NCRHI Newsletter, Vol. 22, No. 2 (March/April 1999).