Review of Abnormal Laboratory Test Results and Toxic Effects Due to Use of Herbal Medicines

Amitava Dasgupta, PhD


Am J Clin Pathol. 2003;120(1) 

In This Article

Regulatory Issues Affecting Herbal Medicines

The US Food and Drug administration (FDA) mandates that only medicines have to be proven to be safe before being released into the market. Herbal products do not fall under the category of drugs as long as they are not marketed for the prevention of any diseases, and, as such, FDA approval is not needed. Herbal products are classified as "dietary supplements" and are marketed pursuant to the Dietary Supplement Health and Education act of 1994. However, herbal products are regulated differently in other countries. In the United Kingdom, any product not granted a license as a medical product by the Medicines Control Agency is treated as a food, and no health claim or medical advice can be given on the label. Similarly, herbal products are sold as dietary supplements in the Netherlands. In Germany, herbal monographs are prepared by an interdisciplinary committee (German Commission E), using historic information; chemical, pharmacologic, clinical, and toxicologic studies; case reports; epidemiologic data; and unpublished manufacturers' data. If an herb has an approved monograph, it can be marketed.


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