Regulatory Focus™ > News Articles > FDA Approval of Botanical Drugs

FDA Approval of Botanical Drugs

Posted 01 January 2009 | By Max Sherman 

The US Food and Drug Administration (FDA) defines a botanical drug as a product used as a drug that contains as ingredients vegetable materials, which may include plant materials, algae, macroscopic fungi or combinations thereof. Unfortunately, active ingredients found in botanical products are difficult to characterize, as are the methods to measure their potency. Moreover, the composition of vegetable materials can vary from season to season and farm to farm. Most botanical drugs are complex mixtures and may lack a distinct active ingredient. For these reasons, the agency historically paid little heed to or generally neglected any form of herbal medicine.1

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