Volume 1, Issue 29, 08/06/2009
What are the criteria for the FDA to remove an herbal or natural medicine from the market in the United States (U.S.)?
Periodically Pharmacology Weekly will devote an issue to explaining common principles related to the purposes and information contained in the Natural Medicines Newsletters. It is our desire to provide busy clinicians with the facts that they need, as well as the foundational knowledge that each newsletter builds upon. The question above is a fairly common question and helps to put the regulation and use of natural medicines into perspective.
As reviewed in a previous newsletter, the Dietary Supplement Health and Education Act (DSHEA) in 1994 allowed herbal and natural products to be marketed without being reviewed or regulated by the Food and Drug Administration (FDA).(1,2) This means that both the safety and efficacy of herbal products are not verified prior to their being available on the market. In fact, the DSHEA gives the...
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