USP Announces Botanical Criteria

ROCKVILLE, Md.--The U.S. Pharmacopoeia (USP), www.usp.org, announced it has establishedcriteria [Levels of Evidence] for evaluating the safety and efficacy of botanicals. Uponestablishing safety and efficacy, the articles would be considered for inclusion in the UnitedStates Pharmacopoeia.

The guidelines were based on those already in place with the World HealthOrganization/American Health Care Policy Research and the Canadian Health Care Task Force.The USP revised them to apply specifically to botanical articles.

There are four Levels of Evidence that must be passed. Level I includes randomizedcontrolled trials, meta-analyses and epidemiological studies of high quality. Level II israndomized controlled trials, meta-analyses and epidemiological studies of moderatequality. Level III is inconclusive studies, and Level IV is anecdotal evidence. Theminimum Level of Evidence that would be considered for admission to the USP is Level IIrandomized controlled trials of moderate quality. The USP is online at www.usp.org.