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USP Announces Safety Criteria for Supplements
March 31, 2003
2 Min Read
USP Announces Safety Criteria for Supplements
ROCKVILLE, Md.--The U.S. Pharmacopeia (USP)published new safety admissions criteria for dietary supplement monographs inits January/February 2003 edition of the Pharmacopeial Forum (PF). Thecriteria have been approved by the Council of Experts Executive Committee, andwill be used by the committee to advise USP about proposed monographs to beincluded in the USP-National Formulary (NF). Among the criteria are:human data (safety studies, clinical studies, post-marketing surveillance,etc.), pharmacological data (reproductive toxicity, experimental animal studies,etc.), contemporaneous extent of use and historical usage.
The criteria provide a framework to use in safety reviews ofproposed supplement monographs, which consist of the following classes:
Class 1: Articles for which the committee is unaware of significant safety issues present when the article is used and formulated appropriately that would prohibit a monograph being developed.
Class 1a: Articles for which the committee is aware of limited human scientific data concerning safety of the article, but is unaware of significant safety issues present when the article is used and formulated appropriately that would prohibit a monograph being developed.
Class 2: Articles for which the committee is unaware of significant safety issues present when the article is used and formulated appropriately that would prohibit a monograph being developed, provided there is a warning statement in the labeling section.
Class 3: Articles for which the committee is aware of significant issues present that would prohibit a monograph being developed.
"We're aware of safety issues concerning dietarysupplements," said David Roll, director of dietary supplements for USP (www.usp.org)."That is why USP decided to create a classification system we could use toassess dietary supplement safety. We wouldn't want to publish a monograph on anarticle if there are significant safety issues that are not addressed."
In additional news from USP, the name of the current chapter inthe USP-NF on nutritional supplements will be changed to DietarySupplements. Beginning with the 2004 edition, USP 27-NF 22, all dietarysupplement monographs, including botanicals formerly listed in the NF, will befound in one section of the book.
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