AHPA Urges USP to Adopt Guidelines on Heavy Metals

December 16, 2008

The American Herbal Products Association (AHPA; Silver Spring, MD) has petitioned U.S. Pharmacopeia (USP; Rockville, MD) to adopt AHPA’s guidance limits for heavy metals in “orally consumed botanical-containing finished products,” AHPA announced on December 16.

The American Herbal Products Association (AHPA; Silver Spring, MD) has petitioned U.S. Pharmacopeia (USP; Rockville, MD) to adopt AHPA’s guidance limits for heavy metals in “orally consumed botanical-containing finished products,” AHPA announced on December 16.

“The setting of specification limits for heavy metals should be risk-based, which does not confer a testing requirement unless the risk is likely to be present. USP has provided no justification that additional testing is required, or that initial testing is needed to provide safety assurance that would not otherwise already be handled under CGMP,” said AHPA chief science officer and USP metal impurities ad hoc advisory panel member, Steven Dentali, PhD.

AHPA also requested that USP communicate that the listing of limits for metal impurities does not present an implied need to employ analytical testing.
USP is an official public standards–setting authority for all prescription and over–the–counter medicines and other health care products manufactured or sold in the United States.

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