AHPA Submits Comments on USP Heavy Metal Proposal

SILVER SPRING, Md.—The American Herbal Products Association (AHPA) submitted comments to the U.S. Pharmacopeia (USP) requesting the standards-setting organization adopt AHPA’s interim guidance limits for heavy metals in orally-consumed botanical-containing finished products. USP took comments through Dec. 15 on the best way to control heavy metal impurities in dietary supplements and drugs and proposed limits on the toxins.

AHPA further asked USP to clarify whether it is seeking to require companies to employ additional testing to control levels of heavy metals. “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,” said Steven Dentali, Ph.D., AHPA’s chief science officer and a member of USP’s Metal Impurities Ad Hoc Advisory Panel. “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.”