The American Herbal Products Association (AHPA) has 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.
AHPA also requests in Dec. 15 comments that USP clearly communicate that the listing of limits for metal impurities does not present an implied need to employ analytical testing. Appropriate risk assessment/analysis should be conducted, as for any other contaminant, in order to determine specifications, AHPA writes. Such assessments may include the proper creation and implementation of Good Agricultural and Collection Practice and current Good Manufacturing Practice (cGMP) and supply chain and source analysis.
“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 AHPA Chief Science Officer and USP Metal Impurities Ad Hoc Advisory Panel Member Steven Dentali, Ph.D. “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.”
USP requested comments in response to the Pharmacopeial Forum 33(6) Stimuli article on a proposed General Chapter, “Inorganic Impurities: Heavy Metals.” AHPA’s interim guidance limits were developed by a Standards Committee working group after extensive consultation with industry members and laboratories, as well as review of established authoritative limits. The interim limits were adopted by AHPA’s Board of Trustees in October.
AHPA’s Dec. 15 comments to USP are available online at www.ahpa.org/portals/0/08_1215_AHPA Comments_USP_HM_stimuli.pdf
For additional information, see also the following press releases:
Oct. 21, 2008 - “AHPA Adopts New Trade Recommendation; Guidance on Heavy Metal, Microbiological Limits”
Oct. 31, 2008 - “AHPA’s Dentali Appointed to USP Metal Impurities Advisory Panel” http://www.ahpa.org/Default.aspx?tabid=69&aId=493&zId=1
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Website: www.ahpa.org.