AHPA said orally consumed botanical products should adhere to risk-based assessment methods that include “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, PhD.
AHPA added that USP should 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, the AHPA said.
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.
“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,” Dentali added.
AHPA recommends inorganic arsenic, cadmium, lead, and methylmercury be classified as metal impurities.
In its interim guidance it recommended 10μg/day of arsenic, 4.1ug of cadmium, 10ug of lead and 2ug of methylmercury as safe levels. USP's list is more extensive.
“Other impurities should be considered only if there is a reasonable belief
that they may be a problem, in which case measures should be taken by industry as
appropriate,” AHPA wrote in a December 15 letter to USP.
AHPA wrote its letter in response to a USP request after a Pharmacopeial Forum 33(6) Stimuli article on a proposed General Chapter, “Inorganic Impurities: Heavy Metals”.
AHPA’s wide-ranging interim guidance was developed 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.
“These measures were developed at the committee level and represent the community’s commitment to self-regulation and the association’s dedication to providing industry with tools to meet current good manufacturing practices and conduct responsible commerce in herbal products,” said AHPA President Michael McGuffin at the time.
“We are proud to support industry with this good work.”
To read AHPA’s comments click here.
Proposition 65
McGuffin also recently attended a meeting where California’s controversial Proposition 65, which governs the way some chemicals are used in products in the state, was discussed.
Coming away from a Decmber meeting of California’s Office of Environmental Health Hazard Assessment (OEHHA) on the topic of warnings for food products that contain Proposition 65-listed chemicals, McGuffin said the meeting had recognized the difference between foods and other products.
With this in mind amendments are being considered for Prop. 65 that would include warnings for listed chemicals in some foods that may provide legal protection for manufacturers and retailers.
“AHPA appreciates OEHHA’s investment of resources in trying to craft regulations that can work for both marketers of foods, and for each of us as food consumers,” said McGuffin.
“Pragmatic options should be developed to provide clear and reasonable warnings for the many foods that may require warnings under California law without branding grocery stores as dangerous places.”