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The American Herbal Products Association (AHPA) issued a new
trade recommendation regarding the definition of “extract” in October, as well
as guidance on establishing heavy metal and microbiological limits for herbal
products.1
“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,
in an AHPA press release.1 “We are proud to support industry with
this good work.”
According to
the new trade recommendation, use of the word “extract” in the labeling of
herbal ingredients should not be used to describe dehydrated plant materials
that have not undergone additional processing (beyond size reduction). AHPA
explained that an extract is the result of some processing of a raw
agricultural commodity, such as maceration, distillation, or steeping.
This new
recommendation, like all AHPA trade recommendations, is considered an amendment
to AHPA’s Code of Ethics and Business Conduct. All AHPA members are required to
conform to the organization’s Code in order to maintain their membership in
good standing.
In addition
to the new trade recommendation, AHPA has adopted an interim guidance with
quantitative limits of certain heavy metals that may be present in herbal
supplements. AHPA has recommended the following limits for botanical-containing
finished products consumed at a total daily amount of 5 grams or less: 10 µg
per day of inorganic arsenic, 4.1 µg per day of cadmium, 10 µg per day of lead,
and 2 µg per day of methylmercury. If the highest labeled dose of a supplement
is over 5 grams, heavy metal limits should be established at appropriate levels
under current good manufacturing practices (cGMPs), according to AHPA.
AHPA
further adopted as guidance a recommendation that manufacturers and marketers
of non-liquid dietary supplements establish specifications under cGMPs for
microbiological limits of certain substances, such as yeasts and molds,
salmonella, Escherichia coli, and
others. AHPA has provided a few suggested limits for these substances, although
the organization has also stipulated some limitations and conditions that manufacturers
can apply when referring to the guidance.
More
information about the trade recommendation and guidance, as well as AHPA’s Code
of Ethics and Business Conduct, is available from AHPA’s website.
—Courtney Cavaliere
Reference
1. AHPA
adopts new trade recommendation; guidance on heavy metal, microbiological
limits [press release]. Silver Spring,
MD: American Herbal Products
Association; October 24, 2008.
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