The American Herbal Products Association (AHPA) issued a new trade recommendation regarding the definition of “extract” in October 2008, 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 Web site.
1. AHPA adopts new trade recommendation; guidance on heavy metal, microbiological limits [press release]. Silver Spring, MD: American Herbal Products Association; October 24, 2008.