AHPA Adopts New Trade Recommendation; Guidance on Heavy Metal, Microbiological Limits

The Board of Trustees of the American Herbal Products Association (AHPA) adopted several self-regulatory measures during its Oct. 15 meeting in Boston that expand the association’s list of trade recommendations and guidance documents, namely a trade recommendation on the use of the word “extract,” an interim guidance on heavy metal limits and a guidance policy on microbiological limits.

“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. “We are proud to support industry with this good work.”

Trade Recommendation on use of the word “extract”

AHPA’s By-Laws defines Obligations of Membership to include “…adherence to all policies and principles of business as outlined in the Code of Ethics.” The AHPA “Code of Ethics and Business Conduct” has established that a trade recommendation of the Board of Trustees constitutes an amendment to the Code. The trade recommendation described in this communication, therefore, constitutes an amendment to the Code and should be considered as such by all AHPA members.

The new trade recommendation follows:

Use of the word “extract”

The use of the word “extract” in the labeling of herbal ingredients is not used to describe dehydrated plant materials that have not been subject to additional processing other than size reduction (i.e., cutting, milling, etc.).

An herbal “extract” is a substance that results from some processing of a raw agricultural commodity, often by using a solvent such as ethanol or water. To obtain an herbal extract the raw material may undergo such processing as maceration, distillation or steeping. AHPA’s “Guidance for Manufacture and Sale of Bulk Botanical Extracts” (2001) provides the following definition of “extract”:

The complex, multicomponent mixture obtained after using a solvent to dissolve components of the biomass [defined as “The botanical material from which an extract is made.”]. Extracts may be in dry, liquid, or semi-solid form. Excipients may be added to extracts in order to adjust the concentration; enhance stability; limit microbial growth; and to improve drying flow, or other manufacturing characteristics. Extracts are not the same as expressed juices, pure chemicals isolated from an herb, or synthetically modified plant constituents.

Dehydrated plant material, on the other hand, consists of plants that have been dried to remove most of the naturally-occurring moisture found in fresh plants. The drying process may be accomplished with or without artificially generated heat under current good agricultural practice. Drying specifications may dictate a specific maximum moisture content for the dehydrated plant material, or may describe one or more qualitative criteria. Dehydrated plant material necessarily weighs less than the starting fresh plant material, but the ratio of fresh weight to dried weight is immaterial to product quality or strength.

Interim Guidance on Heavy Metal Limits

The approval of guidance policies by the Board suggests that adherence to these guidelines will support responsible trade in herbal products and is in the best interest of consumers. Therefore, AHPA highly recommends members and industry follow the association’s guidelines in addition to its trade requirements.

AHPA adopted as interim guidance specifications under current good manufacturing practice for quantitative limits of certain heavy metals that may be present in herbal supplements:

AHPA Heavy Metal Interim Recommended Limits for

Orally Consumed Botanical Containing Finished Products

Arsenic (inorganic)

Limit (µg/day)

The following limitations and conditions apply to this guidance:

§ Heavy metal quantities should be determined at the amount of a supplement that would be consumed when used at the highest labeled dose; however, the above limits are only applicable to herbal supplements that are consumed in a total daily amount of 5 grams or less. If the highest labeled dose is over 5 grams, heavy metal limits should be established at appropriate levels under current good manufacturing.

§ A product in compliance with this interim guidance may require a clear and reasonable warning to comply with Proposition 65’s listing of these chemicals as known to cause cancer or reproductive toxicity.

Manufacturers and marketers are encouraged to submit information to AHPA to identify specific herbal ingredients that may require a different limit on one or more of the chemicals identified in this guidance, or to disclose the portion of manufactured or marketed products that exceed any of the quantitative limits established here or that require reformulation or reductions in daily serving size in order to meet these limits.

Guidance on Microbiological Limits

AHPA adopted as guidance a recommendation that manufacturers and marketers of non-liquid dietary supplements establish specifications under current good manufacturing practice for microbiological limits as follows:

§ Total aerobic plate count: 107 colony forming units/gram

§ Total yeasts and molds: 105 colony forming units/gram

§ Total coliforms: 104 colony forming units/gram

§ Salmonella : absent in 10 grams

§ Escherichia coli: not detected in one gram

§ Total aflatoxins (B1 + B2 + G1 + G2): 20 µg/kg (ppb)

§ Aflatoxin B1: 5 µg/kg (ppb);

The following limitations and conditions apply to this guidance:

§ Some individual herbs may require higher limits on total aerobic plate count; total yeasts and molds; and total coliforms. Any specification at a higher limit should be individually justified by the manufacturer.

§ In determining whether Salmonella is absent and E. coli is not detected, a larger sample size than indicated may be used.

§ Depending on the analytical method used to detect Salmonella or E. coli, failure to detect a microorganism may be reported as “absent,” “not detected,” “negative,” or “less than” the detection limit.

§ The recommended limits do not apply to finished products where boiling water is added before use.

The adopted limits are at the same levels as AHPA’s current guidance for quantitative limits for raw agricultural materials ready for oral consumption without further processing, which were adopted in June 2003 and revised in July 2005.

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