Silver Spring, MD (July 26, 2005) -- The American Herbal Products Association (AHPA) Board of Trustees revised two established trade recommendations and adopted one new one at its July 15 meeting. AHPA’s Association 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 new and revised trade recommendations described in this communication, therefore, constitute amendments to the Code and should be considered as such by all AHPA members.
As is standard for all newly adopted or substantively amended trade recommendations, these trade recommendations are effective six months from their date of adoption, that is, on December 15, 2005, unless otherwise noted.
Traditional metal-processed herbs
The last few months have seen a heightened awareness of the presence in the US market of a few Ayurvedic products that are made with herbal ingredients that are processed with heavy metals, such as lead, mercury, and silver. The Board therefore adopted the following trade recommendation at the suggestion of the AHPA Standards Committee:
Whereas traditional Ayurvedic formulas may include ingredients that consist of herbs that are processed with metals; and whereas the presence of several of these metals in herbal dietary supplements sold in the United States may cause such products to be adulterated under the Federal Food, Drug and Cosmetic Act; therefore, AHPA recommends that manufacturers and marketers of herbal products that are based on Ayurvedic traditions refrain from the inclusion in such products of any ingredient that is processed with metals if the resultant presence of heavy metal(s) would cause the product containing the ingredient(s) to be adulterated under labeled or ordinary conditions of use.
To the degree that this trade recommendation addresses products that adulterated under current regulations, it is effective immediately.
Prohibition against drug masking claims
AHPA has a long-standing policy against labeling goldenseal (Hydrastis canadensis) supplements as agents to assist in masking the results of drug tests that are required by many employees and the military. This past May, a Congressional hearing was held to discuss products, including some that are labeled as dietary supplements, that are marketed with the deliberate intention of masking drug testing (see the June 2005 AHPA Report). The Board’s attention was therefore extended beyond the one herb, goldenseal, and the existing policy was revised as follows:
AHPA recommends that marketers of dietary supplements refrain from labeling or marketing any dietary supplement in any manner that suggests that the product masks or defrauds drug testing.
Pesticide Analysis for Ginseng
AHPA’s policy on pesticide analysis for ginseng (Panax spp.) has included the identification of a specific analytical method since its adoption in 1999. When Steven Dentali, PhD, AHPA’s vice president for scientific and technical affairs, was informed that FDA now uses a different method, he contacted the AHPA Analytical Labs Committee for review and feedback. Based on that committee's suggestion, the Board has amended the current trade recommendation to remove any identification of a specific analytical method for pesticide analysis. The revised policy, effective immediately, is:
AHPA recommends that processor and manufacturer members analyze cultivated ginseng (Panax spp.) by an appropriately validated analytical method at an appropriate and relevant limit of detection for the presence of quintozene and related compounds, including known degradants and impurities of quintozene*, and also for the presence of difenoconazole; and further, that the analyses identified herein be performed by qualified analytical labs using validated analytical methods; and further, that bulk lots of ginseng be accompanied by a certificate that provides actual test results for quintozene and its degradants, and for difenoconazole; and further, that in lieu of analysis by the processor or manufacturer, the accompanying certificate identified above may be accepted from a supplier provided that the processor or manufacturer establishes the reliability of the supplier's analysis; provided that, any cultivated ginseng that is produced in a manner that assures that the ginseng is free of quintozene and related compounds and of difenoconazole is exempted from this recommendation.
* PCNB, quintozene; PCA, pentachloroaniline; PCTA, pentachlorothioanisol; HCB, hexachlorobenzene; PCB, pentachlorobenzene; alpha-BHC, alpha-benzenehexachloride; beta-BHC, beta-benzenehexachloride; delta-BHC, delta-benzenehexachloride; gamma-BHC, gamma-benzenehexachloride (lindane); TCA, tetrachloroaniline; and TCZ, technazene.
Please feel free to contact Dr. Dentali to identify an appropriately validated analytical method for this purpose. He can be reached at 301-588-1171 x106 or [email protected].
AHPA’s Code of Ethics is posted online at http://www.ahpa.org/05_0700_CodeOfEthics_July2005.pdf.
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry, the only trade association devoted solely to herbal issues. AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products. AHPA’s mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of responsibility with respect to the way herbs are manufactured, labeled and sold. Website: www.ahpa.org
Contact: Karen Robin, Director of Communications
Telephone: (301) 588-1171, x-107