New policies affect traditional herbs processed with heavy metals, prohibitions against drug-masking claims, and pesticide analysis for cultivated ginseng

The American Herbal Products Association (AHPA), the national trade association and voice of the herbal products industry, has issued new trade recommendations for its members.¹ The first recommendation deals with herbal preparations made with heavy metals according to traditional processing methods; the second two are revisions of two previously issued recommendations regarding herbal products that might be sold to mask drug tests and pesticide levels in cultivated ginseng. The new and revised policies were approved by the AHPA Board of Trustees at its meeting on July 15, 2005.

The primary purpose of a trade association like AHPA is to protect and promote the interests of its members. One of the best ways this can be achieved is through industry self-regulation. In the case of the herb industry, whenever problems regarding quality, safety, and claims for product benefits arise, it is in the interests of the industry association(s) to provide leadership to its members to help improve conditions in the industry, eventually for the presumed benefit for the general public. Throughout its 22-year history AHPA has taken the initiative in a variety of labeling, quality, and safety issues affecting the herb trade by issuing policies and "trade recommendations" designed to help prevent or remedy various problems.² AHPA's self-regulatory initiatives are often produced well ahead of any guidelines or regulations by state or federal regulatory agencies, if any such regulations are ever issued.

AHPA's trade recommendations become incumbent upon all AHPA members as a requirement of membership. AHPA's Association By-Laws defines "Obligations of Membership" to include "É adherence to all policies and principles of business as outlined in the Code of Ethics."³ The AHPA Code of Ethics and Business Conduct established that a trade recommendation of the Board of Trustees constitutes an amendment to the Code. The new and recently revised trade recommendations described below thus constitute amendments to the Code of Ethics and are incumbent on all AHPA members. According to AHPA policy all newly adopted or substantively amended trade recommendations are effective six months from their date of adoption, unless otherwise noted. (In the case of the recommendations below, the effective date is December 15, 2005.)

Traditional Metal-Processed Herbs

Over the past several decades there have been reports of various heavy metals that have been detected in specific "herbal" formulations from both China and India. According to some traditional methods of processing herb and other materia medica in traditional Chinese medicine (TCM) and the Ayurvedic herbal tradition in India, some herbs are processed with heavy metals (e.g., arsenic, lead, mercury) for their presumed health benefits. Although TCM and Ayurvedic formulations sold in the United States in the dietary supplement industry normally do not contain these heavy metals in any appreciable levels that would cause health concerns, there have been reports of their illegal presence in TCM or Ayurvedic products, many of which are imported and sold directly in ethnic markets in the United States. For example, an article published December 2004 in the Journal of the American Medical Association⁴ containing an analysis of Ayurvedic herbal products from India that were purchased in ethnic Indian grocery stores in the Boston area demonstrated that there are excessive levels of some toxic heavy metals in some of these Indian products. The resulting publicity surrounding this article has increased the public's awareness of this problem. The AHPA Board has thus adopted the following trade recommendation dealing with this issue, as recommended by 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.¹

The presence of heavy metals in any herbal product detected at levels which may render it injurious to health constitutes an adulterated or contaminated product and the product is thus illegal. Thus, unlike the two recommendations below, AHPA has made this recommendation effective immediately when issued last July.

Prohibition Against Drug-Masking Claims

In the mid 1980s, with the advent of urine testing for metabolites of marijuana and other illicit drugs, some aggressive marketers began promoting herbal formulations claiming to be able to assist persons in masking a test for marijuana. One of the herbs most often promoted for this purpose was goldenseal (Hydrastis canadensis L., Ranunculaceae) root, even though there is no rational basis for the misguided belief that goldenseal preparations can produce this effectÑthe myth having been derived from a novel written in 1900 by the renowned herbal pharmacist John Uri Lloyd.⁵

AHPA has a long-standing policy, originally published in March 1998, against labeling dietary supplements and teas containing goldenseal root or aerial parts as agents to assist in masking the results of drug tests that are required by many employers and the military. In May 2005, a Congressional hearing was held to discuss various products, including some that are labeled as dietary supplements, which are marketed with the deliberate intention of masking drug testing.⁶ The AHPA Board decided therefore to extend the current AHPA policy beyond goldenseal, and the existing policy published in 1998 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.¹

Pesticide Analysis for Cultivated Ginseng

In 1998 the issue of pesticide and fungicide residues in cultivated American ginseng (Panax quinquefolius L., Araliaceae) roots came to the fore in the US herbal industry. Because ginseng must be grown in conditions that approximate the light conditions of the forest canopy, it is grown under shade cloth that allows only about 25% of the available light through to the plant. Plus, the soil must be moist and the ginseng roots must be at least four years of age before harvested. All this creates ideal conditions for opportunistic fungi and a fungal pathology called "root rot"Ñthe bane of ginseng farmers. For many years agricultural extension agents have encouraged American ginseng farmers to employ a variety of fungicides and other pesticides* on their ginseng to prevent root rot and related problems. This practice is now also employed in China in the production of both Asian ginseng (Panax ginseng C.A. Meyer) and American ginseng grown in China from seeds imported from the United States.

In November 1999 AHPA published a policy which included a specific analysis for pesticides used in cultivated ginseng, including all members of the genus Panax. In April 2005 when AHPA's vice president for scientific and technical affairs, Steven Dentali, PhD, learned that the Food and Drug Administration (FDA) was using a different analytical method, he conferred with the AHPA Analytical Labs Committee for review of the FDA method and a recommendation on its potential use by industry. Based on that committee's review and recommendations, the AHPA Board in July amended AHPA's current trade recommendation on ginseng pesticides, removing the identification of a specific analytical method for pesticide analysis. The revised policy, which went into effect immediately, follows:

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.¹

*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.

Quintozene (pentachloronitrobenzene, PCNB) is rated by American and international organizations as a relatively mild toxic agent, a fungicide. It is not classified as a human carcinogen according to the American Conference of Governmental Industrial Hygienists.⁷ The Pesticide Action Network rates quintozene as having "slight toxicity" due to the possibility of consuming a relatively high level due to its use on many different food crops.⁸ The World Health Organization's International Programme on Chemical Safety states that quintozene is "unlikely to be hazardous" and that it is a weak skin sensitizer, but not an irritant.⁹ The US Environmental Protection Agency classifies it as a Group C, possible human carcinogen, and that "No information is available on the chronic (long-term), reproductive, developmental, or carcinogenic effects of pentachloronitrobenzene in humans."¹⁰ 

Quintozene is approved for use in ginseng in Canada but it has not been registered for such use in the United States. It has reportedly been used in Asian ginseng cultivation for the past 30 years.¹¹ Generally, only a relatively small amount of quintozene remains on ginseng roots after they are harvested, so the amount of quintozene ingested by a ginseng supplement or tea consumer is low, due to the low level of the quintozene in the material and because of the relatively small amount of herb material usually ingested as teas and dietary supplements, i.e., compared with conventional foods consumed as vegetables, with the most likely human intake of quintozene coming from peanuts and leafy green vegetables. The current FDA standard is for ginseng to be quintozene free; this is defined as containing a level less than 0.01 parts per million, the current limit of analytical detection.¹¹ There is a small but growing movement in North America to produce pesticide-free and/or organically-grown American ginseng. Further, some herb suppliers have developed methods to remove pesticides from cultivated ginseng roots before they are sold to manufacturers for further processing into dietary supplements and other consumer products. The acceptable level for these pesticides according to the FDA is the current limit of analytical detection (10ppb or 0.001ppm). In the European Union the legal limit for such pesticides is 1 ppm (part per million), according to Volker Wypyszyk, CEO, MB North America, a supplier of quintozene-free ginseng material through the affiliated company Finzelberg GmBH & Co. KG of the Martin Bauer Group (W. Wypyszyk e-mail to M. Blumenthal, July 28, 2005).

An extensive article on quintozene is available on the Web site of the Institute for Traditional Medicine.¹¹ Members of the herb industry can contact Steven Dentali, PhD, Vice-President of Scientific and Technical Affairs, at AHPA to identify an appropriately validated analytical method for testing their ginseng material for this purpose. He can be reached at 301-588-1171 begin_of_the_skype_highlighting FREE 301-588-1171end_of_the_skype_highlighting ext.103 or sdentali@ahpa.org.

References

1.AHPA Board Adopts New and Revised Trade Recommendations [press release]. Silver Spring, MD: American Herbal Products Association. July 26, 2005.

2. McGuffin M. Self Regulatory Initiatives by the Herbal Industry. HerbalGram. 2000;No. 48:42-43.

3. AHPA Code of Ethics and Business Conduct. Silver Spring, MD: American Herbal Products Association; July 2005. Available at: http://www.ahpa.org/05_0700_CodeOfEthics_July2005.pdf. Accessed December 13, 2005.

4. Saper RB, Kales SN, Paquin J, et al. Heavy Metal Content of Ayurvedic Herbal Medicine Products. JAMA. 2004;292:2868-2873.

5. Foster S. Goldenseal masking of drug tests: From fiction to fallacy, an historical anomaly. HerbalGram. 1989:No. 21:7,35.

6. House committee calls for federal legislation to ban drug test masking products. The AHPA Report. June 2005:4-5.

7. American Conference of Governmental Industrial Hygienists. Documentation of the threshold limit values and biological exposure indices. 7th ed. Cincinnati, OH; 2001:6. [Note: Abstract available at toxnet.nlm.nih.gov.]

8. Pesticide Action Network. Toxicity Information for PCNB. Available at http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC35123#Toxicity. Accessed December 10, 2005.

9. International Program on Chemical Safety. Environmental Health Criteria 41. Quintozene. Geneva: United Nations Environment Programme, International Labor Organization, and World Health Organization, 1984. Available at: http://www.inchem.org/documents/ehc/ehc/ehc41.htm#SubSectionNumber:1.1.5. Accessed December 10, 2005.

10. EPA. Technology Transfer Network Air Toxics Website. Hazard Summary. Pentachloronitrobenzene (Quintozene). US Environmental Protection Agency. January 2000. Available at: http://www.epa.gov/ttn/atw/hlthef/quintoze.html#ref1. Accessed December 10, 2005.

11.Dharmananda S. The source of quintozene residues in ginseng. Portland, OR: Institute for Traditional Medicine; November 2001. Available at: http://www.itmonline.org/arts/quintozene.htm. Accessed November 29, 2005.