(AUSTIN, Texas, Jan. 8, 2015) The ABC-AHP-NCNPR Botanical Adulterants Program announces the inaugural publication of its Laboratory Guidance Document (LGD) series for botanical ingredients. The LGD on skullcap (Scutellaria lateriflora) is the first in the Program’s new series of comprehensive, extensively peer-reviewed, and up-to-date analytical assessments of methods for authentication of the identity of ingredients and detection of adulterants. These free documents – available at no cost thanks to the Program’s underwriters and supporters – are intended for use by quality control personnel and lab technicians in the herbal medicine, botanical ingredient, and dietary supplement sectors to help them choose the most appropriate techniques and methods for their specific analytical needs.

The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program (BAP) is an international consortium of nonprofit organizations, analytical laboratories, industry members, professional scientists, and others that advises industry, researchers, health professionals, and the public about the various challenges related to adulterated herb and botanical ingredients sold in commerce. To date, more than 130 American and international parties financially support or otherwise endorse the Program.

“For the first several years of our Program we published articles alerting members of the herb industry about adulteration of specific herbs,” said Mark Blumenthal, founder and executive director of the American Botanical Council and director of the BAP. “Now, in addition to our continuing series of publications on adulterated herbs, we are offering technical resources to assist industry and third-party laboratories to detect adulteration and help prevent adulterated botanical ingredients and extracts from being processed into finished consumer products.”

Official compendial methods (e.g., those published in the United States Pharmacopeia or the European Pharmacopoeia) exist for the authentication of many botanical materials, but such methods can be outdated for materials that may be adulterated in ways not conceived at the time of the development of officially recognized analytical methods, or may not be applicable to ingredients made using a specific manufacturing process. Additionally, unscrupulous ingredient suppliers driven by short-term financial gains have become more creative in finding ways to deceive a potential buyer’s analysts, making the proper detection of adulterants a potentially daunting, time-consuming, and increasingly challenging task.

The ABC-AHP-NCNPR Laboratory Guidance Documents are intended to provide reliable expert guidance on suitable methods to comply with the mandated requirements of testing for identity, purity, strength, and composition outlined in the United States Food and Drug Administration’s current Good Manufacturing Practices (cGMPs) for dietary supplements. Per the cGMPs, it is the responsibility of the dietary supplement manufacturers to “conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient.”¹

The Program’s LGDs provide information about the most suitable analytical methods for detection of certain adulterants and authentication of specific botanical materials in the form of whole, cut, or powdered raw materials, extracts, and essential oils. Recommendations are based on a thorough review of available analytical methods (e.g., from official and unofficial compendia as well as the peer-reviewed literature) and input from up to 20 peer reviewers from academia, government, and industry in multiple countries. The primary assessment of each method is based on its performance characteristics (i.e., suitability in detecting known adulterants); labor and analysis time comprise the secondary evaluation criteria.

Stefan Gafner, PhD, ABC chief science officer and BAP technical director, shared his appreciation for everyone who participated in the extensive peer-review process: “I am grateful for the many analytical experts who spent the time to peer-review the Skullcap Laboratory Guidance Document. This process has led to numerous improvements in the paper and has ultimately resulted in a document that is helpful for those whose job it is to determine the authenticity of skullcap and the absence of adulterants.” 

The BAP’s LGDs begin with a statement of purpose and scope in regard to the particular species covered, followed by a short overview of the botanical nomenclature of the species and its known adulterants. Also included are sections on analytical techniques (generally including macroscopic, microscopic, chemical, and genetic assays) and a phytochemical composition overview of the species and known adulterants. The LGDs conclude with a concise table of strengths and limitations of the various assays. Complete references are provided with links to original source documents. 

The ABC-AHP-NCNPR Botanical Adulterants Program plans to release additional LGDs in 2015. 

For the skullcap and forthcoming bilberry (Vaccinium myrtillus) extract and black cohosh (Actaea racemosa) LGDs, 23, 38, and 31 analytical methods were evaluated, respectively, including the following methods: macroscopic analysis, botanical microscopy, genetic analysis, HPTLC, HPLC/UHPLC, flow-injection MS, NMR, and NIR hyperspectral imaging.

“We recently added a skullcap-based product to our line and the conclusions of the [Skullcap LGD] mirror our own,” commented Katie Huggins, vice president of Technical Services at Traditional Medicinals, Inc., after reviewing the skullcap LGD. “I can say from experience that having such a document when evaluating a new ingredient for inclusion in a product and when writing specifications would be invaluable.”

To date, the ABC-AHP-NCNPR Botanical Adulterants Program has published five extensively peer-reviewed and referenced articles on the history of adulteration, the adulteration of the herbs black cohosh and skullcap, adulteration of bilberry fruit extract, and so-called “grapefruit seed extract.” These open-access articles are available on the Program’s webpage here. The Program also publishes a quarterly e-newsletter, the "Botanical Adulterants Monitor," that highlights new scientific publications related to botanical authenticity and analysis to detect possible adulteration, recent regulatory actions, and Program news.  

Reference

1. US Food and Drug Administration. Code of Federal Regulations Title 21, Volume 2, Part 111 (21CFR111): Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111. Revised April 1, 2014. Accessed December 16, 2014.

About the ABC-AHP-NCNPR Botanical Adulterants Program

The ABC-AHP-NCNPR Botanical Adulterants Program is a consortium of independent nonprofit organizations whose mission relates to education, scientific research, and quality of botanical dietary ingredients and related plant-derived materials. The consortium is headed by three nonprofit groups dealing with education and research on medicinal herbs and other beneficial plants: the American Botanical Council, the American Herbal Pharmacopoeia, and the National Center for Natural Products Research at the University of Mississippi. The program is underwritten or endorsed by more than 130 natural products industry companies, independent analytical laboratories, contract research organizations, nonprofit and professional organizations, trade associations, accredited institutions of education in natural medicine, law firms, and media companies — which are involved in the production, supply, manufacture, distribution, marketing, analysis, research, and/or education of herbal dietary ingredients and supplements, in the United States and internationally. All publications of the Program are available free-access on its homepage including the "Botanical Adulterants Monitor," an e-newsletter that conveys Program news, regulatory updates, and recent scientific publications related to adulteration, contamination, identity, and authenticity of botanical raw materials, extracts, and essential oils. Companies, organizations, foundations, and/or individuals interested in supporting this program are invited to contact Ms. Denise Meikel, ABC Development Director, at (512) 926-4900, ext. 120, or by email.

Underwriters and Supporters of the ABC-AHP-NCNPR Botanical Adulterants Program (as of Jan. 7, 2015)*

*By acknowledging the generous support of these companies and organizations, ABC, AHP, and NCNPR are not endorsing any ingredients or products that may be produced or marketed by them.