Botanical Adulterants Program Introduces "Laboratory Guidance Documents" Series to Help Industry Detect Potential Herb Adulteration

Quality Consortium's First Lab Guidance Document Reviews 23 Laboratory Methods for Skullcap

Detailed reports from independent initiative will help quality control personnel identify appropriate analytical methods to authenticate botanical products and detect potential adulteration

08 Jan, 2015, 17:36 ET from American Botanical Council

AUSTIN, Texas, Jan. 8, 2015 /PRNewswire-USNewswire/ -- 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 analyticalmethods 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)*

Financial Underwriters
21st Century Healthcare
AdvoCare International L.P.
Agilent Technologies, Inc.
Aloecorp, Inc.
Amen Clinics
Amway/Nutrilite Health
    Institute
Artemis International, Inc.
Aveda Corporation
Beachbody, LLC
BI Nutraceuticals
Bioceuticals
Bionorica SE
Blackmores
Capsugel
Cepham, Inc.
Chemi Nutra
CNCA Health
Crila Health
dicentra, Inc.
Doctor's Best
Dr. Bronner's Magic Soaps
Douglas Laboratories
DSM Nutritional Products, Inc.
Emerson Ecologics
Enzymatic Therapy, Inc.
Ethical Naturals, Inc.
Eu Yan Sang International
EuroMed
EuroMedica
EuroPharma
Flavex Naturextrakte GmbH
FoodState/MegaFood
Fruit d'Or
Gaia Herbs
Gencor Nutrients, Inc.
GNC, Inc.
Helios Corp.
Herb Pharm
Herbalife International, Inc.
Horphag Research
iHerb
Indena USA, Inc.
Ingredient Identity
Linnea
Markan Global Enterprises, Inc.
Martin Bauer, Inc.
MediHerb / Integria Healthcare
Metagenics, Inc.
Natural Factors Nutritional
    Products, Inc./Bioclinic
    Naturals
Natural Grocers by Vitamin
    Cottage
Nature's Sunshine Products
Nature's Way
Naturex, Inc.
NBTY, Inc.
New Chapter, Inc.
The New Frontier Foundation
    Fund of the Greater Cedar
    Rapids Community
    Foundation
Ningbo Greenhealth
    Pharmaceutical Co., Ltd.
Novel Ingredients
NOW Foods
Nu Skin Enterprises/Pharmanex
    Nutritional Laboratories
    International
Ortho Molecular Products
Pacific Nutritional Inc.

Financial Underwriters (cont'd)
Paragon Laboratories
Pathway International Pty
    Limited
Perrigo Company
Pharmatoka SAS
Pharmavite, LLC
Polyphenolics, Division of
    Constellation Brands, Inc.
Pure Encapsulations
Rainbow Light Nutritional Systems
RFI Ingredients, LLC
Rosenbush and Zimmerman Family
    Fund
Sabinsa Corporation
Schwabe North America
Seroyal
Shaklee Corp.
Standard Process, Inc.
Thorne Research, Inc.
Traditional Medicinals, Inc.
Triarco Industries, Inc.
Unigen
Univera, Inc.
Valensa International
V.D.F. FutureCeuticals
Verdure Sciences
Vitamin Shoppe
Weil Lifestyle, LLC
Whole Foods Market
ZMC-USA

Trade Associations
Australian Self Medication
    Industry (Australia)
Australian Tea Tree Industry
    Association (Australia)
Complementary Medicines
    Australia (Australia)
Consumer Healthcare Products
    Association (US)
Council for Responsible Nutrition
    (US)
International Alliance of 
   Dietary/Food Supplement
   Associations (IADSA)
Natural Products Association (US)
United Natural Products Alliance
    (US)

Nonprofit/Professional Associations
American Association of 
    Naturopathic Physicians
American Society of
    Pharmacognosy
Council of Colleges of Acupuncture
    and Oriental Medicine
Personalized Lifestyle Medicine
    Institute
Society for Medicinal Plant
    and Natural Product Research -    GA

Colleges/Universities

Bastyr University
Boucher Institute for
   Naturopathic Medicine
National College of Natural
   Medicine
Southwest College of
    Naturopathic Medicine
University of Bridgeport College
    of Naturopathic Medicine

Third-Party Analytical Laboratories
Alkemist Labs
AuthenTechnologies LLC
Bent Creek Institute
British Columbia Institute of Technology
ChromaDex
Covance Laboratories
Eurofins Scientific Inc.
Flora Research Labs
NSF International

Spectrix Labs
Tampa Bay Analytical

Media

Delicious Living
Engredea
Functional Ingredients
Holistic Primary Care
Informa Exhibitions US
Integrator Blog
Media Relations, Inc.
Modern Healthcare Practitioner
Natural Foods Merchandiser
Natural Products INSIDER
NewHope360.com
Nutraceuticals World
NutraingredientsUSA.com
Nutrition Business Journal
Nutrition Industry Executive
Nutritional Outlook
Vitamin Retailer
WholeFoods Magazine

Law Firms & Regulatory Consultants
Amin Talati & Upadhye, LLC
Greenberg Traurig, LLP (James
    Prochnow)
Law Office of Holly Bayne, P.C.
Robert Forbes & Associates

Contract Research Organizations
KGK Synergize
Medicus Research

Research Institutes
Korean Ginseng Research
    Institute
Shanghai Research Center for
    TCM Modernization/Shanghai
    Institute of Materia Medica of
    the Chinese Academy of
    Sciences 

 

*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.

About the American Botanical Council

Founded in 1988, the American Botanical Council is a leading international nonprofit organization that addresses research and educational issues regarding botanicals, teas, medicinal plants, essential oils, other therapeutic plant-derived materials, and beneficial fungi. ABC's members and stakeholders include researchers, health professionals, consumers, nonprofit organizations, libraries, universities, herb, food, pharmaceutical, and cosmetic industry members, and others in more than 80 countries. The organization occupies a historic 2.5-acre site in Austin, Texas, where it publishes the peer-reviewed quarterly journal HerbalGram, the monthly e-publication HerbalEGram, the weekly e-newsletter Herbal News & Events, HerbClips (summaries of scientific and clinical publications), reference books, and other educational materials, including the new Botanical Adulterants Monitor newsletter. ABC also hosts HerbMedPro, a powerful herbal database, covering scientific and clinical publications on more than 250 herbs. ABC also co-produces the "Herbal Insights" segment for Healing Quest, a television series on PBS, and manages the ABC-AHP-NCNPR Botanical Adulterants Program, an international consortium of nonprofit professional societies, industry trade organizations, analytical laboratories, industry members, and other parties committed to increasing educational information on the quality and authenticity of botanical raw materials, extracts and essential oils in the global marketplace.

ABC is tax-exempt under section 501(c)(3) of the IRS Code. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: www.herbalgram.org. Contact: Public Relations.

CONTACT: Sara O'Connor, 512-926-4900, publicrelations@HerbalGram.org

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SOURCE American Botanical Council



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