AUSTIN, Texas, Nov. 2, 2011 — Three leading nonprofit organizations - the American Botanical Council (ABC), the American Herbal Pharmacopoeia (AHP), and the University of Mississippi's National Center for Natural Products Research (NCNPR) - have initiated a large-scale program to educate members of the herbal and dietary supplement industry about ingredient and product adulteration.
Responsible parties in the herbal and dietary supplement community have become increasingly concerned about the suspected and confirmed practice of adulteration of numerous ingredients. The existence of adulteration raises questions about the identity and quality of some popular herbal ingredients sold in dietary supplements in the United States and in other botanical products (e.g., medicines, cosmetics, etc.) in global markets. "There is a major problem in the global herb and dietary supplements industry in which there appears to be a persistent availability of adulterated herbs, herbal extracts, essential oils, and other plant-derived dietary ingredients," said ABC Founder and Executive Director Mark Blumenthal.
Adulteration of botanical ingredients can be accidental or deliberate. The ABC-AHP-NCNPR Botanical Adulterants Program will focus on both accidental adulteration that occurs as a result of poor quality-control procedures, as well as the intentional adulteration of plant-based products for financial gain. The US Food and Drug Administration (FDA) has held a public conference on this issue, which the FDA named "economically motivated adulteration" (EMA). This industry-funded program aspires to serve as a self-regulatory mechanism for industry to address adulteration problems through education rather than federal regulation.
Title 21 of the Code of Federal Regulations defines adulteration as the "Addition of an impure, cheap, or unnecessary ingredient to cheat, cheapen, or falsify an ingredient or preparation." The Code also considers a product adulterated "if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is."
According to AHP Executive Director and herbalist Roy Upton, "With GMPs in full force there are now a lot of companies realizing that the supply chain for ingredients that pass identity and quality good manufacturing practice requirements has shrunk dramatically. Ingredients that used to readily pass manufacturer specifications are now failing when proper identity and quality tests are applied."
Professor Ikhlas Khan, Ph.D., assistant director of the University of Mississippi's NCNPR and the director of the Center's botanical supplement authentication program, said, "We are pleased to partner with ABC and AHP in this effort to raise awareness about adulteration of botanicals and the methods/principles that can minimize this problem." Prof. Khan is an internationally recognized expert on laboratory analytical methods to identify botanical materials. His Center has a cooperative agreement with FDA to identify botanical materials and develop appropriate analytical methods.
The ABC-AHP-NCNPR Botanical Adulterants Program aims to help protect consumers and responsible members of the herb and dietary supplement industry, as well as other manufacturers, by producing a series of detailed white papers, which will serve as an authoritative source of information on botanical adulterants with references to published official and unofficial analytical methods for companies and/or third-party laboratories to utilize to help detect the presence (or absence) of known adulterants.
In the program's first published paper, "A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs," noted botanical expert Steven Foster provides a history of accidental and intentional adulteration of botanical ingredients spanning the past 2 millennia. The article appears in ABC's journal HerbalGram (issue number 92), being published in early November. Foster is a well-known author, photographer, and consultant on herbs and is currently Chairman of the Board of Trustees of ABC. The article was extensively peer reviewed by five experts on the history of pharmacy, plus additional reviewers knowledgeable about herbs.
In addition to the series of white papers, The Adulterants Program will include contributions and consultations from some of the leading independent third-party laboratories with experience in quality control and botanical identification issues. The editorial committee, which will advise on all technical publications, includes expert scientists from various universities, government agencies, and third-party analytical laboratories with extensive knowledge of herbal quality control. The Program is also being supported by several leading trade associations in the dietary supplement industry: the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance.
"The ABC-AHP-NCNPR Botanical Adulterants Program will provide industry quality control laboratories and independent third-party labs the numerous tools and resources they need on how to identify many of the adulterants that are being documented in various herbal and plant-derived dietary ingredients," said Blumenthal.
An important aspect of The ABC-AHP-NCNPR Botanical Adulterants Program is keeping the information current and allowing interested parties to easily access program-related documents. To accomplish this, the Program plans to make certain materials available to the public online. Updates will be featured on the organizations' websites.