Mike Montemarano, Associate Editor 03.10.21
The American Botanical Council (ABC)-AHP-NCNPR Botanical Adulterant Prevention Program (BAPP) announced its tenth year of research and educational activities in the international herb and medicinal plant communities.
BAPP was founded in partnership with consortium members by the nonprofit American Botanical Council in 2011 as a research and education program to assist responsible members of the U.S. and international botanical industry in authenticating botanical raw materials, extracts, and essential oils, as well as to detect their adulteration by unscrupulous suppliers. The ultimate goal of BAPP is to help ensure the authenticity of botanical ingredients in consumer products.
The BAPP partnership also includes the nonprofit American Herbal Pharmacopoeia (AHP), an independent organization that produces high-quality monographs for use by herb industry members, researchers, and regulators on herbs used in commerce, and the National Center for Natural Products Research (NCNPR) at the University of Mississippi, the U.S. FDA-funded Center of Excellence for the analysis of botanical dietary ingredients and the development of appropriate laboratory methods for analyzing botanical ingredients and finished products.
As of early March 2021, BAPP has published 63 extensively peer-reviewed documents, freely available on the BAPP homepage and on the ABC website. BAPP documents include Botanical Adulterants Prevention Bulletins, laboratory guidance documents, the botanical adulterants monitor e-newsletter, and various articles in ABC’s peer-reviewed journal HerbalGram. In addition, BAPP scientists have authored or co-authored research papers in peer-reviewed scientific journals, and have participated in many public speaking events related to the global challenges associated with economically-motivated (intentional) adulteration. BAPP publications are peer-reviewed by numerous international experts in academia, industry, and government.
BAPP was founded by ABC founder and executive director Mark Blumenthal, and its first publication was released in HerbalGram issue 92 in the winter of 2011. Written by botanist, author, botanical expert, and renowned medicinal plant photographer Steven Foster, the article – “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs” – provides clear examples of adulteration, counterfeiting, and fraud in the sale of botanical materials since Greco-Roman times. Foster’s contributions also include HerbalGram articles on the adulteration of skullcap (Scutellaria lateriflora) with potentially liver-toxic germander (Teucrium chamaedrys), and articles on bilberry and the challenges of ginseng taxonomy and nomenclature.
In 2013, BAPP expanded by hiring Stefan Gafner, PhD, as ABC’s chief science officer and BAPP’s technical director. In 2015, BAPP began publishing BAPBs (22 so far) and LGDs (10 so far).
In its 10-year history, BAPP has been supported by over 200 global botanical community and industry entities, including herb companies, trade associations in the U.S. and internationally, professional research and health practitioner organization, research centers, and others. A full list is available on the BAPP homepage.
“There are numerous ingredient suppliers and manufacturers in the botanical industry that operate their businesses ethically and responsibly, producing reliable and authentic botanical and fungal ingredients and a variety of natural consumer products,” Blumenthal said. “We are truly grateful for the financial, scientific, and moral support that BAPP receives from these companies, and many other parties in the global community who recognize the vitally important research and educational role that BAPP plays in the international medicinal plant and botanical industry.”
According to a BAPP survey, nearly half of industry representatives responded that they implemented new quality control measures due to BAPP publications, with 15 revising their ingredient specifications, and 18 changing ingredient suppliers based on information provided by BAPP. The Botanical Adulterants Monitor was considered the most useful resource by the largest number of industry members, followed by HerbalGram articles and BAPBs.
“For me, this is a moment to look back at what BAPP has achieved over the past 10 years,” Gafner said. “If, as industry feedback suggests, BAPP has indeed helped to bring better quality supplements and other botanical products to the consumer, then I would say it has been successful.”
Others, including Roy Upton, founder and president of AHP, and Loren Israelsen, president of the United Natural Products Alliance, shared insights into their experiences working with the BAPP.
“AHP has always believed that educating industry about the prevalence of botanical adulteration, and more importantly, providing solutions, is a key to safeguarding public health,” Upton said. “After 10 years, I can honestly say that various segments of the industry have made changes needed to minimize the incidence of adulteration. There will always be those who intentionally trade in fraudulent materials for economic gain. For those who want to do it right, BAPP has made it much easier. For those who don’t, the FDA hopefully is watching.”
“Intentional adulteration is the bane of the botanical industry and has been for centuries,” Israelsen said. “The American Botanical Council recognized this problem as central to their mission and to the reputation of our industry and trust of our consumers. BAPP has now completed its 10th year and has become the essential science-based resource for information and tools to detect and remove adulterants from commerce. This is a major achievement. There is much work to be done. I salute ABC, AHP, and NCNPR for their determination to openly address and commit to resolving this persistent scourge within our industry.”
BAPP has also created a tool to assist botanical industry companies in removing adulterated ingredients – referred to as irreparably defective articles – from the global botanical supply chain with the BAPP Best Practices Contract Language and Standard Operating Procedure (SOP) for the Disposal or Destruction of Irreparably Defective Articles. These documents have been submitted for public comment on two occasions and will be published by BAPP in 2021.
“While the dietary supplement industry has a requirement to report serious adverse events to the FDA, there is no similar requirement, or even guidance, for buyers to manage irreparably defective ingredients that are economically adulterated in the United States and elsewhere,” Michael Levin, primary author of the BAPP supply contract and SOP, said. “In 2021, BAPP will empower stakeholders to address this regulatory guidance gap by providing carefully vetted contract and SOP templates that supply chain partners can adapt for use in supply contracts. In so doing, both buyers and sellers of ingredients will have a contractual agreement that mutually assures destruction of defective ingredients that cannot be lawfully remediated, thus preventing their reentry into commerce.”
The next BAPP publications will include a laboratory guidance document on olive oil, and BAPBs on pomegranate, saffron, and others. The organization also intends to publish a review of laboratory analytical testing demonstrating the adulteration of elderberry in the upcoming issue of HerbalGram.
BAPP was founded in partnership with consortium members by the nonprofit American Botanical Council in 2011 as a research and education program to assist responsible members of the U.S. and international botanical industry in authenticating botanical raw materials, extracts, and essential oils, as well as to detect their adulteration by unscrupulous suppliers. The ultimate goal of BAPP is to help ensure the authenticity of botanical ingredients in consumer products.
The BAPP partnership also includes the nonprofit American Herbal Pharmacopoeia (AHP), an independent organization that produces high-quality monographs for use by herb industry members, researchers, and regulators on herbs used in commerce, and the National Center for Natural Products Research (NCNPR) at the University of Mississippi, the U.S. FDA-funded Center of Excellence for the analysis of botanical dietary ingredients and the development of appropriate laboratory methods for analyzing botanical ingredients and finished products.
As of early March 2021, BAPP has published 63 extensively peer-reviewed documents, freely available on the BAPP homepage and on the ABC website. BAPP documents include Botanical Adulterants Prevention Bulletins, laboratory guidance documents, the botanical adulterants monitor e-newsletter, and various articles in ABC’s peer-reviewed journal HerbalGram. In addition, BAPP scientists have authored or co-authored research papers in peer-reviewed scientific journals, and have participated in many public speaking events related to the global challenges associated with economically-motivated (intentional) adulteration. BAPP publications are peer-reviewed by numerous international experts in academia, industry, and government.
BAPP was founded by ABC founder and executive director Mark Blumenthal, and its first publication was released in HerbalGram issue 92 in the winter of 2011. Written by botanist, author, botanical expert, and renowned medicinal plant photographer Steven Foster, the article – “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs” – provides clear examples of adulteration, counterfeiting, and fraud in the sale of botanical materials since Greco-Roman times. Foster’s contributions also include HerbalGram articles on the adulteration of skullcap (Scutellaria lateriflora) with potentially liver-toxic germander (Teucrium chamaedrys), and articles on bilberry and the challenges of ginseng taxonomy and nomenclature.
In 2013, BAPP expanded by hiring Stefan Gafner, PhD, as ABC’s chief science officer and BAPP’s technical director. In 2015, BAPP began publishing BAPBs (22 so far) and LGDs (10 so far).
In its 10-year history, BAPP has been supported by over 200 global botanical community and industry entities, including herb companies, trade associations in the U.S. and internationally, professional research and health practitioner organization, research centers, and others. A full list is available on the BAPP homepage.
“There are numerous ingredient suppliers and manufacturers in the botanical industry that operate their businesses ethically and responsibly, producing reliable and authentic botanical and fungal ingredients and a variety of natural consumer products,” Blumenthal said. “We are truly grateful for the financial, scientific, and moral support that BAPP receives from these companies, and many other parties in the global community who recognize the vitally important research and educational role that BAPP plays in the international medicinal plant and botanical industry.”
According to a BAPP survey, nearly half of industry representatives responded that they implemented new quality control measures due to BAPP publications, with 15 revising their ingredient specifications, and 18 changing ingredient suppliers based on information provided by BAPP. The Botanical Adulterants Monitor was considered the most useful resource by the largest number of industry members, followed by HerbalGram articles and BAPBs.
“For me, this is a moment to look back at what BAPP has achieved over the past 10 years,” Gafner said. “If, as industry feedback suggests, BAPP has indeed helped to bring better quality supplements and other botanical products to the consumer, then I would say it has been successful.”
Others, including Roy Upton, founder and president of AHP, and Loren Israelsen, president of the United Natural Products Alliance, shared insights into their experiences working with the BAPP.
“AHP has always believed that educating industry about the prevalence of botanical adulteration, and more importantly, providing solutions, is a key to safeguarding public health,” Upton said. “After 10 years, I can honestly say that various segments of the industry have made changes needed to minimize the incidence of adulteration. There will always be those who intentionally trade in fraudulent materials for economic gain. For those who want to do it right, BAPP has made it much easier. For those who don’t, the FDA hopefully is watching.”
“Intentional adulteration is the bane of the botanical industry and has been for centuries,” Israelsen said. “The American Botanical Council recognized this problem as central to their mission and to the reputation of our industry and trust of our consumers. BAPP has now completed its 10th year and has become the essential science-based resource for information and tools to detect and remove adulterants from commerce. This is a major achievement. There is much work to be done. I salute ABC, AHP, and NCNPR for their determination to openly address and commit to resolving this persistent scourge within our industry.”
BAPP has also created a tool to assist botanical industry companies in removing adulterated ingredients – referred to as irreparably defective articles – from the global botanical supply chain with the BAPP Best Practices Contract Language and Standard Operating Procedure (SOP) for the Disposal or Destruction of Irreparably Defective Articles. These documents have been submitted for public comment on two occasions and will be published by BAPP in 2021.
“While the dietary supplement industry has a requirement to report serious adverse events to the FDA, there is no similar requirement, or even guidance, for buyers to manage irreparably defective ingredients that are economically adulterated in the United States and elsewhere,” Michael Levin, primary author of the BAPP supply contract and SOP, said. “In 2021, BAPP will empower stakeholders to address this regulatory guidance gap by providing carefully vetted contract and SOP templates that supply chain partners can adapt for use in supply contracts. In so doing, both buyers and sellers of ingredients will have a contractual agreement that mutually assures destruction of defective ingredients that cannot be lawfully remediated, thus preventing their reentry into commerce.”
The next BAPP publications will include a laboratory guidance document on olive oil, and BAPBs on pomegranate, saffron, and others. The organization also intends to publish a review of laboratory analytical testing demonstrating the adulteration of elderberry in the upcoming issue of HerbalGram.
