Joanna Cosgrove, Online Editor12.01.11
Adulteration ranks high among the chief complaints from supplement industry detractors—no matter how promising the science, how can a product be trusted if one can’t be absolutely sure what’s on the label is actually in the bottle? With that in mind, the American Botanical Council (ABC) recently announced the formation of a large-scale educational consortium tasked with rooting out adulterated botanical dietary ingredients at all levels of the supply and production chain.
ABC has joined forces with the American Herbal Pharmacopoeia (AHP) and the University of Mississippi’s National Center for Natural Product Research (NCNPR) to create a “self-regulatory mechanism” that would enable members of the herbal and dietary supplement industry to address ingredient and product adulteration problems through education rather than federal regulation.
“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,” commented Mark Blumenthal, ABC’s founder and executive director.
Because the adulteration of botanical ingredients can be accidental or deliberate, the ABC-AHP-NCNPR Botanical Adulterants Program has been geared to 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—a practice dubbed “economically motivated adulteration” (EMA) by FDA.
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.”
“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,” noted Roy Upton, AHP executive director and herbalist. “Ingredients that used to readily pass manufacturer specifications are now failing when proper identity and quality tests are applied.”
According to the founding organizations, the ABC-AHP-NCNPR Botanical Adulterants Program will endeavor 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 papers, “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs,” botanical expert Steven Foster provided a history of accidental and intentional adulteration of botanical ingredients spanning the past two millennia. The peer reviewed article appeared earlier this month in ABC’s journal HerbalGram (issue number 92), being published in early November.
Mr. Blumenthal told Nutraceuticals World the first white paper’s introduction to the history of intentional adulteration will be complemented up by a second paper on the history of accidental adulteration, and another on laboratory methods that will be structured in an approachable way that’s accessible to everyone, not just analytical laboratory chemists. The information will be available for free on ABC’s website.
Mr. Blumenthal also made it clear the program was not designed to test products or ingredients. Its course of action is two pronged and will span many years. The first step will be to identify herb and plant-based materials that have adequate evidence of confirmed adulterants, then use white papers as practical mediums to get the word out to purchasing agents, quality control managers and companies, lab directors, etc.
“Some people know about adulteration, some don’t,” Mr. Blumenthal said. “The first thing we need to do is let people know that there’s adulteration going on, be it accidental or intentional. Then we’ll let them know what to look for and recommend validated and unvalidated analytical methods they can use to detect the presence or absence of adulterants, along with links, references and third party commentary by various lab savvy individuals who have experience as to the relative strengths and or weaknesses of each individual method.
“We’re going to be as comprehensive and specific as possible to give people the best available information on how to protect their company and customers from purchasing adulterated material,” he said.
Mr. Blumenthal also said he’s not worried about the possibility that outing adulterants could court bad press. “The idea that there are potentially misidentified and adulterated products out there is more injurious to the industry’s future than the message that there is an industry-funded, independent, non-profit consortium that’s putting together an educational project to allow the robust, self-regulatory initiative to help identify and prevent many of these adulterated materials from getting into the marketplace,” he said.
The Adulterants Program is currently supported by several leading trade associations in the dietary supplement industry, including the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. Mr. Blumenthal told Nutraceuticals World he hoped the cooperative spirit to quell adulteration would encourage other industry supplement entities to participate in the program, both here and abroad. “We’re hoping various domestic and international organizations and professional associations will be supportive of this program and endorse it,” he said. “It’s one thing to publish something on a website or journal, but if we can all work together to get the message to ‘go viral,’ if you will, the excuse ‘we didn’t know’ won’t be applicable.”
ABC has joined forces with the American Herbal Pharmacopoeia (AHP) and the University of Mississippi’s National Center for Natural Product Research (NCNPR) to create a “self-regulatory mechanism” that would enable members of the herbal and dietary supplement industry to address ingredient and product adulteration problems through education rather than federal regulation.
“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,” commented Mark Blumenthal, ABC’s founder and executive director.
Because the adulteration of botanical ingredients can be accidental or deliberate, the ABC-AHP-NCNPR Botanical Adulterants Program has been geared to 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—a practice dubbed “economically motivated adulteration” (EMA) by FDA.
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.”
“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,” noted Roy Upton, AHP executive director and herbalist. “Ingredients that used to readily pass manufacturer specifications are now failing when proper identity and quality tests are applied.”
According to the founding organizations, the ABC-AHP-NCNPR Botanical Adulterants Program will endeavor 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 papers, “A Brief History of Adulteration of Herbs, Spices, and Botanical Drugs,” botanical expert Steven Foster provided a history of accidental and intentional adulteration of botanical ingredients spanning the past two millennia. The peer reviewed article appeared earlier this month in ABC’s journal HerbalGram (issue number 92), being published in early November.
Mr. Blumenthal told Nutraceuticals World the first white paper’s introduction to the history of intentional adulteration will be complemented up by a second paper on the history of accidental adulteration, and another on laboratory methods that will be structured in an approachable way that’s accessible to everyone, not just analytical laboratory chemists. The information will be available for free on ABC’s website.
Mr. Blumenthal also made it clear the program was not designed to test products or ingredients. Its course of action is two pronged and will span many years. The first step will be to identify herb and plant-based materials that have adequate evidence of confirmed adulterants, then use white papers as practical mediums to get the word out to purchasing agents, quality control managers and companies, lab directors, etc.
“Some people know about adulteration, some don’t,” Mr. Blumenthal said. “The first thing we need to do is let people know that there’s adulteration going on, be it accidental or intentional. Then we’ll let them know what to look for and recommend validated and unvalidated analytical methods they can use to detect the presence or absence of adulterants, along with links, references and third party commentary by various lab savvy individuals who have experience as to the relative strengths and or weaknesses of each individual method.
“We’re going to be as comprehensive and specific as possible to give people the best available information on how to protect their company and customers from purchasing adulterated material,” he said.
Mr. Blumenthal also said he’s not worried about the possibility that outing adulterants could court bad press. “The idea that there are potentially misidentified and adulterated products out there is more injurious to the industry’s future than the message that there is an industry-funded, independent, non-profit consortium that’s putting together an educational project to allow the robust, self-regulatory initiative to help identify and prevent many of these adulterated materials from getting into the marketplace,” he said.
The Adulterants Program is currently supported by several leading trade associations in the dietary supplement industry, including the Council for Responsible Nutrition, the Natural Products Association and the United Natural Products Alliance. Mr. Blumenthal told Nutraceuticals World he hoped the cooperative spirit to quell adulteration would encourage other industry supplement entities to participate in the program, both here and abroad. “We’re hoping various domestic and international organizations and professional associations will be supportive of this program and endorse it,” he said. “It’s one thing to publish something on a website or journal, but if we can all work together to get the message to ‘go viral,’ if you will, the excuse ‘we didn’t know’ won’t be applicable.”
