Robin Ward07.01.01
As industry insiders, we are all too aware of the frequent television, newspaper and magazine releases of disparaging news about dietary supplements. Yet in spite of the constant barrage of bad news, consumers continue to believe in supplements and, in fact, take them in record numbers. A recent report by The Hartman Group, Bellevue, WA, found that 71% of all consumers have used supplements in the past three months, up from 66% in 1998. Another study, published by the Harvard School of Health in the Archives Of Internal Medicine (March 26, 2001) found that many consumers feel so strongly about the potential health benefits of supplements that they would continue to take them even if they were shown to be ineffective in scientifically conducted clinical studies. Respondents also said they do not discuss the use of dietary supplements with their physicians because they believe doctors know little or nothing about the products and may be biased against them.
While it's reassuring to know that most consumers have taken the bad media about supplements with a grain of salt, there is also strong evidence that consumers are looking for greater assurance that the products they take are safe and effective. The Harvard study reported that as loyal as consumers are to the idea that supplements benefit their health, the majority would welcome new laws empowering the Food and Drug Administration to review the safety of new dietary supplements prior to their sale. Consumers also told researchers that FDA should have more authority to remove from sale those products shown to be unsafe. Further, they believe that more government regulation is necessary to ensure that advertising claims are true about the health benefits of dietary supplements.
Globally, the regulatory approach to herbals varies greatly. By way of comparison, herbals are regulated as dietary supplements in the U.S., while in some markets around the world botanical products are regulated under systems that give them a status similar to OTC drugs. In Germany and Sweden, for example, herbals require registration and marketers of herbal products are required to provide authorities with comprehensive details of the manufacturing process (usually in the form of a Drug Master File [DMF] from the manufacturer), including stability and safety data as well as proof of efficacy data either through clinical trials or by proof of traditional use. In other European countries, the status of herbals is less clearly defined.
But Europe-wide legislation may not be too far away. Current EU directives on supplements focuses on vitamins and minerals, but the directive is clearly structured in such a way that herbals can be added to the list of specifically named compounds in the future. Indeed, herbals as a broad category is already mentioned within the directive. In addition, in 1997 the European Agency for the Evaluation of Medicinal Products (EMEA) established an Ad Hoc Working Group on Herbal Medicinal Products to discuss the ESCOP and WHO monographs for herbal medicinal and to establish a framework for good manufacturing practice (GMP) requirements, thus shifting the focus on ensuring quality of input (rather than measuring quality of output).
The Harvard survey and others like it point out the real question all dietary marketers face today. How can consumer confidence in the quality of their products be restored?
There is an answer. The supplement industry must look to due diligence through quality control to ensure that every product that appears in the marketplace meets high quality standards. Otherwise, consumers will reach a point where they stop believing in supplements, a position none of us wants to explore.
Due diligence is a legal phrase that means, "Do everything possible to make sure that what you say is the truth." Hipocrates, founder of the modern medical profession (which herbal medicine predates by thousands of years), expressed an aspect of due diligence as part of the physicians' oath when he said, "Above all, do no harm." When a supplement product appears on FDA's MedWatch web site, this oath is violated to the detriment of the entire industry. When a supplement appears in a negative story in the media, no matter how small the transgression, all supplements are branded with the labels "unsafe," "ineffective" and "unregulated."
Restoring consumer confidence will not be easy. But as seen in the Harvard research, consumers want to believe that supplements will improve their health and well-being. If they haven't already, supplement manufacturers must take the necessary steps to ensure the quality of their products. In more concrete terms, the industry must make certain that all ingredients are safe and efficacious…from the time they arrive at the receiving bay to the time filled cartons leave the loading dock.
In a sense, basic quality control for dietary supplements is more complicated than for pharmaceuticals or food. Where pharmaceuticals are often single-entity compounds that are easily quantified and food products are made from ingredients that the FDA has recognized as safe and that can be analyzed through well-established chemical methods, dietary supplements are made from natural botanicals that defy simple chemical analysis.
For example, many products with St. John's Wort claim to contain 0.3% of the marker compound hypericin. Suppose two bench chemists analyze the same sample, one using photometric assay, the other using high performance liquid chromatography (HPLC). The results should be identical: 0.3% hypericin. However, the analytical methods are different and yield significantly different results.
The industry recognizes the difficulties in testing herbals and is rapidly developing standards and test methods. The Institute for Nutraceutical Advancement(INA) was among the first to work on validity standards and many in the industry visit the INA website for guidance. In addition, the US Pharmacopoeia, AOAC and NSF International have all recently announced standards programs.
The efforts of these and other groups will take time to come to fruition. In the meantime, the lack of standards has resulted in a cry for FDA to formalize good manufacturing practices with guidelines for quality control. Indeed, GMPs are on the FDA's list of priorities for 2001; however, GMPs have been in development since 1994 and there is little hope that finished standards will be released by the end of the year.
Given these obstacles, what can a supplement company do to ensure consumer confidence in supplements? Supplement manufacturers who are serious about tackling these issues of quality, safety and efficacy should ensure due diligence through their supply chain. Initially, it is vital to learn as much as possible about raw material suppliers before you contract their services. This approach filters out substandard material before it arrives at your door.
The following is a step-by-step guide to due diligence in the manufacture of herbal extracts and must form part of supplement manufacturers' own supply chain audits. There are five basic steps: confirm the identity of material, confirm potency, determine purity, verify safety and document results.
Strict raw herb sourcing is vital to ensure the efficacy and safety of an herbal extract. The pharmacological activity and safety profile of an extract is often genus and species specific. Two botanical species with completely different chemical profiles may look very alike; a healing herb and a toxic plant can easily be confused by the inexperienced eye. Botanists and other experts should be employed to confirm the identity of raw materials. And raw materials should be subjected to organoleptic tests for species classification prior to final testing by chemical analysis.
Once the identity of the raw material has been confirmed, the material must be tested for potency, a quantitative measure of the active ingredients and/or marker compounds that make up a particular type of material. One of the classic problems with analyzing herbal material is determining which compounds to measure. Linnea extracts, for example, are the result of broad spectrum extraction, so that not only are key actives and markers included in the material, but a full complement of compounds characteristic of the raw herb as well.
Purity and safety testing is essential to ensure that material is unadulterated and uncontaminated. Supplements have an excellent history, but adulteration and contamination can occur. Contamination, for example, can be a result of exposure to pesticide or other chemical residues. Growers can inadvertently introduce heavy metal pollutants when previously contaminated soil is cultivated. Exposure to microbiological contamination at any point from field to final product is a primary concern and requires constant vigilance, good housekeeping and manufacturing practices, as well as constant controls.
A sound quality assurance program has a number of elements that ensure the quality of the finished product. Good quality control means continuous monitoring during the manufacturing process, in accordance with GMP, so that all quality procedures are in place. Comprehensive analytical and manufacturing data are essential to ensure batch-to-batch consistency of actives, high purity and low residues. These are all vital elements for products often designed for prolonged periods of use.
Testing should be carried out using methods accepted and validated according to international protocols. Finally, after all tests have been performed, the results must be carefully documented. True adherence to due diligence demands proper documentation in accordance with GMP. Adherence to pharmaceutical documentation procedures ensures the validity of test results and ensures complete batch to batch traceability. This data also provides the basis for ongoing product refinement and improvement. One of the reasons many of the highest quality botanicals come from Europe is, quite simply, that Europeans have been manufacturing botanical extracts to pharmaceutical standards for decades.
From raw herb to finished extract, there must be no compromise. By manufacturing better botanicals, we as an industry can establish new levels of acceptance and consumer confidence in our products. With the spotlight so bright on the dietary supplement industry, there can be no trade-off on quality. Only by establishing high levels of product quality, safety and efficacy can the question of consumer confidence be put to rest.NW
About the author:
Robin Ward is marketing manager at Linnea, Inc., Riazzino, Switzerland, a manufacturer of natural botanical extracts for the pharmaceutical, dietary supplement and cosmetics industries. He can be reached Linnea, Via Cantonale, 6595 Riazzino (Locarno),Switzerland; 41-91-850-5050; Fax: 41-91-850-5070; E-mail: rward@linnea-worldwide.com.
While it's reassuring to know that most consumers have taken the bad media about supplements with a grain of salt, there is also strong evidence that consumers are looking for greater assurance that the products they take are safe and effective. The Harvard study reported that as loyal as consumers are to the idea that supplements benefit their health, the majority would welcome new laws empowering the Food and Drug Administration to review the safety of new dietary supplements prior to their sale. Consumers also told researchers that FDA should have more authority to remove from sale those products shown to be unsafe. Further, they believe that more government regulation is necessary to ensure that advertising claims are true about the health benefits of dietary supplements.
Globally, the regulatory approach to herbals varies greatly. By way of comparison, herbals are regulated as dietary supplements in the U.S., while in some markets around the world botanical products are regulated under systems that give them a status similar to OTC drugs. In Germany and Sweden, for example, herbals require registration and marketers of herbal products are required to provide authorities with comprehensive details of the manufacturing process (usually in the form of a Drug Master File [DMF] from the manufacturer), including stability and safety data as well as proof of efficacy data either through clinical trials or by proof of traditional use. In other European countries, the status of herbals is less clearly defined.
But Europe-wide legislation may not be too far away. Current EU directives on supplements focuses on vitamins and minerals, but the directive is clearly structured in such a way that herbals can be added to the list of specifically named compounds in the future. Indeed, herbals as a broad category is already mentioned within the directive. In addition, in 1997 the European Agency for the Evaluation of Medicinal Products (EMEA) established an Ad Hoc Working Group on Herbal Medicinal Products to discuss the ESCOP and WHO monographs for herbal medicinal and to establish a framework for good manufacturing practice (GMP) requirements, thus shifting the focus on ensuring quality of input (rather than measuring quality of output).
The Harvard survey and others like it point out the real question all dietary marketers face today. How can consumer confidence in the quality of their products be restored?
There is an answer. The supplement industry must look to due diligence through quality control to ensure that every product that appears in the marketplace meets high quality standards. Otherwise, consumers will reach a point where they stop believing in supplements, a position none of us wants to explore.
What is Due Diligence?
Due diligence is a legal phrase that means, "Do everything possible to make sure that what you say is the truth." Hipocrates, founder of the modern medical profession (which herbal medicine predates by thousands of years), expressed an aspect of due diligence as part of the physicians' oath when he said, "Above all, do no harm." When a supplement product appears on FDA's MedWatch web site, this oath is violated to the detriment of the entire industry. When a supplement appears in a negative story in the media, no matter how small the transgression, all supplements are branded with the labels "unsafe," "ineffective" and "unregulated."
Restoring consumer confidence will not be easy. But as seen in the Harvard research, consumers want to believe that supplements will improve their health and well-being. If they haven't already, supplement manufacturers must take the necessary steps to ensure the quality of their products. In more concrete terms, the industry must make certain that all ingredients are safe and efficacious…from the time they arrive at the receiving bay to the time filled cartons leave the loading dock.
In a sense, basic quality control for dietary supplements is more complicated than for pharmaceuticals or food. Where pharmaceuticals are often single-entity compounds that are easily quantified and food products are made from ingredients that the FDA has recognized as safe and that can be analyzed through well-established chemical methods, dietary supplements are made from natural botanicals that defy simple chemical analysis.
For example, many products with St. John's Wort claim to contain 0.3% of the marker compound hypericin. Suppose two bench chemists analyze the same sample, one using photometric assay, the other using high performance liquid chromatography (HPLC). The results should be identical: 0.3% hypericin. However, the analytical methods are different and yield significantly different results.
The industry recognizes the difficulties in testing herbals and is rapidly developing standards and test methods. The Institute for Nutraceutical Advancement(INA) was among the first to work on validity standards and many in the industry visit the INA website for guidance. In addition, the US Pharmacopoeia, AOAC and NSF International have all recently announced standards programs.
The efforts of these and other groups will take time to come to fruition. In the meantime, the lack of standards has resulted in a cry for FDA to formalize good manufacturing practices with guidelines for quality control. Indeed, GMPs are on the FDA's list of priorities for 2001; however, GMPs have been in development since 1994 and there is little hope that finished standards will be released by the end of the year.
Given these obstacles, what can a supplement company do to ensure consumer confidence in supplements? Supplement manufacturers who are serious about tackling these issues of quality, safety and efficacy should ensure due diligence through their supply chain. Initially, it is vital to learn as much as possible about raw material suppliers before you contract their services. This approach filters out substandard material before it arrives at your door.
Manufacturing Better Botanicals: The Basic Steps
The following is a step-by-step guide to due diligence in the manufacture of herbal extracts and must form part of supplement manufacturers' own supply chain audits. There are five basic steps: confirm the identity of material, confirm potency, determine purity, verify safety and document results.
Strict raw herb sourcing is vital to ensure the efficacy and safety of an herbal extract. The pharmacological activity and safety profile of an extract is often genus and species specific. Two botanical species with completely different chemical profiles may look very alike; a healing herb and a toxic plant can easily be confused by the inexperienced eye. Botanists and other experts should be employed to confirm the identity of raw materials. And raw materials should be subjected to organoleptic tests for species classification prior to final testing by chemical analysis.
Once the identity of the raw material has been confirmed, the material must be tested for potency, a quantitative measure of the active ingredients and/or marker compounds that make up a particular type of material. One of the classic problems with analyzing herbal material is determining which compounds to measure. Linnea extracts, for example, are the result of broad spectrum extraction, so that not only are key actives and markers included in the material, but a full complement of compounds characteristic of the raw herb as well.
Purity and safety testing is essential to ensure that material is unadulterated and uncontaminated. Supplements have an excellent history, but adulteration and contamination can occur. Contamination, for example, can be a result of exposure to pesticide or other chemical residues. Growers can inadvertently introduce heavy metal pollutants when previously contaminated soil is cultivated. Exposure to microbiological contamination at any point from field to final product is a primary concern and requires constant vigilance, good housekeeping and manufacturing practices, as well as constant controls.
A sound quality assurance program has a number of elements that ensure the quality of the finished product. Good quality control means continuous monitoring during the manufacturing process, in accordance with GMP, so that all quality procedures are in place. Comprehensive analytical and manufacturing data are essential to ensure batch-to-batch consistency of actives, high purity and low residues. These are all vital elements for products often designed for prolonged periods of use.
Testing should be carried out using methods accepted and validated according to international protocols. Finally, after all tests have been performed, the results must be carefully documented. True adherence to due diligence demands proper documentation in accordance with GMP. Adherence to pharmaceutical documentation procedures ensures the validity of test results and ensures complete batch to batch traceability. This data also provides the basis for ongoing product refinement and improvement. One of the reasons many of the highest quality botanicals come from Europe is, quite simply, that Europeans have been manufacturing botanical extracts to pharmaceutical standards for decades.
From raw herb to finished extract, there must be no compromise. By manufacturing better botanicals, we as an industry can establish new levels of acceptance and consumer confidence in our products. With the spotlight so bright on the dietary supplement industry, there can be no trade-off on quality. Only by establishing high levels of product quality, safety and efficacy can the question of consumer confidence be put to rest.NW
About the author:
Robin Ward is marketing manager at Linnea, Inc., Riazzino, Switzerland, a manufacturer of natural botanical extracts for the pharmaceutical, dietary supplement and cosmetics industries. He can be reached Linnea, Via Cantonale, 6595 Riazzino (Locarno),Switzerland; 41-91-850-5050; Fax: 41-91-850-5070; E-mail: rward@linnea-worldwide.com.
