Rebecca Wright05.01.07
When one thinks of "testing" these days the efforts of ConsumerLab.com, White Plains, NY, immediately come to mind. And like them or not, most people agree that this company has generated widespread awareness for the role-good or bad-testing plays in the dietary supplement industry.
Now, as a result consumer demand rather than government enforcement, companies are rearranging their priorities on the testing front, many spending more money in the hopes that in building stronger testing programs in-house or with a contract laboratory, growth in consumer confidence will eventually follow. If things proceed accordingly, experts claim a more legitimate industry will reveal itself in the years ahead.
Testing, for lack of a better description, is enormously complex. So before assessing the state of the market, it is important to know exactly what's involved. In the mind of Tim Romero, president, Integrity Nutraceuticals, Sarasota, FL, nutraceuticals and dietary supplements represent areas of big concern, particularly in the world of analytical science. "Basic quality testing for nutraceuticals and dietary supplements primarily consists of identification, purity and microbial testing. Beyond this, there are tests such as impurity (pesticides and other residuals), heavy metals and filth analysis," he explained. "If testing is performed at all, it would mostly be of a basic nature. It is rare for a company to have full analytical and microbial capability. As a result, some companies may use third party laboratories as a point of quality assurance."
Dr. Sidney Sudberg, lab director, Alkemists Pharmaceuticals, Costa Mesa, CA, agrees that there are many facets to nutraceutical testing due to the broad range or scope of what is defined as a "nutraceutical." He said that the testing of individual vitamin, mineral, amino acid and related single chemical entities is fairly straightforward and allows for analytical method development and validation in a regulated environment similar to that implemented by the pharmaceutical industry for drugs. However, the real challenges arise when trying to analyze/assay individual components of a finished product manufactured within a complex matrix of food-based materials.
"And then there are all the botanicals, which by their very nature are multi-component or constituent complex materials," Dr. Sudberg said. "For example within a same herbal species, levels of secondary metabolites are strongly influenced and can vary significantly by season, growing conditions and location, and finally, depending on the age of the plants. All this makes the analysis of botanicals no simple task."
Jason Lilly, PhD, MBA, director of business development, Neogen Corporation-Food Safety Division, Lansing, MI, added his perspectives on some of the newer requirements on the testing front. "The chemistry side usually comprises minimum guaranteed analysis, bioavailability, chemical profiling, shelf life and toxicity analysis," he said. "Two chemical areas that are beginning to attract more attention in the dietary supplement space, as they have for many years in the food industry, are allergens and mycotoxins."
The Food Allergen Labeling and Consumer Protection Act of 2004 (under the Senate bill S. 741) now requires food manufacturers to clearly label food products using common names to describe the presence of the eight major food allergens (i.e., tree nuts, milk, egg, soy, shellfish, wheat gluten/gliadin and finfish). Mr. Lilly pointed out that while this labeling issue mostly impacts functional food companies that manufacture powders with milk, egg, or soy proteins, and those who include peanuts or tree nuts in their final product, the regulation also underlines the importance of controlling the manufacturing process to eliminate potential cross-contamination.
From a "report card" standpoint, the testing outfits interviewed for this article assigned the dietary supplement industry an average grade of a "C" in the testing department. While most people agree that the state of the market is far better than just five years ago, there are still several companies that don't even have testing programs in place. In addition, adulteration, and to a lesser extent contamination, are still problematic.
The lack of testing on the part of some companies, some experts claim, can probably be attributed to one of three factors: ignorant neglect, neglect or malicious neglect. Whatever the reason, at the end of the day what suffers most is consumer confidence, which impacts the entire industry. "The public is very concerned about the state of food 'safety' in the U.S. at present. The quantity and extent of food product recalls harkens to the need for increased due diligence by companies from all segments," said Dr. Lilly. "Historically food diagnostic testing was conducted due to regulatory guidelines, but now we see numerous multinational organizations investing in their quality programs in an effort to increase consumer confidence. The nutraceuticals industry is no different, and basic regulation needs to be put in place so that all companies are held to the same core standards."
Until then, Darryl Sullivan, senior manager, Covance Laboratories, Madison, WI, believes there needs to be greater commitment from raw material suppliers and manufacturers to ensure that consumers get what they paid for-no more surprises. "As far as where companies are failing, I think some of them are misrepresenting their products, followed by a far fewer number that are dealing with contamination issues," he said. "Failing on label claim is one thing, but a contaminated product can significantly impact sales, or worse, put you out of business."
Interestingly, Mr. Sullivan points out that most companies fail on label claim because they don't put in the necessary overages, instead choosing to formulate at 100% of label claim at the time of manufacture. Because companies often neglect to carry out shelf-life testing, the products can fail on label claim after a certain period of time simply because some of the ingredients in the product may have degraded.
Actions like these leave products vulnerable, particularly if they are selected for random off-the-shelf testing by high profile companies like ConsumerLab.com. Indeed, products that fall short of label claim are often highlighted in reviews conducted by the company. In fact, it recently released a report on arthritis supplements in which it claimed 40% of the products tested were found to lack all or some of their key ingredients. Dr. William Obermeyer, the company's vice president for research, attributed the problems to cost cutting and using non-specific tests to certify chondroitin. "To cut costs, some manufacturers may withhold chondroitin, which is expensive, or buy poor quality material 'certified' with a non-specific test for chondroitin," he said. A common test known as the CPC titration method, said Dr. Obermeyer, is easily tricked by sulfate-containing compounds. ConsumerLab.com avoided this issue by analyzing products with a highly specific test for chondroitin based on high performance liquid chromatography, or HPLC.
The use of non-specific tests raises another issue in the realm of testing. "Many manufacturers still rely on questionable certificates of analysis (CofAs), which probably explains a lot of the problems we are seeing with chondroitin. Manufacturers are either dumb or playing dumb by relying on those results," said Tod Cooperman, president, ConsumerLab.com. "A really good manufacturer will not only make sure the CofA used the right method, but it will also test the material in-house or submit it to a third party as a back-up measure. In the end, I think it's up to manufacturers to demand high quality materials. And there definitely are good materials out there, it's just a matter of whether or not manufacturers choose to purchase those materials."
Following an analytical testing meeting held at Expo West in March, a group of experts decided to organize efforts to address fundamental issues of test method validation, reference material verification and training programs. They hope this initiative, being referred to as the Analytical Research Collective (ARC), will catapult the dietary supplement industry to a new level of confidence in product quality. "I strongly believe that if we had more of these types of meetings we would avoid a lot of the negative press such as the recent MSNBC article surrounding the ConsumerLab.com report of joint supplements," said Jana Hildreth of Blaze Science Industries, LLC. The ARC product quality initiative will focus initially on analytical methods development and validation, with activities being coordinated by Ms. Hildreth.
Still, if all companies were to exercise tight control over their manufacturing process and use quality materials, Srini Srinivasan, vice president of USP's (Rockville, MD) Dietary Supplement Verification Program, believes a lot of the issues surrounding label claim and contamination would disappear. "If you are following all the right steps and procedures, and using consistent quality raw materials, then your finished product should reflect that," he said. "A quality control program solely based on testing is not the whole solution."
USP developed its Verification Program several years ago to make sure dietary supplement products contain the ingredients listed, in the declared strengths and amounts; that they do not contain harmful levels of contaminants; that they will break down and release ingredients in the body within a specified amount of time; and that these products have been made under GMPs.
The merits of this program have been acknowledged industry-wide. And in January this year the program was further legitimized through USP's collaboration with the Therapeutic Research Center and Consumer Reports, which will both include the USP Verified Mark in their nationally-recognized online health databases: Natural Medicines Comprehensive Database and ConsumerReportsMedicalGuide.org. The mark will appear next to dietary supplement products that have passed USP's verification process. According to USP, inclusion of the green and gold USP Verified Mark in the databases provides health professionals and consumers with an additional means of identifying supplements that have met rigorous testing requirements for purity, potency and quality. Currently, consumers can find the mark on over 800 items on pharmacy and retail shelves throughout the U.S.
As mentioned previously, the analysis of vitamins, minerals and amino acids is relatively routine in today's marketplace. By and large, companies are using similar standards to identify materials and assess potency and purity. Herbs and botanicals, on the other hand, are a totally different story.
Dr. Sudberg from Alkemists applies what he calls the "analytical triad" to the testing of botanicals. By combining three very informative analytical techniques, he says it is possible to offer a greater level of confidence to the correct selection and identification of any herb that a company is using as an ingredient in its product line. This triad also allows for monitoring of plant quality during process and manufacturing of the finished product.
The first of the three tests he suggests is microscopic analysis, which looks at the unique anatomical structures of the raw individual herb to differentiate it from a related herb or species and/or to rule out contamination, filth, adulteration, etc. The second test is high performance thin-layer chromatography (HPTLC), which is used as a chemical fingerprinting method to reveal the unique chemical profile of each herb analyzed and compare it to an authentic sample to confirm its identity and/or quality. The third test Alkemists uses is HPLC, which has the capacity to identify and quantify representative and specific constituents of the herb of interest. This too can be applied as a "fingerprint" method for further confirmation of identity.
Dr. Sudberg believes these three tests can be used in any combination or all together depending upon the level of confidence required. For example, if an herb is processed into a powdered or liquid extract then you only need two of the three tests previously described since there are no anatomical features to analyze microscopically. He also points out that in some specific cases, this "analytical triad" might not be able to distinguish between very closely related species and further analytical testing might be needed.
Continuing in the vein of herbs and botanicals, Kerri LeVanseler, technical manager, NSF Chemistry Lab, Ann Arbor, MI, discussed the need for appropriate reference standards. "Botanical reference materials with known and documented plant species identification are needed for comparison when assessing the identification of materials under test. Purified reference standards of specific chemicals are needed for instrument calibration and serve as the basis for doing quantitative measurements," she said. "The American Herbal Pharmacopoeia and ChromaDex have often been valuable in fulfilling these needs. Still, for unusual plant species or components, the unavailability of reference standards can prevent the development of test methods."
Skeptically speaking, both David Bell, Bell Advisory Services, and Boxin Ou, PhD, Brunswick Labs, Norton, MA, believe little significant progress has been made in the past 10 years due to high R&D cost and low demand for tests that are not mandatory. But, they commented, "It is interesting to note that the payoff is often great when the hard work is done. The extraordinary growth in the demand for dark chocolate and cocoa products following antioxidant research is a case in point." Unfortunately, Mr. Bell and Dr. Ou consider the industry to be short-sited when it comes to seeing beyond start-up costs in the context of testing and research.
Speaking of research, testing makes a huge difference in the set-up of a clinical trial. Douglas Kalman, MS, RD, director-Nutrition & Applied Clinical Research, Miami Research Associates, Miami, FL, explained, "When you contract with us to do a study, the material being used must be analyzed to make sure it is safe for human consumption and meets label claims before it is sent to an institutional review board (IRB). If a product is rejected then we have to start all over. Thankfully we are not running into issues with quality these days like we were five years ago."
Many companies believe GMPs will remedy a lot of issues on the testing front. In fact, in 2005 when it was rumored that final GMPs would be released, Covance's Mr. Sullivan said companies were busy ramping up testing efforts. He says now that the issuance of final GMPs has become a huge question mark, companies have become complacent and are not allocating as much money for testing as they were a couple of years ago.
But GMPs won't solve all the problems. Frank Jaksch, president, ChromaDex, Irvine, CA, stated, "GMPs alone will not drive changes. Industry will eventually have to police itself, starting at the top. The companies with their name on the label will need to dictate change throughout the supply chain."
Dr. Lilly divided supply chain testing into three stages: raw material testing, in process/HAACP control point analysis and finished product testing. "The first and last periods can result in inventory holding costs that can quickly reduce cash flows and operating profit," he said. "Therefore, manufacturers must go beyond simply asking for CofA's, and hold their suppliers accountable to a standard of acceptance. The reason for this is simple: a plant/operations manager can have complete control over their process, but all of that can be compromised when a product comes into the facility that contains toxins or microbes. In addition, as it has been often demonstrated in the food industry, companies that do not have some level of CofA verification are opening themselves up to raw materials that could lead to higher levels of rework, or potential recalls."
Dr. Lilly also discussed the relative lack of knowledge among companies when it comes to the microbiological side of testing. "While many conventional chemistry methods work just as well for dietary supplements as they do in food commodities, this is not the case for microbiological tests. The nature of the product to be tested (also called "matrix effect") is a huge issue for any manufacturer of botanicals, herbals, enzymes or protein powders. Conventional microbiology cannot mitigate the issues surrounding heavily dyed compounds, granules (which can often be mistaken for a bacterial colony), or extreme pH," he said. "Even rapid 'ready-to-use' plates or agar films, while simplifying the users workflow, do not work with many of the botanicals, minerals, and extracts that must undergo analysis."
Dr. Lilly continued, "We were working with one customer who was using a ready-plate method for a red-wine extract, and we quickly determined that this method was not suitable due to the fact that even when highly diluted, the matrix colored the agar so dark we could not count individual colonies."
There are few analytical methods validated to an official status using multiple laboratories for nutraceutical products or ingredients, which means that in-house labs or outside testing labs are coming up with their own methods and/or using methods detailed in peer-reviewed journals-and perhaps taking the time to validate them in-house.
Very simply, the Natural Products Association, Washington, D.C., defines analytical methods as a means for determining the composition of samples of matter-these methods can be qualitative or quantitative in nature. A qualitative analytical method yields information about the atomic or molecular species or the functional groups that exist in the sample in most instances, while a quantitative method provides information as to the relative amount of one or more of the components or of the measurable in question. The Natural Products Association says further that analytical method validation provides documented evidence that methods used to analyze raw materials, in process sample from work in-progress, or finished products yield consistent and reliable results.
Some feel validated methods for a variety of products/ingredients are on the horizon, while other more skeptical parties don't feel the testing community at large will ever come to consensus on certain methods. In the meantime, Mr. Jaksch says companies continue to make inappropriate choices when it comes to testing methods. "If a company shops around long enough, they'll find a method that gets them an answer they want to hear," he said. "Perhaps the answer lies in defining a list of methods that are not acceptable."
Robert Green, president, Integrated Biomolecule Corporation/IBC Labs, Tucson, AZ, believes the absence of universally accepted analytical methods is an issue, but that it is an industry situation companies need to adapt to. "Peer-reviewed and validated methods take years to complete and there are just too many products in too many forms to expect this situation to resolve itself in the near future. Acknowledging this, supplement companies and labs alike have a joint responsibility of being thorough when it comes to testing a product," he said. "When an analytical lab is asked to test a product for which there is no widely accepted method available, it is the lab's responsibility to implement a responsible method and support its determination."
Mr. Green added, "Methods used are generally based on or adapted from applicable official methods or those published in peer-reviewed journals (maybe the reference method deals with a different matrix or a compound of the same family that the scientist finds can be applied to the product in consideration). If a lab independently develops a method from scratch, as with all testing, the work must be fully documented and thoroughly supported. In these situations, the lab should disclose the origin of the method."
Covance's Mr. Sullivan believes validated methods are the way forward for the dietary supplement industry. "Right now we are seeing different test results because labs are using different methods," he said. "AOAC International is an association that validates analytical methods and companies need to support these efforts."
Expressing a similar point of view was Steven Dentali, PhD, vice president, scientific and technical affairs, American Herbal Products Association (AHPA), Silver Spring, MD, who said, "AOAC multi-laboratory validated analytical methods, where they exist, have demonstrated their ability to produce consistent results when used by different labs for analyzing the same materials. Failing this level of validation, individuals can conduct single lab validations, which tests the performance of a method in that lab. In any case, it's vital for labs to disclose the methods used for the testing of materials and to make available the raw data upon request."
NSF's Ms. LeVanseler also singled out the efforts of AOAC, as well as the American Herbal Pharmacopoeia. "AOAC, with support from the National Institutes of Health-Office of Dietary Supplements, has worked to bring experts together to select methods for thorough single laboratory validation and multi-laboratory collaborative studies," she said, adding, "The American Herbal Pharmacopoeia is also working to validate methods. The method selection approach seeks to harmonize methodology used by obtaining input from other pharmacopoeias and industry sources."
In addition, Ms. LeVanseler said NIST (the National Institute of Standards & Technology) recently began to develop certified reference materials for the dietary supplement industry. "These valuable new resources will allow laboratories to judge the analytical results they obtain against the results obtained by other laboratories in a confidential manner," she said. "This avenue will hopefully lead to improved consistency between labs."
Most labs agree that contamination is not as common as adulteration in today's marketplace-the reason being that contamination typically occurs by accident, while adulteration is most of the time a pre-meditated occurrence.
One of the most recent high profile cases surrounding contamination surfaced in January when ConsumerLab.com revealed results from a supplement review it conducted on multivitamins. Receiving nationwide media play, the company highlighted the fact that one particular product formulated for women contained amounts of lead higher than permitted in the state of California, without including special labeling. ConsumerLab.com's Mr. Cooperman added his thoughts on the contamination issue. "Ninety-nine percent of the problems with supplements today could be avoided by paying closer attention to quality control. In this respect, contamination issues shouldn't even happen," he said. "I can't imagine manufacturers being aware of contamination in their products and still continuing to sell them."
The high profile unveiling of the ConsumerLab.com test results, while not necessarily indicative of an actual public health problem, stirred enormous concern among many groups-it even prompted Representative Henry Waxman (D-CA) to write a letter to FDA commissioner Andrew von Eschenbach about the issue last month.
According to Ian Milnes, president, Chemical Solutions, Ltd., Mechanicsburg, PA, Congressman Waxman's letter specifically addressed the failure of FDA to investigate serious allegations of potentially dangerous levels of lead in some vitamin products. "He also rebuked the FDA, because these findings were not isolated," said Mr. Milnes. "In November 1997, The Natural Resources Defense Council requested that FDA set limits on the amounts of lead allowed in calcium supplements and antacids based of findings that many supplements were contaminated with lead. In addition, in 2004 Robert B. Saper, et al. reported in The Journal of the American Medical Association that they had found extremely high levels of lead and other heavy metals in Ayurvedic herbal medicine products." (It should be noted, according to Dr. Dentali, that it was not disclosed that these products intentionally contained heavy metals and were not legal for importation into the U.S.)
Mr. Milnes added that while Congressman Waxman chided the FDA for taking no meaningful steps to investigate these allegations, he also admitted that there are no uniform standards for permissible amounts of lead or other heavy metals in food or dietary supplements. Instead, there are multiple standards.
Mr. Milnes continued, "Chemical Solutions has been testing trace levels of metals in products for over 10 years and has found that high levels of lead and other heavy metals (cadmium, mercury and arsenic) in herbal products, nutraceuticals and multivitamins are rare but not uncommon."
Adulteration is an issue the industry has been contending with for years, but it is not alone.
"Adulteration in the marketplace has been a problem since there was a marketplace, especially where there is intense competition," said AHPA's Dr. Dentali. "In the supplement industry, adulteration underscores the need for established standards of identifying materials."
Mr. Dentali called for more accessible test methods in the short term. He says while the American Herbal Pharmacopoeia provides a very comprehensive suite of test methods that do the industry a great service, AHPA wants to provide companies with more simplified tests that can be understood by all employees,including (and perhaps especially) purchasing departments. "Right now a lot of people regard testing as unnecessary science and we want to remove that stigma," Dr. Dentali said. "What companies like Switzerland-based CAMAG Laboratory, Alkemists Pharmaceuticals and others are doing in developing HPTLC tests that allow people to see differences in product samples visually is very valuable."
Dr. Eike Reich is head of CAMAG Laboratory, and one of the most recent events his company tackled was the economic adulteration of black cohosh. Adulteration issues, he said, seem to happen a lot faster than industry can move to develop the tests to detect for it. "Once a test has been developed to identify the adulteration, the issue seems to resolve itself," he said.
AHPA has been ahead of the adulteration issue every step of the way. In fact, in its Code of Ethics it provides a list of known adulterants for its members (see Table 1). In the case of black cohosh, AHPA already had a trade recommendation in place before the paper in the Journal of Agricultural & Food Chemistry came out identifying the problem last April. "An AHPA member identified the problem to us, provided the necessary background information to clearly elucidate the problem, and asked what we could do about it. AHPA responded by including this first case of economic adulteration into its policies. The earlier ones all concerned safety issues," Dr. Dentali explained. "The method described to detect adulteration that was published in the Jiang study is very good, but it's not a routine affair and requires highly sophisticated equipment. It would also be expensive if offered commercially. An AHPA committee working group instead, a year ago, approved a CAMAG method as 'capable of differentiating black cohosh extracts from those of Chinese cimicifuga' as a practical way for companies to recognize which is an adulterant and which is the genuine article."
Dr. Dentali says the association is working to develop similar tests that can be used by companies to quickly identify a genuine article from a known adulterant. AHPA hopes to approve them for use in 2007.
Considering these developments, the dietary supplement industry has its work cut out for it. But not to worry, experts say, while testing is a necessary part of doing business, it doesn't have to be as financially burdensome as some make it out to be. "Analytical testing is like paying the electric bill-people may not like to do it, but it is a necessary part of doing business in this industry," said IBC's Mr. Green. "Companies should also keep in mind, however, that testing can serve as cheap insurance."
Speaking of insurance, what if there was a way to reward companies for their testing efforts? Well, a program with exactly that goal is currently in development, according Mr. Jaksch from ChromaDex, who claims to have come up with a pretty persuasive incentive for companies to conduct a high level of testing.
Recently ChromaDex partnered with Poms & Associates Insurance Brokers, Los Angeles, CA, to design a program to offset quality control costs with insurance savings. "The reason why insurance premiums are so high for dietary supplement companies is because there is a high level of risk associated with their products," Mr. Jaksch said.
ChromaDex and Poms have also joined forces with a major A-rated insurance company to underwrite this program. The thinking behind the program goes like this: insurance premiums are based on risk, so if companies commit to spending money on testing, then they should be considered lower risk and therefore pay less for liability insurance.
"Companies will be interested in this program because they don't want to spend the same amount of money on liability insurance as a less-than-reputable competitor. We truly believe the good guys are going to step up and embrace this," said Greg Doherty, dietary supplement practice leader, Poms & Associates Insurance Brokers. "I think this could be a good way to help the industry rid itself of the 'Wild West' image that's been following it for years."
This idea of rewarding companies that conduct testing is obviously a good one, especially in light of product liability litigation. Tom Delaney, a partner with the law firm Sedgwick, Detert, Moran & Arnold, Orange County, CA, says a program like this actually makes his job easier and should be a no-brainer for companies. "Pre-market testing sends a signal that industry members are increasingly engaging in self-regulation which, in turn, may ultimately remove the industry as a litigation target. In other words, lawyers may think twice about suing a company that engages in responsible manufacturing," he said. "Pre-market testing is simply one of the best things companies can do to minimize their liability."
Ultimately, Mr. Delaney believes the program will be well received if industry members recognize the value in terms of risk management and marketing safe products, as well as saving immediate dollars up front on insurance premiums.
Currently, there's no official name for the program, but there are two pilot companies working through it. By the Fall, Mr. Doherty hopes to officially roll the program out to the entire industry.
Given the state of the market, most experts believe it can only get better from here. In the spirit of cooperation, Dan Fabricant, vice president, Scientific Affairs, Natural Products Association, said, "The more people get out there and develop relationships, the more the analytical testing conversation evolves. I think you are starting to see more collaboration, especially with AOAC bringing people to the table to talk this out. I hope we see more of this in the future."
Both Brian Frisby, business development manager, Capsugel, Americas Region, Greenwood, SC, and George Stevens, quality assurance manager for Licaps, Capsugel, Americas Region, believe the next several years will bring mandatory testing, consolidation and a rapid increase in new testing labs and GMP consultants.
With regard to mandatory testing, Capsugel's Mr. Frisby pointed out that if and when the new GMPs are published, testing may be mandatory rather than an option. In fact, he said, "There is reason to believe that the dietary supplement industry will be held to a high-if not higher-standard than the Rx industry in terms of materials. Rather than spot testing, all materials will be tested lot by lot and process testing also will be uniform across the board. There will be the same amount of ingredients in all products and blending instructions will be standardized," he said. "There will be standardized recipes and processes-like making a cake. If you don't blend a product enough or for too long, it will be a different product."
As far as consolidation, Mr. Stevens says the industry consensus is that such strident standards will "winnow out" companies. "Smaller companies without the means and resources could fold," he said, adding, "On the other hand, smaller companies with excellent products could also cut acquisition deals with larger companies."
Mr. Stevens also commented on the projected boom in new testing labs and GMP consultants. "Companies can prepare by thinking ahead-develop their own testing methods or labs now and/or find a lab to test for a fee," he said. "In this climate, the industry could see a boom in new independent labs and GMP consultants."
For the future, Dr. Sudberg remains concerned about the increasing influence of the pharmaceutical industry and its "single chemical entity model" on the development and monitoring of dietary supplements. "The nutraceuticals industry should not narrow its focus to only a few lead compounds isolated/extracted from the plant but keep in mind instead the broad spectrum approach that nature has to healing," he commented. "The industry needs to develop collaboration between herbalists, phytochemists, pharmacognosists, product formulators and manufacturers to develop within the next 10 years analytical testing procedures that are universally agreed upon by all parties and that are 'fit for the purpose' of what the intended testing needs to accomplish."NW
Now, as a result consumer demand rather than government enforcement, companies are rearranging their priorities on the testing front, many spending more money in the hopes that in building stronger testing programs in-house or with a contract laboratory, growth in consumer confidence will eventually follow. If things proceed accordingly, experts claim a more legitimate industry will reveal itself in the years ahead.
An Industry Under the Microscope
Testing, for lack of a better description, is enormously complex. So before assessing the state of the market, it is important to know exactly what's involved. In the mind of Tim Romero, president, Integrity Nutraceuticals, Sarasota, FL, nutraceuticals and dietary supplements represent areas of big concern, particularly in the world of analytical science. "Basic quality testing for nutraceuticals and dietary supplements primarily consists of identification, purity and microbial testing. Beyond this, there are tests such as impurity (pesticides and other residuals), heavy metals and filth analysis," he explained. "If testing is performed at all, it would mostly be of a basic nature. It is rare for a company to have full analytical and microbial capability. As a result, some companies may use third party laboratories as a point of quality assurance."
Dr. Sidney Sudberg, lab director, Alkemists Pharmaceuticals, Costa Mesa, CA, agrees that there are many facets to nutraceutical testing due to the broad range or scope of what is defined as a "nutraceutical." He said that the testing of individual vitamin, mineral, amino acid and related single chemical entities is fairly straightforward and allows for analytical method development and validation in a regulated environment similar to that implemented by the pharmaceutical industry for drugs. However, the real challenges arise when trying to analyze/assay individual components of a finished product manufactured within a complex matrix of food-based materials.
"And then there are all the botanicals, which by their very nature are multi-component or constituent complex materials," Dr. Sudberg said. "For example within a same herbal species, levels of secondary metabolites are strongly influenced and can vary significantly by season, growing conditions and location, and finally, depending on the age of the plants. All this makes the analysis of botanicals no simple task."
Jason Lilly, PhD, MBA, director of business development, Neogen Corporation-Food Safety Division, Lansing, MI, added his perspectives on some of the newer requirements on the testing front. "The chemistry side usually comprises minimum guaranteed analysis, bioavailability, chemical profiling, shelf life and toxicity analysis," he said. "Two chemical areas that are beginning to attract more attention in the dietary supplement space, as they have for many years in the food industry, are allergens and mycotoxins."
The Food Allergen Labeling and Consumer Protection Act of 2004 (under the Senate bill S. 741) now requires food manufacturers to clearly label food products using common names to describe the presence of the eight major food allergens (i.e., tree nuts, milk, egg, soy, shellfish, wheat gluten/gliadin and finfish). Mr. Lilly pointed out that while this labeling issue mostly impacts functional food companies that manufacture powders with milk, egg, or soy proteins, and those who include peanuts or tree nuts in their final product, the regulation also underlines the importance of controlling the manufacturing process to eliminate potential cross-contamination.
From a "report card" standpoint, the testing outfits interviewed for this article assigned the dietary supplement industry an average grade of a "C" in the testing department. While most people agree that the state of the market is far better than just five years ago, there are still several companies that don't even have testing programs in place. In addition, adulteration, and to a lesser extent contamination, are still problematic.
The lack of testing on the part of some companies, some experts claim, can probably be attributed to one of three factors: ignorant neglect, neglect or malicious neglect. Whatever the reason, at the end of the day what suffers most is consumer confidence, which impacts the entire industry. "The public is very concerned about the state of food 'safety' in the U.S. at present. The quantity and extent of food product recalls harkens to the need for increased due diligence by companies from all segments," said Dr. Lilly. "Historically food diagnostic testing was conducted due to regulatory guidelines, but now we see numerous multinational organizations investing in their quality programs in an effort to increase consumer confidence. The nutraceuticals industry is no different, and basic regulation needs to be put in place so that all companies are held to the same core standards."
Until then, Darryl Sullivan, senior manager, Covance Laboratories, Madison, WI, believes there needs to be greater commitment from raw material suppliers and manufacturers to ensure that consumers get what they paid for-no more surprises. "As far as where companies are failing, I think some of them are misrepresenting their products, followed by a far fewer number that are dealing with contamination issues," he said. "Failing on label claim is one thing, but a contaminated product can significantly impact sales, or worse, put you out of business."
Interestingly, Mr. Sullivan points out that most companies fail on label claim because they don't put in the necessary overages, instead choosing to formulate at 100% of label claim at the time of manufacture. Because companies often neglect to carry out shelf-life testing, the products can fail on label claim after a certain period of time simply because some of the ingredients in the product may have degraded.
Actions like these leave products vulnerable, particularly if they are selected for random off-the-shelf testing by high profile companies like ConsumerLab.com. Indeed, products that fall short of label claim are often highlighted in reviews conducted by the company. In fact, it recently released a report on arthritis supplements in which it claimed 40% of the products tested were found to lack all or some of their key ingredients. Dr. William Obermeyer, the company's vice president for research, attributed the problems to cost cutting and using non-specific tests to certify chondroitin. "To cut costs, some manufacturers may withhold chondroitin, which is expensive, or buy poor quality material 'certified' with a non-specific test for chondroitin," he said. A common test known as the CPC titration method, said Dr. Obermeyer, is easily tricked by sulfate-containing compounds. ConsumerLab.com avoided this issue by analyzing products with a highly specific test for chondroitin based on high performance liquid chromatography, or HPLC.
The use of non-specific tests raises another issue in the realm of testing. "Many manufacturers still rely on questionable certificates of analysis (CofAs), which probably explains a lot of the problems we are seeing with chondroitin. Manufacturers are either dumb or playing dumb by relying on those results," said Tod Cooperman, president, ConsumerLab.com. "A really good manufacturer will not only make sure the CofA used the right method, but it will also test the material in-house or submit it to a third party as a back-up measure. In the end, I think it's up to manufacturers to demand high quality materials. And there definitely are good materials out there, it's just a matter of whether or not manufacturers choose to purchase those materials."
Following an analytical testing meeting held at Expo West in March, a group of experts decided to organize efforts to address fundamental issues of test method validation, reference material verification and training programs. They hope this initiative, being referred to as the Analytical Research Collective (ARC), will catapult the dietary supplement industry to a new level of confidence in product quality. "I strongly believe that if we had more of these types of meetings we would avoid a lot of the negative press such as the recent MSNBC article surrounding the ConsumerLab.com report of joint supplements," said Jana Hildreth of Blaze Science Industries, LLC. The ARC product quality initiative will focus initially on analytical methods development and validation, with activities being coordinated by Ms. Hildreth.
Still, if all companies were to exercise tight control over their manufacturing process and use quality materials, Srini Srinivasan, vice president of USP's (Rockville, MD) Dietary Supplement Verification Program, believes a lot of the issues surrounding label claim and contamination would disappear. "If you are following all the right steps and procedures, and using consistent quality raw materials, then your finished product should reflect that," he said. "A quality control program solely based on testing is not the whole solution."
USP developed its Verification Program several years ago to make sure dietary supplement products contain the ingredients listed, in the declared strengths and amounts; that they do not contain harmful levels of contaminants; that they will break down and release ingredients in the body within a specified amount of time; and that these products have been made under GMPs.
The merits of this program have been acknowledged industry-wide. And in January this year the program was further legitimized through USP's collaboration with the Therapeutic Research Center and Consumer Reports, which will both include the USP Verified Mark in their nationally-recognized online health databases: Natural Medicines Comprehensive Database and ConsumerReportsMedicalGuide.org. The mark will appear next to dietary supplement products that have passed USP's verification process. According to USP, inclusion of the green and gold USP Verified Mark in the databases provides health professionals and consumers with an additional means of identifying supplements that have met rigorous testing requirements for purity, potency and quality. Currently, consumers can find the mark on over 800 items on pharmacy and retail shelves throughout the U.S.
Testing Issues
As mentioned previously, the analysis of vitamins, minerals and amino acids is relatively routine in today's marketplace. By and large, companies are using similar standards to identify materials and assess potency and purity. Herbs and botanicals, on the other hand, are a totally different story.
Dr. Sudberg from Alkemists applies what he calls the "analytical triad" to the testing of botanicals. By combining three very informative analytical techniques, he says it is possible to offer a greater level of confidence to the correct selection and identification of any herb that a company is using as an ingredient in its product line. This triad also allows for monitoring of plant quality during process and manufacturing of the finished product.
The first of the three tests he suggests is microscopic analysis, which looks at the unique anatomical structures of the raw individual herb to differentiate it from a related herb or species and/or to rule out contamination, filth, adulteration, etc. The second test is high performance thin-layer chromatography (HPTLC), which is used as a chemical fingerprinting method to reveal the unique chemical profile of each herb analyzed and compare it to an authentic sample to confirm its identity and/or quality. The third test Alkemists uses is HPLC, which has the capacity to identify and quantify representative and specific constituents of the herb of interest. This too can be applied as a "fingerprint" method for further confirmation of identity.
Dr. Sudberg believes these three tests can be used in any combination or all together depending upon the level of confidence required. For example, if an herb is processed into a powdered or liquid extract then you only need two of the three tests previously described since there are no anatomical features to analyze microscopically. He also points out that in some specific cases, this "analytical triad" might not be able to distinguish between very closely related species and further analytical testing might be needed.
Continuing in the vein of herbs and botanicals, Kerri LeVanseler, technical manager, NSF Chemistry Lab, Ann Arbor, MI, discussed the need for appropriate reference standards. "Botanical reference materials with known and documented plant species identification are needed for comparison when assessing the identification of materials under test. Purified reference standards of specific chemicals are needed for instrument calibration and serve as the basis for doing quantitative measurements," she said. "The American Herbal Pharmacopoeia and ChromaDex have often been valuable in fulfilling these needs. Still, for unusual plant species or components, the unavailability of reference standards can prevent the development of test methods."
Skeptically speaking, both David Bell, Bell Advisory Services, and Boxin Ou, PhD, Brunswick Labs, Norton, MA, believe little significant progress has been made in the past 10 years due to high R&D cost and low demand for tests that are not mandatory. But, they commented, "It is interesting to note that the payoff is often great when the hard work is done. The extraordinary growth in the demand for dark chocolate and cocoa products following antioxidant research is a case in point." Unfortunately, Mr. Bell and Dr. Ou consider the industry to be short-sited when it comes to seeing beyond start-up costs in the context of testing and research.
Speaking of research, testing makes a huge difference in the set-up of a clinical trial. Douglas Kalman, MS, RD, director-Nutrition & Applied Clinical Research, Miami Research Associates, Miami, FL, explained, "When you contract with us to do a study, the material being used must be analyzed to make sure it is safe for human consumption and meets label claims before it is sent to an institutional review board (IRB). If a product is rejected then we have to start all over. Thankfully we are not running into issues with quality these days like we were five years ago."
Many companies believe GMPs will remedy a lot of issues on the testing front. In fact, in 2005 when it was rumored that final GMPs would be released, Covance's Mr. Sullivan said companies were busy ramping up testing efforts. He says now that the issuance of final GMPs has become a huge question mark, companies have become complacent and are not allocating as much money for testing as they were a couple of years ago.
But GMPs won't solve all the problems. Frank Jaksch, president, ChromaDex, Irvine, CA, stated, "GMPs alone will not drive changes. Industry will eventually have to police itself, starting at the top. The companies with their name on the label will need to dictate change throughout the supply chain."
Dr. Lilly divided supply chain testing into three stages: raw material testing, in process/HAACP control point analysis and finished product testing. "The first and last periods can result in inventory holding costs that can quickly reduce cash flows and operating profit," he said. "Therefore, manufacturers must go beyond simply asking for CofA's, and hold their suppliers accountable to a standard of acceptance. The reason for this is simple: a plant/operations manager can have complete control over their process, but all of that can be compromised when a product comes into the facility that contains toxins or microbes. In addition, as it has been often demonstrated in the food industry, companies that do not have some level of CofA verification are opening themselves up to raw materials that could lead to higher levels of rework, or potential recalls."
Dr. Lilly also discussed the relative lack of knowledge among companies when it comes to the microbiological side of testing. "While many conventional chemistry methods work just as well for dietary supplements as they do in food commodities, this is not the case for microbiological tests. The nature of the product to be tested (also called "matrix effect") is a huge issue for any manufacturer of botanicals, herbals, enzymes or protein powders. Conventional microbiology cannot mitigate the issues surrounding heavily dyed compounds, granules (which can often be mistaken for a bacterial colony), or extreme pH," he said. "Even rapid 'ready-to-use' plates or agar films, while simplifying the users workflow, do not work with many of the botanicals, minerals, and extracts that must undergo analysis."
Dr. Lilly continued, "We were working with one customer who was using a ready-plate method for a red-wine extract, and we quickly determined that this method was not suitable due to the fact that even when highly diluted, the matrix colored the agar so dark we could not count individual colonies."
Analytical Methods
There are few analytical methods validated to an official status using multiple laboratories for nutraceutical products or ingredients, which means that in-house labs or outside testing labs are coming up with their own methods and/or using methods detailed in peer-reviewed journals-and perhaps taking the time to validate them in-house.
Very simply, the Natural Products Association, Washington, D.C., defines analytical methods as a means for determining the composition of samples of matter-these methods can be qualitative or quantitative in nature. A qualitative analytical method yields information about the atomic or molecular species or the functional groups that exist in the sample in most instances, while a quantitative method provides information as to the relative amount of one or more of the components or of the measurable in question. The Natural Products Association says further that analytical method validation provides documented evidence that methods used to analyze raw materials, in process sample from work in-progress, or finished products yield consistent and reliable results.
Some feel validated methods for a variety of products/ingredients are on the horizon, while other more skeptical parties don't feel the testing community at large will ever come to consensus on certain methods. In the meantime, Mr. Jaksch says companies continue to make inappropriate choices when it comes to testing methods. "If a company shops around long enough, they'll find a method that gets them an answer they want to hear," he said. "Perhaps the answer lies in defining a list of methods that are not acceptable."
Robert Green, president, Integrated Biomolecule Corporation/IBC Labs, Tucson, AZ, believes the absence of universally accepted analytical methods is an issue, but that it is an industry situation companies need to adapt to. "Peer-reviewed and validated methods take years to complete and there are just too many products in too many forms to expect this situation to resolve itself in the near future. Acknowledging this, supplement companies and labs alike have a joint responsibility of being thorough when it comes to testing a product," he said. "When an analytical lab is asked to test a product for which there is no widely accepted method available, it is the lab's responsibility to implement a responsible method and support its determination."
Mr. Green added, "Methods used are generally based on or adapted from applicable official methods or those published in peer-reviewed journals (maybe the reference method deals with a different matrix or a compound of the same family that the scientist finds can be applied to the product in consideration). If a lab independently develops a method from scratch, as with all testing, the work must be fully documented and thoroughly supported. In these situations, the lab should disclose the origin of the method."
Covance's Mr. Sullivan believes validated methods are the way forward for the dietary supplement industry. "Right now we are seeing different test results because labs are using different methods," he said. "AOAC International is an association that validates analytical methods and companies need to support these efforts."
Expressing a similar point of view was Steven Dentali, PhD, vice president, scientific and technical affairs, American Herbal Products Association (AHPA), Silver Spring, MD, who said, "AOAC multi-laboratory validated analytical methods, where they exist, have demonstrated their ability to produce consistent results when used by different labs for analyzing the same materials. Failing this level of validation, individuals can conduct single lab validations, which tests the performance of a method in that lab. In any case, it's vital for labs to disclose the methods used for the testing of materials and to make available the raw data upon request."
NSF's Ms. LeVanseler also singled out the efforts of AOAC, as well as the American Herbal Pharmacopoeia. "AOAC, with support from the National Institutes of Health-Office of Dietary Supplements, has worked to bring experts together to select methods for thorough single laboratory validation and multi-laboratory collaborative studies," she said, adding, "The American Herbal Pharmacopoeia is also working to validate methods. The method selection approach seeks to harmonize methodology used by obtaining input from other pharmacopoeias and industry sources."
In addition, Ms. LeVanseler said NIST (the National Institute of Standards & Technology) recently began to develop certified reference materials for the dietary supplement industry. "These valuable new resources will allow laboratories to judge the analytical results they obtain against the results obtained by other laboratories in a confidential manner," she said. "This avenue will hopefully lead to improved consistency between labs."
Contamination and Adulteration
Most labs agree that contamination is not as common as adulteration in today's marketplace-the reason being that contamination typically occurs by accident, while adulteration is most of the time a pre-meditated occurrence.
One of the most recent high profile cases surrounding contamination surfaced in January when ConsumerLab.com revealed results from a supplement review it conducted on multivitamins. Receiving nationwide media play, the company highlighted the fact that one particular product formulated for women contained amounts of lead higher than permitted in the state of California, without including special labeling. ConsumerLab.com's Mr. Cooperman added his thoughts on the contamination issue. "Ninety-nine percent of the problems with supplements today could be avoided by paying closer attention to quality control. In this respect, contamination issues shouldn't even happen," he said. "I can't imagine manufacturers being aware of contamination in their products and still continuing to sell them."
The high profile unveiling of the ConsumerLab.com test results, while not necessarily indicative of an actual public health problem, stirred enormous concern among many groups-it even prompted Representative Henry Waxman (D-CA) to write a letter to FDA commissioner Andrew von Eschenbach about the issue last month.
According to Ian Milnes, president, Chemical Solutions, Ltd., Mechanicsburg, PA, Congressman Waxman's letter specifically addressed the failure of FDA to investigate serious allegations of potentially dangerous levels of lead in some vitamin products. "He also rebuked the FDA, because these findings were not isolated," said Mr. Milnes. "In November 1997, The Natural Resources Defense Council requested that FDA set limits on the amounts of lead allowed in calcium supplements and antacids based of findings that many supplements were contaminated with lead. In addition, in 2004 Robert B. Saper, et al. reported in The Journal of the American Medical Association that they had found extremely high levels of lead and other heavy metals in Ayurvedic herbal medicine products." (It should be noted, according to Dr. Dentali, that it was not disclosed that these products intentionally contained heavy metals and were not legal for importation into the U.S.)
Mr. Milnes added that while Congressman Waxman chided the FDA for taking no meaningful steps to investigate these allegations, he also admitted that there are no uniform standards for permissible amounts of lead or other heavy metals in food or dietary supplements. Instead, there are multiple standards.
Mr. Milnes continued, "Chemical Solutions has been testing trace levels of metals in products for over 10 years and has found that high levels of lead and other heavy metals (cadmium, mercury and arsenic) in herbal products, nutraceuticals and multivitamins are rare but not uncommon."
Adulteration is an issue the industry has been contending with for years, but it is not alone.
"Adulteration in the marketplace has been a problem since there was a marketplace, especially where there is intense competition," said AHPA's Dr. Dentali. "In the supplement industry, adulteration underscores the need for established standards of identifying materials."
Mr. Dentali called for more accessible test methods in the short term. He says while the American Herbal Pharmacopoeia provides a very comprehensive suite of test methods that do the industry a great service, AHPA wants to provide companies with more simplified tests that can be understood by all employees,including (and perhaps especially) purchasing departments. "Right now a lot of people regard testing as unnecessary science and we want to remove that stigma," Dr. Dentali said. "What companies like Switzerland-based CAMAG Laboratory, Alkemists Pharmaceuticals and others are doing in developing HPTLC tests that allow people to see differences in product samples visually is very valuable."
Dr. Eike Reich is head of CAMAG Laboratory, and one of the most recent events his company tackled was the economic adulteration of black cohosh. Adulteration issues, he said, seem to happen a lot faster than industry can move to develop the tests to detect for it. "Once a test has been developed to identify the adulteration, the issue seems to resolve itself," he said.
AHPA has been ahead of the adulteration issue every step of the way. In fact, in its Code of Ethics it provides a list of known adulterants for its members (see Table 1). In the case of black cohosh, AHPA already had a trade recommendation in place before the paper in the Journal of Agricultural & Food Chemistry came out identifying the problem last April. "An AHPA member identified the problem to us, provided the necessary background information to clearly elucidate the problem, and asked what we could do about it. AHPA responded by including this first case of economic adulteration into its policies. The earlier ones all concerned safety issues," Dr. Dentali explained. "The method described to detect adulteration that was published in the Jiang study is very good, but it's not a routine affair and requires highly sophisticated equipment. It would also be expensive if offered commercially. An AHPA committee working group instead, a year ago, approved a CAMAG method as 'capable of differentiating black cohosh extracts from those of Chinese cimicifuga' as a practical way for companies to recognize which is an adulterant and which is the genuine article."
Dr. Dentali says the association is working to develop similar tests that can be used by companies to quickly identify a genuine article from a known adulterant. AHPA hopes to approve them for use in 2007.
The Rewards of Testing
Considering these developments, the dietary supplement industry has its work cut out for it. But not to worry, experts say, while testing is a necessary part of doing business, it doesn't have to be as financially burdensome as some make it out to be. "Analytical testing is like paying the electric bill-people may not like to do it, but it is a necessary part of doing business in this industry," said IBC's Mr. Green. "Companies should also keep in mind, however, that testing can serve as cheap insurance."
Speaking of insurance, what if there was a way to reward companies for their testing efforts? Well, a program with exactly that goal is currently in development, according Mr. Jaksch from ChromaDex, who claims to have come up with a pretty persuasive incentive for companies to conduct a high level of testing.
Recently ChromaDex partnered with Poms & Associates Insurance Brokers, Los Angeles, CA, to design a program to offset quality control costs with insurance savings. "The reason why insurance premiums are so high for dietary supplement companies is because there is a high level of risk associated with their products," Mr. Jaksch said.
ChromaDex and Poms have also joined forces with a major A-rated insurance company to underwrite this program. The thinking behind the program goes like this: insurance premiums are based on risk, so if companies commit to spending money on testing, then they should be considered lower risk and therefore pay less for liability insurance.
"Companies will be interested in this program because they don't want to spend the same amount of money on liability insurance as a less-than-reputable competitor. We truly believe the good guys are going to step up and embrace this," said Greg Doherty, dietary supplement practice leader, Poms & Associates Insurance Brokers. "I think this could be a good way to help the industry rid itself of the 'Wild West' image that's been following it for years."
This idea of rewarding companies that conduct testing is obviously a good one, especially in light of product liability litigation. Tom Delaney, a partner with the law firm Sedgwick, Detert, Moran & Arnold, Orange County, CA, says a program like this actually makes his job easier and should be a no-brainer for companies. "Pre-market testing sends a signal that industry members are increasingly engaging in self-regulation which, in turn, may ultimately remove the industry as a litigation target. In other words, lawyers may think twice about suing a company that engages in responsible manufacturing," he said. "Pre-market testing is simply one of the best things companies can do to minimize their liability."
Ultimately, Mr. Delaney believes the program will be well received if industry members recognize the value in terms of risk management and marketing safe products, as well as saving immediate dollars up front on insurance premiums.
Currently, there's no official name for the program, but there are two pilot companies working through it. By the Fall, Mr. Doherty hopes to officially roll the program out to the entire industry.
On the Horizon
Given the state of the market, most experts believe it can only get better from here. In the spirit of cooperation, Dan Fabricant, vice president, Scientific Affairs, Natural Products Association, said, "The more people get out there and develop relationships, the more the analytical testing conversation evolves. I think you are starting to see more collaboration, especially with AOAC bringing people to the table to talk this out. I hope we see more of this in the future."
Both Brian Frisby, business development manager, Capsugel, Americas Region, Greenwood, SC, and George Stevens, quality assurance manager for Licaps, Capsugel, Americas Region, believe the next several years will bring mandatory testing, consolidation and a rapid increase in new testing labs and GMP consultants.
With regard to mandatory testing, Capsugel's Mr. Frisby pointed out that if and when the new GMPs are published, testing may be mandatory rather than an option. In fact, he said, "There is reason to believe that the dietary supplement industry will be held to a high-if not higher-standard than the Rx industry in terms of materials. Rather than spot testing, all materials will be tested lot by lot and process testing also will be uniform across the board. There will be the same amount of ingredients in all products and blending instructions will be standardized," he said. "There will be standardized recipes and processes-like making a cake. If you don't blend a product enough or for too long, it will be a different product."
As far as consolidation, Mr. Stevens says the industry consensus is that such strident standards will "winnow out" companies. "Smaller companies without the means and resources could fold," he said, adding, "On the other hand, smaller companies with excellent products could also cut acquisition deals with larger companies."
Mr. Stevens also commented on the projected boom in new testing labs and GMP consultants. "Companies can prepare by thinking ahead-develop their own testing methods or labs now and/or find a lab to test for a fee," he said. "In this climate, the industry could see a boom in new independent labs and GMP consultants."
For the future, Dr. Sudberg remains concerned about the increasing influence of the pharmaceutical industry and its "single chemical entity model" on the development and monitoring of dietary supplements. "The nutraceuticals industry should not narrow its focus to only a few lead compounds isolated/extracted from the plant but keep in mind instead the broad spectrum approach that nature has to healing," he commented. "The industry needs to develop collaboration between herbalists, phytochemists, pharmacognosists, product formulators and manufacturers to develop within the next 10 years analytical testing procedures that are universally agreed upon by all parties and that are 'fit for the purpose' of what the intended testing needs to accomplish."NW
