Rebecca Wright07.01.06
The herbs and botanicals market is as complicated as ever. Still reeling from recent negative clinical outcomes for some of the market's strongest herbs, quality issues, strong pricing pressures from abroad, and constant regulatory roadblocks, it will take a strong commitment to ethical manufacturing and marketing, and a willingness to look outside the box for more novel plants and uses for this market to recapture the popularity it once had.
Things are starting to look up, albeit slowly, as sales figures climb out of the red and inch their way into the black. Could this market be headed into a new era? Many experts believe so.
According to Nutrition Business Journal (NBJ), San Diego, CA, the herbs and botanicals market grew nearly 1% in all retail channels of distribution combined in 2005, bringing in $4.4 billion in sales. In the mass market channel, herbs and botanicalsslipped about 3%, while in other channels of distribution, including health food stores, direct-to-consumer, multilevel marketing, mail order, and Internet, there was positive growth for the category.
What this indicates, according to Mark Blumenthal, founder and executive director, American Botanical Council (ABC), Austin, TX, and editor/publisher of HerbalGram, is that the market as a whole is growing, with the exception of the mass market. But, as he points, out the mass market only brings in $713 million in herb sales, compared to the other channels of distribution, which bring in the bulk of sales. "The most recent figures seem to suggest that this industry's 'core' shoppers remain committed to these products despite some of the negative headlines that influence the mainstream perception of herbs and botanicals," he said. "And in effect it is the core shoppers, not the peripheral mainstream shoppers, that are responsible for the overall growth in this market."
In terms of products, most of the growth in the market is taking place amongst combination herbs, which grew nearly 5% in 2005. As far as the top selling single herbs, the list includes those herbs that have experienced much recent success, as well as those that continue to bring in a majority of sales based on their historical success. In 2005, the fastest growing herbs were noni, green tea and mangosteen juice.
Before exploring the opportunities in the market, it makes sense to discuss the raft of issues facing herbs and botanicals. One issue that has herbal companies and industry critics alike frazzled is the issue of quality. Jim LaValle, RPh, NMD, CCN, founder of the Living Longer Institute, Cincinnati, OH, said, "I think botanical products are still suspect to a lot of people in the mainstream medical community because of the variable quality. For example, I have used Relora (a product from Next Pharmaceuticals) on at least 1000 patients and it works great. But it is important to remember that this particular product combines a specific fraction of magnolia and phellodendron that is prepared in a very specific way. This, however, is not the norm for botanical products in general."
Mr. LaValle added, "I think the industry needs to create some standards for quality and efficacy because it is not fair for one company using ground up ginkgo leaves, for example, to be able to make the same claim as someone selling an extract that is a 50:1 concentration of a standardized minimum guaranteed percentage of active or a biochemical compound marker."
One high profile quality issue recently brought to light was a study on black cohosh, which was published in the Journal of Agricultural & Food Chemistry in May. Very briefly, the study brought unwelcome news that a significant number of black cohosh supplements sold in the U.S. did not contain the right kind of black cohosh. Instead, according to the American Herbal Products Association (AHPA), Silver Spring, MD, three of 11 products tested contained less expensive extracts of Chinese cimicifuga (specific other Actaea spp.) that do not have all the same chemical compounds or clinical uses as the native North American plant.
Greg Ris, vice president of sales, Indena USA, Seattle, WA, recognizes the importance of this issue, and points out that both ingredient suppliers and supplement manufacturers need to make themselves responsible in making sure consumers receive the product providing the biological benefit proven in the clinical trials.
Last year, AHPA added these Asian Actaea species to its list of potential botanical adulterants to warn industry to be on the lookout for this economic substitution. "Manufacturers have a responsibility to know what they are selling and to take adequate steps to ensure that the ingredients in their products match the product labels," the organization said.
This study underscores the rising incidence of adulteration in the industry, and companies are only just starting to realize that the propensity to spike products is very real (i.e., green tea being spiked with caffeine; ginkgo biloba spiked with rutin to inflate flavonoid content).
Stefan Wypyszyk, vice president of marketing, MB North America, Torrance, CA, said, "It is hard to say how much of the material on the market is adulterated but I think it is important to stress that companies are concerned about it and actively working to prevent these products from reaching the market."
Offering her thoughts on adulteration, Katie Ferren, director of sales and marketing, TR Nutritionals, Alpharetta, GA, saidshe believes the industry is in transition because manufacturers have to choose between meeting the needs of hitting a certain price point or taking the high road of buying a quality product. "A good example of this is ginkgo biloba extract, as a lot of it is being adulterated," she said. "TR Nutritionals only offers a ginkgo biloba extract with a quercetin/kaempferol ratio between 0.8 and 1.65. This is the ratio that naturally occurs in the ginkgo biloba leaf in nature. If the extract is outside of this range, it is possible the product has been 'spiked' just to meet the 24% ginkgoflavoneglycoside/6% terpene lactone specification that most manufacturers request."
Another quality issue facing the industry has to do with contamination. In late May, ConsumerLab.com, White Plains, NY, released its product review of ginseng supplements. Of the 18 products reviewed, six failed to pass due to lead contamination, lack of ingredient or inadequate ingredient identification. The good news? Contamination with pesticides-a problem found in earlier reviews of ginseng products from North America and Japan-was not found in this recent round of testing.
Certainly not helping the quality issue is the influx of players and herbal material from regions outside the U.S., which continue to put the industry in a precarious position both with FDA and consumers. That said, it is important to point out that quality and knowledge in these regions continue to improve on a daily basis. As such, competition is set to heat up in the coming years.
"This is an international market and therefore there are a lot of price pressures to contend with from competitors. Being a European manufacturer, we are not only feeling the pressure from an exchange rate point of view, but we are also facing increased price competition from suppliers in China and India," Mr. Wypyszyk said. "As quality and knowledge continue to increase in these regions, companies will eventually have to face this competition and realize that there is an increasingly level playing field."
George Pontiakos, president and CEO, BI Nutraceuticals, Long Beach, CA, highlighted the increasing awareness of the dangers of ethylene oxide (ETO) and irradiated products. He says California Proposition 65 (Prop 65) identifies ETO as being carcinogenic and a reproductive toxin. Due to environmental concerns, it is banned throughout Europe. Like ETO, Mr. Pontiakos said, irradiation is also banned in Europe. "North American consumers are becoming more educated about the dangers of ETO/irradiated products. In fact, they are starting to ask the question: why take an herb to benefit health if it is sterilized with a caustic process," he said.
In response to these issues, BI Nutraceuticals has developed a line of botanical powders called Protexx HP, which have been sterilized with super-heated dry steam to reduce microbiological load with results comparable to that of treatment with ETO or irradiation without the potential regulatory issues. "Steam sterilization delivers maximum reduction in potential contaminants while preserving color, flavor and bioactive components," he said, adding, "And the process keeps Protexx HP powders all-natural in addition to being safe."
Jeff Wuagneux, president and CEO, RFI Ingredients, Blauvelt, NY, said meeting certain requirements in blended formulas can be quite challenging as far as lead levels are concerned, citing Prop 65 as a major obstacle companies are working to overcome. He also mentioned that controlling the growing and processing of raw materials is becoming crucial in meeting quality requirements in today's marketplace.
Beyond Prop 65 issues, Ginny Bank, vice president of R&D, RFI Ingredients, said another challenge lies in the antioxidant botanical market. Along with the popularity of using botanicals based on fruits, she claims companies have a tendency to focus on their antioxidant potency and therefore the use of oxygenradical absorbance capacity (ORAC) scores to assess and promote their antioxidant effectiveness. Unfortunately, according to Ms. Bank, "We are continually faced with competition from companies that use ORAC incorrectly."
At the heart of the controversy, according to a position paper put together by RFI ingredients, is that companies continue to use figures based on old ORAC data. "In 2001, a successful attempt by the USDA and Brunswick Laboratories to increase the method's repeatability and reproducibility resulted in the use of a new reference standard. However, using this new reference standard produces ORAC values 2-3 times higher than the original method," the position paper states. "This becomes an issue when comparisons are made between ORAC values of antioxidant products and foods, such as servings of fruits and vegetables."
In other words, the old data says a serving of fruits and vegetables has an ORAC value of between 300 and 500 units, while the new data indicate it's more like 900 ORAC units. But companies still use the old data, and, for example, put 900 ORAC units into a particular product and then claim the product is equivalent to three servings of fruits and vegetables.
Rising quality issues have indeed forced companies to shoulder a lot of the burden as far as research, safety/quality testing, and other responsibilities go. According to Mr. Ris, "Manufacturers of herbal dietary supplements are requiring more information from ingredient suppliers to substantiate their products. This includes standardizing the active components responsible for a product's efficacy, making sure the product is free from adulterants and operating more stringent quality assurance programs."
To handle the broad spectrum of quality issues, Indena recently introduced the Indena 30 Quality Control System to better communicate its comprehensive quality assurance program. "Indena 30 emphasizes more than 30 quality controls from the starting material to the finished product," Mr. Ris explained.
In the end, Cecilia McCollum, vice president, Sales & Marketing, Blue California, Rancho Santa Margarita, CA, believes the quality in the industry is a direct reflection of the lack of integrity on the part of some companies. "I truly believe that the greatest challenge our industry faces is the lack of responsibility and integrity of some end-users and contract manufacturers who are concerned about price only, not the quality of the ingredients," she said "These companies keep unscrupulous ingredient suppliers in business with substandard or even fraudulent raw materials offered at very low prices, and by doing so they hurt our industry."
Many companies and herbs/botanicals proponents have been searching for a way to herd those herbs and botanicals with demonstrated traditional value into a separate regulatory category. "For years, the dietary supplement industry has debated the value of a Traditional Medicine category. Immediately after the Dietary Supplement Health & Education Act (DSHEA) passed, this issue went quiet because we all wanted to see how herbs would fare under the new law. With the benefit of 12 years of experience, herbs remain a challenge" said Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT.
To address the potential of creating a new traditional medicines category, AHPA and several other organizations banded together to form the Traditional Medicines (TM) Congress, which issued "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components," last November. At least 70 comments have been received to date, but in March the TM Congress received requests from several practicing herbalists to extend the comment period.
According to AHPA, the TM Congress is not suggesting that herbs now marketed as dietary supplements under DSHEA be required to be sold as traditional medicines. Instead, the vision of the TM Congress is to create an optional new category. As envisioned, products in this new category could be labeled with their traditional uses (including medicinal uses), so long as such products conform with traditional criteria such as dose and preparation.
AHPA makes it clear that the TM Congress is not attempting to influence the practice of medicine or the scope of practice of any therapeutic discipline. The TM Congress drafted its regulatory model to differentiate between products that are offered for retail sale and traditional medicines that are provided directly to a patient, for example, by an acupuncturist or an herbalist. The primary focus of the model is on the first of these, and attention has been given to the need to ensure that practitioners maintain direct control over traditional medicines that they produce for their patients.
The TM Congress takes no position for or against license requirements for practitioners. Licensing for healthcare practitioners of every discipline is regulated on a state-by-state basis. The TM Congress has expressed neither support for nor opposition to expanding licensure requirements for any of the practitioners that use herbs in their practices, as this issue is outside of the scope of the Congress' purpose.
"Many of us agree that Traditional Medicine is the right idea, but actually creating such a category remains a daunting task,"said Mr. Israelsen.
For starters, he pointed out, who's tradition do you follow? TCM (Traditional Chinese Medicine), the European approach, Ayurveda, Native American usage? And how would this category dovetail into DSHEA to assure that the protections currently afforded botanicals remain intact?
In recent months, there has been much attention paid to herb-drug interactions, many using the issue as the impetus for implementing an adverse event reporting (AER) system for dietary supplements. But one study presented at the North American Research Conference on Complementary and Integrative Medicine in May suggested that herb-drug interactions might not be as common as frequently claimed.
The subjects in this study were participants in the Canadian Multicentre Osteoporosis Study (CaMOS), a prospective cohort study, evaluating the prevalence, incidence and determinants of osteoporosis. Participants were recruited to the study in 1995 from an age-sex stratified random sample of non-institutionalized persons aged 25 years and older. At five years, 7652 (81%) of the original 9423 participants were remaining. Of the 7652, 1069 were taking at least one of the prescription medications for which herb-drug interactions were assessed. In total, only 14 (1.3%) of the 1069 participants were using at least one contraindicated herb-drug combination. Of the 514 subjects on one of the cardiovascular medications, 13 (2.5%) were concomitantly using a contraindicated herb. Only one of the 514 subjects taking a neuroleptic agent was identified as at-risk for a potential herb-drug interaction (lithium and psyllium). No subjects were concomitantly using the potentially dangerous combination of St. John's Wort with cyclosporine, spironolactone or venlafaxine.
In this randomly selected population-based sample, researchers found a relatively low rate of potential herb-drug interactions, most of which were among subjects using specific cardiovascular medications.
Despite these findings, UNPA's Mr. Israelsen feels the herb-drug interaction issue is going to cause consumers to choose carefully when using pharmaceuticals and herbal supplements. "Most consumers want to know the risks and at this point they don't know who to trust in finding that information. Part of the problem is that there are not a lot of informed opinions on this issue that are widely accepted yet," he said.
Mr. Israelsen continued, "What I think will happen, at least initially, is that Consumers Union's (publisher of Consumer Reports) new Natural Medicines Ratings guide on supplements will likely be the 'go-to' guide for consumers looking for more information on supplements and supplement-drug interactions."
To provide some background, in an effort to protect consumers from what it calls a "largely unregulated" natural medicine marketplace, Consumers Union decided to launch Natural Medicine Ratings through its Consumer Reports Medical Guide earlier this year. These ratings, the organization says, offer consumers extremely detailed and thorough evidence-based safety and effectiveness information about natural medicine products. The continuously updated database contains information on close to 14,000 natural medicines, including herbs, vitamins and nutritional supplements, as well as other ingredients widely available to consumers without a prescription. Consumers also have the ability to search by any product ingredient, brand name or get ratings for effectiveness by condition. They can also get information on interactions between drugs and natural medicines by using the Natural Medicine/Drug Interaction checker.
The only problem, Mr. Israelsen claims, is that some of the information regarding supplements is incomplete or inaccurate. "I do think the people at Consumers Union are well-intended and want to do a thorough job, but it is up to this industry to help them work out the bugs in their database pertaining to supplements," he said.
And as far as herb-drug interactions go, ABC's Mr. Blumenthal said with respect to many herbs more data must be compiled in order to come to any firm conclusions. "For several years we have been calling for more and better data regarding herb-drug interactions. However, we believe many of the reported interactions are theoretical and speculative," he said. "In addition, many of the interactions being reported are based on in vitro data, which do not necessarily have a relationship to an animal or human model. Therefore, we need to look at the growing body of herb-drug interaction data rationally."
Mr. Blumenthal qualified that statement, adding, "At the same time, we don't want to dismiss the potential issue of herb-drug interactions as a possible public health issue. As seen with St. John's Wort, there are interactions with a wide variety of conventional drugs that have been well documented."
Todd Norton, president and COO, Sabinsa Corporation, Payson, UT, said there is a virtual contradiction when it comes to herb-drug interactions versus ineffective products. He explained, "There are many people raising a lot of concern about herb-drug interactions as a huge issue. And often that same group claims that our industry's products are, for the most part, ineffective. So how can these products cause interaction issues if their claim is little to no potency for these products in the first place?"
Increasingly concerning among industry experts is the mounting evidence from government-funded clinical trials on herbs and botanicals that have yielded largely negative results.
Responding to these recent studies, MB North America's Mr. Wypyszyk said it is important for the industry to hold these recent results in perspective. "In these particular studies, there were a lot of reasons why the results were negative or portrayed as such," he said, suggesting that the process by which these products were studied was likely flawed in a majority of cases.
In fact, some of the recent trials conducted on herbs either focused on the wrong components of the plant material in question, including the dosage, while others have been studied in the wrong indications or at least the wrong degree of a specific indication.
With regard to high profile publicity on negative outcomes of new clinical trials and how this can adversely affect the peripheral mainstream consumer, the saw palmetto trial was a perfect case in point, according to ABC's Mr. Blumenthal. "Saw palmetto has been positioned for years as being effective in mild to moderate benign prostatic hyperplasia (BPH), yet the study published in the New England Journal of Medicine in February focused on its effects in moderate to severe BPH," he said. "This is probably why, not surprisingly, this study resulted in a negative outcome for saw palmetto."
Mr. Blumenthal added, "However, the researchers of this study were very honest and honorable in the way they reported their results by saying the outcome was not consistent with previously published studies on saw palmetto."
Unfortunately, this conclusion was not trumpeted in the media. "I have a real issue with the way the media reports on clinical outcomes and/or misinterprets the significance of the results of clinical trials in relation to herbs and botanicals and supplements in general. In many cases, there is a huge variation in the way the results are presented to the media and the way the results are presented to the public by the media."
But as the industry well knows, according to Danielle Thomas, director of marketing & sales, Nutratech, Wayne, NJ, "The media love to report on the negatives because that's what makes compelling headlines. We will always face this as an industry." On the bright side, Ms. Thomas said, "I believe that the core consumer is educated enough to realize that studies can be flawed and that one study does not determine the true worth of an ingredient."
With all of the bad news surrounding herbs and botanicals, there would seem to be a shortage of opportunity, but actually the opposite is true. "Just because this market has experienced some glitches from marketing/sales, public relations and regulatory perspectives does not in any way shut down the windows of opportunity in this market," said ABC's Mr. Blumenthal. "It just means that companies need to adjust their vision."
In fact, there are some real opportunities for companies that have made a commitment to a particular composition for a particular indication. "The patenting process continues to be very robust, as companies look for ways to patent ingredients and/or uses of ingredients," Mr. Blumenthal said. "One major reason companies are taking this direction has to do with the susceptibility of herbs and botanicals to 'copy cat' or generic products."
Another potential opportunity lies in harnessing the reputation of exotic or "super" fruits, and this is where many companies are headed. "One of the hottest trends this last year has been for nutraceutical manufacturers to explore the function benefits of the so-called super fruits," said Alex Moffet, president and CEO of Renaissance Herbs, Chatsworth, CA. "In fact, there have recently been some exciting product and clinical research developments related to mangosteen, goji berry and pomegranate."
Steve Siegel, vice president, Ecuadorian Rainforest, Belleville, NJ, also believes in connecting the herbs/botanicals market with the growing popularity of fruits and vegetables. He claims consumers are turning to herbs and botanicals with more frequency because they want to get their vitamins and nutrients from whole food sources rather than heavily processed foods. "Even some multivitamins, which previously consisted of only common vitamins and minerals, now contain botanical additives," he added.
UNPA's Mr. Israelsen believes consumers are headed back to more traditional roots, presenting many opportunities for product development. "I think the adoption of a lifestyle approache to health is really good news for the herbs and botanicals category," he said. "Consumers are waking up again to the beauty of plants in every aspect of their lives, whether it is in their kitchen while cooking a meal, working in the garden or using beautiful essential oils in a bath. Getting back to a traditional appreciation of these things will only help boost the image and value of herbs and botanicals."
There is another opportunity that seems to be gaining some momentum among herb enthusiasts and that is a new regulatory category currently being explored by several companies. This new category is called Botanical Drugs, which allows companies to rely heavily on history or traditional use in order to, more or less, skip the pre-clinical step and head right into clinical trials for a particular composition. The "Botanical Drug Guidance" issued by FDA in June 2004 made it possible to bring to market a complex mixture for which adequate safety and efficacy evidence had been established. Those companies successfully making it through the process would then be awarded a certain period of exclusivity. But navigating this new regulatory scheme has not been easy for companies, and only one product has actually received approval and been allowed to go to market.
Mr. Blumenthal believes the botanical drug route is a potential direction for pharmaceutical and herb companies that have significant capitalization and a pharmaceutically oriented corporate culture. The problem, as Mr. Blumenthal sees it, is that the regulation has created an easier and more attractive way for companies to get in but there is no guarantee they will ever make it through the process. (For more information on Botanical Drugs, see this issue's feature on the subject by turning to page 78.)
Other opportunities avail themselves in the functional food market, according to Paul Dijkstra, executive vice president, InterHealth Nutraceuticals, Inc., Benecia, CA, who sees an increased number of consumers who prefer to obtain the benefits of herbs and botanicals via foods and beverages when and where possible. "This trend has created new opportunities for manufacturers to develop alternative forms of delivery that are more appealing to consumers which, in turn, increase compliance, results and repeat purchases," he said. "Companies can leverage consumers' increasing knowledge, familiarity and interest in these options. As consumers become more knowledgeable and sophisticated in this arena, they will expect to see branded ingredients with research supporting the products' claims."
Julie Hirsch, director, Product Development, Wellgen, New Brunswick, NJ, touched on functional foods and botanical drugs. "The growth of functional foods and the role that herbs and botanicals play will require a higher level of sophistication from ingredient suppliers with regard to efficacy and quality. Because 'new' drives the category, new TCM (traditional Chinese medicine) and Ayurvedic herbs/botanicals will continue to surface," she said. "However, we predict that old will become new again. R&D from companies like ours and the new botanical drug companies that are springing are beginning to develop a deeper understanding why very familiar plants have their effects.
Things are starting to look up, albeit slowly, as sales figures climb out of the red and inch their way into the black. Could this market be headed into a new era? Many experts believe so.
The Latest Market Dynamics
According to Nutrition Business Journal (NBJ), San Diego, CA, the herbs and botanicals market grew nearly 1% in all retail channels of distribution combined in 2005, bringing in $4.4 billion in sales. In the mass market channel, herbs and botanicalsslipped about 3%, while in other channels of distribution, including health food stores, direct-to-consumer, multilevel marketing, mail order, and Internet, there was positive growth for the category.
What this indicates, according to Mark Blumenthal, founder and executive director, American Botanical Council (ABC), Austin, TX, and editor/publisher of HerbalGram, is that the market as a whole is growing, with the exception of the mass market. But, as he points, out the mass market only brings in $713 million in herb sales, compared to the other channels of distribution, which bring in the bulk of sales. "The most recent figures seem to suggest that this industry's 'core' shoppers remain committed to these products despite some of the negative headlines that influence the mainstream perception of herbs and botanicals," he said. "And in effect it is the core shoppers, not the peripheral mainstream shoppers, that are responsible for the overall growth in this market."
In terms of products, most of the growth in the market is taking place amongst combination herbs, which grew nearly 5% in 2005. As far as the top selling single herbs, the list includes those herbs that have experienced much recent success, as well as those that continue to bring in a majority of sales based on their historical success. In 2005, the fastest growing herbs were noni, green tea and mangosteen juice.
Contending with Quality Issues
Before exploring the opportunities in the market, it makes sense to discuss the raft of issues facing herbs and botanicals. One issue that has herbal companies and industry critics alike frazzled is the issue of quality. Jim LaValle, RPh, NMD, CCN, founder of the Living Longer Institute, Cincinnati, OH, said, "I think botanical products are still suspect to a lot of people in the mainstream medical community because of the variable quality. For example, I have used Relora (a product from Next Pharmaceuticals) on at least 1000 patients and it works great. But it is important to remember that this particular product combines a specific fraction of magnolia and phellodendron that is prepared in a very specific way. This, however, is not the norm for botanical products in general."
Mr. LaValle added, "I think the industry needs to create some standards for quality and efficacy because it is not fair for one company using ground up ginkgo leaves, for example, to be able to make the same claim as someone selling an extract that is a 50:1 concentration of a standardized minimum guaranteed percentage of active or a biochemical compound marker."
One high profile quality issue recently brought to light was a study on black cohosh, which was published in the Journal of Agricultural & Food Chemistry in May. Very briefly, the study brought unwelcome news that a significant number of black cohosh supplements sold in the U.S. did not contain the right kind of black cohosh. Instead, according to the American Herbal Products Association (AHPA), Silver Spring, MD, three of 11 products tested contained less expensive extracts of Chinese cimicifuga (specific other Actaea spp.) that do not have all the same chemical compounds or clinical uses as the native North American plant.
Greg Ris, vice president of sales, Indena USA, Seattle, WA, recognizes the importance of this issue, and points out that both ingredient suppliers and supplement manufacturers need to make themselves responsible in making sure consumers receive the product providing the biological benefit proven in the clinical trials.
Last year, AHPA added these Asian Actaea species to its list of potential botanical adulterants to warn industry to be on the lookout for this economic substitution. "Manufacturers have a responsibility to know what they are selling and to take adequate steps to ensure that the ingredients in their products match the product labels," the organization said.
This study underscores the rising incidence of adulteration in the industry, and companies are only just starting to realize that the propensity to spike products is very real (i.e., green tea being spiked with caffeine; ginkgo biloba spiked with rutin to inflate flavonoid content).
Stefan Wypyszyk, vice president of marketing, MB North America, Torrance, CA, said, "It is hard to say how much of the material on the market is adulterated but I think it is important to stress that companies are concerned about it and actively working to prevent these products from reaching the market."
Offering her thoughts on adulteration, Katie Ferren, director of sales and marketing, TR Nutritionals, Alpharetta, GA, saidshe believes the industry is in transition because manufacturers have to choose between meeting the needs of hitting a certain price point or taking the high road of buying a quality product. "A good example of this is ginkgo biloba extract, as a lot of it is being adulterated," she said. "TR Nutritionals only offers a ginkgo biloba extract with a quercetin/kaempferol ratio between 0.8 and 1.65. This is the ratio that naturally occurs in the ginkgo biloba leaf in nature. If the extract is outside of this range, it is possible the product has been 'spiked' just to meet the 24% ginkgoflavoneglycoside/6% terpene lactone specification that most manufacturers request."
Another quality issue facing the industry has to do with contamination. In late May, ConsumerLab.com, White Plains, NY, released its product review of ginseng supplements. Of the 18 products reviewed, six failed to pass due to lead contamination, lack of ingredient or inadequate ingredient identification. The good news? Contamination with pesticides-a problem found in earlier reviews of ginseng products from North America and Japan-was not found in this recent round of testing.
Certainly not helping the quality issue is the influx of players and herbal material from regions outside the U.S., which continue to put the industry in a precarious position both with FDA and consumers. That said, it is important to point out that quality and knowledge in these regions continue to improve on a daily basis. As such, competition is set to heat up in the coming years.
"This is an international market and therefore there are a lot of price pressures to contend with from competitors. Being a European manufacturer, we are not only feeling the pressure from an exchange rate point of view, but we are also facing increased price competition from suppliers in China and India," Mr. Wypyszyk said. "As quality and knowledge continue to increase in these regions, companies will eventually have to face this competition and realize that there is an increasingly level playing field."
George Pontiakos, president and CEO, BI Nutraceuticals, Long Beach, CA, highlighted the increasing awareness of the dangers of ethylene oxide (ETO) and irradiated products. He says California Proposition 65 (Prop 65) identifies ETO as being carcinogenic and a reproductive toxin. Due to environmental concerns, it is banned throughout Europe. Like ETO, Mr. Pontiakos said, irradiation is also banned in Europe. "North American consumers are becoming more educated about the dangers of ETO/irradiated products. In fact, they are starting to ask the question: why take an herb to benefit health if it is sterilized with a caustic process," he said.
In response to these issues, BI Nutraceuticals has developed a line of botanical powders called Protexx HP, which have been sterilized with super-heated dry steam to reduce microbiological load with results comparable to that of treatment with ETO or irradiation without the potential regulatory issues. "Steam sterilization delivers maximum reduction in potential contaminants while preserving color, flavor and bioactive components," he said, adding, "And the process keeps Protexx HP powders all-natural in addition to being safe."
Jeff Wuagneux, president and CEO, RFI Ingredients, Blauvelt, NY, said meeting certain requirements in blended formulas can be quite challenging as far as lead levels are concerned, citing Prop 65 as a major obstacle companies are working to overcome. He also mentioned that controlling the growing and processing of raw materials is becoming crucial in meeting quality requirements in today's marketplace.
Beyond Prop 65 issues, Ginny Bank, vice president of R&D, RFI Ingredients, said another challenge lies in the antioxidant botanical market. Along with the popularity of using botanicals based on fruits, she claims companies have a tendency to focus on their antioxidant potency and therefore the use of oxygenradical absorbance capacity (ORAC) scores to assess and promote their antioxidant effectiveness. Unfortunately, according to Ms. Bank, "We are continually faced with competition from companies that use ORAC incorrectly."
At the heart of the controversy, according to a position paper put together by RFI ingredients, is that companies continue to use figures based on old ORAC data. "In 2001, a successful attempt by the USDA and Brunswick Laboratories to increase the method's repeatability and reproducibility resulted in the use of a new reference standard. However, using this new reference standard produces ORAC values 2-3 times higher than the original method," the position paper states. "This becomes an issue when comparisons are made between ORAC values of antioxidant products and foods, such as servings of fruits and vegetables."
In other words, the old data says a serving of fruits and vegetables has an ORAC value of between 300 and 500 units, while the new data indicate it's more like 900 ORAC units. But companies still use the old data, and, for example, put 900 ORAC units into a particular product and then claim the product is equivalent to three servings of fruits and vegetables.
Rising quality issues have indeed forced companies to shoulder a lot of the burden as far as research, safety/quality testing, and other responsibilities go. According to Mr. Ris, "Manufacturers of herbal dietary supplements are requiring more information from ingredient suppliers to substantiate their products. This includes standardizing the active components responsible for a product's efficacy, making sure the product is free from adulterants and operating more stringent quality assurance programs."
To handle the broad spectrum of quality issues, Indena recently introduced the Indena 30 Quality Control System to better communicate its comprehensive quality assurance program. "Indena 30 emphasizes more than 30 quality controls from the starting material to the finished product," Mr. Ris explained.
In the end, Cecilia McCollum, vice president, Sales & Marketing, Blue California, Rancho Santa Margarita, CA, believes the quality in the industry is a direct reflection of the lack of integrity on the part of some companies. "I truly believe that the greatest challenge our industry faces is the lack of responsibility and integrity of some end-users and contract manufacturers who are concerned about price only, not the quality of the ingredients," she said "These companies keep unscrupulous ingredient suppliers in business with substandard or even fraudulent raw materials offered at very low prices, and by doing so they hurt our industry."
A New Regulatory Model?
Many companies and herbs/botanicals proponents have been searching for a way to herd those herbs and botanicals with demonstrated traditional value into a separate regulatory category. "For years, the dietary supplement industry has debated the value of a Traditional Medicine category. Immediately after the Dietary Supplement Health & Education Act (DSHEA) passed, this issue went quiet because we all wanted to see how herbs would fare under the new law. With the benefit of 12 years of experience, herbs remain a challenge" said Loren Israelsen, executive director, United Natural Products Alliance (UNPA), Salt Lake City, UT.
To address the potential of creating a new traditional medicines category, AHPA and several other organizations banded together to form the Traditional Medicines (TM) Congress, which issued "A Proposed Regulatory Model for Traditional Medicines: Guiding Assumptions and Key Components," last November. At least 70 comments have been received to date, but in March the TM Congress received requests from several practicing herbalists to extend the comment period.
According to AHPA, the TM Congress is not suggesting that herbs now marketed as dietary supplements under DSHEA be required to be sold as traditional medicines. Instead, the vision of the TM Congress is to create an optional new category. As envisioned, products in this new category could be labeled with their traditional uses (including medicinal uses), so long as such products conform with traditional criteria such as dose and preparation.
AHPA makes it clear that the TM Congress is not attempting to influence the practice of medicine or the scope of practice of any therapeutic discipline. The TM Congress drafted its regulatory model to differentiate between products that are offered for retail sale and traditional medicines that are provided directly to a patient, for example, by an acupuncturist or an herbalist. The primary focus of the model is on the first of these, and attention has been given to the need to ensure that practitioners maintain direct control over traditional medicines that they produce for their patients.
The TM Congress takes no position for or against license requirements for practitioners. Licensing for healthcare practitioners of every discipline is regulated on a state-by-state basis. The TM Congress has expressed neither support for nor opposition to expanding licensure requirements for any of the practitioners that use herbs in their practices, as this issue is outside of the scope of the Congress' purpose.
"Many of us agree that Traditional Medicine is the right idea, but actually creating such a category remains a daunting task,"said Mr. Israelsen.
For starters, he pointed out, who's tradition do you follow? TCM (Traditional Chinese Medicine), the European approach, Ayurveda, Native American usage? And how would this category dovetail into DSHEA to assure that the protections currently afforded botanicals remain intact?
Herb-Drug Interactions: How Serious are They?
In recent months, there has been much attention paid to herb-drug interactions, many using the issue as the impetus for implementing an adverse event reporting (AER) system for dietary supplements. But one study presented at the North American Research Conference on Complementary and Integrative Medicine in May suggested that herb-drug interactions might not be as common as frequently claimed.
The subjects in this study were participants in the Canadian Multicentre Osteoporosis Study (CaMOS), a prospective cohort study, evaluating the prevalence, incidence and determinants of osteoporosis. Participants were recruited to the study in 1995 from an age-sex stratified random sample of non-institutionalized persons aged 25 years and older. At five years, 7652 (81%) of the original 9423 participants were remaining. Of the 7652, 1069 were taking at least one of the prescription medications for which herb-drug interactions were assessed. In total, only 14 (1.3%) of the 1069 participants were using at least one contraindicated herb-drug combination. Of the 514 subjects on one of the cardiovascular medications, 13 (2.5%) were concomitantly using a contraindicated herb. Only one of the 514 subjects taking a neuroleptic agent was identified as at-risk for a potential herb-drug interaction (lithium and psyllium). No subjects were concomitantly using the potentially dangerous combination of St. John's Wort with cyclosporine, spironolactone or venlafaxine.
In this randomly selected population-based sample, researchers found a relatively low rate of potential herb-drug interactions, most of which were among subjects using specific cardiovascular medications.
Despite these findings, UNPA's Mr. Israelsen feels the herb-drug interaction issue is going to cause consumers to choose carefully when using pharmaceuticals and herbal supplements. "Most consumers want to know the risks and at this point they don't know who to trust in finding that information. Part of the problem is that there are not a lot of informed opinions on this issue that are widely accepted yet," he said.
Mr. Israelsen continued, "What I think will happen, at least initially, is that Consumers Union's (publisher of Consumer Reports) new Natural Medicines Ratings guide on supplements will likely be the 'go-to' guide for consumers looking for more information on supplements and supplement-drug interactions."
To provide some background, in an effort to protect consumers from what it calls a "largely unregulated" natural medicine marketplace, Consumers Union decided to launch Natural Medicine Ratings through its Consumer Reports Medical Guide earlier this year. These ratings, the organization says, offer consumers extremely detailed and thorough evidence-based safety and effectiveness information about natural medicine products. The continuously updated database contains information on close to 14,000 natural medicines, including herbs, vitamins and nutritional supplements, as well as other ingredients widely available to consumers without a prescription. Consumers also have the ability to search by any product ingredient, brand name or get ratings for effectiveness by condition. They can also get information on interactions between drugs and natural medicines by using the Natural Medicine/Drug Interaction checker.
The only problem, Mr. Israelsen claims, is that some of the information regarding supplements is incomplete or inaccurate. "I do think the people at Consumers Union are well-intended and want to do a thorough job, but it is up to this industry to help them work out the bugs in their database pertaining to supplements," he said.
And as far as herb-drug interactions go, ABC's Mr. Blumenthal said with respect to many herbs more data must be compiled in order to come to any firm conclusions. "For several years we have been calling for more and better data regarding herb-drug interactions. However, we believe many of the reported interactions are theoretical and speculative," he said. "In addition, many of the interactions being reported are based on in vitro data, which do not necessarily have a relationship to an animal or human model. Therefore, we need to look at the growing body of herb-drug interaction data rationally."
Mr. Blumenthal qualified that statement, adding, "At the same time, we don't want to dismiss the potential issue of herb-drug interactions as a possible public health issue. As seen with St. John's Wort, there are interactions with a wide variety of conventional drugs that have been well documented."
Todd Norton, president and COO, Sabinsa Corporation, Payson, UT, said there is a virtual contradiction when it comes to herb-drug interactions versus ineffective products. He explained, "There are many people raising a lot of concern about herb-drug interactions as a huge issue. And often that same group claims that our industry's products are, for the most part, ineffective. So how can these products cause interaction issues if their claim is little to no potency for these products in the first place?"
Research Issues
Increasingly concerning among industry experts is the mounting evidence from government-funded clinical trials on herbs and botanicals that have yielded largely negative results.
Responding to these recent studies, MB North America's Mr. Wypyszyk said it is important for the industry to hold these recent results in perspective. "In these particular studies, there were a lot of reasons why the results were negative or portrayed as such," he said, suggesting that the process by which these products were studied was likely flawed in a majority of cases.
In fact, some of the recent trials conducted on herbs either focused on the wrong components of the plant material in question, including the dosage, while others have been studied in the wrong indications or at least the wrong degree of a specific indication.
With regard to high profile publicity on negative outcomes of new clinical trials and how this can adversely affect the peripheral mainstream consumer, the saw palmetto trial was a perfect case in point, according to ABC's Mr. Blumenthal. "Saw palmetto has been positioned for years as being effective in mild to moderate benign prostatic hyperplasia (BPH), yet the study published in the New England Journal of Medicine in February focused on its effects in moderate to severe BPH," he said. "This is probably why, not surprisingly, this study resulted in a negative outcome for saw palmetto."
Mr. Blumenthal added, "However, the researchers of this study were very honest and honorable in the way they reported their results by saying the outcome was not consistent with previously published studies on saw palmetto."
Unfortunately, this conclusion was not trumpeted in the media. "I have a real issue with the way the media reports on clinical outcomes and/or misinterprets the significance of the results of clinical trials in relation to herbs and botanicals and supplements in general. In many cases, there is a huge variation in the way the results are presented to the media and the way the results are presented to the public by the media."
But as the industry well knows, according to Danielle Thomas, director of marketing & sales, Nutratech, Wayne, NJ, "The media love to report on the negatives because that's what makes compelling headlines. We will always face this as an industry." On the bright side, Ms. Thomas said, "I believe that the core consumer is educated enough to realize that studies can be flawed and that one study does not determine the true worth of an ingredient."
Windows of Opportunity
With all of the bad news surrounding herbs and botanicals, there would seem to be a shortage of opportunity, but actually the opposite is true. "Just because this market has experienced some glitches from marketing/sales, public relations and regulatory perspectives does not in any way shut down the windows of opportunity in this market," said ABC's Mr. Blumenthal. "It just means that companies need to adjust their vision."
In fact, there are some real opportunities for companies that have made a commitment to a particular composition for a particular indication. "The patenting process continues to be very robust, as companies look for ways to patent ingredients and/or uses of ingredients," Mr. Blumenthal said. "One major reason companies are taking this direction has to do with the susceptibility of herbs and botanicals to 'copy cat' or generic products."
Another potential opportunity lies in harnessing the reputation of exotic or "super" fruits, and this is where many companies are headed. "One of the hottest trends this last year has been for nutraceutical manufacturers to explore the function benefits of the so-called super fruits," said Alex Moffet, president and CEO of Renaissance Herbs, Chatsworth, CA. "In fact, there have recently been some exciting product and clinical research developments related to mangosteen, goji berry and pomegranate."
Steve Siegel, vice president, Ecuadorian Rainforest, Belleville, NJ, also believes in connecting the herbs/botanicals market with the growing popularity of fruits and vegetables. He claims consumers are turning to herbs and botanicals with more frequency because they want to get their vitamins and nutrients from whole food sources rather than heavily processed foods. "Even some multivitamins, which previously consisted of only common vitamins and minerals, now contain botanical additives," he added.
UNPA's Mr. Israelsen believes consumers are headed back to more traditional roots, presenting many opportunities for product development. "I think the adoption of a lifestyle approache to health is really good news for the herbs and botanicals category," he said. "Consumers are waking up again to the beauty of plants in every aspect of their lives, whether it is in their kitchen while cooking a meal, working in the garden or using beautiful essential oils in a bath. Getting back to a traditional appreciation of these things will only help boost the image and value of herbs and botanicals."
There is another opportunity that seems to be gaining some momentum among herb enthusiasts and that is a new regulatory category currently being explored by several companies. This new category is called Botanical Drugs, which allows companies to rely heavily on history or traditional use in order to, more or less, skip the pre-clinical step and head right into clinical trials for a particular composition. The "Botanical Drug Guidance" issued by FDA in June 2004 made it possible to bring to market a complex mixture for which adequate safety and efficacy evidence had been established. Those companies successfully making it through the process would then be awarded a certain period of exclusivity. But navigating this new regulatory scheme has not been easy for companies, and only one product has actually received approval and been allowed to go to market.
Mr. Blumenthal believes the botanical drug route is a potential direction for pharmaceutical and herb companies that have significant capitalization and a pharmaceutically oriented corporate culture. The problem, as Mr. Blumenthal sees it, is that the regulation has created an easier and more attractive way for companies to get in but there is no guarantee they will ever make it through the process. (For more information on Botanical Drugs, see this issue's feature on the subject by turning to page 78.)
Other opportunities avail themselves in the functional food market, according to Paul Dijkstra, executive vice president, InterHealth Nutraceuticals, Inc., Benecia, CA, who sees an increased number of consumers who prefer to obtain the benefits of herbs and botanicals via foods and beverages when and where possible. "This trend has created new opportunities for manufacturers to develop alternative forms of delivery that are more appealing to consumers which, in turn, increase compliance, results and repeat purchases," he said. "Companies can leverage consumers' increasing knowledge, familiarity and interest in these options. As consumers become more knowledgeable and sophisticated in this arena, they will expect to see branded ingredients with research supporting the products' claims."
Julie Hirsch, director, Product Development, Wellgen, New Brunswick, NJ, touched on functional foods and botanical drugs. "The growth of functional foods and the role that herbs and botanicals play will require a higher level of sophistication from ingredient suppliers with regard to efficacy and quality. Because 'new' drives the category, new TCM (traditional Chinese medicine) and Ayurvedic herbs/botanicals will continue to surface," she said. "However, we predict that old will become new again. R&D from companies like ours and the new botanical drug companies that are springing are beginning to develop a deeper understanding why very familiar plants have their effects.
