12.01.05
2005 should be characterized as a year of uncertainty for the nutraceuticals industry. While many thought the new dietary supplement GMPs would reveal themselves during the course of the year, they have yet to be finalized. And it is anybody's guess as to how the new GMPs will affect the companies that participate in this industry. Another issue that took center stage was that of New Dietary Ingredient (NDI) registration. Many companies, and regulatory agencies, regard this as a priority going forward in the context of enforcement when it comes to DSHEA. Also receiving a lot of attention of late is the topic of qualified health claims. To cut through the confusion surrounding qualified health claims, a meeting was held in November to discuss recent consumer studies. These studies suggest a lack of understanding on the part of consumers when it comes to comprehending these types of claims. Unfortunately the meeting did not end with a resolution, and a consensus on labeling language that will be clearer to consumers has not yet been reached. Stay tuned...
"In 2006, new opportunities for U.S. companies will arise for the marketing of herbal products in Europe. The Traditional Herbal Medicine Products Directive (THMPD) permits the simplified registration of herbal products if usage of the individual herb in Europe for at least fifteen years can be shown. New combinations of herbs and additional vitamins and minerals are possible. This permits for the first time the marketing of new botanical products all over Europe with the same composition and the same claim. With the experience of 300 botanical registrations in Europe, we look forward to bringing U.S. products into the European markets."
Joerg Gruenwald
President
analyze & realize AG
Berlin, Germany
"I believe you will see ingredient manufacturers play a bigger role in the future of the industry. While the number of FDA and FTC actions against companies in the industry has decreased, less-than-reputable companies continue to appear and take advantage of consumers. The raw material makers have started to band together to raise and set quality standards, and I believe the next step is being proactive in how they work with their customers to ensure that those customers do not damage the industry or their own businesses. I also believe people will begin to embrace China and India, rather than fear their impact on the industry. Companies will recognize the positive role they can play in the development of the sector in both the raw material and consumer segments. In turn, China and India have already started improving quality, intellectual property protection and other serious barriers to acceptance."
Adam Ismail
Business Development Manager
Cargill Health & Food Technologies
Minneapolis, MN
"On a macroeconomic level, the Japanese economy finally appears to have strengthened after several years of difficulties. Japanese consumers are beginning to increase their spending levels, reflecting more confidence in the direction of the economy.
"The functional food and beverage market is continuing to grow, including the FOSHU (Foods for Specified Health Uses) category. There are now over 540 active approved FOSHU products, with new products approved on a regular basis. A new regulatory system allowing qualified health claims is in place, although implementation has been slower than anticipated. Future potential categories of FOSHU health benefits are being aggressively researched by Japanese companies-related to stress, fatigue, allergies and weight loss, for example-which if accepted by the government essentially guarantee that the over $5 billion FOSHU retail market will continue to grow in the future."
Ron Bailey
President
California Functional Foods
Ashland, OR
"This year we saw the continuation of two industry trends. As in past years, the industry is on the lookout for new and exciting ingredients. Once one is found, the industry pounces on it. A current example is Hoodia gordonii. This trend creates all sorts of issues, one of which is analytical. It is rare indeed for a generally accepted analytical method to exist for a new star. This means reliance must be placed on the analytical labs' professionalism to expend the resources necessary to develop an accurate method and the expertise to conduct it.
"Another continuing trend is the increasing complexity of finished products. In an effort at product differentiation new combinations are continually created. Every component in a finished product can have an effect on the analysis of the other components, so great care and expertise is required to ensure that an analysis is accurate and not affected by another ingredient."
Robert Green
President
Integrated Biomolecule Corporation/IBC Labs
Tucson, AZ
"Quality is the key trend that has been evolving for the combined industries serving dietary supplements and functional foods. From the pending governmental regulations that will establish GMPs for industry manufacturers, or regulations regarding organic standards, to sourcing materials, developing products, marketing to consumers, and in every single relationship or transaction throughout the industry, special attention is being placed on quality. And, this is an excellent trend because it will ensure the industry's successful future."
Paul Altaffer
Product & Business Development
RFI Ingredients
Blauvelt, NY
"The year is ending on a note of uncertainty for marketers of functional foods and nutraceuticals. The concerns raised in the quali-fied health claims (QHCs) consumer research conducted by FDA, IFIC and academic studies give pause to the future construct for QHCs. The impetus to permit QHCs, from the Pearson vs. Shalala ruling, promised an avenue for emerging science. This spurred entrepreneurial research investigation across the spectrum of investigators and ingredient suppliers to identify and document promising health propositions for market. It shifted emphasis from marketing speculation to emerging science for FDA review. This science-driven discovery process now seems less fruitful for food application, and less certain for longer-term dietary supplement positionings. The QHC discussions bear watching."
Nancy Childs
Professor of Food Marketing
St. Joseph's University
Philadelphia, PA
"With 2006 nearly upon us, the nutraceutical industry should be reminded that two important regulatory requirements will take effect between the end of 2005 and the new year. First, the Food Allergen Labeling and Consumer Protection Act of 2004 will require food labels to identify in plain English if the product contains any of the eight major food allergens. This requirement goes into effect January 1, 2006, and since dietary supplements are regulated as food they will be subject to compliance with the labeling law. The eight major allergens are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybean. In the EU, a similar allergen labeling law required compliance by November 25th. This law called for the listing of 12 allergens.
"The second regulatory development taking effect on December 9, 2005 is the Bioterrorism recordkeeping requirement (Federal Register Vol. 69, No 236, 12/9/04). This is the third of a trilogy of FDA regulations designed to help protect the integrity of our food supply. The first requirement was facility registration followed by notice of import and now the third requirement, recordkeeping, takes effect in December with the exception of small businesses. The law requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of the food. The company records must be available to the FDA within a specified period of time. One way for companies to comply is to work with their information technology department to create a report containing the critical information required by the final rule that can be generated on short notice."
Richard Barndt
Director, Product Assurance & Regulatory Affairs
National Starch Food Innovation
Bridgewater, NJ
"While the drive toward making foods 'better for you' will continue, functional foods need to expand beyond current consumer perceptions. Consumers do not talk or think like marketers. They understand the notion of healthier foods, but perceive the 'functional food' term to mean that such foods are 'artificial,' 'not real' and 'made in a lab.' Success will come to those that look beyond merely marketing added ingredients and specific health benefits, and acquire a real comprehension of consumer behavior as an integration of how consumers live, where they shop and how they use today's products within the contexts of their varied lifestyles."
Laurie Demeritt
President
The Hartman Group
Bellevue, WA
"Marketplace place confusion and product safety topped consumer concerns facing our industry this year and are likely to remain front and center in 2006. As a global supplier, Cognis Nutrition & Health recognizes the enormous responsibility our industry bears to earn the public's trust. While there are no easy solutions, science is where our focus should be now and always. We know that consumers are choosing branded ingredients like Tonalin CLA by name because they know the product is backed by clinical research. We also know that consumer confusion is at an all-time high thanks to conflicting media headlines. It is imperative for our industry to work together to advance the science and work with government officials to support health claims so consumers can purchase our products with confidence."
Dave Eckert
Vice President
Cognis Nutrition & Health
La Grange, IL
"The industry is simply booming from a strategic consulting perspective. As is always the case when industries experience sustained high growth rates, hyper-competition and the growing complexity of consumer markets have encouraged smaller organizations to make their efforts more efficient and effective, as well as formalize marketing planning and implementation functions. In addition, the continued proliferation of larger players entering the scene has created a need for them to understand an unfamiliar market, which is another tremendous opportunity for service companies. I think we will see more of this."
Darrin Duber-Smith, MS, MBA
President
Green Marketing
Nederland, CO
"All indications point to our seeing a final regulation for good manufacturing practices for dietary supplements in early 2006. Clearly, this rule will have a major impact on the industry. Our chief concern is that the proposed regulation greatly underestimated the costs to implement some of its provisions, particularly in regard to product testing. Whether the FDA has incorporated some of the extensive suggestions NNFA and others in the industry have made, we'll be eager to see. From a legislative perspective, adverse event reporting for dietary supplements is getting renewed attention and is currently under discussion in the Senate Health, Education, Labor, and Pensions committee. While industry has been generally supportive of the possibility of such a system, the devil is in the details."
David Seckman
Executive Director and CEO
National Nutritional Foods Association (NNFA)
Washington, D.C.
"2005 has been a challenging and exciting year. As I travel in Europe and the U.S. there is both concern and optimism that the global food supplement business is evolving into one, which is respected and criticized at the same time. We are dealing with a dichotomy of companies who have the integrity and values to do only the right thing with their products and their customers versus some companies who are only in this business for a quick buck. Companies who invest in the industry for the long haul will be successful. The sooner GMPs are mandated by the FDA, the sooner the good will separate from the bad and the ugly."
Peter Zambetti
Global Business Development Manager
Capsugel, Div. of Pfizer Inc.
Greenwood, SC
"One of the key issues facing the industry is how to effectively communicate the strength of the science supporting the role of a functional food or nutraceutical in health and wellness to consumers-particularly in light of the current regulatory environment. In my opinion, qualified health claims have done nothing but muddy the waters in this regard. Case in point: the recently approved qualified claim for green tea and breast cancer: 'Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.' A similar 'D' level claim is approved for green tea and prostate cancer. On September 29, 2005, FDA released the results of its long-awaited consumer research study on qualified health claims. The results indicate that preliminary claims on food labels confuse consumers. What a surprise"
Clare Hasler
Executive Director
Robert Mondavi Institute for
Wine and Food Science
Davis, CA
"The last 12 months or so have seen considerable activity with respect to federal regulatory embracement of DSHEA. FDA has published significant guidance with respect to its regulatory strategy for full implementation of this good law and has included industry in discussions regarding New Dietary Ingredient (NDI) submissions. More recently FDA has provided notable dietary supplement labeling guidance and pushed the final GMPs off its desk. The American Herbal Products Association (AHPA) has created a searchable NDI database from the FDA docket and has planned six teleconferences as an aid for industry implementation of the supplement GMPs starting in 2006."
Steven Dentali, PhD
Vice President, Scientific & Technical Affairs
American Herbal Products Association (AHPA)
Silver Spring, MD
"From our perspective at NAII, the state of the industry has been steady. This year has seen those companies who have carefully invested in their business activities over the last decade rewarded with growth in opportunities and revenues. This is not to say that the year has been without challenge. The adverse media reports surrounding some esoteric research conclusions on some vitamins has had a negative impact on several channels of distribution, and the recent resignation of the newly confirmed FDA Commissioner, combined with rapidly escalating petroleum and energy pricing are all factors which are destined to challenge many participants in the industry.
"Responsible industry continues to press the FDA for publication of the GMPs for dietary supplements, originally authorized under DSHEA in 1994. The value of the U.S. currency has made our product more attractive in foreign markets, so those that are able to engender relationships there are destined to prosper.
"The prediction for 2006 is for significant consolidation in manufacturing and distribution and the return of some pricing power given the inevitable increases in components costs where plastics and other materials are derived from hydrocarbon sources. The consumer is still willing to purchase well-made supplements that deliver real value. We are looking forward to a record-setting year at NAII."
Mark LeDoux
Chairman and CEO
Natural Alternatives
International, Inc. (NAII)
San Marcos, CA
"Emerging trends in the industry include an increasing focus on bioavailability, validation of product safety and efficacy. By meeting label claims, supplement companies will be better able to increase consumer confidence and satisfaction. BASF continues to invest in science and state-of-the-art manufacturing facilities, leveraging our knowledge and expertise in nutrition to introduce innovative formulations that are safe and supported by sound scientific data, without compromising on bioavailability and stability. We also participate in industry groups to help improve public awareness and knowledge about nutrition, so consumers understand that vitamins have numerous health benefits and are safe when used properly."
Emile Henein
Industry Manager,
Dietary Supplements
BASF
Florham Park, NJ
"The evolution of diet trends throughout the past year, which included redefining low carb, understanding glycemic index and interactive nutrition concepts such as MyPyramid, will present the industry with new challenges and opportunities in 2006 in the areas of functional foods and nutraceuticals. Foods that offer health benefits are well received in the marketplace, and GTC Nutrition, a leading supplier of natural, specialty ingredients, will continue to work closely and partner with manufacturers to create innovative products that meet the needs of today's health-conscious consumers. Taking it one step further, we, in conjunction with key customers, will launch a Nutrition for Life program early in the year to educate and empower consumers to make healthier food and lifestyle choices."
Patrick Smith
President
GTC Nutrition
Golden, CO
"In 2005, we saw an increase in the sales of herbal products, more favorable media toward natural remedies, and a weakening of federal standards for USDA certified organic foods. 2006 will offer the same mixed set of circumstances. 'Green companies' involved with herbs, chocolate, coffee and other items will continue to push fair wage and positive environmental standards. The year also looks excellent for receptive media around herbal medicine. At the same time, corporate consolidation in the food sector, weaker organic standards and ugly politics will make it increasingly difficult to define what we stand for as an industry."
Chris Kilham
Medicine Hunter
Amherst, MA
"From my perspective as a journalist covering holistic medicine, I see tremendous changes in the healthcare landscape in the near future. The status quo of mainstream medicine is unsustainable from an economic viewpoint and 'corporate America' is balking at the continuously rising costs; morale among conventional physicians is very low; patients are frustrated, angry and actively seeking alternatives. Healthcare is once again a major political issue. All of this spells opportunity for holistic healthcare and natural medicine, provided the industry leadership wakes up and sees the big picture. We have the chance now to demonstrate the clinical and economic value of natural healthcare, so that hopefully, it will become the foundation on which to develop a stronger, cost-effective, prevention-oriented health care system. But that will require long-term vision, serious research and diligent bridge-building. The insular, short-term, 'next quarter' thinking that has characterized business strategy throughout much of this industry, won't likely carry us too far in an increasingly turbulent healthcare environment."
Erik Goldman
Editor-in-Chief
Holistic Primary Care
New York, NY
"There is no question that the avian flu threat will be one of the most important areas of concern to consumers if a human-to-human transmissible bird flu virus appears. Without a vaccine, the natural products industry, with its contingent of antioxidant and immune-enhancing products will stand to benefit. New immune enhancers recently developed as nutraceuticals will appear in 2006-just in time.
"In 2004 and 2005, AIBMR Life Sciences experienced dramatic increases in requests to commission research by clients around the world who desire well designed studies that meet the 'competent and reliable' standard set by FTC that could determine the properties, attributes, and characteristics of nutraceutical ingredients and products. The trend to conduct more safety and efficacy studies of these products will continue due to pressure from Congress, regulatory agencies, the media, distributors, and consumers, a continuation of the shift within the nutraceutical industry from a predominately market driven to science driven paradigm begun 10 years ago. Antioxidants and the role of inflammation in disease processes associated with obesity and aging will continue to be a focal point for the media.
"Unfortunately, 'rascals' will continue to hurt the industry's reputation and undermine public confidence with their outlandish and unsubstantiated product claims."
Alex Schauss, PhD, FACN
President and CEO
AIBMR Life Sciences, Inc.
Puyallup, WA
"There are more exciting opportunities than ever before for new products that are safe, effective, and backed by science. New branded ingredients are being created on a regular basis with some companies actually doing good science and contracting for good clinical trials. But there appears to be fewer and fewer companies with real consumer marketing capability that are willing to take these new ingredients and develop them into successful products. I believe that future product successes will come from consumer branding companies partnering with new ingredient development companies. Together they can combine research with marketing, especially PR and promotions, to create the synergy necessary for new product successes."
Bob Garrison
President & CEO
Next Pharmaceuticals, Inc.
Irvine, CA
"The year in venture capital for the nutraceuticals industry was largely optimistic with new funds being committed to the sector by Nestle, and a focus on the sector in the new Burrill Life Sciences III Capital Fund. Sherbrooke Capital, the other mainstay in the sector, was also rumored to be fundraising. Functional food company Brand New Brands made headlines as the largest early stage investment in a consumer goods company in 2005, and perhaps ever. The $15+ million round included Burrill & Company, Prolog Ventures, Great Spirit Ventures and Unilever Corporate Venturing. Overall, the venture investment climate was positive, but fewer exits for venture backed nutraceuticals companies materialized than the VCs would have liked.
"Looking ahead to 2006, I believe that the focus of venture investments in nutraceuticals companies will continue to shift downstream from technology-based companies to those which have a greater marketing component. The investment community will increasingly recognize that the majority of the opportunities in the nutraceuticals space lie in progressive methods of delivering information and products to the end consumer. Overall, venture capital interest in the space will continue to grow, albeit in the guarded pace to which venture investors are ironically accustomed."
Gregg Wurster
Senior Associate
Burrill & Company
San Francisco, CA
"The past year was an interesting one for the nutraceuticals industry on several fronts. I believe we turned a corner in the ORAC category as renewed interest in ORAC formulas kept RFI busy in the last 12 months. While there are still conflicting messages being sent to consumers on ORAC, the playing field is growing more level as suppliers and other concerned parties attempt to work together to standardize the message surrounding ORAC claims.
"In other areas, demand for organics keeps growing and RFI is responding by adding additional organic product offerings. We believe the future for organics is extremely strong and this-tied in with customer concern about sustainability issues and environmental consciousness-continues to drive our business. Our challenge in the organic supplement category is the cost pressure from manufacturers who do not understand the 'premium' nature of organic products or feel they can't justify the cost to consumers. We hope to see this situation resolve itself in the future as organics become more mainstream."
Jeff Wuagneux
President and CEO
RFI Ingredients
Blauvelt, NY
"In the upcoming year regulation will play an increasing role in the marketing of dietary supplements as FDA, FTC, Congress, and even states, get into the action. If we are going to stave off unreasonable, burdensome, and in some cases, malicious regulation, we are going to have to build relationships with regulators and be prepared to accept reasonable measures to drive out the bad actors that destroy consumer confidence. This industry cannot continue to grow if we only sell ingredients that were on the market in 1994, making the same old claims while science outpaces them. A convergence must occur between regulation, science and consumerism."
Steve Mister
President & CEO
Council for Responsible
Nutrition (CRN)
Washington, D.C.
"2005 is a significant year because it represents the 10th anniversary of the birth of functional foods in Europe and the U.S. 1995 saw the launch of Benecol, the first sterol-based cholesterol-lowering food, in Finland. In the same year, Japan's Yakult Honsha and Danone launched their daily dose (65ml-100ml) probiotic dairy drinks in Europe. Ten years on, it's Europe that has become the biggest global market for such cholesterol-lowering products with sales over $700 million a year, 10 times the U.S. In addition, Europe has a market for probiotic daily dose products worth $4 billion, growing at 30% annually-this market basically doesn't exist in the U.S. So what explains the big difference in the outcomes between Europe and the U.S.? The answer to this question is a simple one. These functional food markets have been created by Europeans adopting an Asian packaging innovation-the daily dose bottle-one that American product developers have shied away from. In fact, the packaging innovation has become more important than the science in driving success. That's the single biggest lesson of the last decade: that marketing, branding and packaging innovation matter more than science."
Julian Mellentin
Editor
New Nutrition Business
London, U.K.
"Oasis LifeSciences achieved record 3rd quarter performance behind its breakthrough product AgelessXtra. Sales results were up over 93% compared to the 3rd quarter 2004, behind the dramatic growth of AgelessXtra. Launched in early 2004, AgelessXtra has become one of the fastest growing functional foods in the U.S. and now accounts for 50% of company sales. It promotes vital energy, helps manage stress, supports mental clarity and focus and improves joint health. AgelessXtra is now being used by over 50% of the PGA Senior Tour Professional Golfers. Including its other functional foods, this category now represents 74% of Oasis sales. We believe the consumer demand for quality functional food items will continue to rise dramatically."
Derek Hall
CEO
Oasis LifeSciences
Lacey, WA
"I believe that what we have seen in the past year is a shift in direction by our industry in the way it can best sell the consumer. At Vitaquest International, our Garden State Nutritionals division has always focused on designing value-added products that help the consumer meet a specific need (diet products, complex 'multi' formulations, pain relief, etc.). We have shifted beyond category formulas to a total package of wellness for the individual.
The Past: Ingredient Focused
The Present: Product Focused
The Future: People Focused
"The next level calls for incorporating a whole series of products that can surround the consumer and provide a complete system to meet their needs. It is our job to make sure our clients design their products to be integrated for their clients' lifestyle."
Jon Weisgal
Vice President of Marketing
Vitaquest International, LLC
West Caldwell, NJ
"More educated consumers are seriously exploring the role of dietary supplements and functional foods as part of a more activist health and wellness agenda. During 2005, we observed great strains in the old paradigm of very expensive prescription medicines administered by omniscient practitioners to passive patients administered by an impersonal health insurance network. There are rapidly growing economic and philosophical reasons for more consumers to understand that what the dietary supplement industry offers is in fact a valuable mainstream option rather than something exotic. We strongly believe that the food and beverage industries will play a rapidly growing role in providing the delivery systems through a broader range of supplements, and more information will get disseminated to the consumer. We endorse that trend, and we recognize that different skills are necessary to serve those markets.
"Effectively communicating dietary supplement benefits within confusing regulatory constraints is still an important work in progress. Consumers want to make the best choices to feel better and lower their medical costs. DSEA and AHPA are doing particularly good work in advocating our industry's views on these matters."
Paul Flowerman
President
PL Thomas & Co.
Morristown, NJ
"The ephedra-initiated turbulence of 2004-2005 and the conclusion of regulatory structural efforts in the EU highlighted the principal point about the state of the dietary supplement industry today: after DSHEA, industry still does not get the need for self-regulation and tightening up on quality (particularly ingredient supplier GMPs ). Consumer confidence after the vitamin E publicity, quiet FDA efforts to cut back on innovative dietary ingredients and efforts to restrict broadened dietary supplement distribution in many countries all point to the need for a re-assertion of the industry's incredible value to the baby boom generation in particular. Absent a good quality effort, I think we will see absorption into the food and OTC pharmaceutical sectors, where consumer confidence is stronger."
Scott Bass
Partner
Sidley Austin Brown & Wood
New York City, NY & Washington, D.C.
"With all the progress we've made as an industry, investing in research on safe, effective ingredients-as Nutratech has with the patented bitter orange extract Advantra Z-it's simply not enough. Our industry needs an image makeover and a strong strategic offense. We stand idly by while industry critics promote mistrust of herbs and dietary supplements. When it comes to legislative issues, we get involved too late to be effective whether on national or state levels. Before we end up selling useless placebos, we must stand together, support trade organizations and help them work collectively to build credibility and consumer confidence."
Bill Arthur
Principal
Nutraceutical Solutions Consulting
Miami, FL
"Most recent trends in the botanical extract market are progressively focusing on efficacy, safety and quality. We see an increasing customer demand in ingredients with product specific data in order to substantiate possible claims. Common bibliographic data are losing weight as the pharmacological profile of different botanical extracts can vary drastically.
"Frutarom Switzerland has started an intensive research program based on bio-assay guided development. Thus the activity and safety profile is tested on the raw material level up to the final extract. First product launches are scheduled already in the next year. Target indications are focusing on mental health. This year, Frutarom Switzerland launched the special Olive leaf extract EFLA 943 for the first time showing clinical evidence on blood pressure regulation.
"Purity, possible contaminants and residues are entering the focus of the industry. Our patented EFLA Hyperpure technology has become a key technique to obtain pure, safe and well processable extracts. The validation of the manufacturing process and the tractability of all data are of utmost importance. This can be ensured by adhering to strict production guidelines. Frutarom Switzerland is glad to have more than 10 years experience in cGMP approved production."
Stephan Vautravers
Head of Marketing & Sales-Pharma
Frutarom
Wdenswil, Switzerland
"Quality sums up 2005 for Aloecorp. Entering our 18th year of business, this has been our most exciting ever. In our efforts to raise the bar on quality and innovation, Aloecorp launched its new Qmatrix Proprietary Processing Technology-creating a new era for the nutraceuticals industry-and a new generation of breakthrough Aloe vera products. The crystal flakes produced using Qmatrix contain superior benefits to traditionally produced aloe, allowing us to produce Value Added products that will revolutionize the aloe industry. We look forward to joining our colleagues in 2006 in delivering innovative new products to consumers throughout the world."
Wayne McCune
Senior Vice President of
Sales & Marketing
Aloecorp
Lacey, WA
"If we want DSHEA to work for us, we need to make it work. Our challenge is to focus our efforts on demonstrating that responsible companies practice what they preach. We believe that our products provide numerous benefits to society from providing a smart choice for supplementing other healthful lifestyle choices to potential healthcare cost savings. Our challenge is to demonstrate that to the audiences we care about, including the people who buy our products. It isn't enough to just talk about quality products and science-based formulations. Each company in this industry has a responsibility to turn that talk into action."
Chuck Brice
Chairman of the Board of Directors
Council for Responsible
Nutrition (CRN)
&
Senior Vice President
Kemin Health, L.C.
Des Moines, IA
"In 2006, new opportunities for U.S. companies will arise for the marketing of herbal products in Europe. The Traditional Herbal Medicine Products Directive (THMPD) permits the simplified registration of herbal products if usage of the individual herb in Europe for at least fifteen years can be shown. New combinations of herbs and additional vitamins and minerals are possible. This permits for the first time the marketing of new botanical products all over Europe with the same composition and the same claim. With the experience of 300 botanical registrations in Europe, we look forward to bringing U.S. products into the European markets."
Joerg Gruenwald
President
analyze & realize AG
Berlin, Germany
"I believe you will see ingredient manufacturers play a bigger role in the future of the industry. While the number of FDA and FTC actions against companies in the industry has decreased, less-than-reputable companies continue to appear and take advantage of consumers. The raw material makers have started to band together to raise and set quality standards, and I believe the next step is being proactive in how they work with their customers to ensure that those customers do not damage the industry or their own businesses. I also believe people will begin to embrace China and India, rather than fear their impact on the industry. Companies will recognize the positive role they can play in the development of the sector in both the raw material and consumer segments. In turn, China and India have already started improving quality, intellectual property protection and other serious barriers to acceptance."
Adam Ismail
Business Development Manager
Cargill Health & Food Technologies
Minneapolis, MN
"On a macroeconomic level, the Japanese economy finally appears to have strengthened after several years of difficulties. Japanese consumers are beginning to increase their spending levels, reflecting more confidence in the direction of the economy.
"The functional food and beverage market is continuing to grow, including the FOSHU (Foods for Specified Health Uses) category. There are now over 540 active approved FOSHU products, with new products approved on a regular basis. A new regulatory system allowing qualified health claims is in place, although implementation has been slower than anticipated. Future potential categories of FOSHU health benefits are being aggressively researched by Japanese companies-related to stress, fatigue, allergies and weight loss, for example-which if accepted by the government essentially guarantee that the over $5 billion FOSHU retail market will continue to grow in the future."
Ron Bailey
President
California Functional Foods
Ashland, OR
"This year we saw the continuation of two industry trends. As in past years, the industry is on the lookout for new and exciting ingredients. Once one is found, the industry pounces on it. A current example is Hoodia gordonii. This trend creates all sorts of issues, one of which is analytical. It is rare indeed for a generally accepted analytical method to exist for a new star. This means reliance must be placed on the analytical labs' professionalism to expend the resources necessary to develop an accurate method and the expertise to conduct it.
"Another continuing trend is the increasing complexity of finished products. In an effort at product differentiation new combinations are continually created. Every component in a finished product can have an effect on the analysis of the other components, so great care and expertise is required to ensure that an analysis is accurate and not affected by another ingredient."
Robert Green
President
Integrated Biomolecule Corporation/IBC Labs
Tucson, AZ
"Quality is the key trend that has been evolving for the combined industries serving dietary supplements and functional foods. From the pending governmental regulations that will establish GMPs for industry manufacturers, or regulations regarding organic standards, to sourcing materials, developing products, marketing to consumers, and in every single relationship or transaction throughout the industry, special attention is being placed on quality. And, this is an excellent trend because it will ensure the industry's successful future."
Paul Altaffer
Product & Business Development
RFI Ingredients
Blauvelt, NY
"The year is ending on a note of uncertainty for marketers of functional foods and nutraceuticals. The concerns raised in the quali-fied health claims (QHCs) consumer research conducted by FDA, IFIC and academic studies give pause to the future construct for QHCs. The impetus to permit QHCs, from the Pearson vs. Shalala ruling, promised an avenue for emerging science. This spurred entrepreneurial research investigation across the spectrum of investigators and ingredient suppliers to identify and document promising health propositions for market. It shifted emphasis from marketing speculation to emerging science for FDA review. This science-driven discovery process now seems less fruitful for food application, and less certain for longer-term dietary supplement positionings. The QHC discussions bear watching."
Nancy Childs
Professor of Food Marketing
St. Joseph's University
Philadelphia, PA
"With 2006 nearly upon us, the nutraceutical industry should be reminded that two important regulatory requirements will take effect between the end of 2005 and the new year. First, the Food Allergen Labeling and Consumer Protection Act of 2004 will require food labels to identify in plain English if the product contains any of the eight major food allergens. This requirement goes into effect January 1, 2006, and since dietary supplements are regulated as food they will be subject to compliance with the labeling law. The eight major allergens are milk, egg, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybean. In the EU, a similar allergen labeling law required compliance by November 25th. This law called for the listing of 12 allergens.
"The second regulatory development taking effect on December 9, 2005 is the Bioterrorism recordkeeping requirement (Federal Register Vol. 69, No 236, 12/9/04). This is the third of a trilogy of FDA regulations designed to help protect the integrity of our food supply. The first requirement was facility registration followed by notice of import and now the third requirement, recordkeeping, takes effect in December with the exception of small businesses. The law requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S. Such records are to allow for the identification of the immediate previous sources and immediate subsequent recipients of the food. The company records must be available to the FDA within a specified period of time. One way for companies to comply is to work with their information technology department to create a report containing the critical information required by the final rule that can be generated on short notice."
Richard Barndt
Director, Product Assurance & Regulatory Affairs
National Starch Food Innovation
Bridgewater, NJ
"While the drive toward making foods 'better for you' will continue, functional foods need to expand beyond current consumer perceptions. Consumers do not talk or think like marketers. They understand the notion of healthier foods, but perceive the 'functional food' term to mean that such foods are 'artificial,' 'not real' and 'made in a lab.' Success will come to those that look beyond merely marketing added ingredients and specific health benefits, and acquire a real comprehension of consumer behavior as an integration of how consumers live, where they shop and how they use today's products within the contexts of their varied lifestyles."
Laurie Demeritt
President
The Hartman Group
Bellevue, WA
"Marketplace place confusion and product safety topped consumer concerns facing our industry this year and are likely to remain front and center in 2006. As a global supplier, Cognis Nutrition & Health recognizes the enormous responsibility our industry bears to earn the public's trust. While there are no easy solutions, science is where our focus should be now and always. We know that consumers are choosing branded ingredients like Tonalin CLA by name because they know the product is backed by clinical research. We also know that consumer confusion is at an all-time high thanks to conflicting media headlines. It is imperative for our industry to work together to advance the science and work with government officials to support health claims so consumers can purchase our products with confidence."
Dave Eckert
Vice President
Cognis Nutrition & Health
La Grange, IL
"The industry is simply booming from a strategic consulting perspective. As is always the case when industries experience sustained high growth rates, hyper-competition and the growing complexity of consumer markets have encouraged smaller organizations to make their efforts more efficient and effective, as well as formalize marketing planning and implementation functions. In addition, the continued proliferation of larger players entering the scene has created a need for them to understand an unfamiliar market, which is another tremendous opportunity for service companies. I think we will see more of this."
Darrin Duber-Smith, MS, MBA
President
Green Marketing
Nederland, CO
"All indications point to our seeing a final regulation for good manufacturing practices for dietary supplements in early 2006. Clearly, this rule will have a major impact on the industry. Our chief concern is that the proposed regulation greatly underestimated the costs to implement some of its provisions, particularly in regard to product testing. Whether the FDA has incorporated some of the extensive suggestions NNFA and others in the industry have made, we'll be eager to see. From a legislative perspective, adverse event reporting for dietary supplements is getting renewed attention and is currently under discussion in the Senate Health, Education, Labor, and Pensions committee. While industry has been generally supportive of the possibility of such a system, the devil is in the details."
David Seckman
Executive Director and CEO
National Nutritional Foods Association (NNFA)
Washington, D.C.
"2005 has been a challenging and exciting year. As I travel in Europe and the U.S. there is both concern and optimism that the global food supplement business is evolving into one, which is respected and criticized at the same time. We are dealing with a dichotomy of companies who have the integrity and values to do only the right thing with their products and their customers versus some companies who are only in this business for a quick buck. Companies who invest in the industry for the long haul will be successful. The sooner GMPs are mandated by the FDA, the sooner the good will separate from the bad and the ugly."
Peter Zambetti
Global Business Development Manager
Capsugel, Div. of Pfizer Inc.
Greenwood, SC
"One of the key issues facing the industry is how to effectively communicate the strength of the science supporting the role of a functional food or nutraceutical in health and wellness to consumers-particularly in light of the current regulatory environment. In my opinion, qualified health claims have done nothing but muddy the waters in this regard. Case in point: the recently approved qualified claim for green tea and breast cancer: 'Two studies do not show that drinking green tea reduces the risk of breast cancer in women, but one weaker, more limited study suggests that drinking green tea may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that green tea reduces the risk of breast cancer.' A similar 'D' level claim is approved for green tea and prostate cancer. On September 29, 2005, FDA released the results of its long-awaited consumer research study on qualified health claims. The results indicate that preliminary claims on food labels confuse consumers. What a surprise"
Clare Hasler
Executive Director
Robert Mondavi Institute for
Wine and Food Science
Davis, CA
"The last 12 months or so have seen considerable activity with respect to federal regulatory embracement of DSHEA. FDA has published significant guidance with respect to its regulatory strategy for full implementation of this good law and has included industry in discussions regarding New Dietary Ingredient (NDI) submissions. More recently FDA has provided notable dietary supplement labeling guidance and pushed the final GMPs off its desk. The American Herbal Products Association (AHPA) has created a searchable NDI database from the FDA docket and has planned six teleconferences as an aid for industry implementation of the supplement GMPs starting in 2006."
Steven Dentali, PhD
Vice President, Scientific & Technical Affairs
American Herbal Products Association (AHPA)
Silver Spring, MD
"From our perspective at NAII, the state of the industry has been steady. This year has seen those companies who have carefully invested in their business activities over the last decade rewarded with growth in opportunities and revenues. This is not to say that the year has been without challenge. The adverse media reports surrounding some esoteric research conclusions on some vitamins has had a negative impact on several channels of distribution, and the recent resignation of the newly confirmed FDA Commissioner, combined with rapidly escalating petroleum and energy pricing are all factors which are destined to challenge many participants in the industry.
"Responsible industry continues to press the FDA for publication of the GMPs for dietary supplements, originally authorized under DSHEA in 1994. The value of the U.S. currency has made our product more attractive in foreign markets, so those that are able to engender relationships there are destined to prosper.
"The prediction for 2006 is for significant consolidation in manufacturing and distribution and the return of some pricing power given the inevitable increases in components costs where plastics and other materials are derived from hydrocarbon sources. The consumer is still willing to purchase well-made supplements that deliver real value. We are looking forward to a record-setting year at NAII."
Mark LeDoux
Chairman and CEO
Natural Alternatives
International, Inc. (NAII)
San Marcos, CA
"Emerging trends in the industry include an increasing focus on bioavailability, validation of product safety and efficacy. By meeting label claims, supplement companies will be better able to increase consumer confidence and satisfaction. BASF continues to invest in science and state-of-the-art manufacturing facilities, leveraging our knowledge and expertise in nutrition to introduce innovative formulations that are safe and supported by sound scientific data, without compromising on bioavailability and stability. We also participate in industry groups to help improve public awareness and knowledge about nutrition, so consumers understand that vitamins have numerous health benefits and are safe when used properly."
Emile Henein
Industry Manager,
Dietary Supplements
BASF
Florham Park, NJ
"The evolution of diet trends throughout the past year, which included redefining low carb, understanding glycemic index and interactive nutrition concepts such as MyPyramid, will present the industry with new challenges and opportunities in 2006 in the areas of functional foods and nutraceuticals. Foods that offer health benefits are well received in the marketplace, and GTC Nutrition, a leading supplier of natural, specialty ingredients, will continue to work closely and partner with manufacturers to create innovative products that meet the needs of today's health-conscious consumers. Taking it one step further, we, in conjunction with key customers, will launch a Nutrition for Life program early in the year to educate and empower consumers to make healthier food and lifestyle choices."
Patrick Smith
President
GTC Nutrition
Golden, CO
"In 2005, we saw an increase in the sales of herbal products, more favorable media toward natural remedies, and a weakening of federal standards for USDA certified organic foods. 2006 will offer the same mixed set of circumstances. 'Green companies' involved with herbs, chocolate, coffee and other items will continue to push fair wage and positive environmental standards. The year also looks excellent for receptive media around herbal medicine. At the same time, corporate consolidation in the food sector, weaker organic standards and ugly politics will make it increasingly difficult to define what we stand for as an industry."
Chris Kilham
Medicine Hunter
Amherst, MA
"From my perspective as a journalist covering holistic medicine, I see tremendous changes in the healthcare landscape in the near future. The status quo of mainstream medicine is unsustainable from an economic viewpoint and 'corporate America' is balking at the continuously rising costs; morale among conventional physicians is very low; patients are frustrated, angry and actively seeking alternatives. Healthcare is once again a major political issue. All of this spells opportunity for holistic healthcare and natural medicine, provided the industry leadership wakes up and sees the big picture. We have the chance now to demonstrate the clinical and economic value of natural healthcare, so that hopefully, it will become the foundation on which to develop a stronger, cost-effective, prevention-oriented health care system. But that will require long-term vision, serious research and diligent bridge-building. The insular, short-term, 'next quarter' thinking that has characterized business strategy throughout much of this industry, won't likely carry us too far in an increasingly turbulent healthcare environment."
Erik Goldman
Editor-in-Chief
Holistic Primary Care
New York, NY
"There is no question that the avian flu threat will be one of the most important areas of concern to consumers if a human-to-human transmissible bird flu virus appears. Without a vaccine, the natural products industry, with its contingent of antioxidant and immune-enhancing products will stand to benefit. New immune enhancers recently developed as nutraceuticals will appear in 2006-just in time.
"In 2004 and 2005, AIBMR Life Sciences experienced dramatic increases in requests to commission research by clients around the world who desire well designed studies that meet the 'competent and reliable' standard set by FTC that could determine the properties, attributes, and characteristics of nutraceutical ingredients and products. The trend to conduct more safety and efficacy studies of these products will continue due to pressure from Congress, regulatory agencies, the media, distributors, and consumers, a continuation of the shift within the nutraceutical industry from a predominately market driven to science driven paradigm begun 10 years ago. Antioxidants and the role of inflammation in disease processes associated with obesity and aging will continue to be a focal point for the media.
"Unfortunately, 'rascals' will continue to hurt the industry's reputation and undermine public confidence with their outlandish and unsubstantiated product claims."
Alex Schauss, PhD, FACN
President and CEO
AIBMR Life Sciences, Inc.
Puyallup, WA
"There are more exciting opportunities than ever before for new products that are safe, effective, and backed by science. New branded ingredients are being created on a regular basis with some companies actually doing good science and contracting for good clinical trials. But there appears to be fewer and fewer companies with real consumer marketing capability that are willing to take these new ingredients and develop them into successful products. I believe that future product successes will come from consumer branding companies partnering with new ingredient development companies. Together they can combine research with marketing, especially PR and promotions, to create the synergy necessary for new product successes."
Bob Garrison
President & CEO
Next Pharmaceuticals, Inc.
Irvine, CA
"The year in venture capital for the nutraceuticals industry was largely optimistic with new funds being committed to the sector by Nestle, and a focus on the sector in the new Burrill Life Sciences III Capital Fund. Sherbrooke Capital, the other mainstay in the sector, was also rumored to be fundraising. Functional food company Brand New Brands made headlines as the largest early stage investment in a consumer goods company in 2005, and perhaps ever. The $15+ million round included Burrill & Company, Prolog Ventures, Great Spirit Ventures and Unilever Corporate Venturing. Overall, the venture investment climate was positive, but fewer exits for venture backed nutraceuticals companies materialized than the VCs would have liked.
"Looking ahead to 2006, I believe that the focus of venture investments in nutraceuticals companies will continue to shift downstream from technology-based companies to those which have a greater marketing component. The investment community will increasingly recognize that the majority of the opportunities in the nutraceuticals space lie in progressive methods of delivering information and products to the end consumer. Overall, venture capital interest in the space will continue to grow, albeit in the guarded pace to which venture investors are ironically accustomed."
Gregg Wurster
Senior Associate
Burrill & Company
San Francisco, CA
"The past year was an interesting one for the nutraceuticals industry on several fronts. I believe we turned a corner in the ORAC category as renewed interest in ORAC formulas kept RFI busy in the last 12 months. While there are still conflicting messages being sent to consumers on ORAC, the playing field is growing more level as suppliers and other concerned parties attempt to work together to standardize the message surrounding ORAC claims.
"In other areas, demand for organics keeps growing and RFI is responding by adding additional organic product offerings. We believe the future for organics is extremely strong and this-tied in with customer concern about sustainability issues and environmental consciousness-continues to drive our business. Our challenge in the organic supplement category is the cost pressure from manufacturers who do not understand the 'premium' nature of organic products or feel they can't justify the cost to consumers. We hope to see this situation resolve itself in the future as organics become more mainstream."
Jeff Wuagneux
President and CEO
RFI Ingredients
Blauvelt, NY
"In the upcoming year regulation will play an increasing role in the marketing of dietary supplements as FDA, FTC, Congress, and even states, get into the action. If we are going to stave off unreasonable, burdensome, and in some cases, malicious regulation, we are going to have to build relationships with regulators and be prepared to accept reasonable measures to drive out the bad actors that destroy consumer confidence. This industry cannot continue to grow if we only sell ingredients that were on the market in 1994, making the same old claims while science outpaces them. A convergence must occur between regulation, science and consumerism."
Steve Mister
President & CEO
Council for Responsible
Nutrition (CRN)
Washington, D.C.
"2005 is a significant year because it represents the 10th anniversary of the birth of functional foods in Europe and the U.S. 1995 saw the launch of Benecol, the first sterol-based cholesterol-lowering food, in Finland. In the same year, Japan's Yakult Honsha and Danone launched their daily dose (65ml-100ml) probiotic dairy drinks in Europe. Ten years on, it's Europe that has become the biggest global market for such cholesterol-lowering products with sales over $700 million a year, 10 times the U.S. In addition, Europe has a market for probiotic daily dose products worth $4 billion, growing at 30% annually-this market basically doesn't exist in the U.S. So what explains the big difference in the outcomes between Europe and the U.S.? The answer to this question is a simple one. These functional food markets have been created by Europeans adopting an Asian packaging innovation-the daily dose bottle-one that American product developers have shied away from. In fact, the packaging innovation has become more important than the science in driving success. That's the single biggest lesson of the last decade: that marketing, branding and packaging innovation matter more than science."
Julian Mellentin
Editor
New Nutrition Business
London, U.K.
"Oasis LifeSciences achieved record 3rd quarter performance behind its breakthrough product AgelessXtra. Sales results were up over 93% compared to the 3rd quarter 2004, behind the dramatic growth of AgelessXtra. Launched in early 2004, AgelessXtra has become one of the fastest growing functional foods in the U.S. and now accounts for 50% of company sales. It promotes vital energy, helps manage stress, supports mental clarity and focus and improves joint health. AgelessXtra is now being used by over 50% of the PGA Senior Tour Professional Golfers. Including its other functional foods, this category now represents 74% of Oasis sales. We believe the consumer demand for quality functional food items will continue to rise dramatically."
Derek Hall
CEO
Oasis LifeSciences
Lacey, WA
"I believe that what we have seen in the past year is a shift in direction by our industry in the way it can best sell the consumer. At Vitaquest International, our Garden State Nutritionals division has always focused on designing value-added products that help the consumer meet a specific need (diet products, complex 'multi' formulations, pain relief, etc.). We have shifted beyond category formulas to a total package of wellness for the individual.
The Past: Ingredient Focused
The Present: Product Focused
The Future: People Focused
"The next level calls for incorporating a whole series of products that can surround the consumer and provide a complete system to meet their needs. It is our job to make sure our clients design their products to be integrated for their clients' lifestyle."
Jon Weisgal
Vice President of Marketing
Vitaquest International, LLC
West Caldwell, NJ
"More educated consumers are seriously exploring the role of dietary supplements and functional foods as part of a more activist health and wellness agenda. During 2005, we observed great strains in the old paradigm of very expensive prescription medicines administered by omniscient practitioners to passive patients administered by an impersonal health insurance network. There are rapidly growing economic and philosophical reasons for more consumers to understand that what the dietary supplement industry offers is in fact a valuable mainstream option rather than something exotic. We strongly believe that the food and beverage industries will play a rapidly growing role in providing the delivery systems through a broader range of supplements, and more information will get disseminated to the consumer. We endorse that trend, and we recognize that different skills are necessary to serve those markets.
"Effectively communicating dietary supplement benefits within confusing regulatory constraints is still an important work in progress. Consumers want to make the best choices to feel better and lower their medical costs. DSEA and AHPA are doing particularly good work in advocating our industry's views on these matters."
Paul Flowerman
President
PL Thomas & Co.
Morristown, NJ
"The ephedra-initiated turbulence of 2004-2005 and the conclusion of regulatory structural efforts in the EU highlighted the principal point about the state of the dietary supplement industry today: after DSHEA, industry still does not get the need for self-regulation and tightening up on quality (particularly ingredient supplier GMPs ). Consumer confidence after the vitamin E publicity, quiet FDA efforts to cut back on innovative dietary ingredients and efforts to restrict broadened dietary supplement distribution in many countries all point to the need for a re-assertion of the industry's incredible value to the baby boom generation in particular. Absent a good quality effort, I think we will see absorption into the food and OTC pharmaceutical sectors, where consumer confidence is stronger."
Scott Bass
Partner
Sidley Austin Brown & Wood
New York City, NY & Washington, D.C.
"With all the progress we've made as an industry, investing in research on safe, effective ingredients-as Nutratech has with the patented bitter orange extract Advantra Z-it's simply not enough. Our industry needs an image makeover and a strong strategic offense. We stand idly by while industry critics promote mistrust of herbs and dietary supplements. When it comes to legislative issues, we get involved too late to be effective whether on national or state levels. Before we end up selling useless placebos, we must stand together, support trade organizations and help them work collectively to build credibility and consumer confidence."
Bill Arthur
Principal
Nutraceutical Solutions Consulting
Miami, FL
"Most recent trends in the botanical extract market are progressively focusing on efficacy, safety and quality. We see an increasing customer demand in ingredients with product specific data in order to substantiate possible claims. Common bibliographic data are losing weight as the pharmacological profile of different botanical extracts can vary drastically.
"Frutarom Switzerland has started an intensive research program based on bio-assay guided development. Thus the activity and safety profile is tested on the raw material level up to the final extract. First product launches are scheduled already in the next year. Target indications are focusing on mental health. This year, Frutarom Switzerland launched the special Olive leaf extract EFLA 943 for the first time showing clinical evidence on blood pressure regulation.
"Purity, possible contaminants and residues are entering the focus of the industry. Our patented EFLA Hyperpure technology has become a key technique to obtain pure, safe and well processable extracts. The validation of the manufacturing process and the tractability of all data are of utmost importance. This can be ensured by adhering to strict production guidelines. Frutarom Switzerland is glad to have more than 10 years experience in cGMP approved production."
Stephan Vautravers
Head of Marketing & Sales-Pharma
Frutarom
Wdenswil, Switzerland
"Quality sums up 2005 for Aloecorp. Entering our 18th year of business, this has been our most exciting ever. In our efforts to raise the bar on quality and innovation, Aloecorp launched its new Qmatrix Proprietary Processing Technology-creating a new era for the nutraceuticals industry-and a new generation of breakthrough Aloe vera products. The crystal flakes produced using Qmatrix contain superior benefits to traditionally produced aloe, allowing us to produce Value Added products that will revolutionize the aloe industry. We look forward to joining our colleagues in 2006 in delivering innovative new products to consumers throughout the world."
Wayne McCune
Senior Vice President of
Sales & Marketing
Aloecorp
Lacey, WA
"If we want DSHEA to work for us, we need to make it work. Our challenge is to focus our efforts on demonstrating that responsible companies practice what they preach. We believe that our products provide numerous benefits to society from providing a smart choice for supplementing other healthful lifestyle choices to potential healthcare cost savings. Our challenge is to demonstrate that to the audiences we care about, including the people who buy our products. It isn't enough to just talk about quality products and science-based formulations. Each company in this industry has a responsibility to turn that talk into action."
Chuck Brice
Chairman of the Board of Directors
Council for Responsible
Nutrition (CRN)
&
Senior Vice President
Kemin Health, L.C.
Des Moines, IA