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Expanded Education Program Equals Expanded Minds

SupplySide West’s education program, sponsored by Cognis Health & Nutrition, added a fourth track this year, bringing cosmeceutical experts to the podium to join the usual dietary supplement and food/beverage seminars. However, the sessions were anything but usual. The hottest topics and ingredients of the day owned the spotlight, as highly qualified speakers presented the most recent science, research data and inside expertise on functional foods, omega-3s, vitamins, regulatory issues, quality control (QC), herbal medicine, consumer trends and body/skin care.

“Cognis continues to invest in sponsoring the SupplySide Education program so all of us in the industry can together learn the latest news from the top experts in their fields,” said Dave Eckert, vice president, Cognis Nutrition & Health. “As a leading global supplier, our role is evolving into new areas at record speed, and these educational sessions provide invaluable insights.”

A good portion of the education program covered the highly active areas of regulation and quality control. Joseph M. Betz, Ph.D., Office of Dietary Supplements (ODS), and Karen Andrews, USDA, discussed compliance and the new supplement GMPs (good manufacturing practices), including details on setting and meeting specifications using qualified labs.

Documentation is a key part of the new GMPs, as Anthony L. Young, Esq., Kleinfeld, Kaplan & Becker LLP, advised in his presentation on QC, which highlighted some of the finer points in the regulation. He urged manufacturers to “keep it simple,” when it comes to specs, and “document at the time of the task.” QC teams need enough authority to complete all the mandated tasks, he noted, and they must be able to explain processes and methods uses, including any reprocessing of product.

Two speakers with extensive experience in meeting various GMPs— Paul Bolar, Pharmavite LLC, and Joy A. Joseph, Joys QM Systems—got to the nitty-gritty of compliance with the new regs, including who is responsible for what, and fielding questions on specific issues and concerns from manufacturers in attendance.

Quality and safety go hand-in-hand. Jay Udani, M.D., Medicus Research and UCLA, described improving product safety tasks, including data collection, adverse event reporting (AER), conducting safety studies and evaluating all collected safety info.

More specific information on the AERs was provided by FDA’s Bill Frankos, Ph.D., who reviewed the filing requirements associated with the legislation passed by Congress in 2006. The lion’s share of responsibility with AERs is records maintenance; understanding the differences between types of forms (manufacturers use the 3500A form) and submission guidelines (industry must submit as hard copy with attachments, not electronically or via fax) is crucial. “We’ve never had this type of systematic system before, so it is a challenge, but we want to use data mining technology to identify signals, not causality,” he said.

Among the solutions created for companies in this new era of quality and safety scrutiny of natural products is the SIDI (Standardized Information on Dietary Ingredients) protocol, a joint effort from the industry’s trade associations, designed to streamline raw materials exchange between suppliers and manufacturers. Andrew Shao, Ph.D., Council for Responsible Nutrition (CRN), Nicki Jacobs, B&D Nutritional Ingredients, and Edward Wyszumiala, NSF International, discussed the background of SIDI and detailed the forms and questionnaires involved. Jacobs called supply chain security one of the most important aspects of this materials process.

In the raw materials trade, sourcing is an international enterprise rife with potential problems. P.K. Dave, Nature’s Formulary, and Ranjit Puranik, Shree Dhootapapeshwar, gave an overview of India as a global player on the dietary supplement scene. The topic proved particularly prescient, as many companies on the exhibit floor were showing ingredients cited by the Indian government as high priority for market growth, among them amla (Indian gooseberry), garcinia and shatavari. In addition, shortly after SupplySide West, Natrol Inc. was acquired by an Indian pharmaceutical firm seeking a strong North American presence in the dietary supplement arena.

George Pontiakos, BI Nutraceuticals, also touched on global concerns with his presentation about sourcing challenges. He noted his company imports approximately 70 percent of its ingredients from 35 countries worldwide. “Sourcing is the most complex function and it’s a violent marketplace out there,” he said, citing challenges such as geography, weather, time pressures and pricing. He urged attendees to examine a range of issues such as certifications and specs to come up with the entire cost of quality when comparing vendors.

Botanicals are sourced from around the world, as manufacturers explore the latest and most effective herbal remedies. Promising botanicals took center stage in two presentations on Tuesday. Navinda Seeram, Ph.D., UCLA, discussed the advancing research surrounding pomegranate. “Pomegranate’s ancient uses have been substantiated with current scientific studies into its unique tannins,” he said. Seeram and his team have conducted several studies into the impact of pomegranate ellagitannins on prostate cancer, and he shared preliminary information on a Phase II trial on its efficacy. Herbs with potential also were the focus of Mark Blumenthal’s presentation, who noted, “We’re seeing more specialization, differentiation and proprietarization.” Among the botanicals he cited as having new studies were hibiscus, hops, rhubarb, Danish rose hip powder and guava leaf extracts. He also lauded companies for doing more research on proprietary branded ingredients, such as EpiCor and Decursinol.

The National Institutes of Health (NIH) has funded much research in the area of botanicals, as well as other natural ingredients. Leila G. Saldanha, Ph.D., ODS/NIH, provided an overview of ODS funding of natural products research. In the same seminar, Traci Clemons, Ph.D., The EMMES Corp., detailed AREDS (Age-Related Eye Disease Study) results, including carotenoids, fatty acids and multivitamins; and Joanne M. Holden, USDA, outlined the intake goals, challenges and findings associated with her agency’s newly launched Dietary Supplement Ingredient Database, which involves for micronutrients in products reported in the National Health and Nutrition Examination Survey (NHANES).

Surveying is also a component of market research, including effective marketing and understanding the target audience. Steve French, Natural Marketing Institute, presented several macro consumer trends, including specialization/personalization (one size does not fit all) and the use of foods and supplements as medicine. “Consumers are increasingly willing to use foods and beverages to treat and prevent health issues, even more than supplements,” he said. One of those health conditions they’re treating is sleeplessness, which was a draw for Physic Ventures to invest in Dreamerz, a company that developed a functional supplement beverage to treat occasional sleeplessness. During the panel discussion on functional food and beverage opportunities, moderated by Garrett Lindemann, Ph.D., GourmetCeuticals, speakers discussed the need for companies to lead in the self-care space by developing foods and beverages that deliver health.

Also emphasizing the importance of identifying a target audience was Felicia Wyrick, Adfinity Marketing, who addressed how to generate buzz among the trade press. She noted it’s critical to start out with your own company to understand its trends and how the company is addressing industry concerns. “Then you’re better situated to determine what news is and how it relates to the readers of the publication,” she said.

Market research also took center stage in food and beverage seminars. Kate Peringer, The Hartman Group, discussed functional food from the lens of the consumer. Results from interviews showed “consumers have no idea what functional foods are,” she said. “So, it’s important to talk to consumers on their level by using subtle benefit claims, rather than claims that sound too medicinal” when marketing functional foods. She further noted, although pills are still the preferred deliver form for vitamins and minerals, juice and food bars are generally accepted as functional food products among consumers.

David Schmidt, International Food Information Council, offered an overview of the 2007 IFIC Foundation Food and Health Survey: Consumer Attitudes Toward Food, Nutrition & Health.” Results include: 75 percent of consumers surveyed believe food and nutrition play a great role in health; 53 percent rate heart health as the top health concern, followed by weight management and cancer; and 92 percent can name a functional food and its associated health benefit.

Chef Kurt Stiles, Intelligent Ingredients, moderated a discussion with Cheryl Forberg, RD, NBC’s “The Biggest Loser”, and Mark Newman, MN Flavor Consulting, on designing functional food products. “Flavor is usually the biggest problem with functional foods,” Newman said, adding that safety, texture, color and shelf life are other product-development obstacles.

In a panel discussion moderated by James S. Tonkin, Tonkin Consulting, Steve Allen, Nestlé, and Marigread Eichten, The FRS Co., offered an in-depth look at the future of functional beverages. Eichten noted there are more than 335 energy drinks on the market. “The desire for energy is universal,” she said. “Humans have a thing for stimulus.” In addition, she noted, consumers are interested in weight management and nutrition/wellness, so the days of sugar- and caffeine-derived energy are done. “Bringing healthy energy is the new trend,” she said.

Taste was top of mind in the session featuring Coca Cola’s Grant E. DuBois, Ph.D., who discussed the interaction of smell, taste and chemosynthesis and their contributions of the definition of taste. DuBois has worked for years on developing new sweetener technologies, and walked the audience through some of the current offerings and some of the newer alternative sweeteners, such as Rebiana from stevia, that may have an impact on future product development.

Two of the hottest topics in the food and beverage industry, obesity and functional foods, were addressed in this year’s education program. Brian Herr, Alliance for a Healthier Generation, outlined the organization’s mission to eliminate childhood obesity and inspire young people to develop lifelong healthy habits. The organization is working with schools, the food and beverage industry, healthcare workers and kids themselves to help fight this health threat. “With obesity, there is no single cause, no single solution,” he said.

Functional food, a category not officially recognized or defined by FDA, was the focus of several education sessions. George A. Burdock, Ph.D., Burdock Group, explained the regulatory barriers to developing functional foods, reviewed FDA claims, reviewed basic concepts in regulations, and noted that the most significant barrier is “an impasse among FDA, industry and consumers” with regard to functional foods.

Functional products, especially beverages, were one of the hot investment categories discussed by David Thibodeaux, Canaccord Adams Investment Banking Group. He reported aging, obesity and convenience are primary drivers in the natural products markets, many of which have seen good growth. While merger and acquisition activity remains strong, he said some of the high multiples being paid for various natural products companies should come down; the sub-prime market fiasco has also affected the natural markets, as the credit market tightens and debt availability is more limited.

The newest of the education program tracks focused on cosmeceuticals, providing a look at marketing trends, growth drivers, ingredient reviews and the latest information on the role of organic personal care, botanical innovations and new science, as well as formulation tips and new findings for this booming category.

The use of botanicals in personal care garnered the biggest interest. Rebecca James Gadberry, YG Laboratories, kicked things off with a presentation on the key points in selecting botanicals for use in personal care formulations. She noted companies must stay in line with their values and philosophy, choosing ingredients and packaging based on what the targeted demographic cares about, choosing labels, certifications and “sexy” ingredients based on market value—what kind of venue will the company like to serve and how much education will be required when introducing a new ingredient. Mindy Goldstein, Ph.D., Estee Lauder, shared the hottest new botanicals for cosmeceutical use, looking at the folklore and the active components of a selection of botanicals such as milk thistle, chaparral, green tea and Gingko biloba. Ken Jones, Aloecorp, provided new research and the effectiveness of Aloe vera; Vladimir Badmaev, M.D., Sabinsa Corp. discussed the use of turmeric, potato, black pepper and coconut in cosmeceutical products; and David Djerassi, Intrachem Technologies, outlined the benefits of L-hydroxyproline for topical applications. Exciting innovations were highlighted in discussions by Sylvia Nefkens, Ph.D., Laboratoires Serobiologique, who spoke about use of phytosterols as an anti-inflammatory and a topical base for locking in skin moisture; and Deborah Pierce of Cognis brought up the idea that “slowing down cell turnover may be a successful new approach to anti-aging” during her discussion of the narcissus plant as a potential anti-aging ingredient. The need for industry regulations and standards was also brought into the forefront as Rob McCaleb, Herb Research Foundation, and consultant Linda Chaé discussed the controversy behind grapefruit seed extract as an anti-microbrial preservative. Chaé suggested the use of Eco Cert’s positive list of approved preservatives and other options such as sugar, honey, heavy corn syrup, alcohol, enzymes, essential oils, plants from land and sea with stable active components. Timothy Kapsner, Aveda Corp., dug into the many ways personal care manufacturers are using the term organic on labels. He also highlighted the challenges a manufacturer may face when wanting to put an organic product on the market in the United States and in Europe. In an attempt tie all these strings together, Kapsner announced the formation of a new trade organization called Organic and Sustainable Industry Standards (OASIS) to develop an organic standard for health and beauty products.

According to Julia McNamara, Datamonitor, skin care cosmeceutical products account for nearly 80 percent of the total U.S. and European cosmetic market. These numbers continue to rise as appearance conscious consumers want to look good on the outside and feel well on the inside. Some potential hot beds for cosmeceutical formulations include products that address specific body part such as dry skin for the feet and the scalp, facial treatments, anti-wrinkle, anti-cellulite, whitening toothpaste, luminous/skin whitening, spider vein treatment and eyelash strengthening. Christine Chufo and Alison Tirone, both from SPINS, provided insight into the natural body care market and the health and wellness lifestyle movement that is driving the category. While consumer awareness is driving natural personal care purchases, new trends such as Hawaiian and tropical-based ingredients, baby and mom, glow and shimmer, honeybee products, marine and Ayurvedic products are also garnering attention.

Another “first” at SupplySide West was a post-conference workshop, “Essential Fatty Acids: The Opportunity is Now.” More than 100 industry execs stayed on for the three-hour intensive, which offered a science overview, legal considerations, consumer expectations, and current market trends. Heather Granato, group editor at Virgo Publishing, provided an overview of the science from 30,000 feet, detailing the biological makeup of essential fatty acids (EFAs), as well as the various health conditions they impact, including eye health, brain development, cardiovascular wellness and mood stabilization. Anthony Young, Kleinfeld, Becker & Kaplan, gave the look at the regulatory aspects, including GRAS (generally recognized as safe) status of ingredients and the current and potential health claims associated with EFAs. “We can put this ingredient right up there with calcium,” Young noted, “but the industry is going to have to get together to champion the use of omega-3 EFAs for promoting good health.”

Market research data was presented by David Sprinkle, MarketReserach.com, and Gregory Stephens, Natural Marketing Institute (NMI). Sprinkle took a global look at product introductions and the momentum in the market. Formulation appears to be shifting from just alpha linolenic acid (ALA) from seed sources such as flax to more eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from marine sources, whether fish or algae. While in 2006, 70 percent of omega-3 enhanced products featured ALA, that number should shift to 2/3 of products featuring DHA and EPA by 2010. Sprinkle added products are calling out both “omega-3s” and “DHA” on labels, and there is a new emphasis on flavor development and retro graphics. Stephens used NMI’s proprietary Health & Wellness database information to provide consumer trend data on usage patterns and familiarity. Their data shows 28 percent of consumers are familiar with DHA, and that consumers who are using fish oil and enhanced functional food products in the category tend to trend older, higher income and higher education level, with an even split between the sexes. Also, users of omega-3s tend to have greater overall use of dietary supplements, and are using them for specific health conditions.

EFAs were also the focus of the SupplySide West featured presentation, in which renowned researcher Jorn Dyerberg, M.D., delivered an entertaining and informative presentation about his experience with the Greenland Eskimos and the health benefits associated with omega-3 fatty acids from marine sources. Speaking to a max capacity crowd, Dyerberg captivated the audience with stories about his time as a young doctor traveling to the Greenland islands and studying the eating habits of the Greenland Eskimo, or Inuits. “There was a low incidence of cardiovascular events; they were eating diets with lots of fat, but had a low incidence of coronary heart disease,” he said.

The results of Dyerberg’s and colleague Hans Olaf Bang’s observations were first reported in the Lancet in 1971. Their original study detailed the difference between the high-cholesterol, high-fat diet of the Inuits and the high-cholesterol, high-fat diet of counterparts in Denmark was the levels of omega-3s the Inuits took in. “We couldn’t fully explain the differences, but wanted to look at the diet composition and the particular fats, particularly the polyunsaturated omega-3s and omega-6s,” he said. “We found that their levels of omega-6s were half that of the Danish and they had five times the levels of omega-3s.”

Dyerberg and Bang’s original observations serve as the foundation for more than 36 years of research and findings on long-chain essential fatty acids (EFAs). Dyberberg highlighted the latest clinical findings on the beneficial effect of omega-3s such as the impact on inflammatory leukotrienes. He noted DHA and EPA are forging the way for new anti-inflammatories, and research is underway to see if they can help reduce the intake of non-steroidal anti-inflammatory drugs (NSAIDs), which could help mitigate the severe side effects of these drugs. He also mentioned the role of omega-3 and the brain, from its importance to fetal development to its role in postpartum depression and Alzheimer’s disease and ADHD. “Twenty percent of the brain and nervous system is fatty acids and 50 percent of that is DHA,” he said. “Fetal development is dependent on it. Postpartum depression has been found linked to different country’s fish consumption. Alzheimer’s disease—during the Framingham health study, they found consuming more DHA reduced the risk of Alzheimer’s disease.”

According to Dyerberg, omega-3s will continue to serve as an essential food component and primary player in disease prevention. “In the future, we’ll see a firmer establishment of its health impacts. Anticipate a firmer recommendation on supplementation in pregnancy for brain development, and we’ll be seeing more positive findings in cancer.”