|
The ever-expanding SupplySide East education program, sponsored this year by EPAX, offered many new opportunities in 2008 for participants to learn, discuss and contribute to the hot topics and issues in the natural products industry, from regulatory to research. This year's program also featured the debut of cosmeceuticals at SupplySide, including workshops and presentations from leading experts.
Today's natural products industry is global, and companies wishing to compete on the international scene must learn the ins and outs of the markets in various countries. Peter Zambetti, global business development manager, Capsugel, took attendees on a quick trip around the world with his overview of the regulatory and consumer trends facing dietary supplement marketers. With the title “The Good, the Bad and the Ugly,” he outlined markets with expanding opportunity, such as North America (despite its fickle consumer base) and Western Europe (where probiotics and nutricosmetics are among the leading categories). Interestingly, while Asia Pacific is the largest market currently, regulatory changes in Japan have negatively affected sales.
Also on a global scale is malnutrition, which is the cause of 11 percent of the world's disease and is especially devastating to children, who can experience stunting, wasting and underweight, according to Clayton Ajello, managing partner, inlexo. The consequences of malnutrition are dire, with death or morbidity the primary endings. Ajello said one-third of childhood death is related to malnutrition, with half of those deaths due to only five diseases—diarrhea, HIV, malaria, measles and ARTI. In addition to grim statistics, Ajello noted total funding worldwide for programs combating malnutrition are a paltry $124 million a year, and he challenged industry members to initiate or step-up contributions, especially capital, for reputable programs focused on malnutrition.
The education program took a more narrow look at a hot market for exporters and importers—India. Ranjit Puranik, executive director at Shree Dhootapapeshwar, and R.V. Appaji, executive director of Pharmexcil, India’s regulatory oversight body, presented the opportunities at hand. Puranik particularly laid out the land, with India positioned as the fourth largest global economy, growing at 8 percent annually, with a historical basis in herbal and natural medicine. Appaji added India’s government has tightened review of regulatory and GMP (good manufacturing practice) procedures and importers should have the highest expectation of quality in Indian botanicals.
Government and regulatory trends at home were also on the minds of attendees, as the two-part state of the industry session drew a full house. Speakers included Michael McGuffin, American Herbal Products Association (AHPA); Daniel Fabricant, Ph.D., Natural Products Association (NPA); and Steven Mister, Council for Responsible Nutrition (CRN). Each of the speakers gave a brief overview of their association’s current outreach efforts, including AHPA’s ongoing focus on GMPs (good manufacturing practices) via seminars and white papers; NPA’s work to educate legislators through its Lobby Day and Coalition to Preserve DSHEA; and CRN’s positive public relations outreach effort, Life…supplemented. Once the floor opened up to questions, the temperature began to rise, with attendees asking about GlaxoSmithKline’s petition to disallow weight loss claims on dietary supplements (general consensus—probably not going anywhere) and the current status of adverse event reporting (AERs) and companies’ responsibilities in that arena. While AERs have been coming in, the numbers have not been unexpected, though there was some concern on what constitutes “serious” in terms of reporting. Fortunately, Vasilios Frankos, Ph.D., FDA’s director of the division of dietary supplement programs, was in the audience, having arrived early for his Featured Presentation, and gave some clarification on the point as well as advising companies to be sure to keep all records and look at AERs as signal generation.
With the deadline looming for the companies with more than 500 employees, the dietary supplement GMPs are the hot topic, with many questions about specific compliance issues still unanswered. Longtime QC experts Annette Dickinson, president of Dickinson Consulting, and Joy Joseph, president of Joys Quality Management Systems, clarified a few important points of the regulation, including the scope of required documentation and testing. The crowd peppered the experts with many specific questions on implementing the GMPs in their respective businesses. The pair noted FDA has not clarified many of these points.
FDA did not shy away from the spotlight, however, as Frankos delivered SupplySide East's featured Presentation, updating the achievements, priorities and ongoing challenges in the agency's supplement program, including GMPs, AERs, NDIs (new dietary ingredients) and agency funding and abilities. Among the highlights, Frankos said FDA has the ability and authority to enforce GMPs to the fullest extent.
One of the biggest questions in this current climate of quality and testing is where to get good information for analysis of ingredients and products. Gabriel Giancaspro, Ph.D., director of dietary supplements, documentary standards, U.S. Pharmacopeia (USP), looked at the history of compendia and outlined the USP latest compendium, The Dietary Supplements Compendium (aka green book). He reviewed criteria for inclusion and the many categories of scientific information presented on each ingredient, from contaminant limits and safety information to guidance on testing and regulation.One of the biggest sources of bad or misleading media coverage of supplement safety and quality is the combination of athletics and dietary supplements, a tumultuous pairing in the world of failed doping tests and redirected blame. Marc Ullman, Esq., partner at Ullman, Shapiro & Ullman, reviewed the finer points of recent and historic cases involving athletes, dietary supplements and doping scandals. He cautioned the lead congressional investigator of the baseball-steroid scandal, which is beginning to focus on supplements, is Rep. Henry Waxman (D-Calif.), a known critic of natural products and DSHEA. The scientific perspective on these issues was provided by Paul Klinger, executive director of Informed-Choice LLC, a former WADA (World Anti-Doping Association) program lab. He explained the controversial findings his now-third-party lab found when investigating dietary supplement products for contamination with WADA-banned substances. The seminar crowd passionately questioned Klinger and a representative from associated lab HFL—who was in the crowd—about the manner in which the results were first published in USA Today, as well as the methods used to conduct the survey/test.
The crux of nutritional supplementation in sports is the drive to optimize energy and body composition for increased strength and activity. On the opposite end of this activity spectrum, obesity continues to be the hot button for dietary supplement manufacturers, as consumers search for the magic bullet to help control their growing waistlines. Professor Jacques Goulet, Ph.D., from Laval University provided “evidence of probiotics’ effectiveness” in the prevention of various conditions such as irritable and inflammatory bowel syndrome, dermatitis, obesity and overall improvement of the immune system. Goulet also discussed other promising developments in the use of probiotics for autism and as an oral vaccine.
Harry Preuss, M.D., tenured professor at Georgetown University Medical Center, continued the discussion of obesity by discussing the theories behind why America is obese. While it can be said that a diet of fewer complex carbohydrates and too many refined foods is a culprit, Preuss suggested that Americans are gaining too much weight and losing muscle. He noted that “a one pound muscle consumes 35 to 40 calories” and the importance of exercise and maintaining muscle is essential in weight management. He also discussed the science behind various dietary supplements, from maitake mushrooms to starch and sugar blockers, that hold promise in the weight loss and diabetes category.
Sticking to the science, many SupplySide East presenters outlined research on specific ingredients. Commander Joseph Hibbeln, M.D., acting chief of nutritional neuroscience, National Institute of Alcohol Abuse and Alcoholism, National Institutes of Health (NIH), surveyed the research behind essential fatty acids (EFAs) and improved emotional wellness. Among his revelations: "Neurons cannot create basic synapsis unless DHA (docosahexanoeic acid) is present, and DHA must come from the diet." He further said fish oil omega-3s can change the emotional color, calling this action "basic neuroscience.”
Similarly, Daniel Barry, M.D., assistant professor, University of Colorado Denver and Health Sciences Center, looked at several studies that suggested consuming calcium citrate before and after exercise may prevent an increase in PTH and CTX, which could positively impact bone health.
Likewise, Paul Gross, Ph.D., consultant and author, Wolfberry: Nature’s Bounty of Nutrition and Health, peeled away the hype surrounding superfruits. In his presentation, he looked inside the marketing success of the superfruit category, the history behind how fruits became “super” and weighed the scientific evidence of a handful of fruits against their marketing campaign. He noted the superfruit category affords a great opportunity to educate consumers and stressed the importance of studies; he cited the success and the systematic published science of pomegranate and concord. Additionally he added some interesting points for new innovations suggesting that manufacturers should consider products that are adopted early in childhood and create habits for a lifetime, offer convenience and satisfaction, and are energetic and fun. “These overwhelming underdogs are just getting started and have much more to give.”
Immune function is among the top health concerns of consumers of all ages, especially in the natural products channels, but there are certain demographics that have greater concern for their longevity relative to immunity. Barry Ritz, Ph.D., research associate and professor at Drexel University reviewed the connection between the $152 billion worldwide Nutraceuticals market and immune restoration in the elderly. He detailed the research showing how improving micronutrient status through regular nutraceutical intake can enhance immunity in at-risk populations.
One of the biggest pursuits at trade shows is finding the next hot products, which for SupplySide East meant popular ingredients and applications. LuAnn Williams, senior analyst, Innova Market Insights, enlightened the final morning of education audience with ingredient trends by category, including sweeteners, satiety, digestive health, low-salt, low trans-fats, skin health and high-fiber. She gave examples from around the world of applications of hot ingredients such as stevia, probiotics, aloe, collagen and many branded ingredients across the popular categories. Among the top trends Williams cited were: natural over organic; functional and condition-specific products; eco-friendliness; minimal packaging; increased brand development; private label innovation; and a focus on "retro".
Market research was also center stage with Greg Stephens, vice president of strategic consulting with the Natural Marketing Institute (NMI). Stephens cited the continued phenomenal growth in functional foods, particularly as the level and scope of fortification and enrichment has evolved. He outlined an evolutionary curve from traditional foods to dietary supplements and then into functional foods, using omega-3s as an example (fatty fish dinners gave way to omega-3 supplements, which moved on into enhanced orange juices and chocolate bars). Consumers are using functional foods to promote their health, increase consumption of certain nutrients and take greater control of their own health care.
As trends go, the herbal marketplace is pretty active. Mark Blumenthal, executive director of the American Botanical Council (ABC) and Herbalgram, sifted through the various trends and issues relative to herbal products, He covered everything from herbs in the media and newly applicable regulations--adverse event reporting and GMPs—to invigorated pharma interest in the category and the growing presence of herbs such as pelargonium, which may help bronchial health via effects of cell adhesion.
Trends on the supply-side of the industry also focus on delivery. Leo Mendez, senior technical services specialist, BASF, tackled this category with a presentation on the various methods and trends in controlled-release delivery, highlighting both the impact these forms can have on consumer compliance and convenience, and the ease with which manufacturers of any size can go "controlled".
New Kid on the Block—Cosmeceuticals
SupplySide East 2008 welcomed a new education track, reflecting the growing interest in cosmeceuticals. In this sold out event, R&D, industry consultants, formulators and scientists from niche, specialty brands to large cosmetic manufacturers such as Avon, Estee Lauder, Loreal, N.V. Perricone and Bayer Healthcare were in attendance to discuss the burgeoning trend of cosmeceuticals. Jim McParland, director, claim substantiation, from L’Oreal, opened the workshop with an overview of the regulatory landscape for cosmeceuticals. He noted that from a regulatory point of view there is no official definition of a cosmeceutical; instead, it is a coined term to bridge the gap between cosmetic and drug. As the cosmetic marketplace has evolved—products have become more effective, knowledge of skin science and testing methods have improved—so have claims that reside in the gray area between a cosmetic that is intended to clean, beautify or alter the appearance of the human body; and a drug that is intended for use in the diagnosis, cure, treatment and or prevention of disease. Marketing messages and claims such as “rebuilds collagen,” “repairs skin’s cellular structure” have taken a cosmeceutical-like stance and could potentially face regulatory scrutiny from the FDA, FTC, National Advertising Agency (NAD), competitors, network television, department stores, state attorney general and class action lawsuits. McParland discussed how these agencies take action, how claims can be substantiated, tests that are accepted and the various regulatory challenges at hand.
Denise Herich, research director from the Benchmarking Company, was on hand to discuss the female consumer—the trends, attitudes and behaviors toward natural and organic beauty brands. Herich discussed the move toward a holistic lifestyle and why women are purchasing more natural beauty products. Sixty-six of all women interviewed in the 2008 Pink Report ™: The Age of Naturals said they bought natural/organic beauty products because they did not want synthetic chemicals on her skin. In addition, these shoppers are buying based on labels, curiosity, and are willing to purchase nutricosmetics and cosmeceuticals. Marketing information from Datamonitor also noted that appearance conscious consumers are increasingly buying cosmeceuticals with active ingredients, most notably they are looking for specific personal care problem solving solutions and are willing to pay a premium for these items.
Overall, the speakers delivered consumer attitudes, market and sales trends and advice on how to develop substantiated, consumer-friendly product claims. In addition, attendees participated in a lively Q&A discussion regarding new European regulations, organic standards for personal care, company sustainability, and animal testing. “This was an outstanding event that brought together emerging issues associated with the merging of functional food, cosmetics and personal care,” said Meyer Rosen, president, Interactive Consulting. “The workshop focused on a whole new opportunity to draw on technical transfers between the food and personal care industry. Some excellent market trends and regulatory presentations were presented, as well as a piece on the inner thinking of women and their personal care buying habits—great discussion of terms such as organic, natural and sustainable.” |
