Seminars Provide the Latest on Science, Regulations,Marketing

Seminars Provide the Latest on Science, Regulations,Marketing

Click here to see picturesfrom the conference programs!

The three-day educational series,co-sponsored by EPAX and Nutrilearn.com, brought attendees breaking informationon regulatory affairs, new research on nutritional ingredients, and sales andmarketing tips to drive business development.

Scientific sessions took center stage from the opening of theeducation program on Wednesday afternoon, as Mark Blumenthal from the AmericanBotanical Council presented a thorough and informative session detailing alitany of promising new botanicals, from the well-known ginseng and guarana tolesser known mangosteen and sea buckthorn. The crowd of attendees learned aboutexisting and emerging research supporting these herbs, as well as informationabout the plants properties and bioactivity. Of particular note were herbsindicated as useful in the hot health area of glucose controlbitter melon,banaba leaves and cinnamon. Other herbs covered included catuaba, butterbur, Andrographispaniculata, muira puama, caraluma, LoHan Guo, lemon myrtle, prickly pear and Chineseskullcap.

Additional botanical-focused seminars included a presentationfrom Norman Farnsworth, Ph.D., distinguished professor from the University ofIllinois, Chicago, on the research and biochemical actions of black cohosh andother botanicals important in womens health; and a seminar by Navindra P.Seeram, Ph.D., from the UCLA Center for Human Nutrition, covering theantioxidant properties of the polyphenolic compounds in pomegranate, includingpunicalagin and ellagic acid. Another scientific seminar, presented by StephenAshmead, M.S., from Albion Advanced Nutrition, reviewed the moleculardifferences between amino acid mineral chelates and complexes, as well as theimportance of using validated analytical methods that can detect the presence ofbonds in actual mineral chelates.

At the crossroads of science and marketing are label claims,which was the focus of David Sehardt, senior nutritionist at the Center forScience in the Public Interest (CSPI). Sehardt noted that, contrary to popularbelief, We [at CSPI] dont hate supplements. ... But, when you go down thesupplement aisle, only a small fraction of the products are justified withresearch. He detailed examples of products that he said dont live up totheir claims (including CortiSlim, conjugated linoleic acid, vinpocetine forbrain health, and ginseng for energy) as well as some that CSPI believesdo have substantiation (i.e., glucosamine, saw palmetto, phytosterols,long-chain omega-3 fatty acids).

A number of those ingredients may have a place inaddressing some of the hot health areas identified by Elizabeth Sloan, Ph.D.,president of Sloan Trends, in her seminar on up-and-coming health areas,including weight management, glucose control, fortification and antioxidantsupport. Sloan also presented data on consumer purchasing habits, with a notethat many shoppers, particularly younger consumers, are becoming increasinglyhealth-conscious, scanning product labels for details including fat, calories,sugar and sodium content.

Weight management was also the topic of a presentation byAlexander Schauss, Ph.D., from AIBMR Life Sciences Inc. He noted the incidenceof obesity has spread rapidly over the past 20 years, with four states nowreporting more than a quarter of their population is obese (body mass index over30). He noted there are a host of factors influencing the obesity epidemic,particularly lifestyle changes such as less exercise and more calories consumedaway from home. This affords a great opportunity for the nutraceuticalindustry to provide functional foods and foods in general such as promotingconsumption of lower glycemic index foods, he said. We must educateconsumers on the structure and function of ingredients activity againsthealth concerns.

The importance of consumer education was further illustratedin the seminar on dietary supplement usage in the general population, with newstatistics presented by the Natural Marketing Institute (NMI) and the NationalInstitutes of Health (NIH). Johanna Dwyer, D.Sc., R.D., from Tufts University,noted more than two-thirds of the population use a vitamin or mineral product,but a large percentage of those consumers are only taking a multi and couldntstate why they actually take the product. The reasons people take supplementsare complex, and we have to look deeper to see different motivators, shesaid. Supporting data was presented by Steve French, managing partner with NMI,who noted 50 percent of supplement users believe condition-specific supplementsare a vital part of staying healthy. In addition, the greater the number ofpills a consumer takes per day, the greater the likelihood that they are takingproducts for more than just general health. In addition, those consumers aremore likely than the general population to report using supplements to manage agreater number of health conditions, which French suggested could be aself-fulfilling prophecy, because they are more aware in general of theirhealth.

Beyond market research, attendees also discovered sales tipsand techniques to further their business development. Author Patricia Gardnerpresented her secrets to close bigger sales faster, including doing the advancehomework, making it all about the client, and assembling case studies and quotesthat will help build your sales case. You must learn about your product fromyour marketing team as well as customers using the product, in order to convincenew customers that they will get the return on investment they seek, she said. If you can let customers know how long it willtake to get their investment back, it removes price from the equation, allowingyou to focus on quality and value.

Manufacturers looking for insight into retail sales had theopportunity to hear a panel of retailers, including Tony Welder, R.Ph., owner ofseveral independent pharmacies; Salam Salam, vice president of the VitaminShoppe brand; and Adrienne Mastrobattista, owner of the Organic Warehouse inStroudsburg, Pa. The key topic on deck was the importance of educational andscientific support when purchasing inventory for their respective retailsegments.

Befitting an industry facing myriad challenges, there was agreat deal of interest in the sessions covering regulatory and safety issues. Aswith most SupplySide shows, the Industry Update panel, led by Marc Ullman,partner at Ullman, Shapiro & Ullman drew a crowd interested in hearingassociation leaders discuss various regulatory efforts impacting the future ofthe industry. Michael McGuffin, president of the American Herbal ProductsAssociation (AHPA) outlined the challenges facing herbal products, such asconfusing media coverage; Steven Mister, Esq., president of the Council forResponsible Nutrition (CRN), relayed his expertise on supplement bills at thestate level; David Seckman, executive director of the National Nutritional FoodsAssociation (NNFA) reviewed Congressional activity related to industry; andMartin Last, vice chairman of the U.K. Health Food Manufacturers Association(HFMA) provided an overview of the current regulatory situation formanufacturers selling supplements in the European Union (EU).

International regulation was also the subject of apresentation by Mark LeDoux, Natural Alternatives International, who addressedthe Codex Alimentarius commissionand what impact it has on the U.S. dietary supplement market. While thereremains a great deal of concern about Codexs upper limit requirements, LeDouxnoted Codexs guidelines on dietary supplements are designed to promote andfacilitate international trade. Contrary to information on some Web sites,big pharma is not controlling the Codex process, he said. Theprocess is totally transparent, and will not restrict consumers access todietary supplements.

The subject of dietary supplement safety and U.S. policy wasthe subject of an expert panel that included Joseph Betz, Ph.D., director of theDietary Supplements Methods and Reference Materials Program at the Office ofDietary Supplements (ODS). Betz discussed a few of the challenges supplementshave faced in testing and research, including misidentification of sourcematerial, as well as the importance of good manufacturing practices (GMPs) anddiligent quality assurance and control programs. Additional speakers includedClif McClellan, director of toxicology for NSF International, discussingtoxicity testing; Mary Palmer, M.D., from George Washington University, whosuggested the industry develop a supplement safety database; and Jason Woo,clinical evaluation team leader for the Food and Drug Administrations (FDA)Division of Dietary Supplement Programs, who highlighted FDAs new dietaryingredient (NDI) notification process.

Additional seminars addressing regulatory issues included apanel presentation focused on development of analytical methods by AOAC and alook at the substantiation requirements for making label claims. In the AOACpanel, Loren Israelsen, executive director of the Utah Natural ProductsAlliance, issued a call to arms on development of analytical methods, calling itthe issue of the year and critical to implementation of the forthcoming federal GMPs(good manufacturing practices). And the substantiation seminar emphasized the need for competent and reliablescientific evidence, and the types of evidence needed. You must look at boththe express and implied claims, and ensure the evidence relates specifically tothat claim and the ingredient, said Michael Glade, Ph.D. Remember thatanalyses and reviews are sources of citations, but are not substantiationthemselves.

The SupplySide East program ended with a special presentationby regulators and industry members, including Susan Walker, M.D., director ofFDAs division of Dietary Supplement (DDS); Linda Pellicore, Ph.D., seniorsupervisory toxicologist for FDAs Center for Food Safety and AppliedNutrition (CFSAN) and manager of the agencys New Dietary Ingredient (NDI)program; Vasilios Frankos, Ph.D., special assistant for science review for DDS;McGuffin and Ullman.

Summarizing FDAs plan to fully implement the DietarySupplement Health and Education Act (DSHEA), Walker reiterated the agencyspriority to finalizing dietary supplement GMPs, telling the packed house, Iknow you all want me to say GMPs will be out on X day, but you know Icannot do that. [However] I can tell you it is a high priority.

Pellicore outlined the requirements for NDI notifications,noting the need for filing companies to be explicit in identifying theingredient. Among her recommendations was advice on including Latin names forbotanicals, and ensuring scientific and safety data involves the specificingredient petitioned. She said the burden for reasonably showing an ingredientssafety is on the manufacturer or supplier.

Frankos skimmed the surface of the many public commentssubmitted to FDA on the NDI policy, which included 50,000 comments fromindividuals and 10,000 comments submitted via the internet. From grandfatheredingredient qualification to opposing opinions on changes to DSHEA, the commentsprovided the audience with a glance at the many intricacies involved in decidingwhat is considered a NDI, what level of scientific proof is needed to provesafety and who should submit the NDI for an ingredient.

McGuffin thoroughly detailed problems encountered by botanicalNDI applications, including scientific reference matching the ingredient andissue with nomenclature. He gave examples of how botanical NDIs are complicatedby differentiation within the same species by extract type and method, as wellas the by plant part used. He urged companies to refrain from involving claims, whichhave nothing to do with NDI notification and will only draw red flags that couldlead to NDI rejection.

Ullman highlighted the problem of a companys spending timeand money gaining NDI approval only to have a competing company ride the NDIacceptance for a like product. He hammered away at the idea of marketexclusivity, which could be achieved by a company using a proprietary process toproduce a certain ingredient. An NDI approval would then be for that proprietaryor patented process, which would create exclusivity for the company. He also called on FDA to employ strict enforcement of the NDIstatus of ingredients on the market.

The panel faced a barrage of questions from the audiencemembers, who were especially curious on what is considered a NDI. There werenumerous questions on when a new production process generates the need for a NDIapplication, and how much traditional and historical use matters in decisions oningredient safety.