SupplySide

NUTRITION SCIENCE ADVISORY BOARD

SESSIONS

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Stuart P. Richer, OD, MS, Ph.D., FAAO, chief of optometry, Dept. of Veterans Affairs Medical Center

For the Zeaxanthin and Visual Function (ZVF) Study, 60 patients with mild/moderate age-related macular degeneration (AMD) were randomized to receive placebo or one of two supplements: 8 mg zeaxanthin, or 8 mg zeaxanthin plus 9 mg lutein. After the one-year intervention, researchers found zeaxanthin induced macular pigment elevation similar to that of lutein and provided complementary distinct visual benefits by improving foveal shape discrimination and providing better central scotoma resolution in early macular degeneration patients. These results make biological sense based upon the unique retinal distribution of the two carotenoids.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Richard A. Anderson, Ph.D., research chemist – diet, genomics and immunology lab, U.S. Department of Agriculture

Polyphenols from cinnamon are continuing to suggest a wide range of benefits to humans. Consuming cinnamon polyphenols, especially from cinnamon extract, lowers fasting plasma glucose. While much of the initial human studies have focused on blood glucose, and its relationship to insulin resistant populations, new research suggests cinnamon extract has a role beyond diabetes. Cardiovascular disease, including heart disease and stroke, metabolic syndrome, cognitive aging, Alzheimer’s disease and cancer also may be affected.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Mark Blumenthal, founder and executive director, American Botanical Council

The growth of the use of herbs and medicinal plant products for health purposes is a global phenomenon. Market statistics in the U.S. marketplace for 2009 demonstrate that despite the recent recession worldwide, consumers are purchasing herbal dietary supplements at increasing levels, with this category experiencing a strong increase in sales--4.5 percent in the natural food channel and a whopping 14 percent increase in mainstream retail outlets. This presentation will review recent economic trend data from the United States, including which single herbs are the top-selling botanicals in various classes of trade in the United States. In addition, data from a new research project by the American Botanical Council dealing with the widespread use of solvents in botanical extracts and natural foods – and possibly excessive residue levels – will be presented. Finally, Blumenthal will discuss recent human clinical trials on various herbal ingredients and products, as well as the often-confusing and erroneous coverage in the media.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Paul Mittman, N.D., Ed.D., president and CEO, Southwest College of Naturopathic Medicine

Cancer patients have long sought cures outside mainstream medicine, with many traveling south of the border and overseas for treatment. Given the medical establishment’s censure of these practices, few would have predicted oncology would be at the forefront of the integration of conventional and alternative medicine. Today, partnerships and collaborations abound, including a national hospital network that markets its dedication to whole person, integrative and multidisciplinary care. Dr. Mittman will summarize the clinical research and discuss market opportunities for leading nutrients and dietary supplements used in the treatment of cancer and for the prevention of adverse effects of radiation and chemotherapy.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: John J. Kronebusch, program analyst – Office of Diversion, Drug Enforcement Administration

Federal regulations on transactions for tableting and encapsulating machines will be presented. The requirements for reporting to the Drug Enforcement Administration (DEA) the transactions on domestic distributions, imports and exports of these machines will be provided. Disposal of older machines by current end users usually will place users in the category of a distributor or an exporter. The presentation will include definitions, reportable items, maintenance of records, and proof of identity of the other party in the transaction. An overview of activities associated with regulated chemicals that may require registration from DEA also will be provided.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Michael T. Murray, N.D., president, Dr. Murray Natural Living Inc.; director of product development, Natural Factors Nutritional Products Inc.; managing director, BioMedica LLC

There are a number of substances the body normally produces in sufficient quantities, but increased need/demand, or impaired synthesis, converts these physiological compounds into “conditionally essential nutrients.” Glucosamine, coenzyme Q10, carnitine, GABA, DHA and EPA, SAMe and 5-HTP are well known examples of these sorts of nutrients. The term “anutrient” was used in the past to describe food compounds without nutritional value known to have considerable health benefits including dietary fiber, flavonoids, non-vitamin A carotenoids and many other phytochemicals. Given the tremendous importance of these compounds to human nutrition, this term is now antiquated. In this session, Dr. Murray will highlight the expanding definition of what should be considered a nutrient, the critical role these conditionally essential nutrients and compounds formerly referred to as anutrients play in specific clinical indications, and will look at some natural product candidates that might be best-sellers in the future.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: John F. Gay, executive director and CEO, Natural Products Association

John Gay, executive director and CEO of the Natural Products Association, and a 25-year veteran of Washington’s political scene, gives his review of the national elections and what they could mean for the natural products industry. Less than two weeks after SupplySide West, the entire U.S. House of Representatives and one third of the U.S. Senate must stand for election. How strong is the anti-incumbent wave? Will the Democratic Party maintain its grip on Congress? What industry friends and foes will lose their seats? And what impact will these elections have on the last two months of this session of Congress, and the next two years as the new Congress takes office in what has become the most pro-regulatory atmosphere in recent memory?

• Location: Congress Center, Casanova 501, Level 1
• Speakers: Michael McGuffin, president, American Herbal Products Association; Anthony L. Young, Esq., partner, Kleinfeld, Kaplan and Becker LLP

Now that FDA has provided its long awaited guidance about new dietary ingredients (NDIs), AHPA’s president, Michael McGuffin and AHPA general counsel, Anthony Young will discuss the ramifications of this guidance for ingredient manufacturers, suppliers and supplement manufacturers. AHPA maintains an NDI notification database that provides the industry’s most accessible and user-friendly way to access NDI notifications and FDA responses. McGuffin has followed the FDA’s responses to NDI notifications as he has edited the AHPA NDI database. AHPA’s comments to FDA on the NDI process have been detailed and extensive over the years. Together, Young and McGuffin will discuss FDA’s latest teaching on this subject.

• Location: Congress Center, Casanova 501, Level 1
• Moderator: Thomas Aarts, founder and principal, Nutrition Capital Network
• Speakers: Robert Gillison, vice president of corporate development, Martek Biosciences Corp.; Andrew R. Lefkowitz, Esq., president and CEO, Ganeden Biotech

The absence of debt financing and public capital options has heightened the importance of private capital and strategic partnerships for corporate development in the nutrition industry. A panel composed of a strategic investor, investment banker and growth company that recently raised capital will provide valuable perspective on how growth companies should approach raising capital in today’s economic climate. Sample transactions, types of investors that remain active in nutrition science and food ingredients, and characteristics of appealing deals will be presented and discussed.

• Location: Congress Center, Casanova 501, Level 1
• Speaker: Devin Domond, Esq., attorney, Division of Advertising Practices, Federal Trade Commission

An attorney in the Division of Advertising Practices at the Federal Trade Commission (FTC) will discuss recent developments in the enforcement of the FTC Act as it pertains to advertising for food and dietary supplements. The session will include a discussion of recent advertising cases and updated substantiation language in specific order provisions.

• Location: Congress Center, Casanova 501, Level 1
• Speakers: Mark Levine, Esq., senior attorney, National Advertising Division of the Council of Better Business Bureaus; Douglas MacKay, N.D., vice president – scientific and regulatory affairs, Council for Responsible Nutrition

Dietary supplement advertisers face the unique challenge of truthfully communicating the benefits of their products and ingredients while staying within the regulatory confines of two federal regulatory agencies—FDA and FTC. A 2009 supplement-related FTC decision in which not only the retailer, but also the ingredient supplier, was charged with making false advertising claims suggests that ingredient suppliers can be held accountable for claims. The National Advertising Division of the Council of Better Business Bureaus (NAD) and the Council for Responsible Nutrition (CRN) have increased the monitoring of dietary supplement advertising through a self regulatory initiative. These detailed reviews encourage advertisers to provide substantiation for their advertising claims. The resulting case reports, based on case law and FTC and FDA regulations, now represent the largest database of advertising law decisions that dietary supplement advertisers can consider and rely on. Join MacKay and Levine as they explore supplement advertising guidelines through a synopsis of important advertising cases that highlight the recurring issues in dietary supplement advertising that are relevant to suppliers.