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Nutrition Science Advisory Board |
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Jon Benninger, Director, Business Development, Virgo Publishing LLC
Mark Blumenthal, Founder and Executive Director, American Botanical Council (ABC)
Shane Durkee, Director, Global Medical Area Nutritionals, Bayer HealthCare
Sefali Patel, Pharm.D., Associate Director, Nutritional Science and New Business – Medical Affairs, Bayer HealthCare
Guru Ramanathan, Ph.D., Senior Vice President, Scientific Affairs, General Nutrition Corp. (GNC)
Andrew Shao, Ph.D., Vice President, Scientific and Regulatory Affairs, Council for Responsible Nutrition (CRN) |
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Nutrition Track I
As of 10/08/09
WEDNESDAY, NOVEMBER 11
10-10:50am
Location: Congress Center, Casanova 601, Level 1
Smart Sourcing of Omega-3 Fish Oil: A Technical Discussion
Omega-3 is one of the bright stars in the dietary supplement market, and as
research continues to confirm its benefits, sales are projected to stay strong.
With high demand for raw material, more players are emerging with product to
sell. Historically with popular ingredients, this is the stage at which sourcing
quality becomes more challenging. At the same time, manufacturing capabilities
and technical advances are increasing the options in omega-3 ingredients. This
presentation will bring together companies that make different types of omega-3
ingredients, and will cover some options available for a variety of applications
with a buyer for a finished products manufacturer who has experience with good
and bad ingredient purchases. Attend this session to learn how, as an ingredient
purchaser, to make the right choices for your needs.
Moderator: Adam Ismail,
executive director, Global Organization for EPA and DHA Omega-3s (GOED)
Speakers: Alejandro Diaz, operations manager, Originates
Hogne Vik, M.D., Ph.D., EVP documentor, Aker BioMarine
11-11:50am
Location: Congress Center, Casanova 601, Level 1
Nanotechnology for Ingredients: Opportunities and Risks
Attend this session to hear an explanation of some opportunities in the emerging field of nanotechnology, and the exciting applications in use and under development in the food industry, in the context of an uncertain and rapidly changing regulatory environment. One of the key questions is whether engineered nanomaterials pose unique health risks that require a new regulatory paradigm. This presentation will provide an overview of the health and environmental risks, current regulatory developments, consumer perceptions and perspectives on the state of the science for risk analysis for nanotechnologies.
Speaker: Jo Anne Shatkin, Ph.D., managing director, CLF Ventures Inc.
Noon-12:50pm
Location: Congress Center, Casanova 601, Level 1
Methods Validation, Quality and Compliance: Resources for a Quality-Assurance Unit
The Dietary Supplements Analytical Methods and Reference Materials Program (AMRM) at the Office of Dietary Supplements (ODS), National Institutes of Health (NIH), supports laboratory research and the infrastructure necessary for evaluation and dissemination of validated analytical methods and reference materials. This session will provide a comprehensive update on two of the efforts supported by the AMRM program; an overview of an ODS-sponsored workshop on the status of analytical methods for vitamins and minerals in dietary supplements; and an introduction to ODS’s Web-based resources for finding AMRM-supported analytical methods and reference materials for dietary supplements.
Speakers: Joseph M. Betz, Ph.D., director, Analytical Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health
John H. Cardellina II, Ph.D., health science administrator, Office of Dietary Supplements, National Institutes of Health
1-1:50pm
Location: Congress Center, Casanova 601, Level 1
Methods Validation, Quality and Compliance: Analytical Tools for a Quality-Assurance Unit
The current GMPs (good manufacturing practices) for dietary supplements define quality in terms of product identity, purity, strength and composition. The Analytical Methods and Reference Materials Program (AMRM) at the National Institutes of Health’s (NIH) Office of Dietary Supplements (ODS) supports work that creates tools for laboratories in the business of providing GMP support to the dietary supplement industry. To date, the AMRM program has resulted in the creation of 18 AOAC Official Methods of Analysis for dietary supplements. In tandem with this effort, the National Institute of Standards and Technology (NIST) has established several programs in collaboration with ODS. The NIST Standard Reference Material (SRM) and Dietary Supplement Laboratory Quality Assurance program provide tools for calibration of analytical equipment and for assessing the proficiency of quality control labs. This session will provide important information on available AOAC official methods for dietary supplements and on the NIST programs.
Moderator: Joseph M. Betz, Ph.D., director, Analytical Methods and Reference Materials Program, Office of Dietary Supplements, National Institutes of Health
Speakers: Catherine A. Rimmer, Ph.D., research chemist, National Institute of Standards and Technology
Mark C. Roman, Ph.D., president, Tampa Bay Analytical Research Inc.
2-2:50pm
Location: Congress Center, Casanova 601, Level 1
How to Prepare for and Survive a Dietary Supplement GMP Audit
The Nutrilite facility of Amway Global was one of the first facilities to be audited for compliance of the new current Good Manufacturing Practices (cGMP) for Dietary Supplements by the Food and Drug Administration (FDA). Attend this session to learn how Amway Global prepared for the audit and listen as insight is provided on what to expect during the multi-day audit.
Speakers: Amy Caplette, quality assurance supervisor group leader, Amway Global Nutrilite Products
Andrew Shao, Ph.D., vice president, scientific and regulatory affairs, Council for Responsible Nutrition
3-3:50pm
Location: Congress Center, Casanova 601, Level 1
Vital Consumer and Market Trends You Need to Know -- Now!
The concept of "recalibration' is the overarching theme across health,
wellness and sustainability according to research from Natural Marketing
Institute (NMI). From a rising demand for consistent and nourishing energy as an
alternative to the roller coaster of caffeine and sleep aids to the connection
of personal and planetary health--consumers desire "The Middle Way," defined as a
lifestyle approach grounded in comfort, safety, sustainability and moderation.
Based on newly gathered data and insight from NMI's annual consumer research
studies across 10 countries (now with 10 years of trends based on results from
more than 500,000 consumers), trend expert Steve French from NMI will examine
some key trends for 2009 and beyond.
Speaker: Steve French,
managing partner, Natural Marketing Institute
THURSDAY, NOVEMBER 12
10-10:50am
Location: Congress Center, Casanova 601, Level 1
Advertising Claims: FTC Compliance and NAD/ERSP Challenges
The new cops on the beat at FTC have pledged that unsubstantiated health claims will be a top law enforcement priority. And dietary supplement advertising challenges at the Council of Better Business Bureau’s National Advertising Division and Electronic Retailing Self-Regulation Program (NAD/ERSP) have increased dramatically. Learn about FTC's new initiatives, including the new game-changing Guides on Testimonials and Endorsements, and the relevance of recent enforcement actions involving cold and flu remedies and major retailers. The speakers will also discuss the rising importance of the NAD and the ERSP in keeping advertisers on alert and providing much needed guidance on the requisite evidence needed to support claims.
Speakers: Richard L. Cleland, Esq., assistant director – division of advertising practices, Federal Trade Commission
Anne V. Maher, Esq., partner, Kleinfeld, Kaplan & Becker LLP
11-11:50am
Location: Congress Center, Casanova 601, Level 1
Qualifying Dietary Supplement Ingredient Suppliers: FDA’s Perspective
A major component of meeting the Food and Drug Administration’s (FDA) new dietary supplement GMP (good manufacturing practice) regulations is the need to “qualify” suppliers of ingredients used in dietary supplements. If a manufacturer wants to use ingredient suppliers’ Certificate of Analysis (COA) for GMP compliance purposes, the ingredient supplier must be “qualified.” This presentation will provide information for dietary supplement manufacturers and ingredient suppliers on FDA’s expectation of the types of information that would be collected when a supplier is “qualified.”
Speaker: Vasilios H. Frankos, Ph.D., director, Division of Dietary Supplement Programs, Food and Drug Administration
Noon-12:50pm
Location: Congress Center, Casanova 601, Level 1
Contamination and Adulteration: Protection through Testing
Contamination and adulteration of products has garnered much attention both within the United States and at a global level. Contamination of materials with pesticides, dioxin, heavy metals, aflatoxin and allergens are an ongoing concern. In the botanical area, collection of the incorrect plant can have toxic consequences. Another type of adulteration involves supplements which have been found to contain undeclared drug ingredients, so an herbal extract is spiked with prescription pharmaceutical drugs. What should companies do to protect their products and their reputation? This presentation will discuss contamination and adulteration issues and the test methods employed. It will also address the actions companies might take to mitigate their risk by establishing testing programs and partnering with suppliers that follow GMPs (good manufacturing practices) to develop traceability programs for their ingredients.
Speaker: Kerri L. LeVanseler, Ph.D., technical manager – chemistry laboratory, NSF International
FRIDAY, NOVEMBER 13
9-9:50am
Location: Congress Center, Casanova 601, Level 1
State-of-the-Industry Q&A
From negative media coverage to regulatory issues to quality problems, the
dietary supplement industry faces many challenges. Listen as representatives
from the American Herbal Products Association (AHPA) and Council for Responsible
Nutrition (CRN) interact with you - the audience - in an exchange of opinions,
ideas and solutions.
Moderator: Jon
Benninger, director of business development, Virgo Publishing LLC
Speakers: Michael McGuffin, president, American Herbal Products Association
Steven M. Mister, Esq., president and
chief executive officer, Council for Responsible Nutrition
10-10:50am
Location: Congress Center, Casanova 601, Level 1
DSHEA: 15 Years Later
DSHEA is under imminent threat of attack. After 15 years, powerful and key opponents of this iconic law are poised to “fix this mistake.” What is at the heart of this continuing struggle over the regulation of dietary supplements? There are seven fundamental reasons and 11 critical players that will likely determine DSHEA’s future and how the dietary supplement industry (globally) will struggle or thrive. This session will detail the key moments in DSHEA’s creation and passage, and provide a look at the present situation with predictions of how all this will turn out.
Speaker: Loren D. Israelsen, executive director, United Natural Products Alliance