Moderator
Christopher L. Hagenbush, Partner, Patton Boggs LLP

Speakers
Elizabeth J. Campbell, Vice President, EAS Consulting Group, LLC
Barbara O. Schneeman, PhD, Director, Office of Nutrition, Labeling and Dietary Supplements, CFSAN, FDA

Program Description
As new leadership takes the helm at FDA, key regulatory and marketing concerns have re-emerged with respect to what can and can’t be said in product labeling about potential health benefits from food and dietary supplements.

FDA’s recent Warning Letter questioning the lawfulness of prominent health benefit claims made on the box label of “Cheerios” presents a topical, important case in point.

Learn about FDA’s concerns with respect to such claims. Hear two labeling experts, one a current and the other a former high ranking FDA official, explain applicable legal requirements and provide practical tips for complying with FDA’s requirements to avoid regulatory concern. Receive clarification with respect to the subtle and sometimes murky distinctions between various kinds of health benefit claims. Gain insight into and discuss the decision making process FDA follows in deciding whether nutrient content and health claims are “implied” by a given representation.

The panelists will present prepared remarks which will be simultaneously displayed via internet and, in turn, will be followed by an ample open discussion and question and answer period to allow the audience to participate. Don’t miss this lively discussion.

Learn about FDA’s concerns with respect to distinctions between structure/function and health claims. If a claim is truthful but not consistent with FDA regulations, what are the important policy issues that could result in FDA’s willingness to challenge a claim? Come hear what the debate is about and how it affects the claims you are making or considering making.

Who Should Attend?
Attendance at this webinar is ideal for those interested in learning more about health benefit claims, including those with a beginning or intermediate knowledge of the subject.

Handouts
Slides will be made available to registrants before the webinar.

Registration Fees
$295 Member
$495 Non-member
$295 Academics & Government

Special CD Price!
Purchase the CD set for just $75 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, DC addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact Customer Service at (800) 956-6293 or (202) 371-1420,
or by e-mail at CSDept@fdli.org, if you have any questions about your conference registration or CD order.

ELIZABETH J. CAMPBELL is Vice President of EAS Consulting Group, LLC. She provides regulatory advice and training to the food and dietary supplement industry, particularly on labeling. Ms. Campbell began consulting in 1999, after a 35-year career with FDA. She has considerable expertise in the regulation of food products, having served as a division director in the Office of Food Labeling in the Center for Food Safety and Applied Nutrition (CFSAN), and most recently as Acting Director of the Office of Food Labeling. Ms. Campbell played a key role in writing the Nutrition Labeling and Education Act (NLEA) regulations in the early 1990s and then had major responsibility for implementing those regulations. She also helped develop current FDA policies on claims under the Dietary Supplement Health and Education Act and the FDA Modernization Act of 1997.. Ms. Campbell also served nearly ten years as a chemist in FDA’s New Orleans and Atlanta Districts prior to transferring to Washington DC in 1972. Ms. Campbell received her BS in chemistry from Louisiana State University.

CHRISTOPHER L. HAGENBUSH is a Partner in the law firm of Patton Boggs LLP, Washington, DC. With his diverse experience in managing a variety of U.S. and international legal and business issues, he helps clients confront complex business, legal and policy challenges in the food, drug and medical device industries. Before joining the firm, he worked as in-house counsel for The Coca-Cola Company. In his most recent position as Senior Counsel, Mr. Hagenbush managed legal and regulatory matters related to formulation, production, labeling and advertising of beverages, as well as product safety, security and quality. He represented the company’s interests before the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) in addition to self-regulatory, international and supra-national regulatory bodies, plus trade associations, NGOs and other non-profit organizations. He worked in Tokyo, Japan for Coca-Cola as General Counsel for the Asia-Pacific region. For more than 10 years, Mr. Hagenbush was Chief Counsel for Food Law for The Coca-Cola Company in Atlanta, Georgia and was Associate General Counsel in Houston, Texas for the company’s Foods Division. Earlier in his career, he was Legal Director for the consumer products division of Schering Plough, Associate Counsel for S.C. Johnson and Sons, Inc, and Senior Attorney for Miles Laboratories. He was an adjunct faculty member at Georgia State College of Law in the Food and Drug Law area during the Fall of 2005 and 2006. He currently serves on the FDLI Board of Directors. Mr. Hagenbush received his AB from Indiana University and his JD from Indiana University School of Law at Indianapolis.

BARBARA O. SCHNEEMAN, PhD is Director, Office of Nutrition, Labeling, and Dietary Supplements (ONLDS), in the Center for Food Safety and Applied Nutrition (CFSAN), with the Food and Drug Administration (FDA). She oversees the development of policy and regulations for dietary supplements, nutrition labeling and food standards, infant formula, and medical foods. Prior to joining FDA, she served as a member of the faculty and administration at the University of California, Davis. She held a faculty appointment in the Departments of Nutrition, Food Science and Technology, and Internal Medicine in the School of Medicine. Dr. Schneeman has served as Assistant Administrator for Nutrition in the Agricultural Research Service in the U.S. Department of Agriculture. She has many professional activities and honors to her credit. Dr. Schneeman received her BS from the University of California, Davis in food science and technology, and her PhD in nutrition from the University of California, Berkeley.