Speakers
David W.K. Acheson, MD, Managing Director, Food and Import Safety Practice,
Leavitt Partners
Steven H. Armstrong, Senior Food Law Counsel, Campbell Soup Company
Kristen E. Blanchard, Vice President, Legal and Government Affairs,
Nutramax Laboratories, Inc.
Stephen Gardner, Litigation Director, Center for Science in the Public Interest
Brian Giannini, National Account Manager, Retrieval/Recall, Stericycle, Inc.
Christopher L. Hagenbush, Partner, Patton Boggs LLP
Martin J. Hahn, Partner, Hogan & Hartson LLP
Leslie T. Krasny, Partner, Keller and Heckman LLP
Christine Lee DeLorme, Senior Attorney, Division of Advertising Practices, Bureau of Consumer Protection, Federal Trade Commission
Mark Levine, Senior Attorney, National Advertising Division, Council of Better
Business Bureaus, Inc.
Anne V. Maher, Partner, Kleinfeld Kaplan & Becker
William Ment, Senior Consultant, EAS Consulting Group, LLC
Robert J. Moore, PhD, Supervisor, Regulations Implementations Team,
Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Food and Drug Administration
Amy Ralph Mudge, Counsel, Arnold & Porter LLP
Lewis Rose, Partner, Kelley Drye & Warren LLP
Andrew Shao, PhD, Vice President, Scientific & Regulatory Affairs,
Council for Responsible Nutrition
Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest
Jennifer A. Thomas, Director, Division of Enforcement, CFSAN, FDA
Bradford W. Williams, Manager, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, CFSAN, FDA
Carmine R. Zarlenga, Partner, Howrey LLP

Program Description
Not your typical food program, these four, half-day workshops are designed for intermediate level professionals in the food and dietary supplement industries. This is your opportunity to interact with the experts in a small setting focused on critical issues affecting food and dietary supplement law and regulation. Register for one or all four programs!

January 27, 2010

• FDA Enforcement of the New Dietary Supplement GMP’s and What it May
  Portend to the Conventional Food Industry if Congress Passes Food Safety
  Reform Legislation
• Food Advertising and the National Advertising Division
  

January 28, 2010

• The Future of Food and Dietary Supplement Recalls
• Claims Substantiation and Fraud Issues
  

Click on the Agenda Tab at top for more information about each program.

Who Should Attend
These intermediate level, half-day programs are intended for regulatory affairs, legal, marketing, manufacturing, quality and consulting professionals working in the food and dietary supplements industries who need an update with respect to good manufacturing practices, advertising, recalls, and, claims substantiation and fraud issues, as regulated by the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), and the United States Department of Agriculture (UDSA).  Government employees who have responsibilities for matters concerning foods and dietary supplements and combination products should also attend.

Handouts will include a copy of speakers’ presentations and other materials.

Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.

Register for one, two, three or all programs!

Registration Fees
For individual program registrations:
$325 Member
$495 Non-member
$295 Academics & Government
$225 Full-time Student

Registration for all programs:
Early Bird Rate (Received by Monday, December 28, 2009)
$845 Member
$1,220 Non-member
$670 Academics & Government
$375 Full-time Student

Regular Rate (Received after Monday, December 28, 2009)
$945 Member
$1,295 Non-member
$745 Academics & Government
$375 Full-time Student

Special CD Price!
Purchase the CD set for just $99 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 and 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.

January 27, 2010

7:30 a.m.
Registration and Continental breakfast

8:30 a.m.
FDA Enforcement of the New Dietary Supplement GMP’s and What it May Portend to the Conventional Food Industry if Congress Passes Food Safety Reform Legislation

Moderator:
Martin J. Hahn, Partner, Hogan & Hartson LLP

Speakers:
William Ment, Senior Consultant, EAS Consulting Group
Bradford W. Williams, Manager, Division of Dietary Supplement Programs,
Office of Nutrition, Labeling and Dietary Supplements, CFSAN, FDA

Program Description:
As the Dietary Supplement GMPs are now effective for the large and medium-sized firms and will become effective for small firms in June of 2010, FDA is ramping up to begin enforcement of these regulations. This session, “FDA Enforcement of the New Dietary Supplement GMPs” will provide insights into what industry can expect during the first round of inspections and will provide helpful hints on what can be done now to prepare. They will also hear from a dietary supplement firm that has already undergone an FDA GMP inspection. Attendance at this session is a must for anyone involved in the implementation of the new dietary supplement GMPs.

12:30 – 1:00 p.m.
Lunch

1:00 p.m.
Food Advertising and the National Advertising Division

Moderator:
Anne V. Maher, Partner, Kleinfeld Kaplan & Becker

Speakers:
Steven H. Armstrong, Senior Food Law Counsel, Campbell Soup Company
Kristen E. Blanchard, Vice President, Legal and Government Affairs,
Nutramax Laboratories, Inc.
Mark Levine, Senior Attorney, National Advertising Division,
Council of Better Business Bureaus, Inc.

Program Description:
The National Advertising Division (NAD) of the Council of Better Business Bureaus (CBBB) has substantially increased its influence in the food and dietary supplement marketing world.  More and more companies are turning to this self-regulatory forum to decide advertising challenges that are initiated by competitors or by the NAD itself as part of its ad monitoring program.  This session will feature speakers from the food and drug bar, NAD, and food and dietary supplement companies.  The discussion will include such topics as the NAD process and what participants can expect, salient issues that have been addressed by the NAD in recent food and dietary supplement challenges, illustration of these issues through particular case studies, and how companies are increasingly taking NAD precedent into account in the creation of marketing materials.

5:00 p.m.
Day 1 Adjournment

January 28, 2010

7:30 a.m.
Registration and Continental breakfast

8:30 a.m.
The Future of Food and Dietary Supplement Recalls

Moderator:
Christopher L. Hagenbush, Partner, Patton Boggs LLP

Speakers:
David W.K. Acheson, MD, Managing Director, Food and Import Safety Practice,
Leavitt Partners
Frederick H. Degnan, Partner, King & Spalding LLP
Brian Giannini, National Account Manager, Retrieval/Recall, Stericycle, Inc.
Andrew Shao, PhD, Vice President, Scientific & Regulatory Affairs,
Council for Responsible Nutrition
Jennifer A. Thomas, Director, Division of Enforcement, CFSAN, FDA

Program Description:
The recurrence of widespread food and dietary supplement recalls has eroded consumer confidence in the safety of those products, raised questions about the capabilities of federal and state regulators and ultimately led the Congress to attempt to significantly increase the authority of the Food and Drug Administration to force product withdrawals.  This "Recalls" Hot Topics session will discuss the challenges faced by regulators, producers and distributors in managing retrievals of regulated products. The efforts of FDA, USDA and the regulated industries to more effectively manage product retrievals through improvements in supply chain management, product traceability and post production documentation will be thoroughly discussed in this session. The potential impact of pending food safety legislation will also be discussed in this session.

12:30 – 1:00 p.m.
Lunch

1:00 p.m.
Claims Substantiation and Fraud Issues
 
Moderator:
Leslie T. Krasny, Partner, Keller and Heckman LLP

Speakers:
Stephen Gardner, Litigation Director, Center for Science in the Public Interest
Christine Lee DeLorme, Senior Attorney, Division of Advertising Practices,
Bureau of Consumer Protection, Federal Trade Commission
Robert J. Moore, PhD, Supervisor, Regulations Implementations Team, Division of Dietary Supplement Programs, Office of Nutrition, Labeling and Dietary Supplements, Food and Drug Administration
Amy Ralph Mudge, Counsel, Arnold & Porter LLP
Lewis Rose, Partner, Kelley Drye & Warren LLP
Carmine R. Zarlenga, Partner, Howrey LLP

Program Description:
This session will cover regulatory (FDA and FTC) criteria and enforcement actions with respect to food and dietary supplement claim substantiation (amount, type and quantity of evidence, as well as defining the type of claim) and litigation (attorneys general and private actions) regarding unfair competition and false advertising, including fraud allegations. Products to be covered are foods, dietary supplements and combination products (OTC drugs/dietary supplements). The substantiation of probiotic, energy and weight loss claims will be specifically addressed.  

5:00 p.m.
Day 2 Adjournment

STEVEN H. ARMSTRONG is the Senior Food Law Counsel at Campbell Soup Company. He is responsible for counseling Campbell’s businesses around the world on food safety, labeling compliance and marketing matters. He advises Campbell’s U.S. businesses on compliance matters involving the U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA), as well as challenges before the National Advertising Division (NAD) of the Council of Better Business Bureaus. Mr. Armstrong came to Campbell in January 2007 from Energizer's Schick-Wilkinson Sword Division. He has had over 15 years of experience in advising companies on marketing and regulatory matters, having previously worked as an Assistant General Counsel at Unilever United States, and Division Counsel at Colgate-Palmolive Company. Before beginning his in-house practice, Mr. Armstrong advised clients on litigation and regulatory matters at the law firm of Townley & Updike in New York. Prior to entering law school, he had over twelve years’ experience as a journalist, including a five-year stint as an editor at The Miami Herald. Mr. Armstrong received his Bachelor’s degree in history and literature from Harvard College and earned his JD from Columbia University.

KRISTEN E. BLANCHARD is the Vice President of Legal & Government Affairs for Nutramax Laboratories, Inc. located in Maryland. Nutramax Laboratories, Inc. researches, develops, manufactures, markets and sells high quality nutritional supplements for consumers and companion animals. Ms. Blanchard has been working for Nutramax Laboratories for over 12 years and her responsibilities include overseeing the regulatory and government affairs matters as well as the intellectual property portfolio for the company. She received her BA degree from the State University of New York at Oswego and did post graduate work at the University of San Diego. She is a very active member in various trade organizations and is a member of the Council for Responsible Nutrition (CRN) Board of Directors and Executive Committee.

MARTIN J. HAHN is a Partner in the Washington, DC law firm of Hogan & Hartson, LLP, and is a member of the firm's Food and Agriculture Practice Group. His practice focuses on a wide variety of regulatory issues affecting the food and dietary supplement industries. Mr. Hahn assists food and dietary supplement companies in complying with the numerous statutes, regulations, and guidances implemented by the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture. He also represents numerous food trade associations. In the area of food labeling, Mr. Hahn has been actively involved in the implementation of the Food Allergen, Labeling and Consumer Protection Act (FALCPA) and in the areas of nutrition labeling, health claims, qualified health claims, structure/function claims, and nutrient content claims. In the area of food safety, he advises clients in determining the regulatory status of food ingredients and has prepared generally recognized as safe (GRAS), food additive, and color additive petitions for submission to FDA. With regard to dietary supplements, he has advised clients on all aspects of the Dietary Supplement Health and Education Act of 1994. He also specializes in the regulation of functional foods, infant formulas, and medical foods. Mr. Hahn has published articles on the FDA regulation of functional foods, the labeling and product liability issues presented by food allergens, complying with the Hazard Analysis Critical Control Point (HACCP) regulations for seafood, meat, and poultry and the regulation of foods derived from biotechnology. He is a frequent speaker on food labeling and food safety. Mr. Hahn received his BS, cum laude, in food technology from The Ohio State University and his JD from Northwestern University School of Law.

LESLIE T. KRASNY is a Partner at the law firm of Keller and Heckman LLP, San Francisco CA. She specializes in food and drug law, with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology, advertising, and international trade. She worked in pharmacology research at the University of California, San Francisco and at Stanford University, School of Medicine, before attending law school. Ms. Krasny is a member of the California bar, the California Food Biotechnology Advisory Committee, and the Partnership Among Industry and Regulators. She speaks and writes regularly on food law issues, including a regulatory column for Wellness Foods magazine. Ms. Krasny received a BA in Zoology from the University of Wisconsin, an MA in Cell and Molecular Biology from San Francisco State University, and her JD from the University of California, Hastings College of the Law, where she was a member of the Hastings Law Journal.

MARK BRIAN LEVINE is a Senior Attorney at National Advertising Division (NAD) of the Better Business Bureau. Currently, he is in charge of NAD’s new initiative with the Council for Responsible Nutrition, focusing on a wide variety of dietary supplement cases. He rejoined NAD in April 2004 and his scientific background has provided an excellent basis for reviewing and understanding the complex technical issues integral to many NAD cases. He has handled many cases in the infant formula and technology fields. Mr. Levine previously worked as an attorney for NAD from 1992 through 1997, and helped NAD transform and grow into the well-respected organization that exists today. During his two tenures with NAD, he has handled numerous cases, and represented NAD on a number of appeals before the National Advertising Review Board. Immediately prior to rejoining NAD, he spent over 4 years as Manager of Business Affairs with Sony Music International. While at Sony, Mr. Levine drafted and negotiated a wide range of agreements relating to domestic and international business and also provided legal counseling on a wide variety of issues. He was also in charge of Sony Music's extensive worldwide anti-piracy activities and worked closely with the recording industry organizations, RIAA and IFPI in their anti-piracy investigations and prosecutions. Before joining Sony Music, he served as the Assistant General Counsel for SESAC, one of the three performing rights societies in the United States. While at SESAC, he litigated copyright infringement actions and drafted and negotiated a wide range of contractual matters. He began his legal career as an associate attorney with a New York City patent, trademark and copyright firm, Hopgood Calimafde, where he litigated a variety of intellectual property matters. Mr. Levine received his undergraduate degree in Biology from Boston University, and his law degree from St. Johns University School of Law.

ANNE V. MAHER is a Partner in the law firm of Kleinfeld Kaplan & Becker LLP (KKB) in Washington, DC specializing in the needs of Food and Drug Administration (FDA)-regulated companies and related entities. She practices in the area of advertising and consumer protection regulation. She counsels clients on food, drug, dietary supplement, cosmetic and device promotional issues and requirements and represents clients in investigations and advertising challenges. She frequently speaks at industry and association meetings involving advertising law and policy. Before joining KKB, she was the Assistant Director for Advertising Practices Division in the Federal Trade Commission’s (FTC) Bureau of Consumer Protection. She supervised law enforcement investigations and industry outreach. Prior to her appointment as Assistant Director, she served in the Office of the Director, Bureau of Consumer Protection, and as Attorney Advisor to an FTC Commissioner and as a staff attorney. Ms. Maher was the FTC’s designated liaison with FDA and the U.S. Department of Agriculture, and worked closely with the staff of both agencies on a wide range of projects and regulatory actions. She directed the development of FTC’s 1994 Food Advertising Enforcement Policy Statement, and was integral in the creation of FTC’s 1998 Dietary Supplement Advertising Guide, and the 1999 Report to Congress on Self-Regulation in the Alcohol Industry. She is a recipient of the Federal Trade Commission’s Award for Distinguished Service. Ms. Maher received her BA from Boston University and her JD from Northeastern University School of Law.

ANDREW SHAO, PhD is Vice President, Scientific and Regulatory Affairs, for the Council for Responsible Nutrition (CRN). Dr. Shao has an extensive background in human nutrition research and an in-depth knowledge of nutrition policy, dietary supplement regulatory affairs and product development. Prior to joining CRN Dr. Shao worked in Scientific Affairs for General Nutrition Corp. (GNC), Pittsburgh, PA, and prior to that in Research and Development for Kemin Health (formerly Kemin Foods), Des Moines, Iowa.   He has authored or co-authored more than 30 peer-reviewed papers, abstracts, trade journal articles and industry position papers.   He holds a Ph.D. in Nutritional Biochemistry and a MS in Human Nutrition Science from Tufts University, and BA in Biology from Brandeis University.   Dr. Shao is a member of the American Society for Nutrition, the American College of Nutrition, American Society of Pharmacognosy and the National Strength and Conditioning Association.

Event Location
Park Hyatt Washington Hotel
24 and M Streets, NW
Washington, DC 20037
Phone: (202) 789-1234 or (800) 233-1234
Visit the hotel's website

Room Rate
$259 single/double + applicable taxes
Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/
Food Hot Topics conference attendee to receive the rate.

Reservation Cut-Off January 5, 2010

Check-in 3 pm
Check-out 12 noon

Directions

Via Metro
The nearest station to Park Hyatt Washington is Foggy Bottom / George Washington University Station (Blue/Orange Lines), located on the corner of 23rd and I Streets, NW.

Please visit the Maps & Directions page on the hotel's website for driving directions.