February 5
8:00 a.m.
Registration and Continental Breakfast
8:30 a.m.
Welcome and Opening Remarks
Khara L. Minter, Conference Manager/Foor Team Member, The Food and Drug Law Institute
8:35 – 9:30 a.m.
Overview of U.S. Food Law and Regulation
- Review the statutory framework of how the government regulates the food industry
- Become familiar with sections of the Federal Food, Drug, and Cosmetic Act
- Define “food”
Miriam J. Guggenheim, Partner, Covington & Burling LLP
9:30 – 10:30 a.m.
Food Safety: Ingredient Preclearance: Intentional Components of Food
- Define “food additive” and the application of Generally Recognized as Safe
George Burdock, President and Founder, Burdock Group
10:30 – 10:45 a.m.
Refreshment Break
10:45 a.m. – 12:00 p.m.
Food Safety: Unintended Components/Contaminants of Food
- Explore the definition and applications of “adulteration”
- Discuss Good Manufacturing Practices and its relation to food
Ricardo Carvajal, Of Counsel, Hyman, Phelps & McNamara, P.C.
12:15 – 1:30 p.m.
Luncheon
1:30 – 2:45 p.m.
Food Labeling: General Requirements (Including Meat & Poultry)
- Review food labeling requirements
- Differentiate “label” from “labeling”
- Examine labeling requirements for menus, bioengineered food and irradiation
Martin. J. Hahn, Partner, Hogan Lovells LLP
2:45 – 3:15 p.m.
Refreshment Break
3:15 – 4:00 p.m.
Food Labeling: Nutrient Content, Health and Other Claims
- Define the various categories and required elements of claims
- Probe the scope of preemption and state requirements
Martin. J. Hahn, Partner, Hogan Lovells LLP
4:00-5:00 p.m.
Advertising: The Federal Trade Commission and Private Rights of Action
- Explore the Federal Trade Commission’s role and statutory authority regarding food advertising
- Review the elements of claims substantiation
Anne V. Maher, Partner, Kleinfeld, Kaplan & Becker LLP
February 6
8:00 a.m.
Continental Breakfast
8:30 – 9:45 a.m.
U.S. Department of Agriculture
- Obtain a clearer view of foods regulated by United States Department of Agriculture
- Review the similarities and differences between FDA and USDA scope of jurisdiction
Jeffrey W. Canavan, RD, Deputy Director, Labeling and Program Delivery Division, USDA
9:45 – 11:05 a.m.
Dietary Supplements
- Define “dietary supplement”
- Examine sections of The Dietary Supplement Health and Education Act of 1994
Anthony Young, Partner, Kleinfeld, Kaplan and Becker, LLP
11:05 – 11:35 a.m.
Refreshment Break
11:35 – 12:15 a.m.
The Regulation of Cosmetics
- Define “cosmetic” and “color additives”
- Explore cosmetic labeling and warning requirements
Claudia A. Lewis, Partner, Venable, LLP
12:30 a.m. – 1:45 p.m.
Lunch
1:45 – 3:00 p.m.
Inspection and Enforcement Authority
- Review FDA’s and USDA’s inspections authorities
- Differentiate FDA’s various enforcement tools
- Review Commissioner Hamburg’s 2009 Enforcement Priorities
Gary L. Yingling, Partner, Morgan, Lewis & Bockius LLP
3:00 – 3:30 p.m. Refreshment Break
3:30 – 4:45 p.m.
Imports and International Issues
- Receive an overview of FDA’s food import authority
- Become familiar with FDA’s international presence and activities that safeguard the public’s health
Mark Mansour, Partner, Akin Gump Strauss Hauer & Feld LLP
4:45 p.m.
Adjournment
Continuing Legal Education Credits
Introduction to Food Law and Regulation Continuing Legal Education credits may be awarded for attending this program. FDLI applies directly to Ohio, Pennsylvania and Virginia. These states are generally recognized as approved jurisdictions by other states. Please contact your Bar Association for guidance.
View FDLI's Continuing Legal Education (CLE) policy.