Explore the essentials of food law and regulation and gain a comprehensive understanding of the various administrative agencies that impact these industries. Learn about pending regulations, food safety, food labeling, enforcement, and related issues. Case studies, hypotheticals, and ample time for discussion are provided.

 

Agenda Highlights

  • Organizational structure of the FDA
  • Concepts and statutes in food law and regulation, and the relationship between state and federal jurisdiction
  • Principles of food labeling requirements and litigation risks as shaped by FDA, the Federal Trade Commission (FTC), and class action litigation
  • Role of inspection and enforcement authorities and practical steps toward compliance
  • Food safety frameworks, including review of Food Safety Modernization Act (FSMA) final rules and guidance for industry
  • International issues that affect food law and regulation in the United States
  • Dietary supplement oversight and the regulation of cosmetics

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Federal Meat, Poultry, and Egg Products Inspections
  • Federal Trade Commission 15 U.S. C. § 41 et. seq.
  • Lanham Act – 15 U.S.C. §1051 et seq.

Attendee Resources

These valuable takeaways will be provided electronically the day of the course:

Who Should Attend

  • New legal and regulatory professionals
  • Seasoned practitioners new to the topic or wanting a refresher

Register

Industry & Firms

$999
  • +$250 for non-members

Non-Profit

$849
  • +$100 for non-members

Government

$849
  • +$100 for non-members

Academic

$849
  • +$100 for non-members

Student

$99
  • full-time students only
Register Now

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Add This Must-Have Reference to Your Registration

Purchase A Practical Guide to FDA’s Food and Drug Law and Regulation, 7th Edition to have an overview of the key legal and regulatory topics at your fingertips. Order your copy today and it will be shipped directly to your office.

You can transfer your registration to another person at your organization for no cost by notifying us of the change. If you notify FDLI in writing at least five business days prior to the meeting, you can cancel your registration for a full refund (less a $75 fee). Refunds will be applied against the original form of payment.  

Our event policies are listed here. If you should have any further questions, please contact us at [email protected] or 800-956-6293.

Agenda

subject to change

Curriculum Advisor: Ann M. Begley, Partner, Wiley LLP

Tuesday, March 16

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Overview of U.S. Food Law and Regulation
Veronica Colas, Counsel, Hogan Lovells US LLP

1:05–1:15 PM
Break

1:15–2:20 PM
Food Safety: Ingredient Preclearance/Intentional Components of Food
Tom Jonaitis, Independent Consultant, EAS Consulting Group

2:20–2:35 PM
Break

2:35–3:50 PM
Food Safety: Current Good Manufacturing Practices and Related Requirements; Unintended Components/Contaminants of Food
Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
Anna El-Zein, Associate, Shook, Hardy & Bacon LLP

3:50–4:00 PM
Break

4:00–5:00 PM
 U.S. Department of Agriculture
Beth A. McKew, Senior Staff Officer, Labeling and Program Delivery Staff, Office of Policy and Program Development, FSIS, USDA

 

Wednesday, March 17

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:05 PM
Food Derived from Biotechnology – the USDA/FDA Conundrum
Ann M. Begley, Partner, Wiley LLP

1:05–1:15 PM
Break

1:15–2:25 PM
Food Labeling: General Requirements (Including Meat and Poultry)
Gisela Leon, Independent Consultant, EAS Consulting Group

2:25–2:35 PM
Break

2:35–3:45 PM
Food Labeling: Nutrient Content, Health and Other Claims
Riëtte van Laack, Director, Hyman, Phelps & McNamara, PC

3:45–3:55 PM
Break

3:55–5:00 PM
Advertising: The Federal Trade Commission and Private Rights of Action
Jacqueline J. Chan, Partner, Kleinfeld, Kaplan & Becker, LLP

Thursday, March 18

12:00 PM
FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

12:05–1:20 PM
Dietary Supplements
Donnelly McDowell, Special Counsel, Kelley Drye & Warren LLP

1:05 – 1:15 PM
Break

1:15 – 2:15 PM
The Regulation of Cosmetics
Georgia C. Ravitz, Partner, Wilson Sonsini Goodrich & Rosati

2:15–2:30 PM
Break

2:30–3:45 PM
Inspection and Enforcement Authority
Maile Gradison Hermida, Partner, Hogan Lovells US LLP

3:45–4:00 PM
Break

4:00 – 5:00 PM
Imports and International Issues
Jessica P. O’Connell, Partner, Covington & Burling, LLP

5:00 PM
Adjournment

Continuing Legal Education

FDLI applies for CLE credits in Ohio and Virginia. These CLE approvals also may be honored by other states. The CLE credits will be posted as they are granted and registrants can request to be notified when approval is received.