Summary

This intensive introductory course provides a thorough overview of the legal framework for drug regulation. Attendees will gain a comprehensive understanding of the Food and Drug Administration’s (FDA) drug regulatory and approval process.

Register

Coming soon.

Draft Agenda

Introduction to Food Law and Regulation Course:
Understanding How the Government Regulates the Food Industry

*Subject to Change

Day 1

8:00 AM
Registration and Continental Breakfast

8:30 AM
FDLI Welcome and Announcements

8:35 – 9:35 AM
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 that define “food”

9:30 – 10:45 AM
Food Safety: Ingredient Preclearance: Intentional Components of Food

  • Define “food additive” and the application of Generally Recognized as Safe (GRAS) substances

10:45 – 11:00 AM
Networking and Refreshment Break

11:00 AM – 12:30 PM

  • Food Safety: Unintended Components/Contaminants of Food
  • Explore the definition and applications of “adulteration”
  • Discuss Good Manufacturing Practices (GMPs) and its relation to food
  • Review Hazard Analysis Critical Control Points (HACCP)

12:30 – 1:45 PM
Networking Lunch

1:45 – 2:45 PM
Food Labeling: General Requirements (Including Meat & Poultry)

  • Review food labeling requirements
  • Differentiate “label” from “labeling” under the FD&C Act and the Fair Packaging and Labeling Act
  • Examine labeling requirements for menus, bioengineered food, and irradiation

2:45 – 3:00 PM
Networking and Refreshment Break

3:00 – 4:00 PM
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

4:00 – 5:00 PM
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

Day 2

8:00 AM
Continental Breakfast

8:30 – 9:30 AM
U.S. Department of Agriculture

  • Obtain a clearer view of foods regulated by United States Department of Agriculture (USDA)
  • Review the similarities and differences between FDA and USDA scope of jurisdiction

9:30 – 10:15 AM
Dietary Supplements

  • Define “dietary supplement”
  • Summarize Dietary Supplement Safety, Serious Adverse Event Reporting (SAER) requirements, and Good Manufacturing Practices (GMPs)

10:15 – 10:30 AM
Networking and Refreshment Break

10:30 – 11:15 PM
The Regulation of Cosmetics

  • Define “cosmetic” and “color additives”
  • Evaluate cosmetics vs. drugs and/or devices
  • Explore cosmetic labeling and warning requirements

11:15 – 12:30 PM
Networking Lunch

12:30 – 1:45 PM
Inspection and Enforcement Authority

  • Review FDA’s and USDA’s inspections authorities
  • Differentiate FDA’s various enforcement tools

1:45 – 2:00 PM
Networking and Refreshment Break

2:00 – 3:00 PM
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 health

3:00 – 4:45 PM
FSMA Updates/Pressing New Issues

  • Report on FSMA’s final rules and identify key developments in food law legislation

4:45 PM
Adjournment

Speaker Biographies

Coming soon.

Onsite Materials

Coming soon.

Continuing Legal Education

Continuing Legal Education credits will be awarded for attending this program.

FDLI applies directly to Ohio, Pennsylvania, and Virginia. New York recognizes Pennsylvania approvals. These states are generally recognized as approved jurisdictions by other states, however, each state bar has its own requirements, and it is the responsibility of the attorney seeking CLEs to know and fulfill such requirements.  Please contact your Bar Association for guidance.

Virginia, Pennsylvania, and Ohio approvals are pending.

FDLI applies for CLE credits prior to each meeting but sometimes the approval is not granted until after the meeting. As approvals are received, updated CLE information will be posted here, and you can request to be notified.

Location and Overnight Accommodations

Coming soon.