Agenda
Program Day I, Monday, July 16, 2012
US Food Law Short Course
8:00 a.m. Registration
8:30 a.m. Welcome from the Dean and Announcements
SPEAKER: JOAN W. HOWARTH, Dean, Michigan State University College of Law
I. OVERVIEW OF U.S. FOOD LAW AND REGULATION
A. Short History and Evolution of Food Law
1. Overview of the U.S. Legal System
2. Agency Procedural Regulation
B. Key Federal Agencies and Scopes of Their Authority
1. Food and Drug Administration (FDA)
2. Center for Food Safety and Applied Nutrition (CFSAN)
3. United States Department of Agriculture (USDA)
4. Food Safety and Inspection Service (FSIS)
5. Agriculture Marketing Service (AMS)
6. Animal Plant Health Inspection Service (APHIS)
C. Key Federal Statutes
1. The Federal Food, Drug, and Cosmetic Act (FDCA)
2. The Public Health Service Act
3. Meat, Poultry, and Egg Products Inspection Acts
4. The Federal Trade Commission Act
5. The Lanham Act
D. Key Concepts
1. What is Food? The Importance of Intended Use
2. Categories: Food (Including Dietary Supplements), Drug, Medical Device, Cosmetic, Tobacco
3. Imported Articles: The “Appearance” Standard, Import Alerts
II. LABELING
SPEAKER: STEVE STEINBORN, Attorney and Partner, Hogan Lovells, US, LLP
A. Terminology
1. “Label” versus “Labeling”
2. Principal Display Panel
3. Information Panel
4. Internet and Labeling
B. Affirmative Label Requirements
1. Statement of Identity (Product Name)
2. Net Quantity of Contents
3. Ingredient Statement
b) Incidental Additives
c) Preservatives
d) Percent Juice Declaration
4. Name and Address of Manufacturer, Packer, or Distributor
5. Allergens
C. Prohibited Representations
D. Other Considerations
E. Nutrition Labeling
1. Nutrients that Must Be Declared
2. Voluntary Nutrients
3. Various Formats that are Available
4. Serving Size & Reference Amount Customarily Consumed
F. USDA Labeling Requirements
1. Prior Label Approval
2. USDA Labeling Requirements
3. USDA - FDA Labeling Differences
12:00-1:00 p.m. Lunch
III. NUTRITIONAL CLAIMS AND HEALTH CLAIMS
SPEAKER: STEVE STEINBORN, Attorney and Partner, Hogan Lovells, US, LLP
A. Nutrient Content (Level) Claims
1. Definitions
a) Implied and Expressed
b) “Healthy”
c) "High," "Low," "Good Source," "Free"
d) Carbohydrate Claims —- "Low," "Net Carbs"
2. Comparative ("Relative") Claims
a) "Less"
b) "Reduced"
c) "Added"
d) "More"
e) "Lite"
1. Definition
2. What are Not Health Claims:
a) General Well-Being Claims
b) Classical Nutrient-Deficiency Disease and Nutrition
c) Structure/Function Claims
3. Pre-Approved Health Claims (NLEA)
4. Qualified Claims – After Pearson v. Shalala
5. Health Claim Petitions
a) Qualifying Requirements
b) Substantiation of Claims
c) Significant Scientific Agreement
d) Evidence-Based Ranking System
6. Authoritative Statements – FDA Modernization Act of 1997
7. Special Considerations
a) Infant Formula
b) Foods for Special Dietary Use and Medical Foods
C. Other Claims
1. Natural
2. Organic
3. Non-GMO
D. Advertising
1. Federal Trade Commission
2. National Advertising Division
3. Deceptive Advertising & Unfairness
4. Overview of Other Regulatory Aspects of Advertising
IV. ECONOMIC AND AESTHETIC ADULTERATION
SPEAKER: ROGER CLEMENS, Chief Scientific Officer, Horn, President, Institute of Food Technologists
A. Key Definitions
B. Standards of Identity
C. Aesthetic Adulteration: Contamination With Filth
1. Defect Action Levels (AKA Allowable Filth)
2. Insanitary Conditions
D. GMPs
E. “Otherwise Unfit for Food”
F. Economic Adulteration
6:00 pm Dinner at the University Club
Program Day 2 – Tuesday, July 17, 2012
US Food Law Short Course
Moderator: Cathy Weir
Welcome and announcements
V. FOOD SAFETY
A. Overview
B. Poisonous or Deleterious Substances
C. Added versus Non-Added Substances
D. Carcinogens & the Delaney Clause
E. Pesticides
1. Tolerances
2. The Food Quality Protection Act (FQPA)
F. Insanitary Conditions and Injury to Health
G. Foodborne Illnesses
H. GMP, HACCP, & HAPCP
VI. FOOD ADDITIVES, COLOR ADDITIVES, AND IRRADIATION
SPEAKER: ROGER CLEMENS, Chief Scientific Officer, Horn, President, Institute of Food Technologists
A. The Food Additive Amendments of 1958
B. Additive Safety and Approval
C. GRAS and Prior Sanctioned Substances (Plus FEMA on Food Flavorings)
D. Additives of Special Interest
E. Colorings
F. Irradiation
G. Bioengineering and Nanotechnology
VII. DIETARY SUPPLEMENTS
SPEAKER: NEAL FORTIN, Professor and Director, Institute for Food Laws
and Regulations at Michigan State University
A. Background
1. What are Dietary Supplements?
2. The Statutory Definition
3. What is Not a Dietary Supplement
B. Notification & Safety
2. New Dietary Ingredients (Post-1994)
3. Adulteration
C. Enforcement
D. Good Manufacturing Practices (GMPs)
E. Labeling
1. DSHEA Authorized Health Claims
2. Claim Substantiation
VIII. INSPECTIONS AND ENFORCEMENT
SPEAKER: STEVE KLUTING, Partner – Co-Chair, Food Law Group, Varnum
A. Inspections
1. Statutory Authorities
2. Statutory Power for Inspections
3. Constitutional Limits – 4th Amendment
B. Federal Enforcement
1. Administrative Tools, Including Recall Authority
2. Civil Actions — Seizure, Injunctions, Contempt
3. Criminal Actions
Presentation of Certificates
Wrap up, Evaluation, and Adjourn
4:15 p.m. Optional activity: Walk to Anthony Hall
John Engstrom, MSU Dairy Plant Manager, will offer a short tour of the MSU Dairy Plant including
a stop at the MSU Dairy Store highlighting MSU’s homemade ice creams for a sample of your favorite flavor!
5:30 p.m. Bus Returns to Candlewood Suites.
Day 3 – Wednesday, July 18, 2012
Food Regulation Current Issues Seminar
8:00 a.m. Registration
8:30 a.m. Welcome from the Dean and Announcements
SPEAKER: JOAN W. HOWARTH, Dean, Michigan State University College of Law
Moderator: Roger Clemens
KEYNOTE
FOOD SAFETY AND GLOBAL FOOD LAW
P. Vincent Hegarty, Founding Director and Professor Emeritus,
Institute for Food Laws & Regulations, Michigan State University
A. The Food Safety Modernization Act (FSMA): Where is it Now, Where is it Going?
FDA – Implementation Challenges & Priorities
FDA District Director (invited)
B. Strategic Management of FSMA Compliance
C. Managing Supplier FSMA Compliance in a Global Market
D. Hazard Analysis & Risk-Based Preventive Controls – What Should Firms Be Doing Now?
E. How to Approach Compliance with the Produce Performance Standards
Charles Woodhouse, Attorney and Partner, Woodhouse Shanahan P.A.
F. Private Food Safety Standards and Third-Party Certification in Global Trade
G. Intentional Adulteration, Food Fraud, and Food Counterfeiting
John Spink, Director, Packaging for Food and Product Protection Initiative
Assistant Professor, Criminal Justice, MSU
6:00 P.M. Dinner at the University Club
Day 4 – Thursday, July 19, 2012
Food Regulation Current Issues Seminar
Moderator: Gerald Wojtala
Opening Talk
Janine Lewis — The Creation of a Binational Food Regulatory Authority
Panels:
I. Health Claims: Comparative EU and US Requirements for Substantiation
Nicole Coutrelis – Health Claims in the EU
James Hoadley – The Science of Substantiation
Ricardo Carvajal – Health Claims in the US
II. International Food Safety Risk Regulation
Janine Lewis — The Regulatory Response to Nutritional Risk
Ed Scarbrough – Codex and Risk Regulation
III. Novel Foods Approvals – Biotechnology, Nanotechnology, GRAS Panels
Roger Clemens – Science and the Safety of Novel Food
Ricardo Carvajal – FDA and Food Ingredient Safety: Biotech, Nanotech, and GRAS
IV. Handling Recalls
Nicole Coutrelis — Handling Recalls in the EU
Cathy Weir — Handling “Recalls” in Industry
Charles Woodhouse – Handing Recalls in the US
4:30 pm Presentation of Certificates
Wrap up, Evaluation, and Adjourn