Register For Both the Dietary Supplements program
and Introduction to Food Law and Regulation and SAVE $200!
| Register for Introduction to Food Law and Regulation only: |
- General Information
- Agenda
- Hotel Information
Speakers
Frederick H. Degnan, Partner, King & Spalding, LLP
Miriam J. Guggenheim, Attorney, Covington & Burling LLP
Christopher L. Hagenbush, Partner, Patton Boggs LLP
Martin J. Hahn, Partner, Hogan & Hartson LLP
Anne V. Maher, Partner, Kleinfeld, Kaplan & Becker
Robert C. Post, PhD, MEd, MSc, Deputy Director, Center for Nutrition Policy and Promotion, U.S. Department of Agriculture
James P. Rathvon, Partner, DLA Piper LLP
Sarah Taylor Roller, RD, MPH, Partner, Kelley Drye & Warren LLP
Gary L. Yingling, Partner, K & L Gates LLP
Program Description
At this newly updated, interactive two-day program, you will not only learn the essential elements of food law and regulation, you will also acquire an orientation to administrative agencies to further your understanding of how the government agencies, the Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA) and Federal Trade Commission (FTC), among others, promulgate and enforce regulations regarding food ingredients, manufacturing, safety, security, labeling, claims, advertising, and more. Additionally, this meeting will provide you with a context for keeping up with current and emerging issues of concern to food manufacturers, regulators, and consumers, such as safety, imports, allergens, structure/function claim, and bioterrorism measures.
The meeting also focuses on the fundamental regulatory requirements that apply to developing, processing, labeling, distributing, and competitively marketing food products. Within each of these "topic areas", this program focuses on real-world examples and identifies the practical issues and considerations you need to get your product to market in compliance with governing requirements.
Who Should Attend?
This intensive program is designed for regulatory affairs personnel, new members of the legal community, representatives from federal and state governments, advertising, marketing and investment professionals who recently joined the conventional food and dietary supplement industry. This meeting is also an excellent refresher for the seasoned professional.
The intense nature of this meeting requires that attendance be limited. Early registration is strongly recommended. This program promotes an informal, classroom atmosphere where dialogue and questions are encouraged. FDLI suggests that attendees dress comfortably, i.e., “casual business attire.”
Handout Materials
A binder of speaker handouts
FDLI's FDCA Statutory Supplement, including the FDA Amendments Act and Related Sections of Additional Statutes
Continuing Legal Education (CLE) Credits
Pending state approvals, CLEs will be awarded.
Registration Fees
Early Bird Rate (Received before Friday, December 26, 2008)
$920 FDLI Members
$1,345 Non-members
$745 Academics & Government
Standard Rate (Received after Friday, December 26, 2008)
$1,020 FDLI Members
$1,420 Non-members
$820 Academics & Government
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 addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.
Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org
Tuesday, January 27, 2009
Go to Wednesday's Agenda
8:00 a.m.
Registration and Continental Breakfast
8:30 a.m.
FDLI Welcome and Announcements
I. Overview of U.S. Food Law and Regulation
A. Key Federal Agencies and Scopes of their Authority
1. Food and Drug Administration (FDA) and the Center for Food Safety and
Applied Nutrition (CFSAN)
2. United States Department of Agriculture (USDA)
3. Federal Trade Commission
B. Key Statutes
1. The Federal Food, Drug, and Cosmetic Act (FD&C Act)
2. Meat, Product, and Egg Products Inspection Acts
3. The Federal Trade Commission Act
C. Key Concepts
1. Statutes prohibit the introduction into interstate commerce of
adulterated or misbranded products
2. Importance of intended use—the claims for a product will dictate
how it will be regulated by FDA and USDA
D. Product Liability Laws Impact on industry
II. Food Safety: Unintended Components/Contaminants of Food
A. Adulteration
1. FD&C Act-Prohibited Acts: Producing/Distributing Adulterated Food
2. When is a Food Adulterated?
3. USDA: Statutory Framework for “Adulteration”
4. Hazard Analysis Critical Control Points (HACCP)
Refreshment Break
III. Food Safety: Ingredient Preclearance: Intentional Components of Food
A. Framework for Food Additive Regulation
1. Definition of “Food Additive”
2. Direct Food Additive Approval Requirements
3. Generally Recognized as Safe (GRAS) Substances
4. State Involvement in Food Safety Regulation
5. Biotechnology Foods
6. Special Issues
12:15-1:30 p.m.
Lunch
1:30 p.m.
IV. Food Misbranding: General Requirements (Including Meat & Poultry)
A. Definition of “Label” and “Labeling”
1. Principal Display Panel
2. Information Panel
3. Websites
B. Statement of Identity/Product Name
1. Common or Usual Names (including juice labeling)
2. Characterization of Flavors
3. Standards of Identity
C.
Net Quantity of Contents
D. Ingredient Statement
1. Order
2. Flavors
3. Allergens
4. Preservatives
5. Incidental Additives
E. Nutrition Labeling
1. Trans Fats
2.
Changes to Nutrition Facts Panel (NFP)
F. Name/Place of Manufacturer or Distributor
G. Country of Origin
H. General False and Misleading
1. False and misleading in any particular under section 403(a)(1)
2. False and misleading for failing to reveal material facts under
section 201(n)
I. Percent Juice Declaration
J. USDA Labeling Requirements
1. Labeling
2. Relationship Between USDA and FDA – Food Additives in Meat,
Poultry and Egg Products
Refreshment Break
V. Food Misbranding: Nutrient Content, Heath and Other Claims
A. Nutrient Content Claims (NCC’s)
1. Definitions - Implied and Expressed
2. Implied Claims
3. Express Claims - Absolute
4. Expressed Claims - Comparative (“Relative”) Claims
5. Factual Statements
6. Percentage Claims
7. Reformulated Traditional Foods
8. Food and Drug Administration Modernization Act of 1997 (FDAMA)
Authoritative Statements
9. Carbohydrate Claims
10. Whole Grain Claims
B.
Health Claims
1. Definition
2. Basic Statutory/Regulatory Provisions – Elements of a Claim
3. Qualifying Requirements
4. FDAMA Authoritative Statement Notification
5. Health Claim Petitions
6. The First Amendment (commercial speech)
C.
Structure/Function Claims
D.
Other claims
1. Natural
2. Organic
3. Fresh
VI. Dietary Supplements
A. The Dietary Supplement Health and Education Act of 1994 (DSHEA)
1. Basic Requirements; Implementation
2. Definition of a Dietary Supplement
3. Nutrition and Ingredient Labeling
4. Third Party Literature
B. Statements of Nutritional Support/Structure- Function Claims; Disclaimers;
Substantiation
C. Safety
1. New Dietary Ingredients
2. Grandfathered Dietary Ingredients
3. Ephedrine Alkaloids
D. Adverse Event Reporting (AER); MedWatch
E. Good Manufacturing Practices (GMPs)
F. State Regulation
5:00 p.m.
Adjournment for the Day
Wednesday, January 28, 2009
Back to Tuesday's Agenda
8:00 a.m.
Continental Breakfast
8:30 a.m.
VII. Meat and Poultry
A. United States Department of Agriculture (USDA) Food Safety and Inspection
Service
1. Meat, Poultry, and Egg Products Inspections Acts (FMIA, PPIA, EPIA)
2. Review of basic statutory and regulatory requirements
B. Continuous Inspection
C. Mandatory HACCP
D. Unique Enforcement
E. Prior Label Approval
1. Mark of Inspection
2. Similarities and Differences between FSIS and FDA labeling
requirements
F. Animal and Plant Health Inspection Service (APHIS)
G. FDA and USDA Jurisdiction; Interacting and Working with FDA and USDA;
Resources
1. Meat and Poultry and All Other Foods
2.
Freedom of Information Act (FOIA)
3.
Who/How to Contact for
4.
Information/Assistance
5.
Citizen Petition
VII. Other Agencies of Interest
A. National Institutes of Health (NIH)/Office of Dietary Supplements
B.
Centers for Disease Control (CDC)
C.
U.S. Department of Justice (DOJ)
1.
FDA’s lawyers-Office of Consumer Litigation
D. Environmental Protection Agency (EPA)
E.
U.S. Department of Treasury/Alcohol and Tobacco Tax and Trade Bureau (TTB)
F.
Consumer Product Safety Commission (CPSC)
G.
U.S. Department of Homeland Security
H.
(DHS)/U.S. Customs and Border Protection (CBP)
I.
U.S. Department of Homeland Security (DHS)/U.S. Customs and Border
Protection (CBP)
J.
The Securities and Exchange Commission (SEC)
VIII. Public Health Security and Bioterrorism Preparedness and Response Act (The Bioterrorism Act of 2002) and Food Safety and Security
A. Registration of Facilities
1. FDA Facility Registration for Low Acid Canned Food
2. USDA Inspected Establishments
3. Bioterrorism Act
B. Recordkeeping and Records Access
C. Prior Notice of Imported Food
D. Administrative Detention
E. Food Security
Refreshment Break
IX. Special Issues
A. Labeling of Bioengineered Foods
B. Genetically Modified Organism (GMO), Genetically Modified (GM) Statements
C. Irradiation – The Farm Security and Investment Act of 2002
D. State Requirements
1. Scope of Preemption under Nutrition Labeling and Education Act of
1990 (NLEA)
2. Areas not Preempted by NLEA
E. Obesity
F. Adulterated Food Registry
X. Inspection and Enforcement Authority
A. Inspections
1. FDA Authority
2. Handling an FDA Inspection
3. Post-Inspection Follow-Up
4. USDA Authority
B. Enforcement
1.
“Warning” Letters (WLs) and “Untitled” Letters
2.
Recalls
3.
Administrative Powers
4.
Seizures
5.
Debarment from Food Importation
6.
Injunctions
7.
Criminal Prosecution
8.
Civil Penalties
9.
USDA Enforcement
C. State Law and Relationship to Federal Law
1. State FD&C Acts – additional authority to detain product and impose
penalties
2. FDA Resource Constraints lead to most food plant inspections being
carried out by states
3. State Attorneys General
4. Specialized Laws: California’s Proposition 65
5. State Product Disparagement Statutes (Oprah Winfrey case)
D. Collaborative Federal-State Programs
1. Pasteurized Milk Ordinance (PMO)
2. Interstate Shellfish Sanitation Conference (ISSC)
3. Association of American Feed Control Officials (AAFCO)
12:15-1:30 p.m.
Lunch
1:30 p.m.
XI. Imports and International Issues
A. Requirements for Labeling and Manufacturing
B. China
1. Regulation of Animal Feed
2. Regulation of Human Feed
C. Bovine Spongiform Encephalopathy (BSE)
D County of Origin Labeling (COOL)
E. Roles of States and Imports
F. Principles of International Harmonization
G. Codex Alimentarius Commission (Codex)
H. World Trade Organization (WTO) Obligations
XII. Advertising: The Federal Trade Commission and Private Rights of Action
A. Statutory Authority: FTC Act
1. Basic Principles
2. FDA and FTC Jurisdiction
3. “Baby FTC” State Consumer Protection Acts
B. Deception Policy
C. Substantiation of Claims
D. Nutrient Content and Health Claims
E. Internet
F. Enforcement Approach
1. Consumer Fraud
2. Dietary Supplements
G. Private Actions - Lanham Act
H. Alternative Dispute Resolution (NAD)
1. Council of Better Business Bureaus, Inc. National Advertising
Division (NAD)
2. Children’s Advertising Review Unit (CARU)
Refreshment Break
XIII. Emerging Food Topics
5:00 p.m.
Adjournment
Meeting Date(s) January 27-28, 2009
Hotel Reservations
L'Enfant Plaza Hotel
480 L'Enfant Plaza, SW
Washington, DC 20024
Phone: 202-484-1000 | 800-635-5065
Web: www.lenfantplazahotel.com
Room Rate
$209 single/double + applicable taxes
Please call the hotel and identify yourself as an FDLI/Food and Drug Law Institute/Introduction to Food Law conference attendee to receive the rate.
If you choose to reserve you room through the hotel's website, please visit L'Enfant Plaza Hotel's reservation page and use code FDL126 to receive the room rate above.
Reservation Cut-Off December 26, 2008
Check-in 3 pm
Check-out 12 Noon
Directions
The L'Enfant Plaza Metrorail Stop, which you can access from the blue, orange, yellow and green lines, is located directly under the lobby of L'Enfant Plaza Hotel. More Information.