This session is sold out. Please let us know if you would like to be notified about the fall course. 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.

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of food law and regulation is needed. The printed course materials provide a valuable reference guide to use back at the office.

Attendee Resources

These valuable takeaways will be provided onsite:

Register

Industry & Firms

$999
  • +$200 for nonmembers

Non-Profit

$699
  • +$200 for nonmembers

Government

$699
  • +$200 for nonmembers

Academic

$699
  • +$200 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Access to an electronic version of the FDCA Statutory Supplement, 2017 is included in your registration. You can also purchase a print copy at a $100 savings during course registration. Select the “bundle option” to take advantage of this offer. The book will be immediately shipped directly to you.

Agenda

subject to change

Curriculum Advisor:
Daniel Dwyer, Partner, Kleinfeld, Kaplan & Becker, LLP

Thursday, March 2

8:00 – 8:30 AM Registration and Continental Breakfast 8:30 – 8:35 AM FDLI Welcome and Announcements

Khara L. Minter, Assistant Director, Training Programs, FDLI

8:35–9:35 AM Overview of U.S. Food Law and Regulation

Daniel Dwyer, Partner, Kleinfeld Kaplan & Becker LLP

9:35–10:45 AM Food Safety: Ingredient Preclearance/Intentional Components of Food

Gary Yingling, Partner, Morgan, Lewis & Bockius LLP

10:45–11:00 AM Networking and Refreshment Break 11:00 AM–12:30 PM Food Safety: Unintended Components/Contaminants of Food

Ricardo Carvajal, Director, Hyman Phelps & McNamara, PC

12:30–1:45 PM Networking Lunch 1:45–2:45 PM Food Safety Modernization Act Implementation

Allen Sayler, Senior Director of Food & Cosmetic Consulting Services, EAS Consulting Group, LLC

2:45–3:00 PM Networking and Refreshment Break 3:00–4:00 PM Food Labeling: General Requirements (Including Meat and Poultry)

Evangelia Pelonis, Partner, Keller & Heckman LLP

4:00–5:00 PM Food Labeling: Nutrient Content, Health and Other Claims

Miriam Guggenheim, Partner, Covington & Burling LLP, and Member, FDLI Board of Directors

Friday, March 3

8:00 – 8:30 AM Registration and Continental Breakfast 8:30–9:30 AM Advertising: Federal Trade Commission and Private Rights of Action

Russell Blythe, Partner, King & Spalding

9:30–10:45 AM U.S. Department of Agriculture

Jeffrey Canavan, MPA, RD, Deputy Directory, Labeling & Program Delivery Division, Food Safety Inspection Services, USDA

10:45–11:00 AM Networking and Refreshment Break 11:00 AM –12:00 PM Dietary Supplements

Rend Al-Mondhiry, Associate General Counsel, Council for Responsible Nutrition Amanda Groves, Partner, Winston & Strawn LLP

12:00–1:15 PM Networking Lunch 1:15–2:15 PM Regulation of Cosmetics

Kristi Wolff, Partner, Kelley Drye & Warren, LLP

2:15–3:30 PM Inspection and Enforcement Authority

Maile Hermida, Partner, Hogan Lovells LLP

3:30–3:45 PM Networking and Refreshment Break  3:45–4:45 PM Imports and International Issues 

John Johnson, Senior Associate Attorney, FDAImports.com, LLC

4:45 PM Adjournment

Speaker Biographies

JEFFREY CANAVAN is Deputy Director of the Labeling and Program Delivery Division (LPDD) in the Food Safety and Inspection Service (FSIS), United States Department of Agriculture (USDA). He is responsible for the development and implementation of policies for food labeling, food standards, and ingredients for meat, poultry and egg products. He has worked extensively on policy issues for food allergens, nutrition labeling, and the use of novel food safety interventions. Mr. Canavan also serves as the U.S. Alternate Delegate for the Codex Committee on Food Labeling. He is a registered dietitian and food technologist with a Master of Public Administration Degree from George Mason University, and a BS in Foods and Nutrition from Radford University.
DANIEL DWYER is a partner at Kleinfeld Kaplan & Becker LLP, who has been with the firm since 1987.  His practice focuses primarily on representing food, cosmetic, pharmaceutical, medical device, and consumer products/services companies on a variety of matters involving FDA law, USDA law and advertising law.  Mr. Dwyer has substantial expertise in food and drug safety issues, clinical trials, labeling and advertising claim substantiation, sales and marketing practices, good manufacturing practices, FDA inspections, recalls, corporate compliance programs and related matters.  He regularly advises clients on developing strategies for FDA compliance; compliance with USDA meat, poultry and egg inspectional requirements; and compliance with federal and state advertising law.  Mr. Dwyer has more than 20 years’ experience in FDA law and related matters.  He has built a national reputation for successfully resolving difficult and complex FDA compliance and regulatory matters.  He has participated in FDA and Lanham Act litigation, and has pursued a number of advertising law cases at the National Advertising Division of the council of Better Business Bureaus involving competitive challenges on behalf of food, dietary supplement, cosmetic and OTC drug manufacturers.  Prior to joining the firm, Mr. Dwyer was investigator and legal advisor to the Vice Chairman at the U.S. International Trade Commission.  He frequently writes an speaks on legal topics and has taught food-and-drug law as an adjunct professor at George Mason University Law School.
MIRIAM GUGGENHEIM is a partner and co-chair of the Food, Drug and Device practice at Covington & Burling LLP.  Her practice focuses primarily on the food and dietary supplement industries.  Ms. Guggenheim counsels clients in all aspects of food and dietary supplement development and marketing, from product formulation, manufacturing, and safety considerations to labeling and advertising.  Her work for a broad range of leading global food and dietary supplement companies and major trade associations includes regulatory advice, advocacy before regulators, courts and legislative bodies, and strategic counseling in light of overarching public health and nutrition policy considerations.  Ms. Guggenheim is ranked as one of America’s Leading Business Lawyers, Food & Beverages: Regulatory & Litigation by Chambers USA.  Ms. Guggenheim received her BA, magna cum laude, from the University of Pennsylvania and her JD, with honors, from Columbia University School of Law.
MAILE HERMIDA is a partner at Hogan Lovells LLP.  She represents all segments of the food industry and their trade associations. She has a keen understanding of the issues affecting the industry, from product development through production, distribution, and retail sale.  Her core practice involves helping companies ensure they are in compliance with regulations from federal agencies such as the Food and Drug Administration (FDA) and U.S. Department of Agriculture. Maile also provides strategic advice on public policy issues, frequently involving agency rulemakings.  Maile has considerable experience with the FDA Food Safety Modernization Act (FSMA), having worked with numerous companies and trade associations on all aspects of the law since the day it was signed. She translates her in-depth knowledge of FSMA into practical solutions for companies working on implementation strategies. She also is a Preventive Controls Qualified Individual (PCQI), as well as a Food Safety Preventive Controls Alliance Lead Instructor for the PCQI training.  Additionally, Maile assists companies with matters involving regulatory enforcement. She helps clients navigate product recalls; government inspections; and other enforcement actions, such as Warning Letters and import detentions. Maile also advises clients on the development of label and advertising claims, as well as labeling requirements for foods and dietary supplements.  Maile is a frequent speaker and contributor to industry publications. Prior to joining Hogan & Hartson (now Hogan Lovells), she served as a judicial clerk to the Honorable Charles F. Lettow of the U.S. Court of Federal Claims. Maile graduated with high honors from The George Washington University Law School, where she served as executive editor of The George Washington Law Review.
REND AL-MONDHIRY is Associate General Counsel at Council for Responsible Nutrition.  Ms. Al-Mondhiry provides legal counsel and advice to CRN’s staff and members in the areas of legislation, regulatory compliance and advocacy, and international policy development with respect to dietary supplements and nutrition issues. She also advises the association on a variety of general business matters, including contract drafting, negotiation and review, non-profit and association governance issues, and general corporate matters affecting CRN, CRN-International, and the CRN Foundation. Previously, Ms. Al-Mondhiry worked as state legislative counsel for the Consumer Healthcare Products Association (CHPA) where she provided testimony and comments on legislative and regulatory proposals, drafted legislation and regulatory language and served as a policy expert in the area of food and drug law. Prior to joining CHPA, she worked at the American Speech-Language-Hearing Association, serving as the director of state legislative and regulatory advocacy. Ms. Al-Mondhiry received her BA from The George Washington University and her JD from Pennsylvania State University, Dickinson School of Law.
EVANGELIA PELONIS is a partner at Keller & Heckman LLP.  Her practice focuses on all regulatory and compliance matters of FDA and the U.S. Department of Agriculture relating to human food, animal feed, food additives and ingredients, and dietary supplements.  Ms. Pelonis works with clients to achieve their marketing goals within the applicable legal frameworks. She counsels clients in all aspects of food development and marketing, from product formulation and manufacturing considerations to food labeling and advertising.  Ms. Pelonis regularly assists clients with issues involving: review of food labeling and promotional materials, including appropriate common or usual names, ingredient declarations, nutrition labeling, health claims, nutrient content claims, structure function claims, allergen labeling, organic labeling; review of substantiation for labeling and advertising claims; food safety and preparing self-determined GRAS positions and GRAS Notifications for submission to FDA; FDA enforcement actions and responses to Warning Letters; Compliance with FDA’s Bioterrorism regulations; assisting clients with product recalls and reports to the Reportable Food Registry; import and export issues regulated by FDA; customs and USDA including assisting companies in gaining release of detained products and removal from Import Alert; international food regulatory matters (Canada, Australia, Far East, Middle East).  While in law school, Ms. Pelonis received a Certificate in Law and Public Policy and was a Note and Comment Editor for the CommLaw Conspectus: Journal of Communications Law and Policy.
ALLEN SAYLER is Senior Director of Food and Cosmetic Consulting Services at EAS Consulting Group.  Mr. Sayler has 16 years of experience as a state, FDA and USDA dairy and food program manager.  He has worked for the last 18 years as a food processing industry consultant, specializing in evaluation, assessments, and trouble-shooting of food plant processing operations and their food safety and quality programs, and carries ISO 22000 and BRC auditor certifications.  He is a certified “Lead Instructor” though FDA’s Food Safety Preventive Controls Alliance (FSPCA), a frequent contributor to Dairy Foods monthly magazine, as well as a frequent speaker at national dairy and food processor meetings.  Mr. Sayler is active in the National Conference on Interstate Milk Shipments (NCIMS), the International Association of Food Protection (IAFP), the Institute of Food Technologist (IFT), the International Dairy Federation (IDF), the FDA Alumni Association, Codex Alimentarius, the American Society of Quality (ASQ), and served on the Board of Directors of 3-A Sanitary Standards, Inc. and the Dairy Practices Council (DPC).  He received Group Excellence Awards from both FDA and USDA.  In 2009, Mr. Sayler received the Harold Barnum Industry Award from IAFP.
GARY YINGLING is a partner at Morgan, Lewis & Bockius LLP in Washington, DC.  He draws on his experience as a former US Food and Drug Administration (FDA) lawyer to advise individuals, partnerships, and corporations in matters involving new drug applications, food ingredient marketing, product labeling, importation, regulatory marketing strategy, recalls, seizures, and criminal matters. His practice focuses on food and drug industry issues, with a particular interest in clinical research, contract research organization, and sponsor matters. Clients seek his advice in matters ranging from ingredient safety questions and product labeling to the preparation of New Drug Applications (NDA) and GRAS Notifications.

Continuing Legal Education

FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received. Ohio: 13.25 CLE credit hours Pennsylvania: 13.0 CLE credit hours Virginia: 13.0 CLE credit hours

Location and Overnight Accommodations

Course Location

Covington & Burling LLP 850 Tenth Street NW Washington, DC 20001

Overnight Accommodations

The following hotels are within walking distance of the meeting location: Marriott Marquis, 901 Massachusetts Avenue NW Renaissance Downtown Hotel, 999 9th Street NW Grand Hyatt Washington, 1000 H Street NW Embassy Suites, 900 10th Street NW Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.

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