Explore the essentials of tobacco law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about FDA’s Deeming Rule, Premarket Tobacco Applications (PMTA) and Modified Risk Tobacco Product Applications (MRTPA), advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.

Agenda Highlights

  • FDA’s regulation of tobacco products
  • Pathways to market
  • Product compliance including advertising and promotion requirements
  • FDA’s enforcement tools and procedures

Statutes Covered

  • Federal Food, Drug & Cosmetic Act (FD&C Act)
  • Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act)
  • Comprehensive Smokeless Tobacco Health Education Act (CSTHEA)
  • Federal Cigarette Labeling and Advertising Act (FCLAA)
  • Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products

This course is designed for attorneys and other professionals needing an overview of the topic. No prior knowledge of tobacco law and regulation is needed.

Attendee Resources

These valuable takeaways will be provided onsite:

  • A binder of speaker handouts and related reference materials.
  • An electronic copy of FDA’s Deeming Rule and relevant guidance documents.

Register

Industry & Firms

$1,099
  • +$200 for nonmembers

Non-Profit

$899
  • +$100 for nonmembers

Government

$899
  • +$100 for nonmembers

Academic

$899
  • +$100 for nonmembers

Student

$99
  • +$100 for nonmembers

Add This Must-Have Reference to Your Registration

Purchase Tobacco and Nicotine Delivery: Regulation and Compliance, 2nd Edition during course registration and save 20%. 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:
Jonathan A. Havens, Attorney, Saul Ewing Arnstein & Lehr LLP

Wednesday, October 25

8:00–8:30 AM
Registration and Continental Breakfast

8:30–8:35 AM
FDLI Welcome and Announcements

8:35–10:00 AM
Overview of Tobacco Law and Regulation

J. Benneville (Ben) Haas, Partner, Latham & Watkins LLP
Adam Susser, Associate, Keller and Heckman LLP

10:00–10:45 AM
FDA’s Deeming Regulations

Bryan Haynes, Partner, Troutman Sanders LLP

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

11:00 AM–12:00 PM
Pathways to Market

Michael Hufford, Vice President, Regulatory Affairs, Behavioral Science, and Innovation, Pinney Associates

12:00–12:30 PM
Pathways to Market Part II: CTP’s Electronic Submission Process

Deborah Sholtes, Director, Division of Regulatory Science Informatics, Office of Science, Center for Tobacco Products, FDA
Jeff Smith, Regulatory Health Information Specialist, Office of Science, Center for Tobacco Products, FDA

 

12:30–1:30 PM
Networking Lunch

1:30–2:45 PM
Product Compliance: Labeling Requirements, Advertisement, and Promotion

David B. Clissold, Director, Hyman, Phelps & McNamara PC

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

3:00–4:00 PM
Inspections and Enforcement

Jonathan A. Havens, Attorney, Saul Ewing Arnstein & Lehr LLP

4:00–4:30 AM
The Public Health Standard

Stacey Gagosian, Managing Director of Public Policy, Truth Initiative

4:30–5:15 PM
Interacting with Regulatory Agencies

Will Woodlee, Partner, Kleinfeld, Kaplan & Becker, LLP

5:15 PM
Adjournment

Join us for the Tobacco Conference reception, Thursday, October 26, 5:00 – 6:30 PM.

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.

Approved:
Virginia – 7.5 CLE credit hours

Location and Overnight Accommodations

Course Location

W Washington DC
515 15th Street NW
Washington, DC 20004
877-946-8357

Overnight Accommodations

Overnight rooms are available at a discounted rate of $379 a night through September 28, 2017. After that date, rates and availability may vary.

Please contact the Conference Department with any accessibility requirements or dietary restrictions, or for other questions.