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Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird discount!

FDA Regulation Update and Preparing for What’s Next
Azim Chowdhury

  • FDA’s New Announcement: How it Will Impact Your Business
  • Product Compliance Overview: Vapor, Cigars, Hookah
  • Flavors and Product Standards
  • Reporting on Harmful and Potentially Harmful Constituents (HPHCs)
  • Premarket Review for Deemed Tobacco Products
  • PMTAs, SE Reports, and Using Master Files
  • Potential Over-the-Counter Drug Pathway
  • Status of Proposed Rulemakings
  • Modified Risk Tobacco Products
  • Online Sales – “Heightened” Age-Verification
  • Retailer Compliance and Adults-Only Requirement
  • Enforcement and Penalties
  • …and much more!

FDA Inspections: Are You Prepared?
Azim Chowdhury and Daniel Rubenstein

  • Overview of FDA Inspection Authority
  • Update on Tobacco Product Manufacturing Practices
  • The FDA Inspection: Before, During and After
  • Enforcement and Penalties
  • Keller and Heckman’s Audit and Inspection Program (AIP)

Key Litigation Update
Eric Gotting

  • Nicopure and Right to be Smoke-Free Coalition v. FDA (Deeming Rule Appeal)
  • American Academy of Pediatrics v. FDA
  • Potential Upcoming Litigation (e.g., flavor and convenience store bans)

Environmental Issues Affecting Nicotine-Containing Products
JC Walker

  • Overview of Hazardous Waste Regulations Governing E-Liquid Manufacturers and Distributors
  • Considerations for Minimizing Regulatory Exposure

OSHA’s Hazard Communication Standard and Considerations for the E-Liquid Industry
Manesh Rath

  • Overview of OSHA’s Hazard Communication Standard (HCS)
  • Scope of Standard and Exemptions
  • Safety Data Sheets (SDSs)
  • Labeling
  • Employee Training
  • Future Challenges for E-liquid Industry

Advertising and Marketing: Implications for Global Public Policy and the Role of Self-Regulation
Sheila Millar

  • Marketing Practices: Impact on Public Perception, Regulations, Enforcement and Litigation
  • Expanding Global Concerns About Child-Appealing Marketing
  • Creating and Implementing Effective Advertising Self-Regulation

Business, IP, and Advertising Issues – How to Stay in Compliance                                       
Tracy Marshall and Bob Niemann

  • Drafting and Negotiating Vendor, Manufacturing, and Distribution Agreements
  • Insurance Policies for Vapor Companies
  • Protecting Trademarks, Copyrights, and Trade Secrets and Avoiding IP Infringement
  • Privacy and Data Security
  • Using Digital Marketing to Promote Your Business
  • Conducting Contests, Sweepstakes, and Other Promotions

State Law Update
Azim Chowdhury

  • Overview of State permit, licensing and tax requirements for tobacco and vapor products
  • Age-verification and delivery requirements

How to Sell Your Products in the EU (Without Getting into Problems): TPD and Beyond
Marcus Navin-Jones

  • Refresher on TPD Requirements
  • EU Requirements which Apply in Addition to the TPD
  • EU Law vs National Law: Areas where EU Countries are Allowed to Have their Own Rules
  • Recalls Withdrawals and Legal Crisis Management.
  • Brexit and How Brexit is Affecting the Vape Industry

Going International: Preparing Your Business for Global Compliance
David Ettinger

  • Current Regulatory Status of Vapor Products Around the World
  • China and Asia
  • New Zealand
  • Australia
  • Russia, India, Middle East, and More
  • World Health Organization

In addition to the topics above, we will also have special guest speakers from Cardno ChemRisk, Broughton Laboratories and others on topics including Premarket Tobacco Product Applications and HPHC Reporting. Stay tuned for the full agenda!

To register, click here.

Seminar Details:
Date: January 29 – 30, 2019
Cost: $899 if you register by January 4, 2019; $1,099 if you register after January 4, 2019
*register 3 or more attendees from the same company and receive a 10% discount. Email seminars@khlaw.com for additional information.

Continuing Legal Education (CLE)
CLE credits are available, pending state approval

Location
Marriott Miami Biscayne Bay
1633 N Bayshore Drive
Miami, FL 33132

Keller and Heckman has negotiated a preferred room rate of $259 per night, plus tax at the Marriott Miami Biscayne Bay. Reservations must be received no later than January 7, 2019. To make your reservation, please click here.

For additional information, please contact:

Sara A. Woldai, CMP
Manager, Marketing Meetings and Events
woldai@khlaw.com
202.434.4174