Course offering number:0909=705
Course ID:
2330
FDA to Regulate Tobacco: What to Expect
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is a must for tobacco manufacturers, and suppliers and importers of tobacco products. Individuals from industry and government
within the following positions will find the course beneficial:
• Quality Assurance and Control
• Regulatory Affairs Representatives
• Managers
• Sales Personnel
• Manufacturers
• Physicians
• Health Care Providers and Practitioners
• Attorneys and In-House Counsel
• Risk Managers
• Enforcement Personnel
• Federal, State and Local Government
In addition, groups/organizations/individuals who are interested in the impact this new regulation will also benefit.
Description
On June 22, 2009, President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act . This historic legislation, a long
time in the “making”, conferred authority to FDA to regulate tobacco products. This law changed the United Stated Federal Food, Drug and
Cosmetic Act by permitting FDA regulatory authority to cover tobacco products. This 90-minute accredited training will focus on the legal
issues involving tobacco regulation by FDA. The program will examine litigation issues, regulatory matters as well as current topics. The
landmark United States Supreme Court decision of Brown & Williamson Tobacco Co. v. FDA that set in motion this legislation will be analyzed.
Participants will be given information on how to make their voice heard in how this historic law will unfold.
Module 1:
• Overview of the Family Smoking Prevention and Tobacco
Control Act
• What Led Up to this Historic Legislation
– Federal Efforts to Regulate Tobacco
– Jurisdiction of the United States Federal Food and Drug
Administration to Regulate Tobacco
– “The” Landmark United States Supreme Court Decision:
Brown & Williamson v. FDA
Module 2:
• Key elements of the Family Smoking Prevention and
Tobacco Control Act
• The United States Food and Drug Administration (FDA)
Authority to Regulate Product Promotion-Tobacco
Advertising
• Labeling issues
Module 3:
• How to Make Your Voice Heard
– Submission of Comments
• Special Topics
– Economics
– "Politics"
Question and Answer Session