Explore the essentials of tobacco and nicotine product law and regulation and gain a comprehensive understanding of the various administrative agencies that impact this industry. Learn about FDA’s Deeming Rule, the Public Health Standard, Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product Applications (MRTPs), compliance, enforcement, advertising, and marketing, recent and pending litigation, and more. The program will conclude with a discussion of industry hot topics, and all sessions will feature ample time for Q&A.
Agenda Highlights
- FDA’s regulation of tobacco and nicotine products
- Pathways to market
- Product compliance including advertising and marketing 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 seeking an overview of the topic. No prior knowledge of tobacco law and regulation is needed.
