A pre-recorded streaming video replay of the June 2021 webcast, FDA and Vaping: Regulatory Scheme, Agency Enforcement, and Developments in the Industry.
Course Outline
- Understand the powers of the FDA to regulate the vaping industry
- Examine the regulatory scheme in place, and that is proposed to replace it
- Learn about how FDA actions are affecting the various players in the industry
Electronic nicotine delivery systems (ENDS), commonly known as vapes or vape pens, have skyrocketed in popularity in the last decade, especially as an alternative to combustible tobacco products. In 2016, the FDA deemed all ENDS to be “tobacco products” under the 2009 Tobacco Control Act, and subject to FDA’s regulatory scheme for tobacco. Over the last five years, various provisions of this so called “Deeming Rule” have been implemented, with substantial impact on the industry. At the same time, the FDA has been hauled into court over several of its actions regarding ENDS, by the industry or the anti-tobacco movement.
This program explores the FDA’s regulations over tobacco and ENDS, its enforcement actions, and how the agency actions have had a profound effect not only on the regulated industry, but also on private litigation involving that industry.
Among the topics to be discussed:
- Overview of the FDA’s legal framework for exercising authority over ENDS
- Examination of the FDA’s stated priorities for regulation
- Discussion of the enforcement actions taken to date
- Ongoing and likely litigation involving manufacturers, retailers, and other market players