FDA and Vaping: Regulatory Scheme, Agency Enforcement, and Developments in the Industry (Online Seminar)

MCLE Credits: 2.0
Ethics Credits Included: 0.0

MCLE Credit: 2.0 (Ethics: 0.0)
Live-Interactive Credit: 0.0
Price: $149 (Includes a downloadable audio version.)
Viewable Through: 07/31/2024

Information

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

 

 
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Schedule

Faculty

FACULTY

David Clissold, Hyman, Phelps & McNamara, PC / Washington, DC
Faraz Siddiqui, Hyman, Phelps & McNamara, PC / Washington, DC


ABOUT THE SPEAKERS


David Clissold, Hyman, Phelps & McNamara, PC / Washington, DC

Dave Clissold advises health care professionals, universities, and medical schools on regulatory compliance issues. He provides pro bono counsel to patient groups and state health care agencies. Mr. Clissold lectures on various FDA topics, including regulation of tobacco products, regulatory obligations in clinical investigations, strategies for developing and marketing drugs and biologics, orphan drugs, and Hatch-Waxman issues. He has presented to the Food and Drug Law Institute, and has published papers in The New England Journal of Medicine, The Journal of Pharmacology and Experimental Therapeutics, Pharmacology, Biochemistry & Behavior, and the Food and Drug Law Journal.

Before joining the firm in 1996, Mr. Clissold conducted clinical and pre-clinical research at Nova Pharmaceutical Corporation and the Johns Hopkins University School of Medicine. His clinical background includes the study of central nervous system disorders, including Alzheimer’s disease, schizophrenia, and rare metabolic disorders. .

Faraz Siddiqui, Hyman, Phelps & McNamara, PC / Washington, DC

Faraz Siddiqui advises clients in the food and life sciences industries on a wide range of FDA-regulatory matters. He has helped drug and device manufacturers at various stages of product development, from advice on regulatory and expedited pathways and reviewing labeling and promotion materials, to advising clients on pharmacovigilance issues and safety reporting. He has drafted white papers to the agency and helped clients prepare for FDA meetings.

Mr. Siddiqui has led FDA-regulatory diligence on several large mergers and acquisitions on behalf of buyers. He has provided post-transaction support on registration and listing, state licensure, and transfer of proprietary information. Mr. Siddiqui also participated as a subject-matter expert in M&A litigations, including in a landmark case that saw the Delaware Chancery Court’s only termination of a merger agreement based on a “material adverse effect” theory.

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