Legal Compliance for the Vape & E-Cigarette Industry

The use of electronic nicotine delivery systems or, "ENDS," has seen tremendous growth in the last five years as vaping and the use of e-cigarettes has become more pervasive nationwide. With the advent of FDA's 2016 "Deeming Rule" which swept ENDS into the jurisdictional fold of the Family Smoking Prevention & Tobacco Act (aka "Tobacco Control Act"), which is an amendment to the Federal Food, Drug, and Cosmetic Act, companies selling such products have been scrambling to comply with the ever-evolving regulatory guidelines, including that of obtaining a "Marketing Order" from the FDA in order to lawfully market and sell such merchandise in the US. Aside from federal requirements, both state and local ordinances are playing a big role in the limited or restricted sale and use of vape devices and its components, such as via flavor bans on e-liquids.

This program, presented by Deanna Clark-Esposito of Clark-Esposito Law Firm, P.C., will help attorneys understand the various vaping laws in existence, and what regulatory framework has yet to be promulgated, in order to comply with relevant governing statutes.     

Learning Objectives:

1. Recognize under what legal framework the Tobacco Control Act currently exists, and key regulatory deficits that remain to be promulgated
2. Distinguish what types of merchandise are considered an "ENDS" product, and therefore subject to compliance with FDA's tobacco products laws
3. Examine the FDA's existing legal requirements for manufacturers, retailers, importers and distributors
4. Review the FDA's Market Authorization Process (including, the Pre-Market Tobacco Authorization ("PMTA"))
5. Consider other federal, state, and local laws impacting the industry