Legal Compliance for the Vape & E-Cigarette Industry

(163 Ratings)

Produced on: May 07, 2018

Course Format On Demand Audio

Taught by

Categories:

Course Description

Time 66 minutes
Difficulty Intermediate

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

Faculty

Deanna Clark-Esposito

Clark-Esposito Law Firm, P.C.

Deanna Clark-Esposito is the Managing Attorney of the New York City based Clark-Esposito Law Firm, P.C., and provides legal representation to domestic and foreign companies with matters involving US federal laws and agencies including, the US Food and Drug Administration (FDA) on vape and tobacco products, and the US Drug Enforcement Administration (DEA) on cannabis.  She also handles matters concerning the import, export, transportation, and fashion industries.

In 2017, she presented at the “Vapor Fair Meets Hookah Fair” trade show, providing an overview of current obligations, deadlines, and what is on the horizon for the vape industry in terms of FDA regulations and compliance.  She was also a panelist at the Women Grow NYC event entitled, “Know the Law: The Legal Side of a Cannabis Business.”  In 2018, Deanna was a panelist at Yale University’s first ever “Business of Legal Cannabis” conference.

Deanna writes legal editorial content for the vape industry’s “B2B Wholesaler” and the cannabis industry’s “CannaBiz Wholesaler” magazines.  Her book, “A Practical Guide to Fashion Law and Compliance,” was also published with Fairchild Books of Bloomsbury Publishing in March 2018.  More about her and the firm may be found at www.clarkespositolaw.com and on Twitter @tradetogrow.

Reviews

JH
John H.

Fantastic overview. Left me with all the materials I could need to follow-up on my own with any questions. Highly recommended.

MW
Megon W.

This is a really clear and concise summary of e-cig regs and litigation. I appreciate Deanna's efforts!

BB
Brandan B.

Great course materials!

BM
Brad M.

Great coverage on this cutting-edge topic!

AM
Antoine M.

Superb presentation with good support

TB
Thomas B.

INFORMATIVE

BK
Brittny K.

Very interesting and informative information in a relatively new area of law.

PS
Paul S.

Deanna's presentation was thorough and informative!

JS
J Thomas S.

Excellent. Informative.

LC
Lisa C.

Interesting

AL
Allison L.

Interesting

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