Source: https://mylawcle.com/products/self-study-video-broadcast/a-beginners-guide-to-vape-e-cigarette-law/
Timestamp: 2020-02-17 07:24:34
Document Index: 430729076

Matched Legal Cases: ['§387', 'art 25', '§387', '§387', '§387', '§387', '§387', '§387', '§387', '§387', '§387', '§333', '§387', '§387']

A Beginner's Guide to Vape & E-Cigarette Law | myLawCLE
The use of electronic nicotine delivery systems or, “ENDS,” has seen tremendous growth in the last six years as vaping and the use of e-cigarettes has become more pervasive worldwide. 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.
• What legal framework under the Tobacco Control Act currently governs the vape industry
• What types of merchandise are considered an “ENDS” product, and therefore subject to compliance with FDA’s tobacco products laws
• FDA’s existing legal requirements for manufacturers, retailers, and importers
• FDA’s Market Authorization Process (including, the Pre-Market Tobacco Authorization (“PMTA”))
• Best Practices for FDA Compliance
• Other issues impacting the industry, such as the imposition of China tariffs on imported merchandise
• Distinguish requirements for sellers of ENDS commercially available pre-Aug. 8, 2016 vs. after
• Gain best practices for creating a Youth Prevention Program for your business
• Develop a framework to design your own Vape Shop Retailer Training Program on FDA law
Deanna Clark-Esposito, Esq. 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 2018, she presented on “Vape & CBD Legalities: A Primer for Retailers, Manufacturers and Importers” at Champs Trade Shows in Las Vegas and taught a course entitled “Legal Compliance for the Vape & E- Cigarette Industry” for Lawline.com. Deanna was also invited to speak as a panelist at Yale University’s first ever “Business of Legal Cannabis” conference. 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.”
Deanna writes legal editorial content for the vape industry’s “B2B Wholesaler” and the cannabis industry’s “CannaBiz Wholesaler” magazines. More about her and the firm may be found at www.clarkespositolaw.com and on Twitter @tradetogrow.
a) What is a “tobacco product” subject to FDA regulation?
b) How FDA came to have oversight of tobacco and vape products
c) Which ENDS industry entities are subject to FDA compliance?
Section II. Overview of FDA’s Tobacco Product Statutes and Regulations
a) Family Smoking Prevention & Tobacco Act (aka “Tobacco Control Act”) (21 USC §387)
b) Tobacco Products Regulations (21 CFR Subchapter K)
c) Environmental Impact Considerations (21 CFR Part 25)
Section III. Current Requirements
a) Establishment Registration and Product Listing (21 USC §387e)
b) Submission of Tobacco Health Documents (21 USC §387d)
c) Submission of Ingredient Listing (21 USC §387d)
d) Packaging, Labeling and Advertising Issues (21 USC §387c)
e) Record’s Maintenance (21 USC §387i)
f) Good Manufacturing Practices (21 USC §387e)
g) Listing of Harmful & Potentially Harmful Constituents (21 USC §387d)
Section IV. Violations & Penalties
a) Non-Compliance with the Above Requirements
b) Misbranded Tobacco Products (21 USC §387c)
c) Adulterated Tobacco Products (21 USC §387b)
d) Penalties (21 USC §333(f)(9)
Section V. Market Authorization Process
a) Requirement for Pre-Market Review (21 USC §387j(a)(2))
b) Pre-Market Tobacco Application (21 USC §387j)
c) Other Pathways to s Marketing Order
Section VI. Pending Litigation and Administrative Activities
a) FDA’s “Deeming Rule,” 81 FR 28974 (May 10, 2016)
b) Nicopure Labs, LLC. v. Food and Drug Administration, case no. 17-5196 (D.C. Circuit)
c) Various FDA “Guidances” including:
d) Applications for Premarket Review of New Tobacco Products, September 2011
e) Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, May 2016
f) FDA Deems Certain Tobacco Product Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements, Small Entity Compliance Guide, May 2016
g) Harmful and Potentially Harmful Constituents” in Tobacco Product as Used in Section 904(e) of the Federal Food, Drug, and Cosmetic Act (Revised), August 2016
h) Health Document Submission Requirements for Tobacco Products (Revised), October 2017
i) Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments (Revised), December 2017
j) Listing of Ingredients in Tobacco Products (Revised), April 2018
k) Tobacco Retailer Training Programs (Revised), August 2018
l) Prohibition of Distributing Free Samples of Tobacco Products, October 2017
m) Civil Money Penalties and No-Tobacco-Sale Orders for Tobacco Retailers (Revised), Dec. 2016
Section VII. Best Practices for FDA Compliance
a) Creating a Youth Prevention Program
b) Drafting tips for an FDA Vape Shop Compliance manual for manufacturers
c) Designing a Vape Shop Retailer Training Program on FDA Law