Skip to content

Tobacco Law Blog

MENU

HomeAbout the BlogContact
Troutman Pepper Hamilton Sanders LLP logo
Home » Lawsuits Being Filed Against the FDA Regarding Deeming Regulations

Lawsuits Being Filed Against the FDA Regarding Deeming Regulations

By Troutman Pepper Tobacco Practice on August 16, 2016
Posted in FDA, State Regulatory

In May through July several groups have filed lawsuits against the US Food and Drug Administration alleging that the deeming regulations that expand the regulation by FDA of additional tobacco products violate the law.

Currently there are eight lawsuits pending, of which 5 pertain to the vapor industry.  Two of these five have been consolidated because they address similar claims.

Nicopure Labs LLC was the first to file and its case will be consolidated with one filed by eleven vapor trade associations.  It asks the court to set aside the unlawful deeming regulations. The FDA estimates that pre-market review will cost $300,000 per product. In this event,  Nicopure Labs alleges that the company, which has 2400 stock keeping units, would have to pay $720,000,000, using FDA’s own estimate per product, to process PMTAs to get its products approved by FDA. However, Nicopure believes the actual cost will be closer to $2-3M per stock keeping unit.  Either way, the cost of complying with the deeming regulations, concludes Nicopure, effectively eliminates the company’s ability to comply.  

Three vape shops filed a law suit, seeking a jury trial, claiming the requirements of the deeming regulations on the vaping industry will effectively eliminate the entire industry.  Another lawsuit was filed by a West Virginia Legislator who claims he was able to quit smoking using vapor products, but that he will likely not be able to use them if they are eliminated by these regulations, and thus will have no choice but to return to use of tobacco products.  

These cases raise an array of legal issues for the vapor industry including that FDA has: (i) improperly regulated vapor products which do not contain tobacco; (ii) failed to consider the effect of deeming regulations on small businesses as required by law; (iii) not quantified costs on small businesses, nor considered any alternatives; (iv) overstated benefits, and understated costs of complying.

 

Print:
Email this postTweet this postLike this postShare this post on LinkedIn
Related Posts
FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount
September 29, 2023
FDA Touts "Significant Strides" in Addressing Reagan-Udall Report but Acknowledges More Work Remains
August 1, 2023
Virginia's New Hemp Regulations – How It Affects Businesses
July 14, 2023

Authors Show/Hide

  • Melissa Aikman
  • Zie Alere
  • Lindsay J. Austin
  • Christopher W. Baxter
  • Chris Carlson
  • Robert Claiborne
  • Molly DiRago
  • Paige Fitzgerald
  • Bryan Haynes
  • Michael Jordan
  • Stephen C. Piepgrass
  • Nick Ramos
  • Agustin Rodriguez
  • Christina Sava
  • Thomas C. Tilton

Stay Connected

RSS Twitter LinkedIn Facebook YouTube Instagram

Subscribe to this blog

Topics

Archives

Recent Updates

  • Members of Congress Propose Massive Tobacco Tax Increase
  • FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount
  • Oregon Court Upholds Local Tobacco Product Flavor Ban
  • Iowa Reaches MSA Settlement with Tobacco Manufacturers, Ending 18-Year Legal Dispute
  • Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan

Tobacco Law Blog

DisclaimerPrivacy Notice
Troutman Pepper Hamilton Sanders LLP logo
RSS Twitter LinkedIn Facebook YouTube Instagram

About Troutman Pepper

Troutman Pepper is a national law firm with more than 1,200 attorneys strategically located in 23 U.S. cities. The firm’s litigation, transactional, and regulatory practices advise a diverse client base, from startups to multinational enterprises. The firm provides sophisticated legal solutions to clients’ most pressing business challenges, with depth across industry sectors, including energy, financial services, health sciences, insurance, and private equity, among others. Learn more at troutman.com.

Copyright © 2023, Troutman Pepper Hamilton Sanders LLP. All Rights Reserved.
Law blog design & platform by LexBlog LexBlog Logo

In addition to cookies that are necessary for website operation, this website uses cookies and other tracking tools for various purposes, including to provide enhanced functionality and measure website performance. To learn more about our information practices, please visit our Privacy Notice.

AgreeDecline