Planning For The FDA's 'Deeming Rule' For E-Cigarettes

Law360, New York (September 21, 2015, 3:39 PM EDT) -- The 2009 Family Smoking Prevention and Tobacco Control Act (TCA)[1] gave the U.S. Food and Drug Administration the authority to oversee the manufacture, distribution and marketing of certain tobacco products, such as cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco and any other tobacco products that the FDA, by regulation, deems to be subject to the law. Pursuant to this authority, the FDA issued a proposed rule in April 2014 (the "Deeming Rule") that would deem electronic cigarettes containing nicotine to meet the statutory definition of a "tobacco product," thereby extending the FDA's regulatory authority to these products.[2] Among other things, the Deeming Rule would require e-cigarette companies to register with the FDA, report product and ingredient listings and obtain FDA premarket approval of new tobacco products. The FDA closed the public comment period for the Deeming Rule on Aug. 8, 2014, after receiving over 135,000 comments from members of industry, individuals, government entities and the public health community.[3] Given that there is no statutory deadline for the FDA to issue a final rule, it is difficult to predict when the Deeming Rule will be finalized; however, members of Congress have been urging the FDA to expedite its review and finalization.[4] If the Deeming Rule is finalized in its current form, e-cigarette companies will have a period of 24 months from the date the Deeming Rule is finalized to achieve compliance. However, given the potentially onerous and costly nature of manufacturing and testing requirements, firms should start planning for compliance now to minimize the risk of the requirements causing delay or interference with business operations....

Law360 is on it, so you are, too.

A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.


A Law360 subscription includes features such as

  • Daily newsletters
  • Expert analysis
  • Mobile app
  • Advanced search
  • Judge information
  • Real-time alerts
  • 450K+ searchable archived articles

And more!

Experience Law360 today with a free 7-day trial.

Start Free Trial

Already a subscriber? Click here to login

Related Sections

Law Firms

Government Agencies

Hello! I'm Law360's automated support bot.

How can I help you today?

For example, you can type:
  • I forgot my password
  • I took a free trial but didn't get a verification email
  • How do I sign up for a newsletter?
Ask a question!