New FDA deeming rule proposed: Clinical trials for e-cigarettes

New FDA deeming rule proposed: Clinical trials for e-cigarettes

The American vaping industry has been feeling under attack since the FDA deeming regulations were first announced last May, but a new rule threatens to make matters even worse.  According to The Hill, the FDA now wants to reclassify e-cigs and vaping technology as a drug or drug delivery device.  If the rule is adopted, then manufacturers may be forced to undergo a very expensive and time-consuming clinical trial process before releasing their products to market.

The Pre-Market Tobacco Application (PMTA) was bad enough.  Now, the FDA wants to take their authority ten steps further.  By reclassifying e-cigs and vaping technology as drug delivery systems rather than tobacco products, retailers would be slapped with a lot more than just clinical trials.

  • Smoking would be labeled as a disease, much like alcoholism.
  • Clinical trials could cost in the multi-millions for each device and could take several years to gain approval.
  • By comparison, the PMTA is estimated to cost anywhere from $300,000 to $1 million per product with an approval time of approximately 6-months to a year.
  • Innovation would stall even more than it already has post-FDA deeming regulations.
  • Manufacturers, retailers, and even local vape shops will no longer be allowed to inform their customers of the primary purpose of e-cigs – namely, to quit smoking - unless their devices have undergone the clinical trial process.
  • Retailers would also not be allowed to include customer testimonials in their online, hardcopy, television, or radio advertisements.
  • Sharing of customer testimonials boasting that “Vaping helped me quit smoking after 20-years” would essentially become illegal because doing so would be legally interpreted by the FDA as a smoking cessation claim.
  • Those retailers who want to continue marketing their products as a smoking cessation tool will be forced to follow the rules of conventional drug inhalers, meaning that customers will likely only be able to purchase these devices through a medical prescription.

The FDA rule would be a disaster for public health

The FDA submitted the additional rule to the White House Office of Management and Budget (OMB) last week.  If the rule is adopted by the OMB, then purchasing vaping technology and e-cigs would become nearly impossible for the average consumer. Unless they have a doctor’s prescription, they would essentially be out of luck.

Thousands of vape shops would go out of business, or at least have to modify their marketing techniques to something like, “Hey!  Buy our funky new gizmo!  Sorry that we can’t tell you what it’s used for.  The FDA won’t let us!” And the Black Market Vaping Industry would gain in strength and number. Meanwhile, millions of former smokers would be driven back into the open arms of Big Tobacco.


The opinions expressed in this article are those of the author's and do not necessarily represent the viewpoints, policy or company position of, the rest of our staff, and/or any/all contributors to this site.

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Matt Rowland - October 20, 2016

This is the story that kicked off the whole debate. For further info, try researching the medical journals. :)

Arthur Donaldson - October 19, 2016

This is terrible, because after trying every “approved” stop smoking aide I quit smoking in less than a year by using vaping and controlled reduction of nicotine. I can tell you vaping worked for me, now I’m smoke free for about 10 years.

Jeremy Berman - October 19, 2016

Looking for any source on this, nothing to be found on the Hill?

Matt Rowland - October 14, 2016

Hi, Kevin. Thanks for reading.

Just sent you a private email. :)

Kevin M Price - October 14, 2016

Matt, please provide the source for this information as I was unable to find it using a search

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