Regulatory Update: FDA Press Release

November 16, 2018

As expected, yesterday the FDA followed through and released a statement outlining their new policies regarding the sale of electronic cigarettes and e-liquids.  There were no real surprises for readers of this blog and the FDA pretty much did what was expected.  The true impact of this move remains to be seen although we are cautiously optimistic (see our last blog post for more on why we think these restrictions aren't as bad as they could have been).  More important, however, is whether we've heard the last from the FDA on the issue of flavored e-liquids (Gottlieb left the door open to impose even tighter measures in the future if the current restrictions do not effectively curb youth vaping).

FDA Commissioner Scott Gottlieb began his press release with a lengthy, impassioned speech.  Drawing on his work as a physician treating cancer patients, his experience as a cancer survivor himself and as a father of three young children, he makes the case that, whatever you think about this move by the FDA, Gottlieb truly seems to believe he is doing what is best to protect people, both young and old, from the devastation of smoking traditional combustible cigarettes. 

However, Gottlieb's primary justification for the new regulations is that electronic cigarette use is a "gateway" to combustible tobacco use--which therefore requires the restriction of e-cig and e-liquid sales to protect the public.  We've touched on the flaws in this argument in previous posts and we may have to devote an entire post to debunking this in the future but, ultimately, it doesn't matter what we think.  It matters what Commissioner Gottlieb thinks, and he thinks that electronic cigarette use leads to smoking cigarettes.

Highlights of the press release include:

• As expected, flavored e-liquids will no longer be available in convenience stores or at other retailers that allow access to shoppers under the age of 18.
• Mint and menthol flavors are exempt from this ban, however, Gottlieb warns that if kid's use of mint and menthol flavors doesn't decline, he may revisit this.
• The FDA will allow continued online sales but will require heightened age verification measures for purchase of e-liquids and electronic cigarettes.  Details and best practices will be published soon.
• Gottlieb hints at possibly easing the onerous and daunting premarket tobacco product applications e-liquid manufacturers are facing soon, saying, "In the coming months, CTP plans to issue additional policies and procedures to further make sure that the process for reviewing these applications is efficient, science-based and transparent."  Obviously, we'll have to wait and see what that means, if anything.
• Most ominously, Gottlieb states, "If youth trends don't move in the right direction, we will revisit all of these issues." In other words, if this doesn't work, measures could get much more draconian very quickly.

Read the full text of the FDA's Press Release.

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