FDA Vaping Regulation Postponed – Is The Tide Shifting?
In case you missed it, there was a big announcement by FDA Commissioner Scott Gottlieb last week. To the complete surprise of almost everyone in the vaping industry, he singlehandedly rolled back the implementation of new FDA vaping regulations by another five years. Previous FDA policies would have imposed a lengthy and expensive approval process for vaping products starting in November 2018, but required Pre-Market Tobacco Applications (PMTAs) will now be postponed until 2022. In addition, there are talks about the process being simplified; and even more notable, the FDA's refocused attention on traditional cigarettes.
FDA Commissioner Scott Gottlieb said in a recent FDA press release:
Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.
This dramatic change in tone is certainly positive, and according to many, Scott Gottlieb may have just saved the American vaping industry. I think its a little too early to make that bold of a statement, but the vaping community has certainly been handed a huge victory in this ongoing battle.
The Fight to Regulate E-Cigs
Prior to May of 2016, free market capitalism was was alive and well in the world of electronic cigarettes. Entrepreneurs were opening retail stores, designing new products, crafting their own e-juice flavors and the vaping industry was booming. But in May of 2016, the authority of the FDA was broadened to include regulating electronic cigarettes and e-liquids. Enforcement was to begin in 2018 with the intention of safeguarding public health and preventing manufacturers from making unsubstantiated health claims about their products.
The rules would have imposed an extensive, expensive and lengthy approval process before a product could be brought to market, which would have certainly decimated the vaping industry. In particular, e-liquid manufacturers, many of which are small independent startups and not part of the tobacco lobby, would be forced to close their doors with application costs running into the millions.
The irony is that in an effort to safeguard public health, the FDA was discouraging a proven, less risky alternative than tobacco. We know more about the potential health benefits of switching from smoking to vaping than we do with many nutritional supplements. Multiple studies have proven that e-cigarettes are not only an effective tool to quit smoking, but a considerably less harmful alternative.
So the question is, is the FDA's change of heart a return to common sense e-cig regulations or a step back to reassess and regroup?
A New Focus on Big Tobacco
In addition to temporarily softening its stance on vaping, the FDA appears to refocused on the real enemy – traditional cigarettes, which have been proven (beyond a shadow of a doubt) to be detrimental to the health of smokers; as well as innocent bystanders. Part of the new strategy is to force cigarette manufacturers to lower nicotine levels to non-addictive levels, thereby reducing the number of traditional cigarette smokers. Objectives outlined by the FDA:
The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.
Because almost 90 percent of adult smokers started smoking before the age of 18 and nearly 2,500 youth smoke their first cigarette every day in the U.S., lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted smokers to quit.
Are We In The Clear?
There's no doubt that postponing the current FDA vaping regulations is a huge win for the vaping industry. And we applaud the FDA's goal to lower nicotine levels in tobacco products, which is likely to help curb their usage. But it's way too early to claim victory. The FDA still retains federal control over electronic cigarettes and vaping products, so prepare yourself for many battles to come.
For now, we can all breathe a sigh of relief knowing that the existing products we've all come to know and love will remain available for several more years. The extension allows the vaping industry a sufficient amount of time to better align itself with FDA target standards and keeps the juice flowing for millions of happy vapers. Enjoy… pop the champagne! But be ready to continue fighting…