What Exactly Is The FDA’s “Deeming Rule,” And How Is It Hurting Vaping?
The controversial “deeming rule” has the potential to decimate the independent vaping industry by giving a distinct advantage to big tobacco
In May of 2016, the Food and Drug Administration announced they would officially consider e-cigarettes as tobacco products. The ruling comes after years of speculation and concern from manufacturers and retailers alike. It subjects vaporizers to all of the stringent regulations of combustible cigarettes, which many claim is baseless. E-cigarette manufacturers now have to register their products, even those already on the market, to keep selling them legally. The FDA requires they file a Premarket Tobacco Application (PMTA) or a Modified Risk Tobacco Product (MRTP). These are mainly large documents meant to prove to a vaguely defined entity that they do in fact possess harm reduction value. Until then though, retailers would be allowed to keep stocking e-cigarettes and vaporizers.
Delay Of Enforcement
The deeming rule passed under the Obama Administration, so many were interested to see how the new FDA Commissioner would handle its implementation and enforcement. We had our first substantial news on this front in July, when FDA Commissioner Dr. Scott Gottlieb went on the record about e-cigarettes. He was speaking about how his administration would try to combat the still prevalent tobacco epidemic. After discussing how their primary goal is going to lower the level of nicotine in traditional cigarettes, he said that they would be reassessing their position on vaping as well. This was an unexpected statement from the head of the historically, very anti-vaping FDA. Executive Director of the Vapor Technology Association, Tony Abboud agrees, saying “There’s excitement now that it acknowledges the possibility of the public health benefit e-cigarettes could provide. It’s also coming up with a new process by which to evaluate how products come to market. That gives companies hope that regulations will ultimately be in place that will allow them to innovate because a lack of innovation right now is still a problem in the industry.” But the most significant announcement from Gottlieb for vapers was his decision to delay the implementation of the deeming rule.
The move delayed the deadline for applications from August 8th, 2018 to August 8th, 2022. Many criticise the FDA for not removing the ruling altogether, claiming that the fundamental idea of equating vaping with smoking is untenable. But if nothing else, the delay gives us more time to fight the legislation. It’s important to note that the suspension does not apply to new products, only ones already on the market before August 8th, 2016. It also doesn’t apply to other portions of the deeming rule, such as strict ID requirements for minors. But something that should be encouraging for vapers is that there is an open comment period where they will take into consideration suggestions before moving forward with a plan. Nicotine reduction in traditional cigarettes could also be excellent for the vaping business in general, says Bonnie Herzog, a senior analyst at Wells Fargo Securities, “the FDA’s new regulation will encourage consumers to shift more rapidly to RRPs/vapor.” But ultimately, the decision to regulate e-cigarettes with the same scrutiny we regulate combustible cigarettes is doing further damage to the credibility of vaping in the general public.
A recent study out of UK based, Action on Smoking and Health (ASH) found that only 13% of people surveyed correctly thought that vaping was “much less harmful than smoking.” This is a stance backed up by several studies, most notably a Public Health England study that found e-cigarettes were at least 95% safer than combustible cigarettes. The study by ASH also found over a quarter of the nearly 13,000 respondents said vaping is at least, if not more, dangerous than smoking. Figures like this make it clear that vaping faces an uphill battle when it comes to proving their smoking cessation utility. So it begs the question why would an agency “responsible for protecting the public health” submit legislation suppressing a product proven to be much safer, as well as a successful smoking cessation aid? In doing so, they are legitimizing the undeserved negative reputation of vaping in society. This type of forced ignorance is directly leading to thousands of deaths every year; Smokers who very well could have quit using vaping never gave it a chance, since they were only fed misinformation on the subject.
If that wasn’t bad enough, the uncertainty caused by the looming deeming rule has led many retailers, both large and small, to shy away from independent manufacturers. Instead, they’re going with the big tobacco smokeless alternatives, believing them to be much better able to handle the future regulations. Anna Bettencourt works as a specialist for VERC Enterprises, which operates 27 convenience stores in the northeast, “I stay away from some of the smaller folks because I worry about them not taking returns. I also have a fear they don’t have the money for PMTAs going forward.”
It’s incredibly unsettling and should be a red flag in many situations, to see the FDA and big tobacco on the same side of an issue. Big tobacco has built its entire industry out of deception and lies and now threatens to take over the very sector that finally started to displace it. In spite of this, and even in the face of mounting evidence, the FDA has shown next to no willingness to support vaping. But when they begin to do things that are actively benefiting big tobacco while hurting small business owners, something has got to be done. That’s why it is so important that we use the next six years to show a unified voice. We must prove to the FDA that vaping is not the same as smoking and treating it that way only benefits big tobacco and shortens lives.
What do you think about the deeming rule? Do you think that it will have a large negative impact on vaping if/when it takes effect? Do you think participating in the open discussion period will improve the final legislation? Let us know in the comments.