On July 28th, FDA Commissioner Scott Gottlieb announced the postponement of the PMTA submission deadline in the deeming rule from 2018 to 2022 and promised a rethinking of tobacco, smoking, and nicotine by FDA.
This is good news
This will give vapor market some breathing space to stabilize and expand, allowing all interested parties four more years to prepare and commence the fight, the final result of which would decide their business as well as the eternal fate of the whole vaping industry.
But hold on a moment…
It is easy to rejoice at such glad tidings and form unverified judgment without considering the announcement of postponement in its greater context. It is also easy to read Gottlieb’s words not in its own spirit, but according to one’s wishes.
Gottlieb’s speech clearly involves a lot more than the postponement of the PMTA submission deadline, which is but a small fraction of the changes to come. It is, in my opinion, prudent to read through the whole text of Gottlieb’s speech before conceiving of any unmerited delight.
After reading the whole content of the speech twice, I find it is clear that there are many points touching the regulation and prospect of E-cigarettes, directly or indirectly. I therefore extracted those points which many vapers are concerned about from the lengthy and vague speech as in the following parts. Let’s read the announcements in Gottlieb’s own words.
Gottlieb saw first-hand the deadly impact of tobacco and rightfully abhors combustible cigarettes, being addicted to which, hundreds of thousands of Americans died of preventable tobacco-related deaths. The central theme of his speech is to “regulate nicotine in combustible cigarettes and render them minimally or non-addictive. ”
The key is nicotine
Even though he declared that nicotine is “ultimately, the solution to the question of addiction, and the harm caused by combustible forms of tobacco” , it is obvious that he hated and blamed the other chemical compounds for directly and primarily causing the illness and death, not nicotine.
Favor instead of antagonism
Rather, he realized that other means of delivering nicotine is the key, as he declares ” we must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. ” Again he said, we need to envision a world…. where less harmful alternative forms, efficiently delivering satisfying levels of nicotine, are available for those adults who need or want them.” It is very clear from these statements that Gottlieb quite understood the importance of these alternative forms, in which E-cigarettes clearly is included and counted as foremost, and showed considerable favor rather than antagonism towards them.
Not only did Gottlieb see the important role these alternative forms of nicotine delivery play, he also encouraged “fostering innovation where innovation could truly make a public health difference”
Mention of E-cigarettes
Then he mentioned E-cigarette quite a few times, asserting that “to reduce nicotine levels in cigarettes so that they are minimally or non-addictive, while not altering the nicotine content of noncombustible products such as e-cigarettes, is a cornerstone of our new and more comprehensive approach to effective tobacco regulation.” This statement sounds quite favorable, but its meaning is incredibly obscure. What does he mean by saying “not altering the nicotine content of noncombustible products such as e-cigarettes”? He did not say that restrictions on the manufacture and sales of vaping products will be lifted. It is extremely difficult to decide to what end this statement might apply its meaning.
Debate over the benefits and risks of E-cigarettes
Gottlieb very prudently commented on the predicament E-cigarettes is falling in, ” On the one hand, there’s the ongoing divisive debate around the pros and cons of e-cigarettes. Precious little progress has been made as competing camps dig in on the benefits and risks of a harm reductionist approach to this new technology. Both sides are convinced that they’re right, but we’ve seen little progress, and virtually no common ground. On the other hand, there’s a pathway forward that reframes the debate around nicotine.”
This, very smartly for him, did not say anything decisive on the agency’s attitude towards E-cigarette, neither did he make any commitment regarding the regulation of E-cigarettes beyond the announced postponement. We can therefore expect more debate concerning the benefits and risks of E-cigarettes, and there is no telling which side will eventually prevail. What we can be sure of, however, is that our opponents, those vape control zealots, will no doubt take advantage of this unsettled debate and create as much slander and confusion as possible. Both sides are working most vigorously, and we know not the outcome.
Gottlieb, after his favorable evaluation of the importance of E-cigarettes, however, expressed his concern. ” I have real concerns about kids’ use of e-cigarettes, and I know many others share those concerns, especially those products marketed with obviously kid-appealing flavors.” And in consequence to this concern, he declared that ” FDA started enforcing provisions that, for the first time under federal law, made it illegal to sell all those products to kids. ”
This, at the end of the day, will prove to be a hard blow to vapers, retailers and manufacturers alike, with E-juice flavor being a central factor in vaping. We can most certainly expect more negative comments and boycott from the side of opponents under the banner of child protection. Since there is no evidence to prove that flavor and child vaping are not correlated, or that vaping does not harm children, we will have to counter attacks and reprisals which, through the restriction of the presentation and sales of flavor, further, and unjustly, curtail other aspects and areas of the vaping industry.
Now we’ve come to the parts that concern our interests the most. Gottlieb stated that FDA needs “a robust and sustainable framework for regulating the non-combustible forms of nicotine delivery. ” and “That means extending further some of the current compliance deadlines for newly deemed products, primarily electronic cigarettes and cigars, that were previously extended.” but “All of the requirements for newly deemed products that have already gone into effect will continue to stay in force.”
This sounds favorable so far, confirming the optimism for some breathing space many vapers bear. We also read some leniency and protection for the survival of existing products when he said “In addition, we’ll also be revising the so-called “sunset policy” through additional guidance so that existing products under review remain on the market.”
In the end, there is just the right amount of caution and obscurity a politician needs. “We need to make sure we strike the right balance between FDA fulfilling its vital consumer protection role while also fostering innovation when it comes to potentially less harmful forms of nicotine delivery.”
There is the extension, and great news it surely is, but what comes then is unclear. Therefore we cannot treat this four-year-postponement as anything other than a respite from further restrictions. The fight is still on, and will only be more vicious. What we need to do is diving even deeper to struggle for the survival and eventually, thrival, of vaping.
But right now, let’s celebrate this unexpected victory!