What’s going on with the FDA?
Well, in the vaping industry it’s both good and bad. We’ll give you the general aspects of what was said, and what is going on so that you can be better informed and hopefully spark that fire to join an advocacy group to help in the fight for your vaping rights!
First off, we’ll start with the good! The FDA Commissioner Dr. Scott Gottlieb postponed the future PMTA (premarket tobacco application) submission deadline in the deeming rule from 2018 to 2022 and promised a complete rethinking of tobacco, smoking, and nicotine by the agency. PMTA’s are basically an application to the FDA for each specific flavor, nicotine strength, PV/VG ratio, and size. For example, for us, just one flavor from our MTO line would need at least 21 different applications to file with the FDA. So over time, this process can become quite expensive, since you have to pay for each PMTA. Many vape shops are over-joyed by the postponement of the PMTA deadline. This lets them have some time to work on expanding and reinvest in the growth of their stores. This also allows many shops to still sell what they currently have in the market longer, for at least 4 more years. This was pretty awesome news for all in the vaping community! But, we still aren’t out of the weeds yet. CASAA (Consumers Advocated for a Smoke-Free Alternative Association) had this to say after hearing the news of the FDA’s plans: “Although this is certainly positive news from FDA, a sincere word of caution: Those who would prefer nicotine and tobacco to be regulated out of existence will be digging in. Now more than ever, attention must be paid to policy fights in local and state governments. The delay proposed by the FDA means we have more time to work on sensible regulation, but it will also embolden ideologues to fight harder against us.”
Here are some comments from Dr. Gottlieb’s statement: “As we move forward, I also hope that we can all see the potential benefits to addicted cigarette smokers, in a properly regulated marketplace, for products capable of delivering nicotine without having to set tobacco on fire.” He also stated, ” The potential to improve product performance here is a significant public health opportunity.” His statements definitely focused on helping those addicted to cigarettes, to find new methods to quit and stay that way. “Reframing shared objectives around the need to rethink nicotine is a start. It can help us all achieve one public health goal I know we all share, and that’s to save lives of current and future cigarette smokers.” Dr. Gottlieb also finished saying “A renewed focus on nicotine can help us achieve a world where cigarettes no longer addict future generations of our kids, and where adults who still want or need nicotine, can get it from alternative or less harmful sources.” His full statement can be viewed here.
There are still concerns about some of the other statements made by Dr. Scott Gottlieb in his speech. First off, flavors. One of their main concerns is the use of e-cigarettes among children; being that these ‘kid-friendly’ flavors entice children to use e-cigarettes to start vaping. This could mean that they may try to target flavors, other than tobacco, and try to eliminate these flavors across the board. We have already seen some states target flavors, and one city – San Fransisco, has even banned flavors including menthol entirely. With the statement made by the FDA, this makes it almost certain that the state and local governments will still fight to ban flavors and pass their own tax laws. There is nothing in the FDA plans that will prevent a state from taxing e-liquid or a city from restricting access to flavors. The focus on flavors will make many nervous — and probably rightly so. But the FDA press release specifically mentions that comments will be sought not just on the possibility that flavors entice children to try products, but also on the possible ability of flavors to help “some smokers switch to potentially less harmful forms of nicotine delivery.” There’s no way of knowing for sure how this will affect flavors as of now, but this statement at least gives us a little hope.
The Vapor Technology Association (VTA) has published a statement saying: “VTA is prepared to work closely with FDA and other stakeholders to ensure that we develop a set of regulations that protect consumers, promote public health and protect the small and mid-sized businesses that are the backbone of the vapor industry.” Other advocacy groups are also helping out as well, as this fight gets more intense. But one thing is for sure, our industry will not go down without a fight! Dr. Gottlieb also stated “To succeed participants from all sectors in the on-going harm reduction debate, need to take a step back and work together to reach greater common ground. And that common ground is worth perusing around the ultimate harm reduction policy, where cigarettes will no longer be addictive.” He also said: “We truly find ourselves at a crossroads when it comes to reducing tobacco use. We have the potential to improve the lives of tens of millions currently addicted to cigarettes and future generations of kids. But if we are going to meaningfully improve the public health, we need to be willing to take a hard look at our entire approach to tobacco to make sure that we have the right regulatory gates in place to evaluate products, and to focus more squarely on the nicotine.” As stated early, the VTA has plans to work closely with the FDA to help steer them in the proper and scientific way to get the real answers about the vaping benefits and risks.
It’s refreshing to see the FDA take a harder look into combustible cigarettes. The FDA press release stated “Tobacco use remains the leading cause of preventable disease and death in the United States, causing more than 480,000 deaths every single year. In addition to the devastating human toll caused mainly by cigarette smoking, tobacco also causes substantial financial costs to society, with direct health care and lost productivity costs totaling nearly $300 billion a year.” “The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes – the only legal consumer product that, when used as intended, will kill half of all long-term users,” said FDA Commissioner Scott Gottlieb, M.D. “Unless we change course, 5.6 million young people alive today will die prematurely later in life from tobacco use. 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 – and we believe it’s vital that we pursue this common ground.”
Overall, this direction from the FDA is at least a step in the right direction. Granted, the fight may not be over, but it’s a new day. The postponement allows many small to mid-size businesses to reinvest in growth and gives advocacy groups the chance to work with legislation and the FDA. This also means that you can be a part of this historic moment in history too! Join an advocacy group, donate money if you can, write or call your congressmen and woman, share educational information about vaping (being sure it’s from a credible source) and as always support your local vape shops! We know we hit the advocacy topic a lot, but honestly, it’s that important! We can’t do it without you and the support from local shops and owners. We got four more years to fight, four more years to make this all count! We need you and your support to make this happen! So please, do what you can to support any advocacy group that you choose. Otherwise, you could possibly lose your favorite flavors and even see more doors of your favorite vape shops close!
If you have any comments or questions, comment below or email us directly. We’ll be more than happy to get you the information you are looking for.
