Dr. Scott Gottlieb (the FDA Commissioner) announced something very dramatic on Friday morning; he postponed future deadlines in 2018-2022 and promised a complete overhaul of tobacco smoke and nicotine by the agency. This move will enable to sell vapor products in the market for at least four more years and leave vaping industry in a certain flexibility to work on a new legal strategy and perhaps participate in new FDA plans. This announcement will boost the vapor industries as well as shops to develop confidence in the growth of vapor products because they have been hit hard by the actions of the FDA in the past.
— CASAA (@CASAAmedia) July 28, 2017
Dr. Scott Gottlieb talked a lot about the idea to reduced nicotine in cigarettes, which had long been a popular idea under a certain tobacco control. The combination of the possibility of low nicotine cigarettes with the availability of high nicotine vapor can be a smart way to get pure fanatics tobacco control and hard to buy a strategy to stop electronic cigarettes and tobacco harm reduction in the regulatory mix. Or it can also be wise, and open up a chaotic debate that leads to nothing.
These are some of the most important concerns of the vapers and how they were treated:
The emphasis on the flavors will make many nerves – and probably right. But the press release of the FDA explicitly mentions that the comments are in the possibility not only of trying to seduce the children to taste the products, but also in the potential ability of flavors to “allow smokers to return to less potential sources and harmful nicotine release. According to the press release of the FDA, “To be further explored about how to protect public health in the tobacco, the agency will also seek public information on a variety of important issues, including approaches to the flavors scheme that children appeal to electronic cigarettes”
The fact is that there is no way to relax the regulation of vapor-free products and also to answer the questions about control of tobacco. If they were excluded from the discussion on all fronts, the process would have been the worst of the political bureaucracy, to repeat each successive administration and the playoff regulations.
All the passed deadlines wouldn’t be affected however, the age requirements are still the same. Some prospect deadlines will not be affected as well, such as
- The list of ingredients
- Deposits of health documentation
- Hazardous and potentially hazardous constituents’ reports
- The elimination of the changed risk claims
The main change is the deadline of 8 November 2018 which demands to submit “Premarket tobacco application (PMTA)” for the products already on the market. This date will be now August 8th, 2022.
According to the press release “In addition to some major policy considerations, the FDA is planning to publish principles to make the product review process more efficient, predictable and transparent to manufacturers while the public health mission of the agency is maintained”.
“Among other things, the FDA’s regulations on the issue will describe the Agency’s information and reports to demonstrate substantial equivalence. FDA is also planning to finalize the leadership to investigate the PMTA ends. The agency also promised to soon sort out the “known risks in vapor products, i.e. Batteries etc”.
Is This The Answer We Had Expected?
The proponents for industry and consumers have been working very hard since the debt rules were announced last year. This is a war fought on several fronts – in congress and state legislations, in the courts and in the media. This message and details come to save many people. But in fact it is only the beginning of a new battle. Vapers and their allies must make great progress in public acceptance. And it must be how we are shaping the fight to continue this new FDA policy.
The plan of Gottlieb was trying to send all things to all people and to accept a variety of competing interests. This strategy often fails because the plan cannot be the perfect answer for all. Cigarette makers will face the serious look at the reduced nicotine cigarettes and vaping industry is facing the same concerns as well. Are all comments on the tempting flavors of children means a ban on products that work best? If the availability of taste is reduced, it greatly helps the tobacco company with a limited scale but a huge sales network.
In fact, almost a shift in the FDA ensures that the challenges at both national and local level are intensified. There is nothing in the FDA plans to avoid the tax status of e-liquid or city restricting access to the flavors. The groups expect the anti-nicotine tobacco and pressure to change the national and local level, in their struggle to hold their influence and power.
The Vapor industry and vapers are dependent on it and they should get together at this time. Now is the time to collect our forces, collect money, carefully plan and try to build a strategy (mostly) united.
So celebrate today. Have a party. Pop the champagne and get ready to fight with new strength.