On Friday the 28th of July, the U.S. Food and Drug Administration (FDA), announced a new comprehensive plan for tobacco and nicotine regulation, under which the much disputed PreMarket Tobacco Applications (PMTA), will be delayed for four years until 2022.
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The delay offers more time to carve a way forward
“This is undoubtedly positive news for the US industry – the only question is how positive”, said Barnaby Page, the editorial director of ECigIntelligence. Page added that many are expecting the FDA to simplify the PMTA process and that if this happens, the vaping industry “will have avoided the most feared potential effect of the deeming regulations.” However, he added, if this process is not made easier, the industry at least now has more time to adjust to be able to comply, and also find ways to affect the regulations further.
“We believe the agency’s approach to e-cigarettes is now much more sympathetic, and the PMTA process probably will become somewhat easier, but approval still isn’t going to be a routine matter – companies will still have to work to convince the FDA that their new products are acceptable from a public health point of view.” said Page.
He also pointed out that the FDA’s decision shouldn’t really impact the market in Europe much, however, he added, “Despite the FDA’s new attitude, compliance with the TPD still remains easier than compliance with the deeming regulations in many ways!”
What will this tobacco plan do for e-cig innovation?
As for product innovation, Page pointed out that since new products do not benefit from the PMTA delay, everything depends on the guideline details that the FDA will set in place. President and Founder of Not Blowng Smoke, Stefan Didak seems to be in agreement with Page.
“The “stay of execution” provided by the FDA also won’t do anything for continued innovation in the product category as all the other parts of the deeming regulations and all the compliance steps have not been moved by the same amount of time. The market freeze of August 2016 is still in effect so it would be unlawful to manufacture and market “new tobacco products”, he said.
Didak said that the FDA announcement was a welcome surprise, even though perhaps the PMTA delay itself, not so much. “The fact that it adds 4 years to the PMTA clock was since what we had been aiming for was something like 2 years, perhaps in intervals instead of all at once. Definitely good news but with good news there’s also a flip side and what this means is that local and State efforts by tobacco control and public health organizations will increase. Just like it did before the deeming regulations when they felt the FDA was not acting fast enough. So in short; 4-5 more years of increased local battles, which really are harder to deal with than anything federal”, he said.
US companies venturing into EU markets
On the topic of US based companies, venturing into EU markets, Didak thinks that most of those companies who were looking into getting Tobacco Products Directive (TPD) certified, were only doing it as “an escape route and a means of survival,” as they were fearing that they would not be able to afford the heavy licensing fees imposed by the FDA, and hence would have to cease operating in the US.
However he thinks that those who were only still considering this route, will probably not proceed just yet, “I do, however, believe that others who may have been considering it may delay those decisions until a later time and continue their focus on the US market. Though based on the TPD and the testing, certification, etc. I don’t think that changes much since most who were serious about that route already were engaged in it.”
Will de-nicotinizing cigarettes really curb addictions?
“The only way you might get smokers to actively switch in that case would be if there was a government and public health push towards these products. This is not, however, what most of government has been doing the past years as their actions have been quite the opposite. Without a strong support for the vapor products category from a public health perspective, lowering nicotine in cigarettes will not accomplish that.” he added.
A positive step forward
Both Stefan Didak, and Barnaby Page agree however, that on the whole, this is a positive first step in the right direction for vapers and the vaping industry in the US. This four year delay gives everyone time to reevaluate and influence the current regulations “into what hopefully will be more sensible, workable, and survivable.”