Reactions to Recent FDA Tobacco Announcement
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This is reblog from Vaping Post: http://bit.ly/2uyuaxK
Last week the FDA announced a major shakeup to the agency’s policy on e-cigarettes which includes the de-nicotinization of cigarettes, and a PMTA deadline delay. But what do the experts who follow these events closely truly think? Vaping post got in touch with some renowned harm reduction/vaping advocates in order to find out
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.
However although a start, this motion is far from perfect. The extension only applies to existing products, as any new ones will still need a PMTA before they can go on sale. Additionally, there is also no change to the controversial grandfather date of February 2007, which is considered as one of the harshest aspects of the infamous deeming rule. Vapingpost approached a number of experts in the field to get their opinion on the FDA’s move.
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.
He thinks that those companies who have already invested money to be TPD compliant will probably carry on with the process. “A lot of effort and money has already gone into that so pulling back from that is not likely to happen. And, as a business, why after already making the investments bail from that?”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.”
In regards to the FDA’s bold statements about the de-nicotinization of cigarettes, Didak is sceptical. “The idea of “low nicotine” or “reduced nicotine” cigarettes is not something I see work out in practical terms. This is something that had already been attempted before without much success.” He added that for those who smoke to get the nicotine hit, reducing nicotine will only make them smoke more, and the demand for regular cigarettes could create a black market.
“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.”