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Last Friday the US 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 until 2022. Additionally, this anti-smoking strategy also includes a plan to de-nicotinize combustible cigarettes that is expected to go into effect in 2021.

“And we must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. “Dr. Scott Gottlieb, FDA Commisioner

“And we must recognize the potential for innovation to lead to less harmful products, which, under FDA’s oversight, could be part of a solution. While there’s still much research to be done on these products and the risks that they may pose, they may also present benefits that we must consider. FDA’s investment in regulatory science will eventually answer many of those benefit and risk questions.” said the newly appointed FDA Commissioner Scott Gottlieb in a press release.

This effort to reduce nicotine levels, is considered by many as a monumental effort to reduce smoking, on par with the 1965 initiative to introduce health warnings on cigarette packs, and is expected to have a tremendous effect on the US$130 billion tobacco industry.

We are encouraged by Commissioner Gottlieb’s announcement today regarding the extension of PMTA submission deadlines through 2022. This is a wise decision and a much-needed delay. However, the deeming rule as a whole still does not change and it still does not take into consideration the harm reduction potential of e-cigarettes. The grandfather date stays the same, and we still cannot launch new products or improve on existing ones to keep up with advances in technology. So, while grateful, much more needs to be done and the entire regulatory framework needs to be reevaluated and changed. We feel strongly this extension only allows for a window of opportunity to ensure a sustainable future for our industry in the form of appropriate regulation and even a change in legislation. Nicopure Labs will stay at the forefront on the fight and engagement to ensure that our consumers, and smokers in general, have acceptable alternatives to combustible cigarettes that will improve their quality of life and give them a chance to move away from smoking.” read a statement released by Nicopure Labs, who has been famously engaged in a legal battle with the FDA over the harsh deeming rule.

A blow for the tobacco industry

Following the FDA’s announcement Altria shares dropped by 19%, British American Tobacco’s (BAT), stocks fell by as much as 14%, and shares for Imperial Brands Plc dropped by 9.5%.
Non-surprisingly, right after the FDA’s announcement, tobacco stocks took a nosedive and many are expecting this motion to set off a lobbying fight at the US capitol. “This was a big surprise and will make it imperative that domestic tobacco companies strive to develop innovative, safer products,” said Jack Russo, an analyst with Edward Jones & Co..

Infact following the FDA’s announcement Altria shares dropped by 19%, in what is considered the biggest drop since 1999, British American Tobacco’s (BAT), stocks fell by as much as 14%, and shares for Imperial Brands Plc dropped by 9.5%. “Until the eventual development of specific proposals, it’s too early to understand the practical implications,” said Simon Evans, a spokesperson for Imperial Brands Plc.

All eyes on Nicotine

In his press release Gottlieb spoke of Nicotine as both causing the problem through addiction, and also being part of the solution, since it is not the most harmful component in cigarettes. “Nicotine is by no means a completely safe and benign compound. But a family and population-focused approach to reducing tobacco-caused disease and death must start from the premise that, as far as nicotine is concerned, the problem isn’t just the nicotine. The bigger problem is the delivery mechanism — how the nicotine gets delivered. Attach it to smoke particles created by burning cigarettes and the mechanism is deadly.” said Gottlieb.

“But attach the very same nicotine to a medicinal product without the other chemicals found in tobacco products and these therapeutic products have been found to be safe and effective by FDA in helping smokers quit. In fact, for nicotine replacement products such as gum, lozenges and patches, FDA doesn’t even require a doctor’s prescription for them,” added the FDA Commissioner, clearly pointing out that Nicotine can be delivered in several relatively safer ways.

“But attach the very same nicotine to a medicinal product without the other chemicals found in tobacco products and these therapeutic products have been found to be safe and effective by FDA in helping smokers quit. In fact, for nicotine replacement products such as gum, lozenges and patches, FDA doesn’t even require a doctor’s prescription for them.” Dr. Scott Gottlieb, FDA Commisioner

Nicotine seems to be getting all the attention in these recent days. Public Health Expert Dr. Kostantinos Farsalinos agrees that nicotine delivery plays a crucial role in harm reduction to smokers who are trying to quit smoking by switching to safer alternatives. Infact a study of which he was the lead author, titled Nicotine delivery to the aerosol of a heat-not-burn tobacco product: comparison with a tobacco cigarette and e-cigarettes, was published last week on NCBI. Additionally, another study also released last week, was published on Molecular Psychiatry and explores the correlation between tobacco addiction (via nicotine), and mood disorders.

A win for public health and a focus shift for Big Tobacco

This is all good news for public health experts, and while regulating nicotine levels is expected to have a negative impact on the cigarette business, big tobacco who had already started preparing for the decline in smoking by branching out to safer alternatives, will probably not receive such a deadly blow. All the major tobacco companies have launched their electronic devices, in fact Philip Morris has already spent over US$3 billion in developing its safer alternatives, and is struggling to keep up with the demand of its iQOS in Asia.

More info : Financial Post