FDA press release : PMTA submission deadline moved to 2022

“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 earlier today.

Setting the record straight about Nicotine

The PMTA delay is part of an anti-smoking plan which also includes the de-nicotinisation of combustible cigarettes that is expected to start in 2021. “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.

The agency will issue a guidance explaining this policy in detail shortly, but the cut off date of applications for non-combustible products such as ENDS or e-cigarettes is expected to be August 8, 2022. On a different note, the new enforcement policy is not expected to affect any current requirements for cigarettes and smokeless tobacco in any way, but only the newly-regulated tobacco products such as cigars and e-cigarettes. Additionally, the plan will not apply to provisions of the final rule for which compliance deadlines have already passed, such as age limits and photo-ID checks at sales counters.

A win for Public Health

“To complement these larger policy considerations, the FDA plans to issue foundational rules to make the product review process more efficient, predictable, and transparent for manufacturers, while upholding the agency’s public health mission,” read one of the final paragraphs of the FDA’s press statement. Many will rest easier tonight upon hearing these reassuring words. The FDA’s harsh stance towards e-cigarettes seems to be softening, and its closed attitude towards the proven safer alternatives seems to be finally opening.