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FDA - Clarification on General Enforcement Discretion Related to Sept. 9 Premarket Tobacco Applications



Broughton Chief Regulatory Officer, Dr Nveed Chaudhary shares his thoughts on the latest FDA announcement, ‘Clarification on General Enforcement Discretion Related to Sept. 9 Premarket Tobacco Applications’.

Centre for Tobacco Products at FDA have clarified that for deemed ENDS the PMTA application deadline was 9th Sep 2020. For those ENDS that have a PMTA filed and do not fall into the category of encouraging youth use or uptake, FDA generally intends to defer enforcement action until Sep 9th 2021. 

What does this mean?

It seems that for products like flavoured pod systems and flavoured disposable systems, if the product is not approved by Sep 9th 2021, there is a high risk that enforcement action will be taken against them. For all other ENDS products, enforcement decisions will be made on a case-by-case basis.

This, I believe gives some great confirmational insights as to what FDA are concerned about. It is clear, that the number one concern in the mind of FDA is preventing youth access and youth use. If a product is unable to demonstrate a lack of youth interest through behavioural studies or market data (or a combination of both), the likelihood is that they will not receive a marketing order and be enforced against sooner rather than later.

So, some thoughts for the future: If your application is still pending a deficiency letter and you think you might not have enough data to prove a lack of youth interest, you might want to start thinking about gathering that data now.

FDA have a very difficult task, with hundreds of thousands of PMTA applications to be assessed by Sep 9th 2021, it’s clear that their approach to ensure that the youth of the USA are protected from using ENDS products seems like a sensible approach to ensure the continued protection of the US public health.

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