Report

April 30

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

Broughton Nicotine Services 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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About the Author

Dr Nveed Chaudhary is Chief Regulatory Officer at Broughton Nicotine Services. He has over 15 years of experience in the Next Generation Nicotine Products (NGPs) industry. His educational background includes a Double Hons Degree in Pharmacology and Physiology from University College London and a PhD in Respiratory Molecular Medicine from the University of Southampton. His goal has always been to reduce the burden that lung disease has on patients, society, and public health. Early in his career he worked for the pharmaceutical industry and at Boehringer Ingelheim was the co-inventor of a novel drug for the treatment of idiopathic pulmonary fibrosis, nintedanib esylate, which received regulatory approval in 2014/15. Since 2006, Nveed had worked at three of the largest tobacco companies in the World, focused on the assessment and subsequent regulatory filing of NGPs, including e-cigarettes, heated tobacco products and modern oral nicotine products. His experience at British American Tobacco and Philip Morris International included leading multi-disciplinary, globally based teams on both pre-clinical and clinical assessment of NGPs. Later in his career at Philip Morris International, Nveed was Director of Strategic Communications, with a focus on Tobacco Harm Reduction (THR). In this role, as well as creating narratives around THR for regulatory and key opinion leader engagement, he also had a critical role in creating the narratives for the Premarket Tobacco Product Applications (PMTA) and Modified Risk Tobacco Product (MRTP) applications for IQOS. Most recently, Nveed directed the PMTA programme at Imperial Brands ensuring the timely submission of PMTA applications to support Imperial Brand’s range of deemed products in the USA. Nveed is a true pioneer for NGPs and has worked collaboratively with FDA in the submission of both PMTAs and MRTPs as well as having heavy involvement in PMTAs for both e-vapor and heated tobacco products. As a scientist and communicator, Nveed is passionate about story-telling and using scientific data to underpin the narratives of both regulatory submissions and tobacco harm reduction.