Report

September 3

Counting Down to the PMTA deadline.

Broughton Nicotine Services, Chief Scientific Officer has recently published an article with leading sector publication Tobacco Reporter – Counting Down to the PMTA deadline.

Counting down the deadline.

Premarket Tobacco Product Applications (PMTA) are probably one of the most talked about topics within the ENDS industry but as the PMTA deadline looms closer, are companies ready and what is the reality for those that have left it too late?

Chris Allen, Chief Scientific Officer at Broughton Nicotine Services, discusses how laboratory services are supporting tobacco product manufacturers to get their products ready for the US FDA’s premarket tobacco application deadline on September 9, 2020. Chris explains how companies working towards a PMTA have benefited from the extended deadline, while those who are not have had a reprieve in the form of an additional 120 days to sell their products in the US.

He stresses the increasing importance of investment in Quality Management Systems (QMS) as regulatory guidance evolves. Whilst not likely to be as stringent as pharmaceutical regulations, ENDS requirements will be far greater than those such companies are used to.

In terms of the US market landscape, the regulations will inevitably mean a reduction in companies and products available. It will also signal a shift towards innovation and product development for those that remain in the market.

You can download a copy of the article here:

 

Counting Down: The Nicotine Industry Prepares For A Shakeout In The Wake Of The Premarket Tobacco Product Application Deadline.

 

 

To discuss pro-active strategies to ensure the regulatory compliance of your products, request a meeting with our team.

About the Author

Chris Allen is the Chief Scientific Officer at Broughton Nicotine Services. Since obtaining a Bachelor of Science degree in chemistry, Chris has gained over 20 years of analytical and regulatory experience working in global Medical Device and Pharmaceutical companies and within leading Contract Research Organizations. Chris co-founded Broughton Nicotine Services sister company (Broughton Laboratories) in 2006 and played a pivotal role in obtaining the first UK Medicinal License for an Electronic Cigarette, a project starting in 2010. Now with over ten years of working with ENDS, Chris has become well established as a recognized SME in the regulations and chemistry of tobacco products. In the position of Chief Scientific Officer, Chris’ key objective is to support the acceleration of safer nicotine delivery products to market and to deliver value and unrivalled experiences to our customers.