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Report

April 24

Key PMTA submission deadline – 30th June 2017

 

On May 10th, 2016, FDA issued a final rule extending its tobacco product authority to all tobacco products (except for accessories of newly deemed tobacco products), including electronic nicotine delivery systems (ENDS) – for example: e-cigarettes and vape pens.

Tobacco products for which timely premarket submissions have been submitted by the applicable compliance date will be subject to a ‘continued compliance period’ for 12 months after the initial compliance period. Once the continued compliance period ends, new tobacco products on the market without authorisation will be subject to enforcement.

We are therefore advising Manufacturers and Importers to take advantage of this continued compliance period with timely premarket submissions.

**** UPDATE: The dates described have now been updated by the FDA Click Here for these new dates ****

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About the Author

Dr. Paul Moran is the Founder and CEO of Broughton Nicotine Services. Paul started Broughton in 2006 after several years’ experience across the medical device, pharmaceutical and animal health industries. His educational background includes a BSc (Hons) in Applied Chemistry and a PhD in Chemistry / Biotechnology from The University of Huddersfield. He is also a Chartered Chemist and a Member of the Royal Society of Chemistry. Paul has significant operational management and analytical experience in senior leadership roles. Originally, Paul began his career in Quality Control at Johnson and Johnson. From there, he obtained Six Sigma Black Belt Certification, and moved on to support the successful growth of a contract laboratory leading to its merger in 2005. Since starting Broughton in 2006, Paul’s focus is to actively identify opportunities and provide distinctive vision to address changing markets and growing customer needs. His vigorous yet stoic leadership style is effective and drives our team and customers to continual success.