Broughton Head of Scientific Affairs, Paul Hardman has recently published an article with leading sector publication Tobacco Reporter.
Nicotine
Broughton celebrates Premarket Tobacco Product Application (PMTA) success for clients.
Marketing order decisions by the US Food and Drug Administration (FDA) are finally giving clarity to Electronic Nicotine Delivery Systems (ENDS) manufacturers on the regulatory benchmark they need to reach to obtain a Marketing Order in North America. This insight has been further strengthened by the PMTA successes of some of Broughton’s clients in recent months.
Having contributed scientific and regulatory services to several successful PMTA applications over the past two years, our team has completed more than 375,000 analytical tests, 700 environmental assessments, and 300 toxicological profiles to support PMTA applications for more than 50 individual products from various manufacturers.
We believe the recent positive decisions give the industry new confidence to move forward with product development, even though not every ENDS manufacturer has benefited. Companies pursuing the PMTA route now have real-life reference points to draw on that can be reapplied to future submissions.
Chris Allen, Chief Executive Officer of Broughton, said he was delighted to see Broughton’s services result in Marketing Granted Orders (MGOs). He said: “Businesses in the ENDS sector have had a long wait to find out if their PMTA applications have been successful. Broughton worked closely with a number of clients on their applications and is extremely proud of our role in helping our clients demonstrate that their ENDS products contribute to tobacco harm reduction targets and are appropriate for the protection of the public health (APPH). As part of this process, our HPHC methodology has been fully reviewed via the Tobacco Product Master File (TPMF), which is a great testament to our work's scientific rigor and our team's deep expertise.”
Chris said Broughton was encouraged by these MGOs and looked forward to similar success for other clients following the PMTA pathway. He added: “Broughton consistently strives to ensure that all applications are robust and have a good chance of being granted a marketing order. We have world-leading knowledge and extensive experience and are always ready to assist clients in navigating the relevant regulatory process.”
Contact us to book a meeting and let’s discuss how together we can advance a smoke-free future.
If you would like to learn more about regulatory pathways and how they create new business opportunities for forward-looking companies, then read our recent Regulatory Digest below:
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