FDA outlines what PMTAs must include: youth protection, comparative risk are key

The US Food and Drug Administration (FDA) today released its draft guidelines for premarket tobacco product applications (PMTAs), spelling out in detail the information that e-cigarette makers will have to submit before next year’s deadline and many of the criteria on which they will be judged.

Crucially for the industry, they acknowledge a continuum of risk in tobacco products, while also placing much emphasis on youth protection.

The broad thrust of of the draft requirements – which now go into a two-month comment period – has not changed from that long-established by the FDA: PMTA applications must show that placing a product on the market would be “appropriate for the protection of the public health”.

But three features in particular stand out as significant.

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Barnaby Page

Editorial director
Before joining ECigIntelligence in early 2014 as one of its first employees, Barnaby had a 30-year career as a reporter and editor for newspapers, magazines and online services, working in Canada, the US and the Middle East as well as his current British location. He has edited publications covering fields including technology and the advertising industry, and was launch editor of the first large daily online news service in the British regional media. Barnaby also writes on classical music and film for a number of publications. Barnaby manages the editorial and reporting teams and works closely with the analyst teams, to ensure that all content meets high standards of quality and relevance. He also writes for the site occasionally, mostly on science-related issues, and is a member of the Association of British Science Writers.

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