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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