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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....