Premarket Tobacco Product Applications (PMTA)

One of the significant and sensitive questions that ENDS manufactures seeking regulatory approval for their products face is whether to commission research to assess the actual level of use or appeal of their ENDS products to young people. The choice either side of that dilemma can be hugely impactful for a company. In the case of JUUL it is all to easy to see how much the issue of youth use of their products has impacted on the company both legally and in terms of sales. E-cigarette companies and Big Tobacco companies with ENDS products may feel that when it comes to youth the best thing to do is simply not to go there. The risk of that strategy however is that those companies then have no answer to the claim that their products appeal to and are being used by young people. There is an alternative thought which these companies can consider- commission and independent behavioural/epidemiological research centre to undertake the work. CSUR has conducted such research for JUUL following presentation of the study methods to FDA and with JUUL itself having no control over what young people are asked and no access to the data collected. The studies undertaken can provide companies with important information on whether their products are appealing to young people, whether they are being used by young people and how they might seek to reduce that use. Responsible ENDS manufacturers can benefit from facilitating that research in a way which does not result in the accusation that they are inappropriately targeting young people for marketing reasons. For more information on youth ENDS use research and appeal contact: [email protected]

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