FDA should make the RJR Vuse e-cig application available for public comment now

Last October, RJ Reynolds submitted its Premarket Tobacco Product Application (PMTA) to FDA seeking approval to market its Vuse e-cigarette.  Because, unlike claims of modified risk, FDA is not required to make PMTA applications available for public comment, we have no idea what is in the RJR application or whether they meet the standard in the law that allowing marketing of Vuse would be “appropriate for the protection of public health.”

As the first known application for an e-cigarette, the Vuse decision will set important precedents for approval of all e-cigarettes.  For this reason alone, FDA should submit the PMTA to its Tobacco Products Scientific Advisory Committee (TPSAC) for external assessment.  Doing so will also make the PMTA available for outside public comment, through comments submitted to TPSAC.

This is particularly important because FDA’s approval of Philip Morris’ heated tobacco product IQOS raised serious questions about how FDA is applying the law.  Rather than putting the burden on the manufacturer to make an affirmative case that allowing marketing of IQOS was appropriate for the protection of public health, FDA took the position that it had to approve Philip Morris’ application unless FDA could prove that IQOS was not appropriate for the protection of public health.  In addition, FDA used the de factor standard that a product is ok if it produces fewer of some toxins than a conventional cigarette, something that is the case for all e-cigarettes.

In particular, as a public comment submitted to FDA earlier this month on how to assess PMTA's from a large number of health groups, led by Tobacco Free Kids, makes the important point that the FDA needs to not only consider the theoretical use of e-cigarettes in the future, but actual use and promotion patterns in the years that these products have been allowed on the market by FDA despite the fact that they had not submitted PMTAs.

Other important information about actual use of e-cigaretttes will include the actual levels of dual use, rather than allowing the FDA to make decisions about hypothetical "switching" from cigarettes rather than contining as dual users (as is the situation with IQOS).

FDA also had many other good ideas in its updated regulation for what has to be in a PMTA, such as requiring applicants to provide a comprehensive summary of the available evidence, not just what the company feels like presenting.  As we observed in our public comment on the proposed rule, applying this requirement could have led FDA to a different decision on IQOS.  We also discuss other important issues, such as making sure that the companies cannot monitor users' behavior and tune every e-cigarette to maximize addiction and consumption.

Sending the Vuse PMTA to TPSAC would open up the process and allow important public input on what information RJR provided and whether it meets these standards.