The difficulties the US Food and Drug Administration (FDA) has encountered in effectively regulating novel nicotine are most obvious with e-cigarettes, rather than other categories, for several reasons: most notably, the sheer number of companies and products involved, and the politically hot issue of youth usage.
But they may also point to fault lines in the agency’s approach to tobacco products in general.
Recently, for example, the FDA notified several more online retailers and manufacturers of significant violations related to the sale of e-cigarettes.
This latest set of warning letters went to 15 online retailers and three manufacturers that the federal agency said were selling or distributing unauthorised e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser.
Yet are these regular warning letters really enough to reassert the FDA’s control over the market?
It is clear from the very regularity of such letters that retailers are still selling unauthorised products, and it’s reasonable to assume that those being warned are not the only culprits; some must be flying under the FDA’s radar. Is the agency really removing these products from the market in significant numbers?
An independent report from the Reagan-Udall Foundation in December 2022 found that the FDA’s “failure to take timely enforcement action jeopardises public health and undermines credibility and effectiveness in tobacco product regulation”, and that “the agency has not been transparent regarding the reasons it has failed to clear the market of illegal products”.
Following that report, in February this year, the FDA announced its plan to hold a joint “summit” with the Department of Justice (DOJ) and other stakeholders to improve enforcement actions. However, such a summit has not taken place or been scheduled yet.
There have also, of course, been delays with the process of reviewing premarket tobacco product applications (PMTAs). In response to the Reagan-Udall report, the federal agency said it would take “at least a year” to complete the reviews.
There is, as our colleagues at ECigIntelligence recently observed, a decent chance that the FDA will meet its revised targets for clearing the backlog of PMTAs – if it can maintain its recently increased pace. But even if does that, some of the many lawsuits related to them will likely still be continuing, adding further confusion – and delay – to resolving the legal status of specific products.
And, of course, merely dealing with the PMTA backlog does not in itself solve the issue of illegal retail sales, especially when the products are imported.
E-cigarettes are the products mostly directly affected (or not affected) by this continuing lack of resolution. But the implications of the FDA’s continuing struggle to keep on top of the market, and the regulatory process, extend beyond vapour. It’s difficult to escape the impression that, despite the lessons of the Reagan-Udall report, the FDA is still approaching the regulation of novel nicotine products in much the same way as it always has – there might have been some speeding-up, but there has been no radical change.
To be fair, of course, Reagan-Udall was less than a year ago, and a more dramatic rethink of regulation and enforcement might well be on the way. It certainly seems needed.
– Antonia Di Lorenzo TobaccoIntelligence staff