Regulating e-cig sales: are FDA warning letters just a drop of ink in the ocean?

The US Food and Drug Administration (FDA) recently notified several more online retailers and manufacturers of significant violations related to the sale of e-cigarettes. But are these regular warning letters really enough to reassert the FDA’s control over the market?

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.

The warning letters cite a range of popular e-cigarette products said to appeal to youth, including disposables, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech.

According to the FDA, the products it targeted were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data as well as data from surveys of youth and other sources helped the agency to identify the rising popularity of these products, which were subsequently prioritised for investigation across the supply chain, from manufacturers to distributors to retailers.

“Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products (CTP). “They’re a critical component of our comprehensive surveillance toolbox so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”

Nevertheless, 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. So it’s important to ask: is the agency really removing these products from the market in significant numbers?


Delays, backlogs and lawsuits


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, and it is expecting to increase its pace as new personnel get up to speed.

There is indeed, as we reported recently, a chance that the FDA will meet its revised targets for clearing the backlog of PMTAs. 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.

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 ECigIntelligence staff

Photo: Nicolas Thomas

Benefits of subscription plans:

  • Stay informed of any legal and market change in the sector that impacts your organization
  • Maximise resources by getting market and legal data analysis daily in one place
  • Make smart decisions by understanding how the regulatory and market landscape evolves
  • Anticipate risks in your decisions by monitoring regulatory changes that impact your organization

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *