How will recent FDA enforcement actions play out in the short and long term?

Ahead of his participation at ENDS US 2018, Azim Chowdhury, Partner at Keller and Heckman LLP, offers insight into the latest industry developments, key challenges, and new opportunities for continued growth and harm reduction efforts in light of recent FDA enforcement actions.


What do you consider to be the biggest opportunities and challenges for the five major e-cigarette brands that recently received requests from the FDA to provide comprehensive plans to address youth use of their products?

The challenge and opportunity for those e-cigarette companies, as well as the entire ENDS industry, is the same – demonstrating to FDA that they can work together with the Agency to prevent minors from getting access to and using their products, which are intended for adults looking for less harmful alternatives to combustible cigarettes. In light of the apparent surge in underage use of certain e-cigarettes over the last year, FDA has threatened drastic action that could put the entire industry in jeopardy, including potentially changing the premarket authorization compliance deadline, as well as banning flavors and online sales. The burden has been placed on industry to come up with new ways to curtail the illegal underage use of these products and prove to FDA that the youth issue can be solved without jeopardizing the millions of smokers who have successfully made the switch.  If the ENDS industry, starting with the major brands cited, can meet this challenge, the opportunity for continued growth and tobacco harm reduction can be achieved.

From your perspective, how will the recent FDA enforcement actions aimed at e-cigarette retailers play out in the short and long term?

FDA’s enforcement actions, including warning letters and civil monetary penalties, aimed at retailers found to have sold ENDS products to minors, should be applauded.  The industry fully supports enforcement efforts such as these, along with the development of appropriately-tailored regulations based on the continuum of risk, that allow adults – but not youth – access to these products. In the short term, FDA’s enforcement actions aimed at retailers is likely to be a harbinger of future enforcement and campaigns designed to deter sales to youth, which is a critical component of the Agency’s Youth Tobacco Prevention Plan.  But as the Agency focuses on youth prevention it will be critical to ensure that (1) its messaging to adults seeking reduced-harm nicotine alternatives does not get confused, and (2) that actions taken now do not have a long-term detrimental impact on the public health by removing potential life-saving products from the market.

What are the biggest challenges facing vapor and e-liquid business owners when it comes to successfully reaching adult consumers? What steps are necessary to combat these challenges?

Misperceptions about the risks of ENDS products among adult consumers remains high. Recent surveys indicate that many consumers incorrectly believe that vaping is as harmful, if not more harmful, then smoking, or that nicotine is a carcinogen. Navigating through the competing messages is a huge challenge for adults who may be unable or unwilling to quit smoking, but are looking to reduce their harm with alternative products.  Because manufacturers and retailers are prohibited from making modified or reduced-risk claims about their products, it is imperative that FDA, CDC and public health organizations work with industry to ensure that the right messaging reaches the right populations.


Hear more from Azim during his presentation,  Updates on Flavor Compliance and Enforcement Efforts, taking place on Day 1 of the conference (Thursday, December 6) at 8:30 AM Eastern.