representing clients in a complicated industry
When electronic nicotine delivery systems (ENDS, which includes e-cigarettes) were first introduced to American consumers, FDA vaping regulations were non-existent. As a result, the agency scrambled to create rules to govern their use. The agency initially sought to regulate them as medical devices, but stumbled over bureaucratic pitfalls, ultimately opting instead to classify them as tobacco products. This was due primarily to their similarities to traditional cigarettes in their delivery of nicotine.
When FDA’s foundational Deeming Rule went into effect on Aug. 8, 2016, it gave the agency’s Center for Tobacco Products (CTP) regulatory authority over all ENDS, including e-cigarettes, vapes, e-liquids, e-cigars, e-pipes, and e-hookahs. Since late 2016, FDA has worked at maximal speed to regulate this rapidly evolving class of new tobacco products, but their policies and procedures are still evolving, seemingly issue by issue. Industry and investors come to FDA Regulatory Counsel for up-to-date, insightful guidance.
The CTP is itself a relatively new addition to FDA's oversight, and the inclusion of tobacco products under the agency's traditional consumer protection umbrella has forced regulators to develop new pathways and paradigms for industry compliance. There are competing interests implicit in the availability and regulation of nicotine products, most notably adult versus youth use and entry versus exit products. As a result, stakeholders often find themselves operating in gray areas when their businesses really require practical rules.
Over the past three years, FDA has issued myriad Guidances for Industry interpreting the Deeming Rule and chunking it down into more useable policies and procedures. It has also sent numerous Warning Letters detailing and prioritizing violations. These and other public markers provide scaffolding for understanding the agency's policies and priorities surrounding vape products. At FDARC, we consider the full body of precedent, as well as our longstanding regulatory relationships, to advise and counsel clients operating in a complicated environment.
We invite all stakeholders in this evolving industry to learn how we can support your goals through transactional diligence, compliance guidance, and regulatory advocacy.