Where great opportunities met reality. Lessons from the U.S regulatory experience

The US Pre-Market Tobacco Application (PMTA) is a complex and expensive application process overseen by the FDA, designed to provide a path to market for reduced-harm products.  Rigorous FDA review of company PMTAs was intended to ensure that authorized products were safer for the individual user and did not present an initiation risk among the nicotine naïve – under a standard called “appropriate for the protection of public health.” More than four years after the filing of the first PMTAs and more than three years since the first authorizations, the US vaping marketplace is increasingly chaotic and there is little evidence that PMTA authorizations have had the impact that had been expected or hoped for them.  In significant part, this is attributable to influential advocacy groups and health bodies that had previously supported the PMTA review framework (and indeed had a strong hand in designing it), but that have in recent years taken a stridently anti-harm reduction position – both based on youth initiation concerns and out of hostility to industry.  Their advocacy has influenced public opinion and has placed significant political pressure on the FDA to limit authorizations, particularly of flavours.  Concurrently, the gap between perception and reality regarding the comparative harm of vaping and smoking continues to grow throughout the world – in the UK as well as in the US.  Where did the US go wrong?  And what is the path forward?  It is a time for new solutions, and an evidence-based implementation of THR will be central to that process.

Jeff Weiss is a former senior executive with NJOY, which was one of the first vaping companies to secure PMTA authorizations for vaping products and, to this point, the only one with authorizations for a non-tobacco flavour.