The issue of tobacco harm reduction and the FDA's regulatory framework for tobacco products is complex. It's my team's job to engage with federal policy makers to talk about what tobacco harm reduction is, educate them about innovative new tobacco products, and the process by which FDA will authorize them – that is to say, helping introduce FDA-reviewed tobacco products, with the potential for less harm, to adult tobacco consumers.
Having conversations grounded in the science and rigor of the FDA's process is incredibly important. The FDA reviewed the science in the IQOS application and made the determination that this product is "appropriate for the protection of public health" – which is a very high bar. When you walk policy makers through that – when they can see the robust research that shows a reduction of harmful constituents [for IQOS, compared to a combustible cigarette], and the FDA's requirements for surveillance and reporting once the product is out on the market – it's eye-opening. It gives policy makers a level of assurance.
Millions of adult cigarette consumers want to transition to a potentially reduced-risk tobacco product and we have a pipeline of innovative, smoke-free products to meet their interests. These products will have to go through that very rigorous FDA process to meet the threshold of "appropriate for the protection of public health." That’s exciting because for the first time, FDA will be able to provide clarity for the marketplace, tobacco consumers and policy makers.