As stated by one of the bill's sponsors, U.S. Senator Ben Cardin, "This bill gives the FDA the power it needs to help addicted smokers overcome their addiction, and to make the product less toxic for smokers who are unable or unwilling to stop."1
With the FDA's expansive authority to define the tobacco marketplace, the Agency is in the leading position to create a mature, regulated tobacco marketplace that successfully reduces the harm caused by combustible cigarettes by:
- executing product authorization pathways to create a diverse marketplace of potential reduced risk tobacco products;
- communicating to address misperceptions that hinder adult smoker adoption of potentially harm reducing smoke-free products;
- investing in proven tactics to reduce underage tobacco use; and
- engaging with key stakeholders to improve upon national surveys and provide appropriate, timely and efficient information to rapidly address emerging challenges in the dynamic tobacco category.
The FDA is the only federal agency with the Congressional mandate and the necessary authority and resources to lead tobacco harm reduction efforts. That's why the Agency's ability to coordinate federal strategy and drive efficient resource allocation towards these efforts is crucial for reducing the death and disease associated with combustible cigarettes.
We have long supported the FDA's regulatory authority and believe that continued engagement between the FDA and tobacco manufacturers is necessary for progress. And as the FDA addresses the necessary regulatory conditions, it is our responsibility to be ready – with a portfolio of potentially reduced-risk products that satisfy adult smokers’ evolving interests.
Nicotine & The "Risk Cliff"
As the FDA states on its website: "Most people know that cigarettes and other tobacco products are addictive, but many people do not understand the role of nicotine in tobacco addiction, disease, and death. Nicotine is what addicts and keeps people using tobacco products, but it is not what makes tobacco use so deadly. Tobacco and tobacco smoke contain thousands of chemicals. It is this mix of chemicals–not nicotine–that causes serious disease and death in tobacco users, including fatal lung diseases, like chronic obstructive pulmonary disease (COPD) and cancer."4
FDA and other public health authorities agree that there is a broad "continuum of risk" among tobacco products, with combustible cigarettes at the highest end of that spectrum and complete cessation at the lowest end. In fact, when FDA announced its Comprehensive Plan in 2017, then-FDA Commissioner Gottlieb stated FDA policy should be used as a vehicle to "move addicted smokers down that continuum of risk to these less harmful [innovative] products."5 The then-Commissioner also shared his concerns regarding the widespread misperceptions around nicotine among the American public.
While there may be differences in risk profiles between specific smoke-free products, it will take years of epidemiology to quantify those differences. The body of evidence, does however, indicate a profound risk differential between combustible and smoke-free product categories as a whole. Data suggest that a two dimensional "Risk Cliff" model is a useful description of the relative risk between combusted and smoke-free products. With millions of U.S. adult smokers seeking less harmful alternatives to cigarettes, we must provide adult smokers with information that can facilitate transition to a variety of smoke-free products.