On July 28, 2017, the FDA announced a comprehensive regulatory plan for tobacco products that establishes a cohesive agency-wide approach to nicotine. We applaud Commissioner Gottlieb’s commitment to working towards a world where fewer people die prematurely as a result of addictive tobacco products. We also continue to appreciate Director Zeller’s leadership at the Center for Tobacco Products and look forward to working with him and other FDA staff as this plan is implemented. There are many elements of the plan that have significant potential for protecting health. At the same time, we are concerned about the delays and possible changes in oversight of certain tobacco products.

While federal regulation of tobacco products is a key component of a healthy, tobacco-free future, the announcement underscores the importance of state and local public health policy work. State and local governments must continue to lead the way by pursuing their own tobacco control agendas to protect health in their communities while helping to build an evidence base that will support future action by the FDA. The urgency for state and local action is heightened in light of the FDA’s proposal to further extend compliance deadlines for the premarket review of newly-regulated tobacco products under the deeming regulation to 2021 for combustible products and 2022 for non-combustible products, which is troublesome. The Consortium has long advocated for improvements in the FDA’s handling of the premarket review process, especially with regard to the backlog of provisional substantial equivalence reports.

We are pleased that the FDA is publicly prioritizing both the reduction of nicotine levels in cigarettes to sub-addictive levels and restrictions on kid-attractive flavors, including menthol. These actions would save millions of lives over the long-term, and we look forward to engaging with the FDA on these topics.

At the same time, there is no need for the FDA to gather additional information on the role of menthol, as the agency has already gathered overwhelming evidence through its past ANPRM and commissioned two separate reviews of the scientific evidence on this topic. Initiating yet another information collection at this juncture only serves to delay an important public health measure. The FDA must act now on all flavors –including menthol –to address youth initiation and health disparities.   

There is also no need for the FDA to issue an ANPRM to further study the public health impact of premium cigars. The agency has already collected relevant information on this topic through the deeming regulation’s rulemaking process, and the FDA came to an evidence-based decision that there is no health reason to exempt premium cigars from FDA regulation.

We share Commissioner Gottlieb’s view that there is nothing more impactful the FDA can do to reduce death and morbidity than take dramatic action on tobacco. Despite our concerns, this plan has the potential to significantly reduce the catastrophic health harms caused by tobacco use. The ultimate success or failure of the plan will depend on when and how these proposed policies are implemented and how the FDA enforces new and existing regulations. We are also keenly aware that the FDA’s regulation of tobacco products does not take place in a vacuum and there are many new hurdles for FDA action that did not exist in the past. What is clear is that the public health and scientific communities must play an active role in the FDA’s rulemaking processes during this critical period of regulation.


July 28, 2017