By Stacy L. Ehrlich
On July 28, 2017, the new FDA Commissioner, Dr. Scott Gottlieb, announced a new comprehensive plan for tobacco and nicotine regulation that will serve as a multi-year roadmap to strike a balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes. This announcement marks a new approach to tobacco product regulation since the enactment of the Tobacco Control Act in 2009, and stakeholders have generally praised FDA’s embrace of harm-reduction principles.
Extension for the Filing of “Deemed” Product Applications
First, FDA announced that it will extend timelines for submitting product review applications for newly regulated (so-called “deemed”) “new tobacco products” that were on the market as of August 8, 2016, as follows:
The Agency additionally announced that the one-year sunset provision for marketing during FDA’s review of these applications will be lifted, and manufacturers will be permitted to continue to market products indefinitely during the pendency of FDA’s review. FDA stated that it was extending these timelines by 3 to 4 years “[i]n order to allow the FDA to encourage innovation that has the potential to make a notable public health difference—and to inform future policies and efforts that will protect kids and help smokers quit cigarettes.”
FDA clarified that it is not extending any deadlines for cigarettes or smokeless tobacco products or future deadlines for other requirements imposed under the landmark 2016 deeming rule, including the requirements for establishment registration and product listing, package and advertising warning statements and rotation plans, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims such as “light,” “low,” or “mild,” or similar descriptors.
Requests for Public Input
Second, FDA announced an intention to seek public input on three main topics via the future publication of an Advanced Notice of Proposed Rulemaking (ANPRM) in the Federal Register:
With respect to the first topic, the Agency indicated that opening this docket “will help begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards.” In that regard, it is important to note that publication of an ANPRM is the step prior to publication of a proposed rule (which must precede issuance of a final rule) and that FDA does not always continue on to issue a rule following publication of an ANPRM. For example, in the tobacco context, FDA has not yet published a proposed or final rule after publication of ANPRMs on menthol in cigarettes and remote sales of tobacco products.
Moreover, under the Tobacco Control Act, in order to promulgate a product standard setting a maximum nicotine level in cigarettes (which, under the statute, cannot be zero), FDA must meet its statutory obligation to consider scientific evidence concerning:
The Agency must additionally consider: (1) the technical achievability of compliance with the standard and (2) the potential creation of a significant demand for contraband and the significance of such demand. Finally, the statute provides that, where FDA proposes a tobacco product standard on the basis that it is appropriate for the protection of public health to require the reduction of a constituent of a tobacco product because it has found that the constituent is or may be harmful, any party may object to the proposed standard on the ground that it will not reduce or eliminate the risk of illness or injury.
Guidance and Regulation on the Content of Applications
Third, FDA announced plans to finalize guidance on how it intends to review Premarket Tobacco Applications (PMTAs) for ENDS products and to issue regulations outlining what information the Agency expects to be included in PMTAs, Modified Risk Tobacco Product (MRTP) applications, and Substantial Equivalence (SE) reports.
FDA additionally announced an intention to develop product standards to protect against known public health risks such as ENDS battery issues and concerns about children’s exposure to liquid nicotine as well as plans to examine actions to increase access to and use of FDA-approved medicinal nicotine products, including working with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.
Finally, both Dr. Gottlieb and Tobacco Center Director Mitch Zeller indicated that FDA has been directed to review the many pending provisional SE reports filed on or before March 22, 2011, to determine if, from a public health and policy perspective, the Agency should continue to use its resources to review certain of these reports or if they should be removed from the queue.