There has been much discussion around the U.S. Food and Drug Administration’s plans to regulate premium, hand-made cigars, particularly after FDA Commissioner Dr. Scott Gottlieb’s July 28, 2017 announcement declaring a comprehensive, risk-based regulatory approach for traditional and newly deemed tobacco products. In its announcement, the FDA extended the Deeming Regulation timelines under a new enforcement policy. Under expected, revised timelines, premarket review applications (including substantial equivalence) for cigar products (including premium cigars) are now required to be submitted to the FDA by August 8, 2021. As before, cigar manufacturers can continue to market products while the FDA reviews product applications.
Significantly, the FDA also communicated its intent to solicit additional comments and scientific data related to the patterns of use and potential public health impacts from premium cigars. This would take the form of a new Advance Notice of Proposed Rulemaking so that the Agency can develop a new administrative record to explore these questions. Dr. Gottlieb stated that the FDA would take into serious consideration any additional data submitted relevant to the appropriate regulatory status for premium cigars.
This comes as no surprise, given the existing debate and congressional attention to premium cigar regulation. At a recent Senate Appropriations Committee to discuss the FDA’s fiscal year 2018 budget, Senator Marco Rubio stressed to Dr. Gottlieb the potentially devastating impact of the Deeming Rule on the premium cigar market, and questioned if the FDA was reconsidering its plans to regulate premium cigars. In doing so, Senator Rubio raised several points distinguishing premium cigars from other newly deemed products, including the point that premium cigars are neither marketed nor commonly used by minors. In response to Senator Rubio’s questions, Commissioner Gottlieb stated that the FDA understood the challenges faced by small businesses and was currently reviewing “aspects” of the Deeming Rule, and that the FDA’s actions would need to be based on science. Dr. Gottlieb also acknowledged the existing legislative efforts to exempt premium cigars from the Deeming Rule, and offered for the FDA to work together with Congress to “mitigate any unintended consequences” of these measures. These congressional measures include bills introduced earlier this year (H.R. 1136, H.R. 564) seeking to exempt traditional large and premium cigars from regulation by the FDA, as well as some cigar-friendly rider provisions in draft versions of the fiscal year 2018 Agriculture Appropriations bill. The fate of these measures is uncertain at this point.
During its July 28, 2017 announcement, the FDA reiterated its commitment to encourage the innovation of novel tobacco products that have the potential to make a notable public health difference, as well as to inform policies to protect minors and help existing smokers quit. Although the FDA’s delay of enforcement action provides some reprieve to cigar manufacturers, we encourage our readers to take this announcement with some degree of cautionary optimism.
Certainly, this delay broadens the time window in which cigar companies must apply for FDA approval of new products. Further, it buys the cigar industry more time to influence the FDA’s plans to possibly amend the regulatory framework for cigar products. In addition, the fact the regulatory framework for premium cigars is being reconsidered is itself encouraging – a sign that the FDA recognizes the “one size fits all approach for regulation” may not represent the best option for the industry or for the protection of the public health.
At the same time, the announcement serves as a reminder that cigars, including premium cigars, may not be completely free of FDA regulation. In addition, the FDA’s renewed focus on nicotine particularly for traditional, combustible cigarettes may impact the fate of cigar product regulation in the not-so-distant future. Finally, there are some political uncertainties, as 2021 may or may not bring a new administration. As such, we encourage our readers to continue their research and compliance efforts. After all, any product improvements and favorable data can be used in response to an ANPRM, and further dissuade FDA from continuing its existing one-size-fits-all regulatory approach to premium cigars.