Perspective: FDA’s Progress on Tobacco Product Application Review and Related Enforcement

By Mitch Zeller, Director of the FDA’s Center for Tobacco Products (CTP)
September 9, 2021

Following updates provided in May and February, as well as our initial perspective published in August 2020, this piece describes the current status of our review of applications for “deemed” new tobacco products submitted by Sept. 9, 2020. Previously, we also created a webpage with general information and resources related to the submission of tobacco product applications for these products.

FDA’s premarket review of tobacco products is an essential tool for ensuring that products on the market meet a set of legal standards set forth by Congress to protect public health, and that products that do not meet the legal standards are not marketed. Although different tobacco products have different levels of risk, all tobacco products are inherently dangerous. Whether they receive a marketing authorization or not—there are no safe tobacco products. People who do not currently use tobacco products, especially young people, should not start.

Background

The Family Smoking Prevention and Tobacco Control Act provided FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the agency, by regulation, deems to be subject to the law. When FDA’s historic “Deeming Rule” took effect in 2016, many of the regulatory and statutory requirements that had been in place for manufacturers of the originally regulated tobacco products since passage of the law in 2009, became applicable to the deemed products, including e-cigarettes and all other electronic nicotine delivery systems (ENDS), cigars, pipe tobacco, nicotine gels, hookah tobacco, and any future products meeting the statutory definition of “tobacco product.” The applicable statutory provisions include the requirement that deemed products that meet the definition of a new tobacco product must receive premarket authorization from the FDA to be legally marketed.

In the deeming rule and subsequent guidance documents, FDA stated that it intended to defer enforcing the premarket review requirements, for a period of time, with respect to “deemed” new tobacco products that were on the market as of Aug. 8, 2016 (the effective date of the deeming rule). This policy did not extend to deemed new tobacco products that entered the market after the rule’s effective date. Under a federal court order, manufacturers of deemed new tobacco products that were on the market as of the deeming rule’s effective date were required to submit premarket review applications by Sept. 9, 2020. Following the court order, FDA accelerated its planning and preparation to receive a large number of applications by the premarket application deadline. FDA received thousands of submissions representing more than 6.5 million products by the deadline of Sept. 9, 2020. Per the court order, products for which applications were submitted by the deadline could generally remain on the market for up to a year from the date of the application—or until Sept. 9, 2021, at the latest—pending FDA review, although FDA retains enforcement discretion.

Over the last year, the agency has worked to review premarket applications for millions of products. The vast majority of the applications are for ENDS products. When reviewing premarket tobacco product applications (PMTAs) for ENDS products, FDA’s job is to assess the scientific evidence presented by the applicant and determine if permitting the marketing of the new tobacco product would be “appropriate for the protection of the public health” – the standard laid out by the statute. The agency makes this determination by following the direction Congress provided in the law to assess the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, as well as the increased or decreased likelihood that those who do not use tobacco products will start using such products. In making this determination, the impact of such products on youth initiation and use is a critical consideration.

FDA has made significant progress in reviewing premarket applications over the last year. This perspective piece provides an update on our work and information about what to expect after Sept. 9, 2021.