FDA Provides Update on Tobacco Product Application Review


In terms of enforcement, Zeller stated that the FDA is still prioritizing the enforcement of any ENDS (Electronic Nicotine Delivery System) product that is being sold currently but doesn’t have a product application that was was submitted and is being processed. The FDA will make enforcement decisions on a case-by-case basis for other deemed products and will prioritize enforcement based on the likelihood of youth use or initiation to better use the FDA’s resources. This approach to enforcement will apply to non-ENDS products and premium cigars, which the FDA is currently enjoined from enforcing the premarket requirements due to a recent court ruling [read more here].

“Due to the large number of applications moving into review at the same time, the novelty of this review, the finite nature of our review resources, and the necessarily rate-limiting effects of ensuring consistency across reviews, FDA developed a process to determine the review order for the applications. This process applied to all applications that were submitted to CTP by Sept. 9, 2020, including originally-regulated products such as cigarettes and smokeless tobacco and deemed products that are not currently marketed,” Zeller shared.

For SE Reports and EX REQs, the review order was determined using randomization by manufacturer. The agency used a basic random number generator and a number was assigned to the manufacturers that submitted at least one application to determine the order for entering acceptance review and subsequent review phases. Applications that were classified as PMTAs were also subject to the same randomization process. Due to the large number of ENDS products that had an application submitted, the FDA decided to dedicate a portion of its resources to reviewing the products that account for most of the current market, a move that is sure to draw some criticism from smaller manufacturers. Zeller had the following to say about this decision:

“The continued marketing of these products has the potential to have the greatest public health impact—either positively or negatively—as they hold the largest overall market share and therefore likely used by the largest number of people. For this reason, FDA pulled several applications into a separate review queue and dedicated resources to their review. By identifying and ensuring first review of these applications, we believe we can achieve the greatest public health impact most quickly. If FDA finds that a widely-used, currently marketed product does not meet the standard in the law for marketing, the Agency will not grant a marketing order and the product must be removed from the market. Conversely, if FDA finds that a widely-used, currently marketed product does meet the standard in the law for marketing, the Agency will grant a marketing order and the product may remain on the market subject to the conditions in the order. In either case, earlier review ensures a faster transition to a marketplace of products that have been scientifically reviewed for their impact on public health.”

The FDA has posted a list of products that were on the market as of Aug. 8, 20216, are currently marketed, and are subject to pending, timely applications submitted through SE and EX REQ. The list includes over 2,000 products, including 1,100 cigars, over 330 pipe tobacco products, and 660 water pipe tobacco products. The list is based on information received from companies and does not include entries for companies that did not verify the marketing status of their products before the time of posting. This list can be viewed by clicking here.

For more information on the FDA’s review of tobacco product applications that were received by the Sept. 9, 2020 deadline, click here.

For all the latest legislation and FDA news impacting the tobacco industry, click here.