Tobacco Business

[ 16 ] TOBACCO BUSINESS [ SEPTEMBER / OCTOBER | 21 ] T STARTUP / LEGISLATION The U.S. Food and Drug Administration (FDA) is under a court order to review and either authorize or decline to authorize by Sept. 9, 2021, the marketing of new tobacco products for which premarket tobacco product applications (PMTAs) were submitted to the agency by man- ufacturers. This article provides an update on the PMTA process and where the FDA is currently at in reviewing these applications. The federal law known as the Family Smoking Prevention and Tobacco Control Act requires that before a tobacco product may be introduced into the U.S. market the new product must undergo pre- market review by the FDA and receive marketing authorization from the agency. If a product was already on the market as of Feb. 15, 2007, the product is grandfathered and does not need a premarket application nor is FDA authorization required. For every tobacco product that entered the market after Feb. 15, 2007, one of two applications will be required: either a substantial equivalence (SE) application that compares a new tobacco product to a similar one that is grandfathered or already has an SE approval order from the FDA, or a PMTA application is required for a new tobacco product that is not similar to a grandfathered product and was introduced into the market after Feb. 15, 2007. The deadline for filing these applications with the FDA was Sept. 9, 2020. Once a manufacturer files an SE or PMTA with the FDA, the agen- cy follows a four-step review process. First, the FDA conducts a prelim- inary review of an application to see if everything is complete. Next, the agency files the application if all the scientific studies, evidence and other data accompany the application. Third, the FDA undertakes its substantive review of the application, which can take up to one year or through the deadline of Sept. 9, 2021. Fourth, the FDA issues an order authorizing or not authorizing the application. To authorize an appli- cation, the FDA needs to determine that the product “is appropriate for the protection of the public health.” On June 11, 2021, the FDA’s Office of Science held a live webinar titled, “Deemed Product Review: A Conversation with the Center for Tobacco Products Office of Science.” The purpose of the webinar was to provide an update on and information about the agency’s sci- entific review of premarket tobacco product applications for “deemed products,” which include cigars, pipe tobacco, hookah tobacco and electronic cigarette/nicotine vapor products. The main focus of the webinar was on the application intake process, application review progress and allocation of agency review resources. With the FDA required to finalize the review of all PMTAs by Sept. 9, 2021, and given the significant number of applications filed, the Office of Science stated that it is “striving to review as many applications as possible during this one-year period described in the court order that set the Sept. 9, [2020] application deadline” date and that the FDA has the “discretion to defer enforcement action against particular products on a case-by-case basis.” According to the FDA website, there were 269 PMTAs filed between October 2019 and July 2020. Then, in August 2020, one month before the Sept. 9, 2020, filing deadline, some 10,184 PMTAs were filed. During the first nine days of September last year, another 4,567 PMTAs were filed. This means that almost 15,000 PMTAs have been filed and are pending with the agency. The FDA has now published a list of filed and accepted PMTAs so that industry members know which products have had applications filed (to view the complete set of PMTA metrics, visit fda.gov/media/150179/download ). The FDA staff also said that “the likelihood of FDA reviewing all of the applications received by Sept. 9, 2021, is extremely low.” This means that if the application review process has not been concluded by Sept. 9, 2021, the FDAmay utilize its discretion and extend the time to review PMTA applications on a case-by-case basis by deciding not to take enforce- ment action against manufacturers who timely filed PMTAs. The graphic below is from the FDA website, which reports that for the “acceptance” stage in the four-step application review process, applications covering the listed number of products by category have been “accepted” by the agency: In addition, the FDA reports on its website that it has issued “Refuse to Accept” letters to manufacturers for applications covering 59,229 electronic nicotine-delivery system products (i.e., electronic cigarettes/ vapor products), five cigar products and 25 other kinds of tobacco products. Moreover, the FDA website shows that the agency issued “Refuse to File” letters to manufacturers for applications covering 3,628 electronic nicotine-delivery system products because necessary information was not included with the applications. Finally, “Filing” letters have been sent to manufacturers for appli- cations covering 138,377 electronic nicotine-delivery system products informing the manufacturers that their applications will be entering the third or “substantive review” stage of the review process. If an SE or PMTA application was not filed for a product and an application needed to be filed by Sept. 9, 2020, then the product is illegally on the market and must be removed from the market. The FDA continues to work through the large number of submitted applications; however, the agency will unlikely review all of the 15,000- plus applications by the Sept. 9, 2021, deadline. The agency may, at its discretion, extend the review time on a case-by case basis and opt not to take any enforcement action. Industry members should regularly check the FDA website for addi- tional information on the status of PMTA applications. TB FDA PMTA Progress Update Contributed by Thomas Briant, Executive Director, National Association of Tobacco Outlets (NATO)