Tobacco Business

[ 18 ] TOBACCO BUSINESS [ JANUARY / FEBRUARY | 22 ] OPINION / VAPOR PMTA RESPONSE T The premarket tobacco product application (PMTA) regulatory process for flavored electronic nicotine-delivery system (ENDS) products has been, in a word, politicized. The knowing rejection of science by the media and “public health” groups has long delayed the acceptance of e-cigarettes as a less harmful alternative to combustible cigarettes. Nonetheless, there was still hope that the FDA would fairly and carefully review the science in PMTAs filed. That hope has been dashed. At a June 11, 2021, public meeting, the FDA’s Center for Tobacco Products’ (CTP) Office of Science (CTPOS) detailed its PMTA review process. 1 Of note, the FDA “created a separate queue for the manufacturers with the largest market share” (e.g., Juul and large tobacco companies), triaging their review since doing so would have “the greatest public health impact.” Alternatively, the FDA randomized the review of small manufacturer PMTAs for predominantly flavored open systems. Further, the FDA said it wouldn’t be able to review all PMTAs by Sept. 9, 2021, but would decide the large manufacturer PMTAs by then and continue to review the small manufacturer PMTAs thereafter. Importantly, when specifically asked about PMTAs with “no long- term health data,” the CTPOS responded, “So if there is missing information like no long-term health data about the product, we would … likely send a deficiency letter.” However, the CTPOS went on to volunteer that “public data” was sufficient as long as the “application clearly explain[ed] how that data is applicable to the product subject to the application.” Hence, product-specific long-term studies were not a PMTA requirement. Little did the CTPOS know, all of that was about to change. On June 23, 2021, the FDA’s acting commissioner, Janet Woodcock, testified before Congress. Woodcock was first confronted with a video in which kids directly implored her to remove all flavored e-cigarettes from the market. Then, committee members demanded that Woodcock deny Juul’s PMTAs and deny any flavored e-cigarette PMTAs, claiming it was her responsibility to protect kids regardless of the science. The hearing was a disaster for Woodcock, who seemed unprepared to defend the FDA’s scientific process or its dedicated employees and who clumsily admitted she had never heard of the FDA’s Tobacco Products Scientific Advisory Committee. What happened next was a surprise even to those inside the FDA. Woodcock got involved over the next couple weeks and “tasked” the CTPOS to implement a “new plan” to “take final action” on as many flavored ENDS applications as possible by Sept. 9, 2021, completely changing the FDA’s focus. On July 9, 2021, the CTPOS documented Woodcock’s instructions and its new “fatal flaw analysis”: “The absence of [randomized control trials or longitudinal cohort studies] is considered a fatal flaw, meaning any application lacking this evidence will likely receive a marketing denial order [MDO].” 2 Not only must applicants prove each specific flavored product helps smokers quit; they also must prove quit rates at levels greater than tobacco and menthol When the FDA Abandons Science