Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares. FDA estimates that it will resolve most of these in the periods before July 2022 and from April through June 2023.
Pursuant to an order entered by Judge Paul W. Grimm in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), on May 13, 2022, FDA filed its first status report regarding its review of pending premarket tobacco applications (“PMTAs”) for certain popular vapor products.
As this blog previously reported, Judge Grimm’s order required reports on the status of pending PMTAs filed on or before September 9, 2020, for new tobacco products: (1) sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, or Puff Bar; or (2) that “reach 2% of total ‘Retail $ Sales’ in Nielsen’s ‘Total E-Cig Market & Players’ or ‘Disposable E-Cig Market & Players’ reports before FDA has completed its review of existing Status Report Products.” Judge Grimm ordered that FDA file the reports quarterly, including estimates of how many of these PMTAs it expects to have resolved (by marketing order, refuse-to-accept letter, refuse-to-file letter, or marketing denial order) by June 2022 and quarterly thereafter.
In its May 13 status report, FDA identified 240 pending PMTAs covered by the Court’s order and estimated that it will have resolved:
- 51% (or approximately 122) by June 30, 2022;
- 52% (or approximately 125) by September 30, 2022;
- 56% (or approximately 134) both by December 31, 2022, and by March 31, 2023; and
- all of the 240 by June 30, 2023.
FDA qualified that these “estimates represent the FDA’s best forecast based on current information.”
In its report, FDA explained that its “progress largely reflects the review priorities that the agency established in 2020, when review began.” FDA prioritized review of PMTAs from manufacturers with the largest market shares at the time, and as of May 13, it estimates that it will have resolved 63% of those PMTAs by June 30, 2022, and 72% of them by the year’s end. FDA “allocated significant resources to review applications from the five companies whose brands represented over 95% of the e‑cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse).” This focus was intended to prioritize review of PMTAs for products that were more prevalently-used and, therefore, “expected to have the greatest impact on public health.”
Providing additional context for its estimates, FDA stated that “not every Covered Application has an equal potential impact on the public health.” More than 25% of the pending PMTAs covered by the Court’s order are for products that are not on the market. And acknowledging that pending PMTAs are for varying numbers of components relative to particular devices, FDA estimated that – of the PMTAs it expects to resolve by the year’s end – “more than half are for components of a limited number of e‑cigarette device systems representing under 2.5% of the e‑cigarette market.”
On May 16, Judge Grimm responded by thanking FDA for its status report and advising that its next quarterly report is due on or before July 29.
It remains to be seen which still-pending PMTAs for popular products will be resolved and when, but FDA estimates that it will resolve several before July (which presumably includes recent determinations for NJOY products), twelve in the latter half of 2022, and the remaining 106 during the period of April through June 2023. The 240 pending PMTAs referenced in FDA’s status report were all filed on or before September 9, 2020. Congress required FDA to issue a marketing order or a marketing denial order “[a]s promptly as possible, but in no event later than 180 days after the receipt of” a PMTA, 21 U.S.C. § 387j(c)(1)(A); cf. 21 C.F.R. §§ 1114.9(b) & .27(c); however, this has not happened. Meanwhile, FDA is in litigation with vapor product manufacturers across the country over marketing denial orders that it has issued so far.
We will monitor for further developments.