Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products.

On April 15, 2022, Judge Paul W. Grimm of the U.S. District Court for the District of Maryland ordered  FDA to submit status reports to the Court and to the Plaintiffs in the case every ninety days, beginning on April 29^th.

• The status reports will relate to pending premarket tobacco applications (“PMTAs”) filed on or before September 9, 2020, and that are 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.”
• FDA’s first report, due April 29^th, must state the estimated percentage of those PMTAs on which it expects – by June 2022, and quarterly thereafter – to have issued a marketing order, refuse-to-accept letter, refuse-to-file letter, or marketing denial order.
• In status reports due in later quarters, FDA must report revisions to its earlier estimates.

Judge Grimm ordered the status reports in a Revised Remedial Order, adding to other matters earlier ordered on July 12, 2019; August 12, 2019; and April 22, 2020.  The case is American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.).

Background

It is difficult to understate the practical significance of this case to the industry (in preparing and submitting PMTAs to keep their products on the market) and to FDA (in processing and acting on numerous PMTAs).

• In August 2017, FDA issued guidance effectively extending deadlines for requests for marketing authorization for new tobacco products into 2021 and 2022.
• On May 15, 2019, the Court held that the guidance was unlawful and vacated it.
• On July 12, 2019, the Court ordered FDA to require the filing of requests for marketing authorization for new tobacco products on or before May 12, 2020 – later extended to September 9, 2020, because of the coronavirus – and also ordered that new tobacco products with requests for marketing authorization meeting that deadline “may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application.”*

Related to their request for Court-ordered deadlines, the Plaintiffs had asked Judge Grimm to require FDA status reports.  Although Judge Grimm decided not to require status reports in his July 12, 2019 order (because of “the steps that FDA has outlined with respect to its coordinated approach” and “the timetable that [FDA] proposed” and he approved), he did “retain jurisdiction to ensure that, if the need arises, further action could be taken by the Court.”

Grounds for the Revised Remedial Order

Judge Grimm issued the above-referenced Revised Remedial Order after the Plaintiffs, on November 15, 2021, requested an order for regular FDA status reports.  The Plaintiffs argued that circumstances had significantly changed since the Court’s order of July 12, 2019, in that (1) FDA had not issued marketing orders or marketing denial orders for products with larger market shares; and (2) it appeared that FDA had not enforced premarket review requirements against any firms whose PMTAs remained pending with FDA.  The Plaintiffs argued that regular FDA reporting would allow the Court to assess FDA’s ongoing compliance with earlier orders.

FDA opposed the Plaintiffs’ request, responding that regular status reports were “not warranted at this time” and referencing its “substantial progress in reviewing an unprecedented number of” PMTAs.  At the time of its filing on December 13, 2021, “FDA has resolved about 98% of the timely” PMTAs, covering approximately 6.4 million out of the “over 6.5 million tobacco products.”  FDA also noted its regulatory efforts (including warning letters) regarding products lacking premarket authorization and its ongoing litigation with various manufacturers over marketing denial orders.

Judge Grimm held that “Plaintiffs have satisfied their burden of showing significant factual changes that support modifying the remedial order at this time.”  While acknowledging FDA’s progress in reviewing timely PMTAs, Judge Grimm stated that allowing popular products to remain on the market unreviewed “is inconsistent with the purpose of this Court’s judgment” on the merits earlier in the case.  “Plaintiffs’ proposed reporting requirement will inform the Court and public when FDA expects to take action on those products that account for the largest share of the market.  The reporting is tailored to allow the Court to assess FDA’s progress, or lack thereof, towards achieving the goals of the remedial order.”

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We will monitor for further developments.

* On May 4, 2020, the U.S. Court of Appeals for the Fourth Circuit dismissed an FDA appeal as mooted by FDA’s issuance of new guidance adopting the PMTA deadlines from Judge Grimm’s order.