On April 22, 2020, the U.S. District Court for the District of Maryland modified its July 12, 2019 Remedies Order (the “Remedies Order”) in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.) to extend the May 12, 2020 premarket application deadline to September 9, 2020 for all deemed tobacco products (e.g., e-cigarettes, cigars, hookah, etc.) on the market as of August 8, 2016. Although the vapor[i] and cigar industries’ appeal of the Remedies Order is still pending with the U.S. Court of Appeals for the Fourth Circuit, in light of the exceptional circumstances presented by the global coronavirus outbreak, on March 30, 2020 the Food and Drug Administration (“FDA”) requested the District Court to extend the compliance date by 120 days.
FDA Commissioner Dr. Stephen Hahn said in a statement announcing the extension that “the coronavirus pandemic has drastically impaired the ability [of manufacturers] to adhere to this timeline” and that the extension was requested “solely as a result of the pandemic and these exceptional and unforeseen circumstances.” FDA received numerous inquiries from companies expressing concern that they could not meet the May 12, 2020 deadline because of the outbreak. Small vapor companies in particular have faced severe disruptions to their businesses, as their suppliers, third-party laboratories and staff comply with stay-at-home orders and social distancing policies, making the already difficult task of preparing and filing Premarket Tobacco Product Applications (“PMTAs”) by the original deadline virtually impossible. Hahn also noted that many personnel from FDA’s Center for Tobacco Products “have been deployed to work on COVID-19 pandemic issues for the U.S. Public Health Service (PHS), leaving fewer staff to process applications.”
The Appeal Continues with the Fourth Circuit
The District Court’s new order follows on its April 3, 2020 indicative ruling, stating that it would grant the 120-day extension if permitted by the Fourth Circuit, and the Fourth Circuit’s subsequent limited remand of the litigation for that purpose. None of the parties to the litigation opposed the limited remand to modify the deadline,[ii] as the 120-day extension is critically needed for both FDA and small businesses impacted by the pandemic. However, the limited remand does not disrupt the Fourth Circuit’s ability to resolve the underlying issues in the ongoing appeal of the District Court’s Remedies Order, which shortened the PMTA deadline previously established by FDA’s 2017 compliance policy guidance by more than 2 ½ years from August 8, 2022 to May 12, 2020. As discussed below, the Fourth Circuit could rule on the merits at any time, but we do not anticipate the deadline moving back to any date sooner than September 9.
In a prior Merits Decision, issued on May 15, 2019, the District Court held that FDA’s 2017 compliance policy guidance, which set the August 8, 2022 premarket application deadline for non-combustible deemed tobacco products (i.e., e-cigarettes), was improperly promulgated without any notice and comment rulemaking in violation of the Administrative Procedure Act (“APA”).[iii] However, rather than remanding the case back to FDA to initiate such rulemaking procedures, the District Court established its own 10-month compliance policy (at FDA’s suggestion), and set the categorical premarket application deadline for all deemed tobacco products on the market as of August 8, 2016 to May 12, 2020. The new deadline applies to companies pursuing Substantial Equivalence (“SE”) Reports and SE exemption requests, such as cigar, pipe tobacco and hookah manufacturers, as well as PMTAs, such as e-cigarette and e-liquid manufacturers. Just last week, FDA updated its website containing resources for companies preparing these premarket submissions.
In October 2019, the Vapor Associations successfully intervened in the case brought against FDA by the public health groups, and appealed the Remedies Order to the Fourth Circuit. In January 2020, the Fourth Circuit denied the Vapor Associations’ motion to stay the May 12 deadline, but granted the motion to expedite the proceedings.[iv] The Fourth Circuit further ordered that the Vapor Associations and the cigar associations, who are still appealing the denial of their intervention request, to file combined briefs moving forward.
In January 2020, before briefing began in the Fourth Circuit, FDA published a new Enforcement Priority Guidance for E-Cigarettes (the “January Guidance”). While the focus of the January Guidance was on the elimination of the compliance policy altogether for flavored cartridge-based e-cigarettes and other products purportedly targeting minors (see recent Warning Letters), FDA also used the guidance to adopt the court-ordered May 12 deadline for all other currently marketed deemed tobacco products.
In their briefs (all linked below), the Vapor Associations argued that the District Court’s Remedies Order should be vacated, and that only FDA has the authority to categorically modify the premarket application deadline through formal notice and comment rulemaking, as required by Section 553 of the APA and the District Court’s own Merits Decision. Otherwise, the Remedies Order was, in essence, an “across-the-board” industry-wide legislative rule, just like the 2017 guidance that was vacated by the District Court and should have instead gone through formal notice and comment rulemaking.
Among other things, both FDA and the public health groups argued that FDA’s adoption of the May 12 deadline in the January Guidance was done independent of the District Court’s Remedies Order and, therefore, that the Vapor Associations’ appeal was now moot.[v] But the Vapor Associations countered that FDA’s new guidance could not moot the appeal because it did not correct the very problem that has been raised in the appeal – that the District Court does not have authority to impose a deadline because only FDA, through formal notice and comment rulemaking, can do so. As the January Guidance was not adopted following such notice and comment procedures, the Vapor Associations’ appeal has not been mooted and the Fourth Circuit has an obligation to decide the appeal.[vi]
Briefing in the appeal was completed in February 2020, and oral arguments were held virtually via video conference on March 18, 2020 (due to coronavirus restrictions). Links to all the legal briefs can be found below.
At this point, it is not entirely clear how the Fourth Circuit is going to proceed. While it can issue an opinion on the merits at any time, and in fact had granted the Vapor Associations’ motion to issue a decision before the May 12, 2020 deadline, the 120-day extension may prompt the Fourth Circuit to hold off for now and then reassess its options in late Summer or early Fall, before the new September 9 deadline. And there are indications that this is the approach that the Fourth Circuit is taking. It has asked the parties to file with the Court monthly status reports for the time-being, a requirement that presumably would not be needed if the Court was going to resolve this suit on the merits in the coming weeks.
- Vapor and Cigar industries opening brief
- FDA opening brief
- Public health reply brief
- Vapor and Cigar industries response
- FDA response
- Oral argument (recording)
Amicus Briefs supporting Vapor Associations
- Michael Siegel
- Consumer Advocates for Smoke-free Alternatives Association
- Washington Legal Foundation
Amicus Briefs supporting Public Health Groups