Consolidated in 4th Circuit with: In re: American E-Liquid, Docket No. 19-02242 (4th Cir. Nov 06, 2019); American Academy of Pediatrics v. American E-Liquid, Docket No. 19-02132 (4th)
Cir. Oct 16, 2019); and In re: Cigar Association, Docket No. 19-02130 (4th Cir. Oct 16, 2019).
Public health groups successfully challenged FDA’s 2017 guidance indefinitely extending premarket review deadlines. FDA issued updated guidance reflecting an expedited schedule. The industry appealed, but the district court’s ruling was upheld by the Fourth Circuit Court of Appeals on May 4, 2020. Due to the COVID-19 pandemic, however, the deadline to submit premarket review applications was extended to September 9, 2020.
Why it Matters for Public Health
Public health groups were able to obtain a court order requiring the FDA to move forward with its premarket review of new tobacco products like e-cigarettes, hookah, and flavored little cigars.
The Tobacco Control Act (TCA) requires “new tobacco products,” defined as those that were commercially marketed after February 15, 2007, to go through a premarket review process and receive affirmative marketing orders before being sold in the U.S. In 2017, the FDA issued guidance announcing its intent to effectively delay the enforcement of that provision for e-cigarettes indefinitely. Public health groups sued to compel FDA’s compliance with the TCA.
District Court Proceedings
After the FDA announced its extension of all premarket review enforcement deadlines for newly deemed products in its August 2017 guidance, public health groups and physicians sued the FDA under the Administrative Procedure Act (APA). The coalition of groups, led by the American Academy of Pediatrics, filed suit in the District of Maryland on March 27, 2018, alleging that (1) the FDA had exceeded its authority under the TCA by authorizing the continued sale of newly deemed products without the required FDA-issued marketing order; (2) the FDA erred procedurally by failing to put out the guidance for public comment, in violation of the APA; and (3) the FDA’s guidance was the result of arbitrary and capricious action because the agency had failed to provide any rationale of its decision to effectively suspend premarket review. As a remedy, the groups requested that the court vacate, or set aside, the guidance.
On July 10, 2018, the public health groups filed a motion for summary judgment on the three claims outlined in their complaint. Additional public health groups, led by the American Thoracic Society, filed an amicus brief in support of the plaintiffs’ motion on July 17, 2018. On August 7, 2018, the FDA filed a motion to dismiss the groups’ lawsuit in conjunction with a brief opposing the plaintiffs’ summary judgment motion.
On November 21, 2018, the FDA filed a notice with the court, informing it of then-Commissioner of the FDA, Scott Gottlieb’s newly announced statement of intent to revise the 2017 guidance in light of the explosion of youth use of e-cigarettes and flavored cigars. Among other things, the notice indicated that the FDA intended to revisit the policy with respect to e-cigarettes and flavored cigars as they are available to and marketed to children, pursue the removal of e-cigarettes marketed to children, propose a product standard that would ban flavors in cigars, and propose a product standard that would ban menthol in combustible tobacco products. The plan to revise the guidance, the FDA argued, further supported its position that the guidance was not “final agency action” subject to judicial review. The public health groups vehemently disagreed in their response, noting that the FDA had merely expressed a future intent to revise the guidance—it had not actually done anything. Further, the public health groups maintained that the proposed revisions still failed to comply with the requirements of the TCA, which requires all new tobacco products to undergo FDA review before they are marketed. The agency did end up issuing a draft guidance document in March of 2019, but the public health groups’ letter to the court in response to that guidance pointed out that the draft guidance perpetuated the problems contained in the earlier guidance, and proposed none of the tobacco product standards discussed in the notice. In short, the revised guidance merely highlighted the scope of the public health impacts caused by the FDA’s inaction and the need for the court’s intervention.
Initially, the court agreed to suspend ruling on the public health groups’ motion for summary judgment (and the FDA’s motion to dismiss the case) until the FDA finalized its draft guidance. However, upon the public health groups’ request for reconsideration, the court granted the their motion for summary judgment and dismissed the FDA’s motion. In his memorandum opinion granting the public health groups’ motion, district court Judge Grimm found, among other things, that (1) the FDA abdicated its statutory duty to review new tobacco products before they entered the market as dictated by Congress; and (2) the APA required the FDA to issue the guidance according to notice-and-comment rulemaking procedures, which the FDA failed to do. The court vacated the 2017 guidance, but requested further briefing on the appropriate remedy.
On July 12, after the submission of numerous amicus briefs and an attempt by several vaping industry groups attempted to intervene in the case, Judge Grimm issued an order setting a ten-month deadline—until May of 2020—for submission of premarket applications for deemed products. The order also provided for a one-year period during which the products for which applications had been submitted by the deadline could remain on the market without being subject to enforcement action by the FDA.
On July 30, 2019, a coalition of e-cigarette industry groups, led by the American E-Liquid Manufacturing Standards Association, filed a notice of appeal, accompanied shortly thereafter by a renewed request to intervene in the case. On September 4, 2019, the cigar industry groups filed their own motion to intervene in the case.
Judge Grimm issued an order by letter on October 2, 2019, allowing the “vapor associations” (e-cigarette trade groups) to intervene for the limited purposes of appealing the summary judgement order and remedy. He denied the cigar associations’ motion to intervene, however, due to the fact that the groups had failed to intervene in the case until final judgment had already been issued.
Proceedings in the Court of Appeals for the Fourth Circuit
The e-cigarette industry groups and the cigar trade associations filed appeals of the district court’s rulings. In early January, 2020, the FDA issued a new guidance document containing the same premarket review application deadlines set by Judge Grimm in the July 12 order. According to an accelerated briefing schedule set by the court, the FDA and the cigar industry groups filed their opening briefs on January 23, 2020. While the industry groups argued that the ruling was incorrect, the FDA’s primary argument was that the industry groups’ appeals were moot due to the newly issued guidance document. In other words, since the new deadlines would be in effect even if the remedy order were vacated, a favorable ruling on appeal wouldn’t provide the industry groups with any relief. The public health groups filed their response brief on February 20, 2020, and the FDA and industry groups filed their reply briefs one week later. The Public Health Law Center, American Thoracic Society, and other public health groups filed a motion to file an amicus brief, but the motion was denied by the court in light of the opposition filed by the cigar industry groups and the expedited briefing schedule. A copy of the PHLC brief is available here.
Due to the evolving Covid-19 pandemic, oral argument was held in front of a three-judge panel via videoconference on March 18, 2020. A recording of the argument is available here.
The global coronavirus outbreak also affected the premarket review application timeline set by Judge Grimm. On March 30, 2020, the FDA filed a notice with the district court stating that both the FDA and the regulated industries faced difficulties in preparing and processing applications due to the pandemic. The FDA requested a 120-day extension, until September 9, 2020, for the submission of applications. The FDA filed a motion for a limited remand with the 4th Circuit on April 3, and on April 21, 2020, the case was remanded to the district court for the limited purpose of revising the timeline. On April 22, 2020, Judge Grimm issued an order modifying the original timeline and providing until September 9, 2020, to submit applications for marketing orders
On May 4, 2020, the three-judge panel of the U.S. Court of Appeals for the 4th Circuit upheld Judge Grimm’s ruling, siding with the FDA in finding that the FDA’s updated guidance mooted the appeal. The Court also dismissed the Cigar industry groups’ motion to intervene in the case.
Both industry appellants filed petitions for rehearing or rehearing en banc (in front of the entire 4th Circuit). On June 30, 2020, the court denied both petitions for rehearing.
While the case has been administratively closed, either party may request that the case be re-opened. On November 15, 2021, plaintiffs motioned to modify the remedial order to require FDA provide status updates on its actions to regulate new tobacco products and namely e-cigarettes. On December 13, 2021, FDA responded in opposition – and so, seeking a Court denial – to the motion, providing as reasons that 1) FDA was making considerable headway on the PMTAs it received, 2) FDA was defending its marketing denial orders against over 48 (at the time) challenges, and 3) FDA’s prioritization for its efforts differing from what plaintiffs would prefer is not “wholesale suspension” of filing and application requirements.
On April 15, 2022, the Court granted the motion to modify the remedial order and require FDA to provide plaintiffs with status reports every 90 days beginning two weeks after the order. As part of its reasoning to support the motion, the Court noted that while FDA had processed most of the PMTA applications it received, they had not moved on the “popular products used by young people…which is inconsistent with the purpose of this Court’s judgment.” These status reports must include FDA’s forecasts for the percentages of PMTAs it expects to have acted on, calculated quarterly, with action comprising marketing orders and refusal letters – and must also reflect action on “the most popular e-cigarette brands that are most deleterious to youthful populations.”