On August 21, 2025, NJOY, LLC (NJOY), a subsidiary of Altria Group, Inc., sued the U.S. Food and Drug Administration (FDA), alleging that the agency has unlawfully delayed rendering a decision on supervisory review of its June 2022 marketing denial order (MDO) for certain flavored, disposable electronic nicotine delivery systems (ENDS).
As we recently covered here, FDA has struggled to control the proliferation of ENDS products that are not in compliance with premarket authorization requirements. Flavored illicit disposable ENDS have been particularly dominant in the face of lacking federal enforcement. This litigation is significant because it highlights another key reason for the illicit products’ dominance: FDA’s failure to timely act on premarket submissions for flavored ENDS.
Background: NJOY Seeks Premarket Authorization
In March 2020, NJOY submitted premarket tobacco product applications (PMTAs) for eight variations of its NJOY DAILY line of disposable ENDS products. The PMTAs sought authorization of two menthol-flavored products, two tobacco-flavored products, and four products with flavors other than tobacco or menthol (other-flavored products).
In December 2020, FDA issued a deficiency letter, asserting that the four PMTAs for other-flavored NJOY DAILY failed to demonstrate that such products “would increase the likelihood of complete switching among adult smokers, compared to” the tobacco- and menthol-flavored varieties. NJOY submitted a response in March 2021 that provided detail on its survey procedures, included six-month outcome data from its user study, and argued that the data demonstrated the requisite switching benefit of the flavored products.
Nonetheless, in June 2022, FDA authorized the marketing of the tobacco- and menthol-flavored NJOY DAILY variants but issued an MDO for the other-flavored varieties. NJOY then sought administrative reversal of the MDO through supervisory review—an internal agency mechanism whereby a “decision of an FDA employee … is subject to review by the employee’s supervisor” at an interested person’s request. See 21 C.F.R. § 10.75(a)(3). FDA acknowledged and accepted NJOY’s request for supervisory review in November 2022, and the review has remained pending since that time.
The Current Litigation
NJOY (along with wholesalers and retailers of its products) filed its complaint against FDA in the U.S. District Court for the Western District of Louisiana. Initiating this litigation in the Fifth Circuit follows the previous example set by R.J. Reynolds Vapor Company, which successfully established venue by suing alongside local retailers from the desired jurisdiction. See FDA v. R.J. Reynolds Vapor Co., 145 S. Ct. 1984. In NJOY, LLC et al. v. FDA et al., No. 6:25-cv-1210, NJOY seeks an order compelling FDA to adjudicate the pending supervisory appeal of the MDO for the other-flavored NJOY DAILY products.
NJOY’s complaint rests on three legal theories: (1) NJOY is entitled under the Administrative Procedure Act (APA) to an order compelling FDA to adjudicate the supervisory appeal because FDA is required to issue a decision “within a reasonable time,” see 5 U.S.C. § 555(b); (2) NJOY is entitled under the Mandamus Act and All Writs Act to an order compelling FDA to adjudicate the supervisory appeal—either because of unreasonable delay under the APA or because a writ is necessary because further agency process would be futile, see 28 U.S.C. §§ 1361, 1651; and (3) NJOY is entitled under the Declaratory Judgment Act to a declaratory judgment that FDA must decide the supervisory appeal within a reasonable time, see 28 U.S.C. § 2201.
Why It Matters
Illicit ENDS have flooded the U.S. market in recent years due in large part to FDA’s failure to: (1) authorize new products (particularly flavored products); (2) provide clarity regarding enforcement discretion; and (3) sufficiently enforce premarket review requirements. FDA has declined to provide public assurances of its enforcement discretion policy for certain timely filed, pending PMTAs, which creates ambiguity about which products may be lawfully sold without full marketing authorization. Given that the agency appears to continue practicing enforcement discretion, a simple articulation of the underlying policy would provide clarity for industry stakeholders. Further, although FDA has stepped up its enforcement efforts, the market remains crowded with illicit products. The resulting environment lacks transparency about which products are subject to enforcement discretion, all while truly illicit products flood the market in the face of insufficient enforcement and artificially limited competition from authorized products.
This litigation implicates an important aspect of FDA’s failure to timely authorize new products—the indefinite limbo of supervisory review. Should NJOY prevail, its victory may establish a model for other applicants that would seek to compel a resolution of supervisory review of their PMTAs. Even if FDA were to deny the supervisory appeal, the final agency decision would allow NJOY to bring its arguments on the merits to federal court.
