In May, we wrote about the Trump administration’s first major enforcement action involving the importation of unauthorized e-cigarettes, in which the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) seized products valued at nearly $34 million. FDA and CBP have once again seized unauthorized e-cigarettes in Chicago, but this time the estimated retail value was $86.5 million — the largest seizure of its kind. This enforcement action is consistent with a statement on FDA’s website: “[e]nforcing against unauthorized ENDS products, including unauthorized products popular with youth, are [sic] among our highest enforcement priorities.” FDA maintains that decisions about whether to take enforcement action will continue to be made on a case-by-case basis after considering youth use and other risk factors.
Drawback Claims Are Increasingly a Boon for Cigarette Importers
Importers of smoking tobacco products, particularly cigarettes, are increasingly saving millions in federal excise taxes by employing a refund mechanism known as the “drawback.”
High Court E-Cig Ruling Opens Door For FDA Challenges
This article was originally published on August 29, 2025 on Law360 and is republished here with permission.
On June 20, in U.S. Food and Drug Administration v. R.J. Reynolds Vapor Co., the U.S. Supreme Court concluded that marketing denial orders issued by the FDA regarding new tobacco products can be challenged not only by the applicants — typically, the manufacturer or importer of the products — but also by retailers of such products.[1]
FDA Sued Over Years-Long Internal Review of Flavored ENDS MDO
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.
Court Denies Indian Tribe’s Injunction Request Pending Appeal in PACT Act Case
We recently wrote about a federal case here and here involving key issues related to the Bureau of Alcohol, Tobacco, Firearms and Explosives’ (ATF) authority to enforce the Prevent All Cigarette Trafficking Act (PACT Act) against federally recognized Indian tribes and ATF’s interpretation of key sections of the PACT Act. In addition to appealing the U.S. District Court for the Central District of California’s decision, we noted that the Twenty-Nine Palms Band of Mission Indians (the Tribe) asked the district court to require ATF to remove it from the agency’s PACT Act noncompliant list (NCL) and prevent ATF and the other defendant, the Department of Justice from taking action against it pending its appeal before the U.S. Court of Appeals for the Ninth Circuit. On July 30, the federal district court denied the Tribe’s request.
Are State ENDS Directories Preempted? Federal Courts Are Split
Over the past two years, at least 14 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in order to be sold in the state. This year, several of these laws have been challenged, and a clear split is beginning to emerge among state courts regarding whether the state laws are enforceable.
Indian Tribe Fights With ATF Over Applicability of PACT Act to Its Cigarette Sales
In 2023, the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) placed Twenty-Nine Palms Band of Mission Indians (Twenty-Nine Palms), a federally recognized Indian tribe that sells cigarettes on sovereign reservations in California, on the Prevent All Cigarette Trafficking Act’s (PACT Act’s) noncompliant list (NCL). The PACT Act generally prohibits common carriers from shipping products to or from companies on the NCL. After ATF placed Twenty-Nine Palms on the NCL, the tribe sued ATF and its parent agency, the Department of Justice (DOJ), in federal court. This case is worth following because it involves key issues related to ATF’s authority to enforce the PACT Act against federally recognized Indian tribes and ATF’s interpretation of key sections of the PACT Act.
Sam’s Club Eyeing Appeal of Hefty Local Tobacco Tax Assessment
In June, the Appellate Court of Illinois upheld an assessment of over $314 million against Sam’s Club for unpaid county cigarette excise taxes, including a 10% late fee, a 25% penalty, and accrued interest. The assessment arose from Sam’s Club’s alleged failure to pay taxes on cigarettes that it sold to out-of-county retailers from 2009 to 2016. Following the June ruling, the company now appears poised to bring its arguments to the state’s highest court in a case illustrating the ambiguities of state and local excise taxation laws.
Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders
On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the products), but also by retailers who would sell such products. As a result, more challenges to MDOs are likely to be brought before the U.S. Court of Appeals for the Fifth Circuit, where litigants have generally had greater success to date in challenging MDOs relative to other appellate courts.
New Mississippi Cigarette and ENDS Directory Laws Take Effect in July
Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The law, enacted through HB 916, creates separate directories for cigarettes, including roll-your-own (RYO) tobacco, and Electronic Nicotine Delivery Systems (ENDS) products, such as e-cigarettes and vapes.