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On October 27, FDA appealed a decision of the U.S. District Court for the Southern District of Georgia that vacated the agency’s 2020 rule requiring graphic health warnings on cigarette packaging and advertisements.  This appeal to the U.S. Court of Appeals to the Eleventh Circuit, along with a separate challenge pending before the Fifth Circuit, may determine whether FDA’s second attempt to impose graphic health warnings on cigarettes will be successful.[1]

In September, the U.S. Food and Drug Administration (FDA) announced that it has launched a pilot program aimed at streamlining the agency’s review of certain premarket tobacco product applications (PMTAs) for modern oral nicotine pouches.

The announcement notes that evidence suggests nicotine pouches can help adults switch away from more harmful tobacco products. Although nicotine pouch PMTAs will still be subject to the traditional case-by-case review, FDA says the pilot program will “increase efficiency by focusing review on the most critical elements for this product category to determine whether permitting the marketing of a product is appropriate for the protection of the public health.”

An Ohio appellate court recently affirmed the dismissal of a case brought by the Ohio attorney general (AG) against Central Tobacco & Stuff Inc. (Central Tobacco), an e-cigarette retailer, in which the AG alleged that Central Tobacco sold e-cigarettes lacking FDA premarket authorization and violated the state’s Consumer Sales Practices Act (CSPA) by failing to inform consumers about the lack of FDA authorization. See State ex rel. Attorney Gen. Dave Yost v. Cent. Tobacco & Stuff Inc., 2025-Ohio-4613 (Ct. App.). This appears to be a novel use of a state consumer protection law, which most states have, to attempt to enforce the Federal Food, Drug, and Cosmetic Act (FDCA). The court concluded that federal law preempts Ohio’s ability to enforce FDCA premarket authorization requirements through the CSPA. The court’s decision may be relevant in other cases involving a state’s attempt to enforce FDA premarket authorization requirements through their consumer protection laws.

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.

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]

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.

In early August, the U.S. District Court for the Northern District of Texas ruled that the civil money penalty (CMP) provision in the Food, Drug, and Cosmetic Act (FDCA) for tobacco products, 21 U.S.C. § 333(f)(9), is unconstitutional. Specifically, the court found that the FDCA improperly allows the U.S. Food and Drug Administration (FDA) to bring an administrative action to collect CMPs because the Seventh Amendment guarantees the right to a jury trial in such cases.

In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be revived under a future administration, the withdrawal ends both of the current rulemaking processes. The move also strongly indicates shifting FDA priorities under the second Trump administration. Amid these changes, industry may find the agency more receptive to its arguments—particularly those submitted in comments to proposed rulemaking.