On October 27, the 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 the 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 the launch of a pilot program aimed at streamlining the agency’s review of certain premarket tobacco product applications (PMTAs) for modern oral nicotine pouches.
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.
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).
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.
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.
Connecticut Attorney General (AG) William Tong has taken legal action against two online distributors, Triggered Brand and Made In China, for allegedly selling research-grade GLP-1 weight loss drugs directly to Connecticut consumers without prescriptions or medical oversight. These drugs, marketed as research compounds, lack Food and Drug Administration (FDA) approval for human use. The lawsuit against Triggered Brand alleges violations of the Connecticut Unfair Trade Practices Act (CUTPA) and seeks civil penalties. Additionally, Tong has issued a civil investigative demand to Made In China to gather information regarding its marketing and sales practices.
We previously wrote about this case last January, here and here, when Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa Department of Revenue (the Department), challenging Iowa House File 2677 (HF 2677), a law imposing certification and directory requirements on vapor products sold in Iowa. On May 2, the court granted plaintiffs’ motion for preliminary injunction and enjoined the Department from implementing and enforcing HF 2677’s vapor product directory provisions. The court held that the Department could, however, continue to enforce the provisions of HF 2677 requiring nonresident vapor product manufacturers not registered to do business in the state as a foreign corporation or business entity to appoint and continually engage an agent for service of process. The parties have a status conference before the court scheduled for May 29.
In recent years, the safety of baby food has become a top priority for state attorneys general (AG) and federal agencies. In April 2021, the U.S. Food and Drug Administration (FDA) announced its “Closer to Zero” plan to “reduce dietary exposure to contaminants to as low as possible, while maintaining access to nutritious foods.” However, multiple coalitions of state AGs have been vocal in advocating for more stringent and urgent measures. Over the last four years, these coalitions have urged the FDA to take decisive action to ensure the safety of baby food products, particularly as it relates to the presence of toxic metals. In January 2025, the FDA issued final guidance setting action levels for lead in processed foods intended for babies and young children under the age of two.