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]
The Agriculture Improvement Act of 2018 (the 2018 Farm Bill) legalized industrial hemp for commercial use to support American farmers and create a regulated industrial hemp market. The 2018 Farm Bill defined “hemp” as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol [THC] concentration of not more than 0.3 percent on a dry weight basis.” The 2018 Farm Bill also removed hemp from the definition of “marihuana” under the Controlled Substances Act. Since 2018, many in the hemp industry have relied on language in the 2018 Farm Bill’s definition of “hemp” (sometimes referred to as the 2018 Farm Bill loophole) to take the position that it authorizes the production and sale of intoxicating, hemp-derived THC products (e.g., beverages, gummies, candies, etc.) that are derived from cannabis plants containing less than 0.3% delta-9 THC on a dry-weight basis. On October 24, the National Association of Attorneys General (NAAG) sent a letter to congressional committee chairs, signed by 39 state and U.S. territory attorneys general (AGs), urging immediate legislative action to close the loophole.
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.
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.
Importers of smoking tobacco products, particularly cigarettes, are increasingly saving millions in federal excise taxes by employing a refund mechanism known as the “drawback.”
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).
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.
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.
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.
On July 17, the U.S. House Committee on Agriculture hosted a closed-door roundtable briefing focused on the regulatory gray areas surrounding hemp-derived cannabinoid products. The session, convened in response to ongoing concerns over consumer safety, regulatory ambiguity, and market disruption, featured expert insights from four panelists: Jonathan Miller, general counsel for the U.S. Hemp Roundtable; Pamela Epstein, chief legal and regulatory officer at Terpene Belt Farms; Cole White, attorney at Troutman Pepper Locke, in his capacity as special counsel for the Attorney General Alliance; and Dr. Gillian Schauer, executive director of the Cannabis Regulators Association. The discussion reflected mounting congressional interest in addressing the unintended consequences of the Agriculture Improvement Act of 2018’s (2018 Farm Bill) legalization of hemp and its derivatives.