12 Days of Regulatory Insights: Day 7 – Tobacco and Nicotine Regulatory Roundup — Regulatory Oversight Podcast
12 Days of Regulatory Insights: Day 9 - Trends in the Tobacco Industry — Regulatory Oversight Podcast
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...more
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...more
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...more
The U.S. Food and Drug Administration (FDA) has recently filed civil actions in federal court highlighting a crackdown on a black market that, in many cases, exists in plain sight. Vapes and electronic cigarettes...more
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...more
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...more
Over the past two years, at least 15 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...more
In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more
In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more
In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine,...more
On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more
Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more
On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more
On December 17, 2024, 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...more
The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...more