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.
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.
Troutman Pepper Locke Tobacco + Nicotine Team to Attend the Next Generation Nicotine Delivery Conference
Bryan Haynes, Agustin Rodriguez and Michael Jordan of the Troutman Pepper Locke Tobacco + Nicotine team will attend the Next Generation Nicotine Delivery Conference in Miami, Florida next week.
This conference will address ongoing changes at the Food and Drug Administration Center for Tobacco Products, legal updates, tax issues, product
California and Denver Impose New Restrictions on Nicotine Analog Products
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, but also nicotinic alkaloids and nicotine analogs.
Supreme Court Weighs Vape Venue Dispute
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.
Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”
Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). As we have previously discussed here and here, FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium cigars to the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act (TCA). On January 24, the U.S. Court of Appeals for the District of Columbia Circuit (the D.C. Circuit) issued an opinion agreeing[1] with (i) the district court’s ruling that FDA acted arbitrarily and capriciously when it sought to include premium cigars in its Deeming Rule and (ii) the district court’s vacatur of the Deeming Rule as applied to premium cigars, but it remanded the case to the district court to determine the appropriate definition of “premium cigar.” Now, the district court will reconsider the appropriate definition of “premium cigar,” which will ultimately determine the types of cigars that are not subject to the TCA and FDA’s Deeming Rule. In one potential setback for industry, the D.C. Circuit also stated that it understood the district court’s order as granting relief from user fees prospectively but that it does not read it as permitting the refunding of past user fee payments.
12 Days of Regulatory Insights: Day 9 – Trends in the Tobacco Industry
In the ninth episode of our 12 Days of Regulatory Insights podcast series, Michael Jordan, a member of the firm’s Tobacco + Nicotine practice, is joined by colleagues Bryan Haynes and Agustin Rodriguez to delve into the regulatory landscape of the tobacco industry in 2024 and what to expect in 2025. Bryan, head of the firm’s Tobacco + Nicotine practice, and Agustin, also a member of the Tobacco + Nicotine practice, discuss the increased state-level actions against illicit flavored e-cigarettes due to FDA’s inaction. They highlight efforts by state AGs to combat these products, including issuing letters to retailers and establishing product registries. The conversation also touches on the anticipated regulatory changes under the new administration, the potential impact on nicotine pouches, and the implications of the Tobacco Master Settlement Agreement (MSA) and the upcoming escrow refunds for nonparticipating manufacturers. Bryan and Agustin provide insights into the evolving regulatory environment and the implications for the tobacco industry in the coming year.
Please join the Troutman Pepper Tobacco + Nicotine team at the 2024 Food and Drug Law Institute Tobacco and Nicotine Products Regulation and Policy Conference on October 24-25, 2024
Bryan Haynes, Agustin Rodriguez, Michael Jordan and Zie Alere will be in attendance.
Bryan will be speaking during the “Recent State Regulatory and Enforcement Activity: Filling Gaps or Impeding Progress” panel. The panel will discuss recent measures enacted by state and local legislators and regulators to combat the illegal e-cigarette
$11M Cigarette Drawback Dispute Could Have Significant Consequences for FTZ Importers
In August, N.C.-based cigarette importer, King Maker Marketing Inc., challenged a decision by U.S. Customs and Border Protection (Customs) that rejected its claims for more than $11 million in drawback duties as untimely.