Bryan Haynes and Agustin Rodriguez of the Troutman Pepper Tobacco + Nicotine team will attend the Food and Drug Law Institute 2023 Enforcement Conference on Wednesday, December 6 in Washington D.C.

The conference will have two panels discussing hot topics in tobacco and nicotine enforcement and litigation matters.  Bryan Haynes will moderate a panel discussing tobacco and nicotine product enforcement challenges, including as related to electronic nicotine delivery systems and the FDA’s contemplated bans on menthol cigarettes and cigar characterizing flavors.

We look forward to seeing our clients and friends at the conference.

Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an (indirect) effort to force them to comply with federal and state laws. R.J. Reynolds Tobacco Company and R.J. Reynolds Vapor Company (collectively, RJR) also recently filed a complaint with the U.S. International Trade Commission (ITC) against more than 25 foreign and domestic manufacturers, distributors, and retailers (collectively, the respondents) that seeks to prevent the import and resale of certain tobacco products. These lawsuits serve as two examples of how industry is trying to take independent legal action to target allegedly noncompliant actors and force them to comply with applicable law.

Continue Reading ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

A new bill, the “Tobacco Tax Equity Act of 2023” (S.2929 and H.R.5715) has been introduced in the U.S. Senate and House of Representatives.  The bill would:

  • double the federal tobacco products excise tax on cigarettes, small cigars and roll-your-own tobacco,
  • increase the pipe tobacco tax rate to the same rate as roll-your-own tobacco (a 2000% increase),
  • increase the tax on moist snuff by 2000%,
  • increase the tax on large cigars under a new weight-based methodology,
  • establish a new tax on smokeless tobacco sold in “discrete single-use units” (such as modern oral nicotine) at $100.66 per thousand units, and
  • establish a new tax on electronic nicotine delivery systems, at a rate equivalent to the tax imposed on cigarettes.

All of these taxes would increase annually with inflation.

Similar legislation has been introduced in previous sessions of Congress, without success.

We will continue to monitor this bill for further developments.

In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products. Notably, FDA’s most recent letters target several popular disposable flavored products, including Elf Bar, EB Design, Lava, Cali, Bang, and Kangertech, which FDA states are particularly appealing to youth. FDA also sought civil money penalties against 22 retailers for failing to comply with prior warning letters and, for the first time, sought the maximum penalty allowed by law.

Continue Reading FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount

Over the last decade, hundreds of localities have passed ordinances restricting or prohibiting the sale of some or all types of tobacco products. Some of these ordinances have been challenged in court, but, in most cases, the localities have prevailed. In this case, a group of retailers (the Retailers), sued Multnomah County, Oregon (the County) in January 2023 alleging that the County’s flavored tobacco product ban was unlawful. Earlier this month, consistent with the overall trend, the court ruled against the Retailers and upheld the County’s flavor ban.

Continue Reading Oregon Court Upholds Local Tobacco Product Flavor Ban

Last summer, we wrote about the Iowa Attorney General’s $133 million suit against the tobacco manufacturers that are signatories to the Master Settlement Agreement (MSA).  Brought in Iowa state court, this suit alleged that those manufacturers (commonly referred to as “Participating Manufacturers”) acted in bad faith by disputing (and delaying the ultimate payment of) the amounts they owe to the state under the MSA. On August 22, 2023, Iowa compromised its past and future claims under the lawsuit and joined 37 other states that have settled similar disputes. Iowa Attorney General Brenna Bird announced that the state reached a settlement with the Participating Manufacturers that will result in the state receiving payments of more than $171 million over the next six years.  

Continue Reading Iowa Reaches MSA Settlement with Tobacco Manufacturers, Ending 18-Year Legal Dispute

On August 22, 2023, the Troutman Pepper Tobacco + Nicotine Team attended the Food and Drug Administration’s Center for Tobacco Products (“CTP”) virtual listening session on the development of CTP’s strategic plan.  We previously blogged about CTP’s intent to issue a finalized five-year strategic plan by December 2023, including the agency’s five proposed strategic goals. 

Continue Reading Takeaways from Listening Session on the Development of FDA’s Center for Tobacco Products Strategic Plan

Oregon has enacted a new “equity assessment” upon non-signatories to the tobacco Master Settlement Agreement (MSA).  We previously blogged about the bill’s introduction. The law replaces Oregon’s escrow deposit system, applicable to tobacco product manufacturers that are nonparticipating manufacturers (NPMs) under the MSA, with an equity assessment.

Continue Reading Oregon Imposes New “Equity Assessment” on Certain Manufacturers

The Food and Drug Administration’s Center for Tobacco Products (“CTP”) will hold a two-day public meeting on the agency’s premarket tobacco product application (“PMTA”) process. The meeting will be held October 23-24 and can be attended in person in Silver Spring, Maryland, or online.

CTP’s press release indicates that staff from the Office of Science will present on topics related to the PMTA process and answer questions from stakeholders. Additional information, including registration and a process to submit questions, will be available soon.

The Troutman Pepper Tobacco + Nicotine team will participate.  Anyone interested in the PMTA process or wanting to provide feedback to CTP is encouraged to participate.

Yesterday, August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016 rule that swept all tobacco products under the same set of regulations.  In previous decisions, the District Court already had vacated the portions of the Deeming Rule that required premium cigars to display health warnings on packaging and advertising and to engage in the burdensome premarket authorization process. 

Continue Reading U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars