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Advocacy Organizations Sue FDA Over Delay in Menthol Cigarette Ban

On April 2, three advocacy organizations filed a complaint in the U.S. District Court for the Northern District of California seeking an order directing the U.S. Food and Drug Administration (“FDA”) to promulgate its...more

PACT Act Basics: 5 Things Tobacco Sellers and Shippers Should Know

The Prevent All Cigarette Trafficking (PACT) Act, 15 U.S.C. § 375 et seq., is a federal law with two primary objectives: (1) to prevent federal and state tax evasion on tobacco products, and (2) to prevent sales of tobacco...more

Massachusetts High Court Upholds Local Tobacco Sales Ban

The Massachusetts Supreme Judicial Court (SJC) recently upheld, in a unanimous decision, the town of Brookline’s ordinance banning the sale of tobacco and e-cigarette products to anyone born after Jan. 1, 2000 (the Tobacco...more

State Excise Tax Considerations for Tobacco and Nicotine Manufacturers, Distributors and Retailers

A couple of years ago we posted an overview of state licensing and excise tax considerations for tobacco companies. In this post, we take a closer look at state excise tax considerations. When approaching state excise tax...more

US Supreme Court Declines to Hear Challenge to California’s Flavor Ban

Over the past decade, at least five states and hundreds of localities have passed, or attempted to pass, laws banning flavored tobacco products. To date, litigants have brought many challenges to these laws, often arguing...more

More States Consider Establishing Vapor Product Directories

We recently reported that several state legislatures are considering bills to establish vapor product directories this year — namely Florida, Indiana, Missouri, and Virginia. Throughout January and early February, similar...more

En Banc Fifth Circuit Solidifies Circuit Split on Flavored ENDS Product MDOs

In early January, the U.S. Court of Appeals for the Fifth Circuit, sitting en banc in Wages & White Lion Investments, L.L.C. v. U.S. Food & Drug Administration, held that the U.S. Food and Drug Administration’s (FDA)...more

Multiple States Consider Establishing Vapor Product Directories

This year, several state legislatures will consider bills to establish vapor product directories. Amid heightened scrutiny of illicit vapor products by the U.S. Food and Drug Administration (FDA), these product directory...more

FDA’s Center for Tobacco Products Releases Annual Regulatory Agenda

We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual...more

FDA’s Center for Tobacco Products Publishes Strategic Plan

The Food and Drug Administration’s Center for Tobacco Products (“CTP”) has released a strategic plan intended to guide the Center’s activity for the next five years. While the strategic plan highlights the laudable goals of...more

FDA Maintains Heightened Enforcement Against Sellers of Illegal E-Cigarettes

In December, the U.S. Food and Drug Administration (FDA) issued warning letters to online retailers for reportedly selling unauthorized e-cigarette products. Consistent with the Center for Tobacco Products’ (CTP) recent...more

ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

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...more

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

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....more

Oregon Court Upholds Local Tobacco Product Flavor Ban

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...more

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

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...more

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

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...more

Oregon Imposes New “Equity Assessment” on Certain Manufacturers

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,...more

FDA’s Center for Tobacco Products to Hold Public Meeting on PMTA Process

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...more

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

On 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...more

FDA Warns 189 Retailers of Elf Bar and Esco Bar Vapes Regarding Unauthorized Sales

FDA recently announced the issuance of warnings letters to 189 retailers found to be selling unauthorized tobacco products, specifically Elf Bars and Esco Bars....more

RJ Reynolds Sues California AG Disputing Applicability of Flavor Ban

On May 11, RJ Reynolds Tobacco Company, along with two convenience stores and the American Petroleum and Convenience Store Association, sued the California attorney general and district attorney for Fresno County in their...more

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces

In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance....more

Federal Government Ramping Up Vapor Enforcement

Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act....more

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force

This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post,...more

FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.”  Here are some preliminary thoughts on the proposed rule...more

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