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FDA Proposes Submission Tracking Number Requirement for ENDS Imports

In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

ATF Rift With California Tribe Could Expand State Authority Over Tribal Tobacco Sales

In June, the Bureau of Alcohol, Tobacco and Firearms (ATF) argued in federal court that the federal Prevent All Cigarette Trafficking (PACT) Act requires tribal retailers to obtain state licenses to sell cigarettes on their...more

Eighth Circuit Decides Case Involving State’s Authority to Regulate Tribal Cigarette Sales

On August 2, the U.S. Court of Appeals for the Eighth Circuit decided a case addressing Nebraska’s authority to require tribal cigarette manufacturers that are not parties to the Master Settlement Agreement (MSA) to comply...more

Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

San Francisco Sues E-Cigarette Distributors for Violating Local Flavor Ban

We have previously reported on the proliferation of tobacco product flavor bans imposed by localities and subsequent legal challenges throughout the U.S. See Oregon Court Upholds Local Tobacco Product Flavor Ban; Troutman...more

PACT Act Basics: Five Things You Should Do if ATF Comes Knocking

“Hi, we’re with the Bureau of Alcohol, Tobacco and Firearms, and we’d like to take a look at your tobacco product sales invoices, shipping records, and PACT Act reports.”...more

What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more

FDA Launches Legally Marketed Tobacco Products Database

FDA recently announced the launch of a new searchable database containing almost 17,000 tobacco products that may be legally marketed in the U.S. The database provides information on each tobacco product including product...more

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

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

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

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...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

Members of Congress Propose Massive Tobacco Tax Increase

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...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

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

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