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
9/17/2024
/ Customs and Border Protection ,
E-Cigarettes ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Importers ,
Imports ,
Life Sciences ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Oversight ,
Tobacco ,
Tobacco Regulations ,
Tracking Systems
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
8/28/2024
/ Administrative Procedure Act ,
Advertising ,
FDA Warning Letters ,
First Amendment ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Marketing ,
Petition for Writ of Certiorari ,
Product Labels ,
Public Health ,
Regulatory Authority ,
RJ Reynolds ,
SCOTUS ,
Tobacco ,
Tobacco Regulations ,
Warning Labels ,
Zauderer
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
8/6/2024
/ ATF ,
California ,
Native American Issues ,
PACT Act ,
Retail Sales ,
Tax Exemptions ,
Tax Liability ,
Tobacco ,
Tobacco Regulations ,
Tribal Governments ,
Tribal Lands ,
Tribal Treaty Rights
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
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
7/19/2024
/ E-Cigarettes ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Montana ,
Preemption ,
Regulatory Agenda ,
Retail Market ,
State Attorneys General ,
Tobacco ,
Tobacco Regulations ,
Vaping
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
7/5/2024
/ Civil Monetary Penalty ,
Department of Justice (DOJ) ,
E-Cigarettes ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Manufacturers ,
Retail Market ,
Retailers ,
Tobacco ,
Tobacco Regulations ,
Vaping ,
Warning Letters
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
“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
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 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
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
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
3/26/2024
/ E-Cigarettes ,
Local Ordinance ,
MA Supreme Judicial Court ,
Preemption ,
Public Health ,
Regulatory Agenda ,
Retail Market ,
Retail Sales ,
Smoking Bans ,
Tobacco ,
Tobacco Litigation ,
Tobacco Regulations
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
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
2/8/2024
/ E-Cigarettes ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Marketing ,
Proposed Legislation ,
Public Health ,
Public Safety ,
Regulatory Agenda ,
Regulatory Reform ,
Retail Sales ,
Tobacco ,
Tobacco Regulations ,
Vaping
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
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
1/22/2024
/ E-Cigarettes ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Marketing ,
Proposed Legislation ,
Public Health ,
Public Safety ,
Regulatory Agenda ,
Regulatory Reform ,
Retail Sales ,
Tobacco ,
Tobacco Regulations ,
Vaping
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
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
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
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
12/6/2023
/ Civil Monetary Penalty ,
Department of Justice (DOJ) ,
E-Cigarettes ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Injunctions ,
Life Sciences ,
Manufacturers ,
Retail Market ,
Tobacco ,
Tobacco Regulations ,
Vaping ,
Warning Letters
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
10/31/2023
/ E-Cigarettes ,
False Advertising ,
Imports ,
International Trade Commission (ITC) ,
Lanham Act ,
Manufacturers ,
PACT Act ,
Public Health ,
Public Safety ,
Regulatory Oversight ,
Regulatory Requirements ,
RJ Reynolds ,
Tariff Act of 1930 ,
Tobacco ,
Tobacco Litigation ,
Tobacco Regulations ,
Unfair Competition Law (UCL) ,
Vaping
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
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
10/2/2023
/ Distributors ,
E-Cigarettes ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Public Health ,
Regulatory Agenda ,
Retail Market ,
Retailers ,
Tobacco Regulations ,
Warning Letters
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
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