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 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
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
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
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
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
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
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
On June 8, more than 50 members of Congress signed a letter addressed to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, expressing concerns over FDA’s delays in reviewing pending Premarket Tobacco Product...more
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
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
Coming on the heels of the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), the U.S. House of Representatives’ Committee on Oversight and Accountability has...more
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
In a largely symbolic gesture, Representative Shelia Cherfilus-McCormick has introduced the “Disposable ENDS Product Enforcement Act of 2023.” The bill is characterized as closing “the Trump Administration’s...more
The U.S. tobacco industry is subject to a variety of regulators at the federal and state level. In this first of a two-part series focused on significant regulatory developments in the tobacco industry, Stephen Piepgrass is...more
The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation,...more
In October 2022, the U.S. Food and Drug Administration (FDA) announced that the Department of Justice (DOJ), on its behalf, filed complaints against six electronic nicotine delivery system (ENDS) companies in federal district...more
California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is...more
Over the past few years, at least five states and several hundred localities have passed, or attempted to pass, laws banning flavored tobacco products. There have been a number of challenges to those laws—few of which have...more