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
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
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
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
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
This is the fifth post in our multipart series evaluating the Food and Drug Administration’s (FDA’s) response to the Reagan-Udall Foundation report (the Report) on the operations of the Center for Tobacco Products (CTP). If...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
In late November, the New Mexico attorney general announced a lawsuit in the Santa Fe County First Judicial District Court against Philip Morris USA Inc., R.J. Reynolds and other signatories to the tobacco master settlement...more
On February 24, 2023, the Food and Drug Administration (“FDA”) issued a response to the report prepared by the Reagan-Udall Foundation in December 2022. The Foundation’s report was originally commissioned by FDA Commissioner...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
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
Dealing in goods subject to cigarette and other tobacco products (OTP) taxes presents considerable administrative burdens. The sale of cigarettes and other tobacco products, on which all 50 states impose an excise tax,...more
House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products...more
Litigation challenging FDA’s cursory denial of thousands of premarket tobacco product applications (PMTAs) continues. We have previously written about electronic nicotine delivery system (ENDS) manufacturers’ claims that the...more
On July 28, the Iowa attorney general’s office filed suit against Philip Morris, USA, R.J. Reynolds Tobacco Co., and 16 other tobacco companies, accusing them of defrauding Iowa of over $133 million by allegedly engaging in...more
Retailers should take note that Philip Morris USA Inc., Altria Group, Inc, R.J. Reynolds Tobacco Company have reached an agreement with the United States Department of Justice on warnings to be placed in retail stores...more
California’s cigarette tax and escrow requirements apply to inter-tribal sales of cigarettes, held the U.S. Court of Appeals for the 9th Circuit in Big Sandy Rancheria Enterprises v. Bonta. Big Sandy Rancheria Enterprises...more