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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 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

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

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

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

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

FDA Responds to Reagan-Udall Foundation Report

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

Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products

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 Approve Flavored Tobacco Ban in Referendum; Is It Unconstitutional?

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

House Representatives Ask FDA to Explain its Handling of PMTAs and Other Issues Within Center for Tobacco Products

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

Cigarette Companies and Federal Government Reach Agreement on Warnings to be Displayed in Retail Stores

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

Ninth Circuit Holds that Inter-Tribal Cigarette Sales are Subject to State Tobacco Laws

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

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