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House Committee Investigates FDA’s Regulation of Tobacco and Nicotine Products

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

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force

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

FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.”  Here are some preliminary thoughts on the proposed rule...more

Oregon Bill Proposes to Replace Escrow Deposit System With “Equity Assessment” for Certain Tobacco Product Manufacturers

The Oregon Legislature’s 2023 regular session kicked off with a bang for the tobacco industry when House Bill 2128 (HB2128) was introduced at the request of Attorney General Ellen Rosenblum who also happens to the be...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

Oregon Court Sides with Businesses Challenging Local Flavor Ban Ordinance

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

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

Deeming Regulations Litigation Update – FDA Files Second Status Report on Pending Vapor Products PMTAs

FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report....more

Industry Comments Loom Large in D.C. Court Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”

On July 5th, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like...more

FDA Set to Propose Maximum Nicotine Level in Cigarettes

The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is...more

Ninth Circuit Denies Petition for Rehearing en Banc in Appeal over Preemption of Los Angeles County’s Flavored Tobacco Ban

The U.S. Court of Appeals for the Ninth Circuit has denied the Plaintiffs’/Appellants’ petition for a rehearing en banc following a divided panel’s holding that the Family Smoking Prevention and Tobacco Control Act neither...more

Virginia Enacts Tobacco Products Tax Law Applicable to Remote Retail Sales of Cigars and Pipe Tobacco

New Virginia law addresses excise taxation and other requirements regarding remote retail sales of cigars and pipe tobacco to consumers in the Commonwealth....more

Deeming Regulations Litigation Update—Federal Court Exercises Even More Oversight over FDA’s PMTA Review

Under Judge Grimm’s Revised Remedial Order, FDA must submit quarterly status reports regarding its review of pending PMTAs for certain popular vapor products....more

Vermont Continues Its Crackdown on Online ENDS Sellers

Last year we reported that Vermont Attorney General T.J. Donovan’s office settled with several online sellers over alleged violations of the state’s delivery sales ban of electronic nicotine delivery systems (ENDS) (the...more

Dr. Califf Takes the Reins at FDA: Five Takeaways for the Tobacco Industry

On February 15, the Senate confirmed cardiologist Robert M. Califf, M.D., to lead the U.S. Food and Drug Administration (FDA). He’s no stranger to the agency. Dr. Califf served a brief stint as FDA’s commissioner of food and...more

Bill Regulating Synthetic Nicotine Clears Congress

As part of a federal funding bill, language giving the Food and Drug Administration authority over synthetic nicotine, and any other nicotine that is not derived from tobacco, was passed by Congress on March 11.  President...more

In a First, FDA Authorizes Marketing of Low-Nicotine Cigarette as “Modified Risk Tobacco Product”

Some cigarette pack labels may soon feature the phrases “95% less nicotine,” “helps reduce your nicotine consumption,” and “… greatly reduces your nicotine consumption.” On December 23, 2021, the Food and Drug Administration...more

New Regulations Potentially on the Horizon for Synthetic Nicotine in 2022

On December 15, New Jersey Congresswoman Mikie Sherrill introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate...more

FDA (Re)Issues Final Rule on Substantial Equivalence

On October 5, 2021, the Food and Drug Administration (“FDA”) published in the Federal Register its Final Rule on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (“SE...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

Congress Seeking to Limit FDA Authority Over Premium Cigars

A number of U.S. Representatives on both sides of the aisle recently cosponsored a proposed bill that would limit the U.S. Food & Drug Administration’s (FDA’s) ability to regulate premium cigars. Although the text of the...more

Tobacco in the 117th Congress

Troutman Pepper Strategies (TPS), a full-service government affairs and issue management arm of Troutman Pepper, regularly communicates with members of Congress and staff, including relevant committee staff, regarding the...more

FDA Withdraws Notice of Proposed Rulemaking For Premium Cigars

On June 11, 2021, the U.S. Food and Drug Administration (FDA) withdrew an advanced notice of proposed rulemaking (ANPRM) for premium cigars issued in March 2018 as part of the Spring 2021 Unified Agenda of Regulatory and...more

Troutman Pepper Tobacco Team to Participate in FDLI Annual Conference

The Troutman Pepper Tobacco Team will participate in the Food and Drug Law Institute’s Annual Conference.  The event is virtual and will be held May 18-20, 2021....more

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