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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

2022 Significant Developments in the Tobacco Industry and What to Expect in 2023 (Part Two) - Regulatory Oversight Podcast [Audio]

In this second of a two-part series, Stephen Piepgrass continues his discussion with colleagues Bryan Haynes, Agustin Rodriguez and Nick Ramos about significant developments in the tobacco industry during the past year, and...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

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

Minnesota Department of Revenue Revokes and Replaces Guidance on Remote Sellers’ Tobacco Tax Responsibilities

The Department has issued updated guidance addressing remote sellers’ cigarette and tobacco tax responsibilities after the Minnesota Legislature’s mid-2021 amendments to the State’s cigarette and tobacco tax and tobacco...more

Iowa Attorney General Brings Suit Against Participating Manufacturers to the Master Settlement Agreement

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

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

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

Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products

On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to...more

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

Status report concerns FDA’s review of 240 PMTAs submitted on or before September 9, 2020, for vapor products with larger market shares.  FDA estimates that it will resolve most of these in the periods before July 2022 and...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

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

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

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

Eleventh Circuit Denies Swisher International’s Request For An Injunction of Further Enforcement by FDA

In August 2021, Swisher International Inc. filed a lawsuit against the Food and Drug Administration (FDA) seeking to have the FDA’s Deeming Rule declared invalid. Swisher followed its lawsuit with a petition for injunction to...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

When Might FDA’s Graphic Warning Rule for Cigarettes Take Effect?

More than a year and a half ago, in March 2020, the U.S. Food and Drug Administration (FDA) issued its final rule on a graphic-warning requirement for cigarettes. The rule—initially slated to take effect June 18, 2021—would...more

U.S. Postal Service Sets Rule Prohibiting the Mailing of ENDS Products

As of October 20, 2021, the final rule of the U.S. Postal Service (the “USPS”) regarding the treatment of electronic nicotine delivery systems (“ENDS”) in the mail is available for public inspection via the link here. The...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

Bipartisan “Resources to Prevent Youth Vaping Act” Introduced in Senate and House

On Friday, July 23, 2021, the attached bill was introduced by a bipartisan group of lawmakers. In the Senate it was introduced by Sen. Jeanne Shaheen (D-NH), along with Lisa Murkowski (R-AK), Richard Durbin (D-IL), Susan...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

Fla. Tobacco Settlement Ruling Offers Caution on Contracts

In December 2020, the Florida Supreme Court refused to take up R.J. Reynolds Tobacco Co.‘s appeal of a ruling requiring the company to continue to make annual tobacco settlement payments to the state of Florida. Originally...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

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