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Juul Labs, Inc. v. FDA: A FOIA Twist on the Challenge to FDA's Marketing Denial Order

Recent Freedom of Information Act (FOIA) litigation raises an interesting question: When federal agency action requires analyses under a holistic, multi-factor statutory standard, may the agency withhold from disclosure as...more

Stakeholders’ Input Welcome: Virginia ABC to Assess Options for Regulating Liquid Nicotine in the Commonwealth

The Virginia ABC will assess a regulatory scheme for liquid nicotine, with the consultation of stakeholders, and issue a report and recommendations. On April 12, the Virginia General Assembly enacted House Bill 2296 and...more

RJ Reynolds Sues California AG Disputing Applicability of Flavor Ban

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

Mid-Atlantic Cannabis Regulatory Update

Several mid-Atlantic state legislatures recently took significant action on the cannabis front, setting the stage for a major expansion of the cannabis market in the region. The impact of these laws varied widely, as shown by...more

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Cross-Cutting and Regulation and Guidance Task Forces

In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance....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

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

Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its...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

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

“Disposable ENDS Product Enforcement Act” Introduced in Congress

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

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

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

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

FDA Implements More Aggressive Approach to Enforcement of ENDS Premarket Requirements

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 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

Practical Tips for Avoiding and Contesting Tobacco Tax Assessments

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

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

FTC Releases Second Report on E-Cigarette Sales and Advertising in the US

In a recent press release, the Federal Trade Commission (FTC) issued its second e-cigarette report, analyzing domestic sales and marketing trends for the years 2019 and 2020. While FTC has issued a similar report for...more

Eleventh Circuit Sets Aside FDA Marketing Denial Orders Issued to Bidi Vapor and Others

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

FDA Cigarette Graphic Warning Rule Delayed … Again

In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the...more

State Taxation of Remote Sellers: US Supreme Court Declines Review of First Post-Wayfair Decision from a State Supreme Court

In determining whether the commerce clause of the U.S. Constitution prohibits a state’s taxation of a remote seller, the U.S. Supreme Court for decades has upheld a tax if (1) there is a substantial nexus between the taxing...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

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