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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

Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Public Education Campaigns and Resources Task Forces

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

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

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

Parsing the New Wave of State Tobacco Settlement Suits

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

New Congressional Bills Seek to Advance FDA CBD Product Regulation

Under the sponsorship of Representatives Morgan Griffith (R-VA) and Angie Craig (D-MN), congressional lawmakers recently renewed their effort to force the Food and Drug Administration’s (FDA) hand in regulating cannabidiol...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

Virginia General Assembly Passes Bill to Regulate Delta-8 THC

The Virginia General Assembly recently passed — in both chambers — a bill to regulate delta-8 THC products in the commonwealth. The bill now awaits the governor’s signature. Governor Youngkin and the Republican-controlled...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

Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales

On February 9, Attorney General William Tong sued five Connecticut retailers for violating the state’s Unfair Trade Practices Act (UTPA) by selling allegedly illegal delta-8 tetrahydrocannabinol (THC) products, many of which...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

Attorneys General Enforce Lemon Laws and Penalize Puppy Mills

The American Veterinary Medical Association estimates that over 65% of US households own a pet. Puppies are a particularly popular choice. But sometimes, after a puppy comes home to its new family, it might appear lethargic...more

FDA Won’t Use Its Existing Authority to Regulate CBD After All

On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate...more

Bipartisan Marijuana Research Bill Heads to Biden’s Desk

The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act...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

Federal Judge Finds NY Cannabis Residency Rules Likely Unconstitutional and Discriminatory Against Out-of-State Applicants

On November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic...more

FDA Hires Cannabis Policy Expert: Is a New CBD Regulatory Framework Around the Corner?

FDA has hired Norman Birenbaum, an experienced cannabis policy expert, as a senior public health advisor at the Center for Drug Evaluation and Research (CDER). The move signals the agency may soon develop a regulatory...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

Uncertainty Ensues Around Sale of Delta-8 THC in Virginia

Is delta-8 tetrahydrocannabinol (THC) legal to sell in Virginia? We previously reported that the legislature rejected the governor’s attempts to stymie sales of delta-8 THC, but recent developments in the commonwealth call...more

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