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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

Cannabis Residency Rules Toppling? First Circuit Is the First Domino to Fall

Certain states where cannabis (or marijuana) is legal have long been getting away with a practice that has been declared unconstitutional in almost all other contexts: giving their residents preferential treatment over...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

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

Cannabis Administration and Opportunity Act Introduced in the Senate: Will It Live Up to the Hype?

On July 21, the Cannabis Administration and Opportunity Act (CAOA), a comprehensive bill to decriminalize, regulate, and tax cannabis, was introduced by Senate Majority Leader Chuck Schumer (D-NY), Senator Cory Booker (D-NJ),...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

Alcohol Regulation as a Model for Cannabis Regulation: The Benefits and Drawbacks

The rapid evolution of the cannabis industry in the United States poses many unique questions, the most interesting of which is what cannabis regulation will look like under federal legalization. Although (legal) cannabis is...more

State AGs Call on Congress to Combat THC Products Attractive to Youth

On June 23, the Virginia and Nevada attorneys general sent a letter on behalf of a bipartisan coalition of 23 state attorneys general, expressing concern about edible products containing tetrahydrocannabinol (THC) sold in...more

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