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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

Virginia Cannabis Control Act: A Tale of Two Legislatures

It was the best of times… the passage of the Virginia Cannabis Control Act (CCA) in 2021 was celebrated by many as the first bill in the South to legalize adult-use cannabis. It was also heralded as the success of a...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

Delta-8 THC Products to Remain on Virginia Store Shelves, for Now

On April 27, the Virginia Senate voted to send SB 591, which would have effectively eliminated the delta-8 tetrahydrocannabinol (THC) product market in Virginia, back to committee, killing the bill for this year’s legislative...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

DC Circuit Set to Weigh In on Lawfulness of DEA Rule Concerning “Hot” Hemp

In the Agricultural Improvement Act of 2018 (also known as the 2018 Farm Bill), did Congress authorize hemp producers to handle “hot” hemp — cannabis byproducts that surpass the legal limit of delta-9 tetrahydrocannabinols...more

The Status of Cannabis Legalization in the South

While cannabis legalization moves full steam ahead through much of the Northeast, the southeastern U.S. has been notably slow to uptake major reforms. These states haven’t made major headlines for their progressive cannabis...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

State AGs Urge FDA to Listen Up and Preserve The States’ Consumer Protection Authority

On January 18, the National Association of Attorneys General (NAAG) sent a letter to the U.S. Food and Drug Administration (FDA), urging the agency to expressly ensure that state attorneys general (State AGs) continue to have...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

US Postal Service posts PACT Act/POSECCA Field Information Kit and Management Instructions

The U.S. Postal Service (USPS) has made available the Field Information Kit and Management Instructions referenced in its November 4, 2021 Postal Bulletin, correcting hyperlinks in the Postal Bulletin.  The Field Information...more

North Carolina AG Opens Investigation Into E-Cigarette Maker Puff Bar

On November 16, North Carolina Attorney General Josh Stein launched a probe into e-cigarette maker Puff Bar and others, citing concerns of youth-appealing flavors, youth marketing, and poor age verification. In a statement,...more

Residency Rules in Cannabis Industry May Not Withstand Constitutional Scrutiny

There are many unique challenges to consider when it comes to opening or investing in a cannabis business. Residency requirements, or prohibitions on licensure of nonresidents, are one that may soon see their end. In other...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

“Aid” or “Aiding and Abetting?” Medical Marijuana and Federal Preemption in Minnesota

On October 13, the Supreme Court of Minnesota barred an employee from getting reimbursed for medical marijuana treatment for a work-related injury. Although the employee was entitled to reimbursement from her employer under...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

California Passes CBD Law That Conflicts With FDA Guidance

Governor Gavin Newsome recently signed California Assembly Bill 45 (AB 45) into law, which, among other things, allows hemp-derived cannabidiol (CBD) to be included in any food, beverages, and dietary supplements sold in...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

IRS Launches Cannabis Industry-Focused Compliance Initiative

It is widely known that trafficking in controlled substances is a crime under federal law. Traffickers and would-be traffickers be warned, however, that if you do choose to make income from trafficking in Schedule I or II...more

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