News & Analysis as of

Tobacco Regulations Food and Drug Administration (FDA)

Carlton Fields

FDA v. Wages and White Lion Investments: A Reminder of the Deference to Agency Determinations Post-Loper Bright

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In FDA v. Wages and White Lion Investments LLC, the U.S. Supreme Court’s unanimous decision in favor of the Food and Drug Administration serves as a reminder of the deference still accorded to regulatory agencies post-Loper...more

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges of the ENDS Industry: Part I

In 2016, the U.S. Food and Drug Administration (FDA) began regulating all manufacturers, retailers, and distributors of electronic nicotine delivery systems (ENDS) with following the agency’s promulgation of the Final Deeming...more

Dorsey & Whitney LLP

The Supreme Court Update - April 2, 2025

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The Supreme Court of the United States issued two decisions today: FDA v. Wages and White Lion Investments, L.L.C., No. 23-1038: This case concerns the validity of the FDA’s denial of electronic cigarette manufacturers’...more

Troutman Pepper Locke

California and Denver Impose New Restrictions on Nicotine Analog Products

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In what appear to be the first restrictions of their kind, the state of California and the city and county of Denver have adopted bans on flavored tobacco products that cover not only products containing tobacco and nicotine,...more

Troutman Pepper Locke

FDA Withdraws Proposed Bans on Menthol Cigarettes and Flavored Cigars

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In late January, the U.S. Food and Drug Administration (FDA) withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. Although either proposal could be...more

Troutman Pepper Locke

Supreme Court Weighs Vape Venue Dispute

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On January 21, the Supreme Court heard arguments in a case addressing who may challenge Food and Drug Administration (FDA) marketing denial orders for new tobacco products....more

Troutman Pepper Locke

Federal Appellate Court Agrees that FDA Cannot Regulate “Premium Cigars”

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Yet again, the premium cigar industry has prevailed in federal court against the U.S. Food and Drug Administration (FDA). FDA appealed a federal district court decision vacating its rule (the Deeming Rule) subjecting premium...more

BakerHostetler

FDA Advances Proposal To Lower Nicotine in Cigarettes

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In the final days of the Biden administration, the Food and Drug Administration (FDA) has taken a significant step toward reducing nicotine levels in cigarettes by submitting a proposed rule to the Office of Management and...more

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

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On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

Troutman Pepper Locke

FDA Proposes Limiting Nicotine Levels in Cigarettes and Certain Other Combusted Tobacco Products

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On January 15, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would set a maximum nicotine level in combusted cigarettes and certain other combusted tobacco products....more

BakerHostetler

Navigating FDA’s Guidance on Validation and Verification of Analytical Testing Methods for Tobacco Products

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The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more

Troutman Pepper Locke

Retailers Tap Into Pricing & Data to Boost Cigar Sales

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Bryan Haynes, a partner in Troutman Pepper Locke’s Tobacco + Nicotine Practice Group, was quoted in the January 10, 2025 Convenience Store News article, “Retailers Tap Into Pricing & Data to Boost Cigar Sales.”...more

Troutman Pepper Locke

Vape Companies Challenge Iowa’s New Vape Directory Law

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On December 17, 2024, Iowans for Alternatives to Smoking & Tobacco, Inc., Global Source Distribution, LLC, and others filed a complaint and motion for a preliminary injunction in federal district court against the Iowa...more

Troutman Pepper Locke

Opportunities for the Trump Administration to Step Up Enforcement Against Unauthorized ENDS

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Throughout 2024, the U.S. Food and Drug Administration (FDA) endeavored to curb sales of unauthorized electronic nicotine delivery systems (ENDS) in the U.S. In light of persistent demand for flavored ENDS — nearly all of...more

BakerHostetler

What a Second Trump Administration Could Mean for Tobacco Industry Regulations

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As the tobacco industry anticipates a second Trump administration, it’s banking on what some public health experts describe as his unpredictable approach to regulation. Trump’s history of abrupt policy shifts makes tobacco...more

Troutman Pepper Locke

FDA Says Agency Will Enforce the Cigarette Graphic Warning Rule in December 2025, But Pending Litigation Could Still Derail Those...

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In September, the U.S. Food and Drug Administration (FDA) told industry that it would begin enforcing the agency’s cigarette graphic warning rule in December 2025 in an enforcement policy outlined in a short guidance...more

Troutman Pepper Locke

State AGs File Amicus Curae Brief in US Supreme Court Case Involving Flavored E-Cigarettes

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Earlier this month, 20 Democratic state attorneys general (AG) filed an amicus brief supporting the U.S. Food and Drug Administration’s (FDA) marketing denial orders (MDOs) of premarket tobacco applications (PMTAs) for...more

Troutman Pepper Locke

FDA Proposes Submission Tracking Number Requirement for ENDS Imports

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In August, the U.S. Food and Drug Administration (FDA) issued a new proposed rule that would require importers of electronic nicotine delivery system (ENDS) products to provide an FDA-issued submission tracking number (STN)...more

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

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FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Fox Rothschild LLP

Minnesota Attorney General Takes Action Against Businesses that Market Nicotine Products to Minors

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Billions of dollars are spent each year on tobacco marketing expenditures. With the increasing use of e-cigarette products, businesses may feel tempted to expand their marketing to other audiences, including minors. ...more

Cozen O'Connor

State AGs Redouble Efforts to Snuff Out Flavored Tobacco Products

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A group of 20 Democratic AGs, led by Massachusetts AG Andrea Campbell, has filed an amicus brief before the U.S. Supreme Court in Food and Drug Administration v. Wages and White Lion Investments, LLC., dba Triton...more

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Troutman Pepper Locke

Eighth Circuit Decides Case Involving State’s Authority to Regulate Tribal Cigarette Sales

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On August 2, the U.S. Court of Appeals for the Eighth Circuit decided a case addressing Nebraska’s authority to require tribal cigarette manufacturers that are not parties to the Master Settlement Agreement (MSA) to comply...more

Troutman Pepper Locke

Federal Court Rules Montana AG Preempted from De-Listing Cigarette Manufacturer

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In late June, the U.S. District Court for the District of Montana held that federal law preempts the Montana Attorney General (AG) from removing the cigarette brands of Grand River Enterprises Six Nations, Ltd. (Grand River)...more

Troutman Pepper Locke

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

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In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

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