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Tobacco Regulations Manufacturers

Troutman Pepper Locke

New Mississippi Cigarette and ENDS Directory Laws Take Effect in July

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Effective July 1, Mississippi will require all cigarette and ENDS manufacturers to provide annual certifications and have their products listed on a state directory in order for their products to be sold in the state. The...more

Bradley Arant Boult Cummings LLP

Cloud Control: Alabama’s Newest Nicotine Regulation That’s Just Too “Juicy” to Ignore

On May 14, Alabama Gov. Kay Ivey signed Alabama HB8 into law. Effective June 1, HB8 introduced sweeping changes that will reshape how nicotine products are sold, marketed, and regulated in Alabama. You heard that right,...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

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

12 Days of Regulatory Insights: Day 9 - Trends in the Tobacco Industry — Regulatory Oversight Podcast

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In the ninth episode of our 12 Days of Regulatory Insights podcast series, Michael Jordan, a member of the firm's Tobacco + Nicotine practice, is joined by colleagues Bryan Haynes and Agustin Rodriguez to delve into the...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

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

State Licensing Considerations for Tobacco and Nicotine Product Manufacturers, Importers, Distributors, and Retailers

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In this post, we take a closer look at state tobacco and nicotine product licensing considerations. When approaching state licensing issues, it may be helpful to establish a checklist to help manufacturers, importers,...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

Troutman Pepper Locke

What’s at Stake for the Premium Cigar Industry as DC Circuit Considers FDA Appeal?

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In August 2023, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia partially vacated a Food and Drug Administration (FDA) rule that had “deemed” premium cigars subject to the Federal Food, Drug, and...more

Troutman Pepper Locke

PACT Act Basics: 5 Things Tobacco Sellers and Shippers Should Know

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The Prevent All Cigarette Trafficking (PACT) Act, 15 U.S.C. § 375 et seq., is a federal law with two primary objectives: (1) to prevent federal and state tax evasion on tobacco products, and (2) to prevent sales of tobacco...more

Troutman Pepper Locke

State Excise Tax Considerations for Tobacco and Nicotine Manufacturers, Distributors and Retailers

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A couple of years ago we posted an overview of state licensing and excise tax considerations for tobacco companies. In this post, we take a closer look at state excise tax considerations. When approaching state excise tax...more

Troutman Pepper Locke

FDA’s Center for Tobacco Products Releases Annual Regulatory Agenda

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We recently discussed the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products’ (CTP) strategic plan intended to guide CTP’s activity for the next five years. On the same day, CTP released its annual...more

Troutman Pepper Locke

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

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The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

Troutman Pepper Locke

ENDS Companies Take Legal Action Against Allegedly Noncompliant Competitors

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Recently, NJOY LLC filed a complaint in the U.S. District Court for the Central District of California against more than 30 foreign and domestic defendants that manufacture, market, distribute, and sell tobacco products in an...more

Troutman Pepper Locke

FDA Ramps Up Enforcement Against Flavored Disposable E-Cigarettes as External Pressures Mount

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In September, the U.S. Food and Drug Administration (FDA) issued two new rounds of warning letters to online retailers, manufacturers, and distributors for reportedly selling or distributing unauthorized e-cigarette products....more

Troutman Pepper Locke

Oregon Court Upholds Local Tobacco Product Flavor Ban

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Over the last decade, hundreds of localities have passed ordinances restricting or prohibiting the sale of some or all types of tobacco products. Some of these ordinances have been challenged in court, but, in most cases, the...more

Troutman Pepper Locke

Iowa Reaches MSA Settlement with Tobacco Manufacturers, Ending 18-Year Legal Dispute

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Last summer, we wrote about the Iowa Attorney General’s $133 million suit against the tobacco manufacturers that are signatories to the Master Settlement Agreement (MSA). Brought in Iowa state court, this suit alleged that...more

Troutman Pepper Locke

Oregon Imposes New “Equity Assessment” on Certain Manufacturers

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Oregon has enacted a new “equity assessment” upon non-signatories to the tobacco Master Settlement Agreement (MSA).  We previously blogged about the bill’s introduction. The law replaces Oregon’s escrow deposit system,...more

Troutman Pepper Locke

U.S. District Court Vacates FDA Deeming Rule With Respect To Premium Cigars

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On August 9, 2023, Judge Amit P. Mehta of the US District Court for the District of Columbia issued his decision vacating the decision of the Food and Drug Administration (“FDA”) to “deem” premium cigars covered by FDA’s 2016...more

Latham & Watkins LLP

FDA Publishes Proposed Rule for Tobacco Product Manufacturing Practice Requirements

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The proposed rule, if finalized, would impose new manufacturing practice requirements on foreign and domestic manufacturers of finished and bulk tobacco products. On March 10, 2023, the Food and Drug Administration (FDA...more

Troutman Pepper Locke

FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

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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

Troutman Pepper Locke

Oregon Bill Proposes to Replace Escrow Deposit System With “Equity Assessment” for Certain Tobacco Product Manufacturers

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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

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