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Manufacturers Tobacco Regulations Tobacco

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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

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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

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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

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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

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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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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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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Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products

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The Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation,...more

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Industry Comments Loom Large in D.C. Court Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”

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On July 5th, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like...more

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Eleventh Circuit Denies Swisher International’s Request For An Injunction of Further Enforcement by FDA

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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

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Cigarette “Buydown” Payments to Retailers Excluded from South Carolina Sales Taxes

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Tobacco manufacturers and distributors have long made refund/rebate payments to retailers for the retailer’s purchase of cigarettes and other tobacco products from the manufacturer, provided the retailer reduces the price of...more

Patrick Malone & Associates P.C. | DC Injury...

Trump administration now seeks to vaporize vaping, banning candy flavorings

After standing to one side while vaping hooked a generation of young Americans on nicotine, the Trump Administration has now abruptly decided to try to vaporize youthful vaping by banning candy-like flavorings favored by...more

Patrick Malone & Associates P.C. | DC Injury...

Did FDA just let Big Tobacco put another burn on Americans’ health?

Federal regulators appear to be getting caught flat-footed yet again as Big Tobacco’s harms metastasize before their very eyes. The federal Food and Drug Administration has given a qualified go-ahead to Philip Morris...more

Mitchell, Williams, Selig, Gates & Woodyard,...

FDA Gives Certain Electronic Cigarette Manufacturers 60 Days to Address Youth Vaping

On September 12, 2018, Food & Drug Administration Commissioner Scott Gottlieb, M.D., addressed the epidemic of youth e-cigarette use, indicating that the FDA will halt sales of certain flavored e-cigarettes if the major...more

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