News & Analysis as of

Manufacturers Tobacco Regulations Food and Drug Administration (FDA)

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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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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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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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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

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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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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

BakerHostetler

FDA and Pharmacy Weekly Digest - September 2019 #4

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Food/Dietary Supplements - FDA to Hold Public Meeting on Food Standards of Identity – The FDA will hold a public meeting “to give interested persons an opportunity to discuss FDA’s effort to modernize food standards 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

Roetzel & Andress

FDA Issues Proposed Tobacco Product Standard for N-Nitrosonornicotine (NNN) in Finished Smokeless Tobacco Products

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On January 23, 2017, the Food and Drug Administration (FDA) issued a proposed tobacco product standard that would establish a limit of N-nitrosonornicotine (NNN) in finished smokeless tobacco products not to exceed 1.0...more

McDermott Will & Emery

FDA Clarifies “Intended Use” for Drugs, Devices, and Tobacco Products

In its Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (Final Rule), FDA codifies its long-standing...more

Mintz - Consumer Product Safety Viewpoints

E-Cigarette Makers Contending with New CPSC and FDA Regulations

Products like e-cigarettes and other electronic nicotine delivery systems (ENDS) have been under intense scrutiny in recent years from public health officials, legislators at all levels of government, and many other...more

Stinson LLP

FDA Regulation of E-Cigarettes: The What, When, and Warnings

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On May 10, 2016, the Food and Drug Administration (FDA) issued a final rule extending its regulation of "tobacco products" to include electronic cigarettes and similar products, sometimes called Electronic Nicotine Delivery...more

Latham & Watkins LLP

FDA to Regulate E-Cigarettes, Cigars and Other Tobacco Products

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Manufacturers and retailers must receive premarket authorization for newly deemed tobacco products and comply with other requirements related to FDA’s long-anticipated deeming rule. On May 10, 2016, the U.S. Food and...more

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