News & Analysis as of

Food and Drug Administration (FDA) E-Cigarettes Manufacturers

Troutman Pepper Locke

Supreme Court Says Affected Retailers May Challenge ENDS Manufacturer’s Marketing Denial Orders

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On June 20, the Supreme Court concluded that marketing denial orders (MDOs) issued by the Food and Drug Administration (FDA) can be challenged not only by the applicants (typically, the manufacturer or importer of the...more

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

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We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...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

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Food and Drug Administration v. Wages and White Lion Investments, LLC

On April 2, 2025, the U.S. Supreme Court decided Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, holding that FDA’s denial of the respondents’ application to market certain flavored...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

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

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

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

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

FDA oversight looks shaky with drug recalls, rising vaping deaths and injuries

Tens of millions of Americans may have been startled in recent days by the much-publicized pulling from the shelves of widely used drugs like ranitidine (aka Zantac), an over-the-counter heartburn remedy, and select lots 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

Sheppard Mullin Richter & Hampton LLP

Regulating E-Cigarettes Remains “Top Priority” For FDA

On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA’s commitment to overseeing the manufacturing, marketing, and sale of e-cigarettes. The...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

Harris Beach Murtha PLLC

FDA and FTC Issue Warnings Concerning e-Cigarette Marketing

The FDA and FTC jointly issued thirteen (13) warning letters to companies involved in the manufacture, distribution and retail of certain e-liquid products to be used in connection with e-cigarettes which feature packaging...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

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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