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

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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

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

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

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

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

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