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On September 11, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition (the “Appellants”) appeared for oral argument before a three-judge panel in the United States Court of Appeals for the District of Columbia Circuit to appeal a decision issued last year by the U.S. District Court for the District of Columbia, which ruled in favor of the U.S. Food and Drug Administration (“FDA”) in the first lawsuit challenging various provisions of the Family Smoking Prevention and Tobacco Control Act (“TCA” or “Act”) and the FDA’s Deeming Rule as they are being applied to the vapor industry. During oral argument, the Appellants argued that the Modified Risk Tobacco Product (“MRTP”) preclearance requirement imposed by Section 911 of the TCA violates the First Amendment as applied to e-cigarettes and other vapor products. In addition, the Appellants argued that application of the Act’s free sample ban to vapor products violates the First Amendment, and that FDA failed to tailor the premarket tobacco application (“PMTA”) requirements to ensure the continued availability of vapor products. Below, we provide a brief overview of the issues discussed at the oral argument. The recording of the hearing is available here. For background on the appeal, see our previous blog posts, including copies of the legal briefs, available here and here.
Continue Reading Oral Argument Held in Deeming Rule Appeal by Nicopure Labs and Right to be Smoke-Free Coalition

Photo of Azim Chowdhury

On June 18, 2018, U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb delivered remarks on “FDA’s Nicotine and Tobacco Regulation and the Key Role of Regulatory Science” at the Tobacco Regulatory Science Program Meeting.[1] While addressing the importance of regulatory science to inform FDA’s Center for Tobacco Products (CTP) regulatory efforts, Commissioner

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On February 20, 2018 several organizations filed amicus (“friend of the court”) briefs in support of Plaintiff-Appellants Nicopure Labs’ and the Right to be Smoke-Free Coalition’s appeal in the Deeming Rule challenge now pending in the U.S. Court of Appeals for the D.C. Circuit.

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Photo of Azim ChowdhuryPhoto of Eric P. Gotting

On February 12, 2018, Nicopure Labs, LLC and the Right to be Smoke-Free Coalition[i] (the Appellants) filed their opening brief in the appeal of last year’s decision from the U.S. District Court for the District of Columbia, which ruled in favor of FDA in the first lawsuit challenging aspects of the Tobacco Control Act