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Azim Chowdhury and Eric Gotting, partners at Keller and Heckman, will discuss the recent decision in the case American Academy of Pediatrics et al. vs. FDA, which struck down the extended premarket review compliance policy for deemed tobacco products.  Find out what the decision will mean to your business, both short and long term.

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Learn how to stay in compliance with FDA’s recent announcements and much more at Keller and Heckman’s upcoming E-Vapor and Tobacco Law Symposium on January 29 – 30, 2019, in Miami, Florida. Below is a sampling of topics that will be covered at the event. Sign up now and take advantage of our early bird

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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.
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Defendant U.S. Food and Drug Administration (FDA) and the Right to Be Smoke-Free Coalition (RSF) recently submitted briefs to the federal district court of Maryland opposing a motion for summary judgment filed by various public health NGOs in American Academy of Pediatrics v. FDA.[1] The NGOs are challenging various extensions to premarket application

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On March 27, 2018, a coalition of public health organizations including the Campaign for Tobacco-Free Kids, the Truth Initiative, the American Cancer Society and the American Academy of Pediatrics, among others, as well as several individual physicians (collectively the “NGOs”) filed a lawsuit in the United States District Court for the District of Maryland challenging

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On February 2, 2018, U.S. Smokeless Tobacco Company LLC (UST), a wholly owned subsidiary of Altria Group, Inc., filed suit against the U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), HHS Secretary Alex Azar, and FDA Commission Scott Gottlieb in the U.S. District Court for the District of Columbia

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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.

The Washington Legal Foundation (WLF) is a nonprofit, public-interest law firm

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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

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On August 30, 2017, the Right to be Smoke-Free (RSF) Coalition, a non-profit, industry-led trade association of vapor businesses dedicated to advocating for reasonable and responsible laws and regulations, joined Nicopure Labs LLC in appealing the recent decision in Nicopure Labs, LLC and Right to be Smoke-Free Coalition et al. v. Food and Drug