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On January 21, 2020, the U.S. Court of Appeals for the Fourth Circuit issued an order disposing of several motions before it in American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al., Nos. 19-2130, -2132, -2198, -2242. This is an appeal from the U.S. District Court for the District of Maryland, which:

  1. held that the FDA’s August 2017 guidance did not lawfully extend tobacco product compliance deadlines; and
  2. ordered new deadlines of May 12, 2020, for filing applications, and one year after application for approval.

The district court’s rulings amounted to a roughly two-year acceleration of the FDA’s deadlines.…
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On October 16, the Montgomery County Council publicly authorized its lawsuit filed in federal court on October 11, against Juul Labs and Altria Group for alleged violations of Maryland and federal law based on claims of aggressive marketing of e-cigarette products to minors.

Council President Nancy Navarro remarked, “The Council authorizes taking legal action against Juul Labs and Altria Group. This lawsuit supports our ongoing efforts to protect our community members from the public health impacts associated with e-cigarette products and vaping. …
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On October 21, 2019, the Massachusetts Superior Court for Suffolk County preliminarily enjoined the State – from and after October 28, 2019 – from implementing and enforcing the ban as to “nicotine-vaping products” unless and until the executive branch promulgated the regulation in accordance with Massachusetts due process requirements.  The court allowed the ban to continue with respect to “products containing tetrahydrocannabinol (THC) and any other cannabinoid or to black market products.” …
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Flavored vapor product bans in two States were temporarily stayed this week.  On Tuesday, October 15, 2019, a Michigan state judge temporarily blocked the State’s emergency ban on flavored vapor products, which went into effect earlier this month.  The plaintiffs were two vapor product retailers and an individual owner.  In addition to presenting evidence that the ban had significantly hurt their businesses (resulting in the complete shutdown of one of the companies’ business), the plaintiffs also presented several witnesses whose testimony showed that the ban presented a harm to the public, challenged the efficacy of certain surveys presented by the State and challenged the supposed correlation between youth consumption of burning tobacco and e-cigarettes. …
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The City of New York filed on October 9, 2019, a lawsuit in federal district court against 22 national online e-cigarette retailers for allegedly selling their products to underage New Yorkers. The complaint alleges the online retailers do not have age verification systems in place and engage in marketing directed toward minors in violation of city law. …
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On the heels of a Maryland federal judge’s order advancing to May 2020 the deadline for premarket review submissions (discussed here), a group of public health advocates (led by Iowa Attorney General Tom Miller) has petitioned the Secretary of Health and Human Services to appeal the court’s decision and to revamp the premarket review process for electronic nicotine delivery systems (ENDS).…
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The cigar industry has found some official support for its challenge to the Deeming Regulations. That official support has come from the State of Arizona, whose Attorney General has filed a brief as amicus curiae, supporting the cigar industry’s position in Cigar Association of America, et al. v. FDA, et al., No. 18-5195 (D.C. Cir.).…
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In an August 2017 Guidance, the FDA gave companies an extension to comply with certain deadlines for premarket review submissions, including “substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).” …
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As we previously reported here, on September 5, 2018, the U.S. District Court for the District of Massachusetts found that FDA “unlawfully withheld” and “unreasonably delayed” the promulgation of a rule mandating color graphic warnings for cigarettes, as set forth in the 2009 Tobacco Control Act. The Court ordered FDA to provide an accelerated timeline for the completion of its rulemaking. On October 5, 2018, FDA provided the Court an accelerated schedule that would result in the submission of the final rule for publication in the Federal Register by May 2021 (six months sooner than FDA’s initial, estimated timeline of November 2021).…
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