Significant Cases

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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. 

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. 

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).

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.).

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).”

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).

An Oregon vape shop owner filed a complaint this month against the State of Oregon over rules that prohibit the packaging of vaping products in a manner that appeals to minors. The plaintiffs, Paul Bates and No Moke Daddy LLC, doing business as Division Vapor, allege that the Oregon Health Authority’s regulations’ standard of being packaged in a manner that is attractive to minors is “vague, incomprehensible, and overbroad” and hinders freedom of expression and the ability of adult consumers to make informed purchasing decisions by preventing otherwise accurate product descriptors in labeling.

In a Joint Status Report filed in federal court on December 13, Plaintiffs Cigar Association of America, Cigar Rights of America, and International Premium Cigar and Pipe Retailers Association requested the extension of the Food and Drug Administration’s harmful and potentially harmful constituent (HPHC) reporting deadline. The Plaintiffs have already obtained a delay of the cigar and pipe tobacco warning labeling requirements until after the resolution of the lawsuit. Now, Plaintiffs seek an extension of the approaching November 8, 2019 deadline for HPHC reporting for cigar and pipe tobacco products.

A federal court recently dismissed a lawsuit filed the State of New York and the City of New York against FedEx Ground and FedEx Freight.  The plaintiffs alleged that FedEx knowingly shipped unstamped cigarettes to unauthorized recipients in violation of several laws, including the Contraband Cigarette Trafficking Act (“CCTA”) the Prevent All Cigarette Trafficking (“PACT”) Act, the Racketeer Influenced and Corrupt Organizations Act (“RICO”), New York State law, and a 2006 Assurance of Compliance (“AOC”) between the State and FedEx.

On October 31, Los Angeles City Attorney Mike Feuer filed a complaint in California state court seeking an injunction against a California-based e-cigarette company to bar online sales of vaping products after investigators alleged the companies targeted minors and failed to conduct proper age verification. By using fake emails and prepaid gift cards, investigators posing as teenage consumers were able to make online purchases from these companies without providing identification. Prosecutors also stated that the company targeted minors by glamorizing youth vaping on Instagram and other social media platforms, and also used packaging resembling fruit-flavored cereal, donuts, and other kid-friendly flavors.