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). Continue Reading Public Health Groups File Renewed Request for Urgent Action, Again Urging Court to Mandate an Expedited Schedule for Graphic Health Warnings Rule

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. Continue Reading Vape Shop Sues State of Oregon Over Labeling Rules for Vaping Products

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. Continue Reading Cigar and Pipe Industries Request Extension of November 2019 HPHC Reporting Deadline

Bryan Haynes of the Troutman Sanders Tobacco Team will be at the Food and Drug Law Institute Enforcement Conference on December 12-13, 2018 in Washington, DC.  Of note, both FDA Commissioner Scott Gottlieb and FDA Center for Tobacco Products Director of the Office of Compliance and Enforcement Ann Simoneau will be presenting at the conference.  Perhaps the FDA will elaborate on its recently-announced policy changes with the stated intention of deterring youth access to flavored tobacco products.  Continue Reading Troutman Sanders Tobacco Team to Attend FDLI Enforcement Conference – Will the FDA Elaborate on its Recently-Announced Enforcement and Compliance Policies?

On November 29, the Food and Drug Administration issued a warning letter to an e-liquid company for allegedly selling products with labeling and advertising causing the products to resemble kid-friendly products, including cereal and candy.  The products are alleged to be misbranded under Section 903 of the Food, Drug and Cosmetic Act because their labeling and/or advertising are false and misleading.  Continue Reading FDA Takes Enforcement Action Against ENDS Company for Selling Products Alleged to Be Kid-Friendly

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. Continue Reading Federal Court Dismisses Cigarette Trafficking Lawsuit Against 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. Continue Reading Los Angeles City Attorney Takes Actions Against E-Cigarette Companies for Online Sales

On December 5, 2018, FDA will hold a public hearing to discuss its efforts to eliminate youth e-cigarette and other tobacco product use. One of the objectives of the hearing is to obtain the public’s perspectives on whether there is a need for drug therapies to support youth e-cigarette cessation. In particular, FDA seeks to explore the appropriate methods and study designs impacting the development of such therapies, as well as safety and efficacy issues. Continue Reading FDA to Hold Public Hearing on Youth E-Cigarette Cessation

Last month, 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 (i.e., six months sooner than FDA’s initial estimated timeline of November 2021). Continue Reading Public Health Groups Urge Court to Reject FDA’s Proposed Schedule for Graphic Health Warnings