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

The FDA has submitted a proposed, expedited schedule for the issuance of a final graphic warnings rule for cigarettes. Last month, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings after finding that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings as mandated by the 2009 Tobacco Control Act. 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. Continue Reading FDA Submits Expedited Timeline for Graphic Health Warnings Rule

As a follow-up to our earlier blog post on this topic, the FDA now has until October 5, 2018 to provide an expedited schedule for the issuance of a final graphic warnings rule in accordance with the Tobacco Control Act. As readers may recall, earlier this month, Judge Indira Talwani of the U.S. District Court for the District of Massachusetts ordered FDA to expedite the issuance of a final rule for cigarette graphic warnings after finding that FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic health warnings. Continue Reading FDA Secures Additional Time to Submit Court-Compelled Expedited Schedule for a Final Graphic Health Warnings Rule

The Troutman Sanders Tobacco Team will attend the FDLI Tobacco and Nicotine Products Regulation and Policy Conference on October 24-26, 2018.  The conference will feature a diverse group of stakeholders – manufacturers, governmental agencies, researchers, public health advocates and attorneys – discussing the effective regulation of tobacco and nicotine products in the U.S. and globally.  The FDA’s Center for Tobacco Products Director Mitch Zeller will speak about the latest updates on regulations, guidance and other initiatives.     Continue Reading Troutman Sanders Tobacco Team to Attend Food and Drug Law Institute Tobacco Conference