Earlier this month, we reported on a lawsuit filed by U.S. Smokeless Tobacco Company (UST) challenging the FDA’s issuance of Not Substantially Equivalent Orders for a smokeless tobacco product.  The FDA has now moved to dismiss the lawsuit for lack of subject matter jurisdiction after rescinding the NSE orders at issue.

Bryan Haynes will moderate a panel entitled FDA implementation of Tobacco Product Pathways.  Panelists, which include the Director of the FDA’s Center for Tobacco Products Office of Science, will discuss the FDA’s implementation of tobacco product review pathways including premarket tobacco applications and modified risk tobacco product applications, as well …

Should vapor products be regulated the same, regardless of whether they contain nicotine? A bill before the Louisiana State Legislature would accomplish just that, with respect to the State’s laws on such things as retailer permits, over-the-counter sales, self-service displays, and vending machines.

In connection with FDA Commissioner Scott Gottleib’s July 2017 announcement regarding a new comprehensive nicotine strategy, the FDA gave manufacturers an extension to comply with certain deadlines under the Deeming Regulations. The extension governed all premarket review submissions for newly-deemed products and “applie[d] only to compliance deadlines relating to . . . substantial equivalence exemption requests (SE EX requests), substantial equivalence reports (SE reports), and premarket tobacco product applications (PMTAs).”

On February 2, 2018, U.S. Smokeless Tobacco Company (UST) (the smokeless tobacco arm of Altria Group) filed a lawsuit in the United States District Court for the District of Columbia, challenging the FDA’s issuance of “Not Substantially Equivalent” (NSE) Orders for a new, portioned moist smokeless product, Copenhagen Bold Wintergreen Flavor Packs (Copenhagen Bold).  This appears to be the first lawsuit challenging the FDA’s denial of an SE submission for a specific product.

A recent Food and Drug Administration Request for Proposal indicates that the agency is poised to more aggressively ensure that vape shops are satisfying their obligations under the Family Smoking Prevention and Tobacco Control Act.  The FDA has asked for bids on a third-party contract to inspect vape shops and other companies that manufacture components of electronic nicotine delivery systems (ENDS).  The agency is apparently prepared to spend $23 million over a five-year period for these services.

The FDA has been quite busy over the last few weeks, issuing three Advanced Notices of Proposed Rulemaking (“ANPR”) that could fundamentally change the tobacco industry in the years to come.  We attempt to synthesize below how the rulemakings fit together in a broader regulatory framework and future implications for tobacco companies.

On Tuesday, April 24 2018, 1:00 – 2:30 PM ET, Bryan Haynes and Paige Fitzgerald will be participating in the American Bar Association webinar, “State and Local Regulations of E-Cigarettes and Other Electronic Nicotine Delivery Systems.” Join our esteemed panel as they:

  • Discuss the current landscape of federal,

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How many tobacco violations can a retailer be charged with for each transaction? On March 20, 2018, the U.S. Court of Appeals for the D.C. Circuit decided Orton Motor, Inc. v. U.S. Dep’t of Health & Human Servs., No. 16-1299 (D.C. Cir.), upholding the FDA Center for Tobacco Products’ (“CTP”) practice of counting multiple violations, even if all violations occurred within a single consumer transaction.

In a pending vapor industry challenge to the FDA’s Deeming Regulations, on March 22, 2018, the Court permitted several anti-tobacco advocacy and public health groups to intervene in the litigation as Codefendants and, at the same time, stayed the case pending the decision of the U.S. Court of Appeals for the D.C. Circuit in Nicopure Labs, LLC, et al. v. FDA, et al., No. 17-5196 (D.C. Cir.). The case is Cyclops Vapor 2, LLC, et al. v. FDA, et al., No. 2:16-cv-00556 (M.D. Ala.).