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The Federal Trade Commission recently issued its Cigarette Report and Smokeless Tobacco Report summarizing 2016 data about the tobacco industry.  Important observations from the Cigarette Report include:

  • The number of cigarettes that the largest cigarette companies in the United States sold to wholesalers and retailers nationwide declined from 244.2 billion in 2015 to 240.5 billion in 2016;
  • The amount spent on cigarette advertising and promotion increased from $8.30 billion in 2015 to $8.71 billion in 2016; and
  • Price discounts paid to cigarette retailers ($5.81 billion) and wholesalers ($1.44 billion) were the two largest expenditure categories in 2016. Combined spending on price discounts increased from $6.95 billion in 2015 to $7.25 billion in 2016, accounting for 83.2 percent of industry spending.

A federal court has dismissed a case challenging the FDA’s allowance of the word “natural” in Natural American Spirit’s (“NAS”) product packaging and labeling. The Plaintiff lacks standing to sue under Article III, § 2, of the U.S. Constitution, which limits federal courts to deciding actual “cases” or “controversies.”

On January 30, 2018, three separate challenges to the Deeming Regulations were filed by vapor-industry plaintiffs represented by the Pacific Legal Foundation (“PLF”), each raising issues under the Appointments Clause and the First Amendment of the U.S. Constitution:

  • Moose Jooce, et al. v. Food & Drug Admin., et al., No. 1:18-cv-203 (D.D.C.);
  • Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.); and
  • Hoban, et al. v. Food & Drug Admin., et al., No. 0:18-cv-269 (D. Minn.).

When PLF announced the filings, it characterized “[t]hese three simultaneously filed lawsuits” as an “opening salvo.” Will the FDA be able to outmaneuver the three-pronged attack?

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 …

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.