The United States Food and Drug Administration recently obtained summary judgment on several cigar industry claims challenging the FDA’s Deeming Regulations.  The case was filed by industry plaintiffs Cigar Association of America, the International Premium Cigar and Pipe Retailers Association and Cigar Rights of America on July 15, 2016, shortly after the FDA issued the final regulations.  The plaintiffs have indicated that they will appeal the court’s decision, and have requested that the court enjoin enforcement of the FDA’s health warning requirements pending the resolution of the appeal. Continue Reading Deeming Regulations Litigation Update – Cigar Industry Plaintiffs Seek Stay of Health Warning Requirements Pending Appeal

There has been new activity in two of the three Deeming Regulations challenges filed by vapor-industry plaintiffs represented by the Pacific Legal Foundation (“PLF”): Moose Jooce, et al. v. Food & Drug Admin., et al., No. 1:18-cv-203 (D.D.C.), and Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.). The cases involve challenges based on the Appointments Clause and the First Amendment of the U.S. Constitution. Continue Reading Deeming Regulations Litigation Update–Case Transferred, Appointments Clause Briefing Scheduled

U.S. Magistrate Judge Kimberly C. Priest Johnson has denied a motion to transfer the Deeming Regulations challenge in En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Administration, et al., No. 4:18-cv-00028 (E.D. Tex.). On June 5, the FDA appealed her decision to District Judge Amos L. Mazzant III. Continue Reading Deeming Regulations Litigation Update–Motion to Transfer Cigar Challenge Denied, Appealed by FDA

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.” Continue Reading Plaintiff Lacks Standing to Force FDA Action Against Tobacco Company

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? Continue Reading Deeming Regulations Litigation Update–FDA Seeking to Consolidate PLF Legal Challenges in Single Court

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. Continue Reading FDA Moves to Dismiss Suit Regarding SE Standards

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).” Continue Reading Deeming Regulations Litigation Update—Anti-Tobacco Groups Challenge the FDA’s Extension of Deadlines for Premarket Review Submissions

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. Continue Reading UST Sues the FDA Regarding SE Standards

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. Continue Reading FDA Poised to Crack Down on Vape Shops

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. Continue Reading The FDA’s Proposed Rulemakings – How Does it All Fit Together?