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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.

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.

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?

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.