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.”
Deeming Regulations Litigation Update–FDA Seeking to Consolidate PLF Legal Challenges in Single Court
Posted in FDA, Significant Cases
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?
FDA Moves to Dismiss Suit Regarding SE Standards
Posted in FDA, Significant Cases
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.
Deeming Regulations Litigation Update—Anti-Tobacco Groups Challenge the FDA’s Extension of Deadlines for Premarket Review Submissions
Posted in FDA, Significant Cases
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).”
UST Sues the FDA Regarding SE Standards
Posted in FDA
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.
FDA Poised to Crack Down on Vape Shops
Posted in FDA, State Regulatory
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’s Proposed Rulemakings – How Does it All Fit Together?
Posted in FDA
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.
Enhancement of FDA Tobacco Retailer Penalties Approved by D.C. Circuit Court of Appeals
Posted in FDA, Significant Cases
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.
Deeming Regulations Litigation Update–Vapor Challenge Stayed Pending Nicopure Labs Decision, Intervention Permitted in Middle District of Alabama
Posted in FDA, Significant Cases
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.).
Deeming Regulations Litigation Update–FDA Attempts to Consolidate Cigar Challenges in U.S. District Court for the District of Columbia
Posted in FDA, Significant Cases
With a merits decision anticipated in a cigar-industry challenge to the Deeming Regulations, will other Courts have the opportunity to decide similar challenges? The FDA has suggested “no,” in a motion to transfer filed on March 19, 2018.