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

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. Continue Reading Enhancement of FDA Tobacco Retailer Penalties Approved by D.C. Circuit Court of Appeals

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.). Continue Reading Deeming Regulations Litigation Update–Vapor Challenge Stayed Pending Nicopure Labs Decision, Intervention Permitted in Middle District of Alabama

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. Continue Reading Deeming Regulations Litigation Update–FDA Attempts to Consolidate Cigar Challenges in U.S. District Court for the District of Columbia

Over the last few weeks, the vapor industry plaintiffs and a number of supporters have filed briefs in an appeal of a decision upholding the FDA’s Deeming Regulations.  On July 21, 2017, a federal district court rejected the industry plaintiffs’ challenge, and the case is now on appeal to the U.S. Court of Appeals for the D.C. Circuit. Continue Reading Plaintiffs and Amici Curiae File Briefs in Deeming Regulations Challenge

In July 2017, California Attorney General Xavier Becerra filed a lawsuit against a Canadian cigarette manufacturer, Grand River Enterprises Six Nations (“Grand River”), for failing to comply with California laws governing nonparticipating tobacco product manufacturers (“NPMs”). The lawsuit alleges that Grand River, an NPM, sold hundreds of millions of cigarettes in California in 2014, 2015, and 2016, and failed to make escrow payments of over $13 million. Continue Reading California Attorney General Files Lawsuit Against Non-Participating Manufacturer

Another challenge from the cigar industry has been filed against the FDA’s Deeming Regulations. Among the plaintiffs are a premium cigar retailer/lounge, a premium cigar manufacturer, and a non-profit association comprised of premium cigar manufacturers and retailers. The case is En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Administration, et al., No. 4:18-cv-00028 (E.D. Tex.). Continue Reading Deeming Regulations Litigation Update–New Challenge Filed on Behalf of Premium Cigar Plaintiffs

A series of challenges to the Deeming Regulations has recently been filed by several vapor-product manufacturers, retailers, and a non-profit supporting the industry. These are constitutional challenges, advanced with representation from the Pacific Legal Foundation (“PLF”). The cases are Rave Salon, Inc. v. Gottlieb, et al., No. 3:18-cv-237 (N.D. Tex.); Hoban, et al. v. Food & Drug Administration, et al., No. 0:18-cv-269 (D. Minn.); Moose Jooce, et al. v. Food & Drug Administration, et al., No. 1:18-cv-203 (D.D.C.). Continue Reading Deeming Regulations Litigation Update–New Challenges Filed on Behalf of Vapor Plaintiffs

In a nearly 250-page Memorandum Opinion and Order, the Honorable James O. Browning of the U.S. District Court for the District of New Mexico has granted in part and denied in part a Motion to Dismiss filed by Defendants Santa Fe Natural Tobacco Co., Reynolds American, Inc., and R.J. Reynolds Tobacco Co. The case is In re Santa Fe Natural Tobacco Co. Marketing & Sales Practices Litigation, No. 1:16-md-02695 (D.N.M.).

By way of background, this multidistrict litigation involves class actions filed by Plaintiffs across various states and under those various states’ respective laws, all directed toward the use of certain descriptors in Natural American Spirit (“NAS”) cigarettes’ packaging, labeling, and advertising. Continue Reading In Case over Cigarette’s “Natural,” “Organic,” and “Additive-Free” Descriptors, Some Claims Dismissed but Most Will Proceed