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?

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

Menthol cigarettes have been around since the 1920s. Will New Jersey become the first State to ban them?

Pending before the New Jersey Legislature are Assembly Bill No. 2185 (primary sponsor Del. Herb Conaway, Jr. [D-Dist. 7]) and Senate Bill No. 1947 (primary sponsors Sen. Joseph F. Vitale [D-Dist. 19] and Sen. Robert W. Singer [R-Dist. 30]). The bills are identical. If enacted, they would “include[] menthol and clove cigarettes in the current prohibition against the sale and distribution of flavored cigarettes.” Continue Reading Menthol Ban Pending Before New Jersey Legislature

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

On January 25, 2018, the United States Department of Justice (“DOJ”) announced a new policy that bars DOJ from using its enforcement authority to convert federal agency guidance documents into binding rules.  The policy follows a November 16, 2017 memorandum by Attorney General Jeff Sessions indicating that agencies should not establish binding obligations through guidance documents, which can be viewed as an attempt to subvert the notice-and-comment rulemaking process that is required when agencies create rules and regulations.  Continue Reading New DOJ Policy Restricts FDA Authority to Take Enforcement Action Based on Guidance Documents