FDA

Subscribe to FDA via RSS

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.

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.).

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.”

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.

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. 

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.).

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.).

A bill was introduced in the New Hampshire legislature on January 3, 2018 regarding the regulation of e-liquids. The bill, NH18-H.1812, specifically addresses labeling requirements for e-liquid products. Distributors and manufacturers of e-liquid products to be sold in New Hampshire would be required to add a product label which…