To mark the nine-year anniversary of the Family Smoking Prevention and Tobacco Control Act and the one-year anniversary of FDA’s Comprehensive Plan for Nicotine, FDA recently provided updates on efforts to improve its tobacco regulatory programs. In addition, FDA announced new initiatives that are designed to help industry have a better understanding of what is needed to submit complete and robust tobacco product applications. The stated objective of these efforts is to improve the transparency and efficiency of the premarket review process. Continue Reading FDA Announces its Plans to Issue Tobacco Product Application “Foundational” Rules

In connection with the FDA’s Advanced Notice of Proposed Rulemaking (“ANPR”) addressing flavored tobacco products, a group of State Attorneys General has recommended that the agency ban all flavored tobacco products.  In their comments on the ANPR, the Attorneys General of New York, Idaho, Illinois, Maine, Massachusetts, New Mexico, Oregon, Pennsylvania and Rhode Island assert that the FDA should ban flavors (including menthol) in all tobacco products, including cigarettes, cigars and electronic nicotine delivery systems (“ENDS”).  The existing flavor ban applies only to “characterizing” flavors in cigarettes, and allows for mentholated cigarettes. Continue Reading State Attorneys General, U.S. Senators Seek to Ban All Flavored Tobacco Products

With a related appeal pending in the U.S. Court of Appeals for the D.C. Circuit, what will become of pending trial litigation in Cigar Association of America, et al. v. U.S. Food & Drug Administration, et al., No. 1:16-cv-01460 (D.D.C.) (“Cigar Association”), and En Fuego Tobacco Shop LLC, et al. v. U.S. Food & Drug Admin., et al., No. 1:18-cv-1797 (D.D.C.) (“En Fuego”)?

It seems that the appeal will take the larger focus for now. Continue Reading Deeming Regulations Litigation Update—Uncertain Path Ahead for Dual Cigar-Industry Challenges Pending at the Trial Level; Appellate Proceedings Moving Forward

The FDA has advanced in its “procedural maneuvering” in three constitutional challenges to the Deeming Regulations. The challenges – premised on the First Amendment and on the Appointments Clause – were 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.), 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.). Continue Reading Deeming Regulations Litigation Update–U.S. District Court for the District of Columbia Expected Forum for Three Appointments Clause Challenges

On June 21, 2018, the United States Supreme Court issued its decision in South Dakota v. Wayfair.  The decision overruled decades of prior precedent holding that remote sellers of products – including tobacco products – ordinarily are not required to collect sales or excise taxes if they lack a physical presence in the purchaser’s state.  In Wayfair, the Court upheld a South Dakota statute that required sellers in other states to collect taxes for sales to South Dakota consumers if the seller annually delivers more than $100,000 worth of goods in South Dakota or makes more than 200 sales to South Dakota consumers. Continue Reading United States Supreme Court Decides South Dakota v. Wayfair, Overrules Decades of Precedent for Taxation of Remote Sales and Imposes New Responsibilities for Internet and Other Remote Sellers of Tobacco Products