The Troutman Pepper Tobacco Team was featured in part two of a two-part podcast on recent developments in the tobacco industry and what to expect for the coming year. In this podcast, Bryan Haynes, Agustin Rodriguez and Nick Ramos discuss tobacco excise taxes; challenges to flavor bans; FDA’s regulation of
Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review
FDA’s approach to a premarket tobacco product application (PMTA) raises new questions about whether its marketing denial order was arbitrary and capricious and whether the deliberative-process exemption justifies its withholding of related records. The Agency’s approach is partially documented in a memorandum that FDA disclosed in response to a Freedom of Information Act request, and there is pending litigation over other records that FDA continues to withhold.
May a federal agency that has issued its final determination on a PMTA set aside a portion of its written analysis and withhold those records under the deliberative-process exemption to the Freedom of Information Act (FOIA)? What if those records actually support the PMTA or undermine the purported bases for the agency’s action? These are questions stemming from two pending cases involving FDA and JUUL Labs, Inc. (JLI). In No. 22-1123 (D.C. Cir.), JLI claims that FDA’s marketing denial order (MDO) on its PMTAs was arbitrary and capricious in violation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the Administrative Procedure Act (APA). In No. 1:22-cv-02853 (D.D.C.), JLI claims that FDA’s withholding of these records is not supported by FOIA’s deliberative-process exemption.
FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”
On March 8, the Food and Drug Administration announced that it is proposing a long-awaited rule on so-called “tobacco product manufacturing practices.” Here are some preliminary thoughts on the proposed rule:
- The timing of the proposed rule was a bit of a surprise. Although the proposed rule had been listed as a priority on FDA’s regulatory agenda for some time, nothing indicated that this proposal was imminent. And FDA has identified a number of other rulemaking priorities for 2023, including the proposed ban on menthol cigarettes, the proposed ban on characterizing flavors in cigars and a proposed standard on nicotine levels in cigarettes. It is becoming more and more clear that new leadership at FDA and the Center for Tobacco Products will be working aggressively to impose new requirements on industry.
FDA Responds to Reagan-Udall Foundation Report
On February 24, 2023, the Food and Drug Administration (“FDA”) issued a response to the report prepared by the Reagan-Udall Foundation in December 2022. The Foundation’s report was originally commissioned by FDA Commissioner Robert Califf, highlighted a number of issues with the operations of the agency’s Center for Tobacco Products, which has been tasked with regulating tobacco and nicotine products in the U.S., and proposed 15 recommendations for consideration by the agency. You can read our summary of the report’s findings here.
Troutman Pepper Tobacco Team Featured in Podcast Discussing Significant Tobacco Industry Developments in 2022 and What to Expect in 2023
The Troutman Pepper Tobacco Team was featured in part one of a two-part podcast on recent developments in the tobacco industry and what to expect for the coming year. In this podcast, Bryan Haynes, Agustin Rodriguez and Nick Ramos discuss developments at the federal level, including important happenings at FDA
Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales
On February 9, Attorney General William Tong sued five Connecticut retailers for violating the state’s Unfair Trade Practices Act (UTPA) by selling allegedly illegal delta-8 tetrahydrocannabinol (THC) products, many of which mimicked snack foods and candies popular among youth.
FDA Won’t Use Its Existing Authority to Regulate CBD After All
On January 26, the Food and Drug Administration essentially threw up its hands and announced that Congress needs to create a new regulatory pathway for cannabidiol (CBD) products because the existing pathways are inadequate to mitigate possible health risks. The agency simultaneously denied three long-pending requests to allow marketing of CBD products as dietary supplements. The move came as a major setback to industry stakeholders that have waited years for clear guidelines on CBD from FDA.
Bipartisan Marijuana Research Bill Heads to Biden’s Desk
The Senate recently passed the Medical Marijuana and Cannabidiol Research Expansion Act (the Act) by a voice vote after the House of Representatives passed the bill with strong bipartisan support (325-95) last July. The Act is the first stand-alone marijuana legislation passed in decades and, according to some news sources, President Biden will likely sign it within the next two weeks. Historically, conducting research with Schedule I controlled substances has been subject to numerous administrative hurdles and onerous security requirements that have deterred many potential researchers. The Act amends key sections of the Controlled Substances Act (CSA) to ease some of those restrictions and to facilitate research on marijuana and its potential therapeutic benefits, without changing marijuana’s designation as a Schedule I controlled substance. Some of the key provisions are summarized below.
California Voters Approve Flavored Tobacco Ban in Referendum; Is It Unconstitutional?
California voters have approved Senate Bill 793, which prohibits tobacco retailers from selling flavored tobacco products or tobacco product flavor enhancers. A lawsuit has been filed in federal court claiming that it is unconstitutional.
On November 8, 2022, California voters said “yes” to Proposition 31, a referendum on a 2020 law that would prohibit the retail sale of certain flavored tobacco products. The constitutionality of the referenced law, Senate Bill 793 (“SB793”), is at issue in a case filed the next day in the U.S. District Court for the Southern District of California, R.J. Reynolds Tobacco Co., et al. v. Bonta, et al., No. 3:22-cv-01755 (S.D. Cal.); however, the plaintiffs’ success in that case will likely depend on the development of favorable precedents in other cases pending before appellate courts.
Federal Judge Finds NY Cannabis Residency Rules Likely Unconstitutional and Discriminatory Against Out-of-State Applicants
On November 3, Judge Gary L. Sharpe of the U.S. District Court for the Northern District of New York issued a preliminary injunction, blocking cannabis regulators from issuing marijuana retail licenses for five geographic regions across the state, while a constitutional challenge to the program proceeds.