This is the second post in our multipart series evaluating the Food and Drug Administration’s response to the Regan-Udall Foundation report on the operations of the Center for Tobacco Products. If you missed our first post, check it out here.

There is a common refrain that appears throughout the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA) — lack of transparency. The report found that stakeholders generally perceived premarket tobacco product applications (PMTAs) — required for all electronic nicotine delivery systems (ENDS) on the market — as “ineffective and problematic” due in part to a “lack of adequate guidance and transparency regarding CTP expectations,” as well as a “lack of clarity regarding review standards.”

Continue Reading Inside FDA’s Response to Reagan-Udall Foundation Report: Spotlight on the Science and Application Review Task Force

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 nicotine levels; potential bans on menthol cigarettes and flavored cigars; enforcement of the PACT Act; and the forecast for litigation in 2023.

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.

Continue Reading Hidden FDA Report Raises Questions About Its Approach to Public Records and Premarket Tobacco Review

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.
Continue Reading FDA Announces New Proposed Rule on “Tobacco Product Manufacturing Practices”

In a largely symbolic gesture, Representative Shelia Cherfilus-McCormick has introduced the “Disposable ENDS Product Enforcement Act of 2023.”  The bill is characterized as closing “the Trump Administration’s loophole on disposable electronic nicotine delivery systems (ENDS),” but would practically accomplish nothing other than expressing Congress’ will that FDA enforce the law under its existing authority.

Continue Reading “Disposable ENDS Product Enforcement Act” Introduced in Congress

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.

Continue Reading FDA Responds to Reagan-Udall Foundation Report

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, including leadership changes, the premarket review process, and actions on non-tobacco nicotine products. They also touch on the premium cigar industry’s challenge to FDA’s warning label requirement, the tobacco industry’s challenge to FDA’s graphic cigarette warning label rule, and a court order that resolved the government’s long-running civil racketeering lawsuit against the largest U.S. cigarette companies.

Stay tuned for part two of this series.

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.

Continue Reading Connecticut AG Sues Retailers for Illegal Delta-8 THC Product Sales

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.

Continue Reading FDA Won’t Use Its Existing Authority to Regulate CBD After All

The Oregon Legislature’s 2023 regular session kicked off with a bang for the tobacco industry when House Bill 2128 (HB2128) was introduced at the request of Attorney General Ellen Rosenblum who also happens to the be president-elect of the National Association of Attorneys General. If passed, HB2128 would replace Oregon’s escrow deposit system, applicable to tobacco product manufacturers that are nonparticipating manufacturers (NPMs) under the Master Settlement Agreement (MSA), with an equity assessment. While HB2128 was only recently introduced and has a number of hurdles to overcome before it becomes law, we are not aware of any other state that has made a similar proposal to retroactively change escrow deposit systems for NPMs. Thus, HB2128 is worth monitoring, not only for its potential impact to Oregon NPMs, but also to see whether similar legislation will be introduced in other states.

Continue Reading Oregon Bill Proposes to Replace Escrow Deposit System With “Equity Assessment” for Certain Tobacco Product Manufacturers