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

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 Reagan-Udall Foundation, an independent nonprofit created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety” recently released its report Operational Evaluation of Certain Components of FDA’s Tobacco Program. The report was commissioned by FDA Commissioner Robert Califf in July, 2022 amid ongoing controversy over the agency’s handling of premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS) and a lack of enforcement against unlawful ENDS.Continue Reading Reagan-Udall Foundation Recommends Improvements to the FDA’s Center for Tobacco Products

In October 2022, the U.S. Food and Drug Administration (FDA) announced that the Department of Justice (DOJ), on its behalf, filed complaints against six electronic nicotine delivery system (ENDS) companies in federal district courts, seeking permanent injunctions. These cases are important because they mark the first time the FDA has litigated against companies to enforce the Federal Food, Drug, and Cosmetic Act’s premarket review requirements for new tobacco products.Continue Reading FDA Implements More Aggressive Approach to Enforcement of ENDS Premarket Requirements

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.Continue Reading Bipartisan Marijuana Research Bill Heads to Biden’s Desk

House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products (CTP). The first half of the letter asks FDA to explain its continued failure to issue meaningful regulations for CBD products, while the second half focuses on issues within CTP that have been echoed across the tobacco industry.Continue Reading House Representatives Ask FDA to Explain its Handling of PMTAs and Other Issues Within Center for Tobacco Products