Over the last several months, FDA and DOJ enforcement efforts have increasingly focused on manufacturers and distributors of vapor products covered by the Food, Drug, & Cosmetic Act and the PACT Act.

The Food & Drug Administration (FDA) and Department of Justice (DOJ) are increasingly focusing enforcement efforts on electronic nicotine delivery systems (ENDS). Such enforcement priorities have been reflected in six DOJ complaints for injunctions and four FDA complaints for civil monetary penalties (CMP) against businesses dealing in ENDS without marketing authorization under the Food, Drug, and Cosmetic Act (FD&C Act). In addition, ENDS businesses have been receiving communications from DOJ’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) alleging violations of the PACT Act, and FDA has issued a substantial number of warning letters alleging ENDS businesses’ FD&C Act violations. Federal prioritization of ENDS enforcement has also been reflected in FDA statements in connection with its CMP complaints and the Reagan-Udall Foundation’s operational evaluation of FDA’s Center for Tobacco Products (CTP), which we have discussed here, here, and here.Continue Reading Federal Government Ramping Up Vapor Enforcement

Coming on the heels of the Reagan-Udall Foundation report on the Center for Tobacco Products (CTP) at the Food and Drug Administration (FDA), the U.S. House of Representatives’ Committee on Oversight and Accountability has commenced an investigation into CTP’s regulation of tobacco and nicotine products.  In a letter to FDA Commissioner Robert Califf, the Committee notes that CTP has failed to effectively administer its tobacco and nicotine regulations, resulting in uncertainty by compliant stakeholders and a proliferation of unsafe and unregulated products in the marketplace.  The Committee has requested a variety of documents and a staff-level briefing regarding CTP’s activities.Continue Reading House Committee Investigates FDA’s Regulation of Tobacco and Nicotine Products

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

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”

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