FDA

Subscribe to FDA

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

Litigation challenging FDA’s cursory denial of thousands of premarket tobacco product applications (PMTAs) continues. We have previously written about electronic nicotine delivery system (ENDS) manufacturers’ claims that the Food and Drug Administration (FDA) acted arbitrarily and capriciously by, among other things, denying their PMTAs without fully considering all elements of the applications. Numerous appeals of PMTA denials are pending before several different federal appellate courts, and decisions continue to trickle in.
Continue Reading Eleventh Circuit Sets Aside FDA Marketing Denial Orders Issued to Bidi Vapor and Others

In a prior update, we discussed the ongoing legal challenges to the U.S. Food and Drug Administration’s (FDA) March 2020 rule on a graphic-warning requirement for cigarettes. Initially slated to take effect June 18, 2021, the rule would require 11 new textual, health warning statements accompanied by color, “photorealistic” images displayed on the top…

FDA reports that the progress of its review of popular vapor products’ pending PMTAs remains in line with its first report.

On July 28, 2022, FDA filed a status report in American Academy of Pediatrics, et al. v. FDA, et al., No. 8:18-cv-00883 (D. Md.), addressing its review of pending premarket tobacco applications (“PMTAs”) for certain popular vapor products.  FDA filed the status report pursuant to a court order previously covered on this blog.  This is FDA’s second status report filed pursuant to that order, the first having been filed on May 13.
Continue Reading Deeming Regulations Litigation Update – FDA Files Second Status Report on Pending Vapor Products PMTAs

On July 5, the U.S. District Court for the District of Columbia ruled that the decision of the Food and Drug Administration (FDA) to “deem” premium cigars subject to the same federal law as other tobacco products like cigarettes was “arbitrary and capricious.” In reaching this conclusion, Judge Amit Mehta relied heavily on industry comments regarding the relative public health risks and negligible youth use of premium cigars, as well as related studies — which the court said FDA either ignored or glossed over. The opinion underscores the importance of the role of public comments in agency rulemaking.
Continue Reading Industry Comments Loom Large in DC Court, Finding FDA Regulation of Premium Cigars “Arbitrary and Capricious”

Bryan Haynes of Troutman Pepper’s Tobacco Team was quoted in a recent article in Bloomberg Law discussing FDA’s recent proposals to ban menthol in cigarettes and “characterizing flavors” in cigars.

Haynes noted that FDA “has authority to implement tobacco product standards,” but that this authority is “not without limits.”  Haynes also noted that bans on…

Bryan Haynes of Troutman Pepper’s Tobacco Team was quoted in a recent article by Emily Field of Law360 discussing FDA’s recently-announced proposal that would limit nicotine levels in combusted tobacco products.

Haynes noted that this proposal, along with FDA’s other recent proposals to ban menthol in cigarettes and flavors in cigars can be summed up…

The US Food and Drug Administration (FDA) recently announced plans to publish a proposed rule that would establish a maximum nicotine level in cigarettes and certain “other combusted tobacco products.” At the moment, it is not clear what “other combusted products” FDA might have in mind. According to the Spring 2022 Unified Agenda of Regulatory and Deregulatory Actions, FDA is targeting May 2023 to issue the proposed rule, but that could always change.
Continue Reading FDA Set to Propose Maximum Nicotine Level in Cigarettes

On June 10, a bipartisan coalition of 31 state attorneys general, led by Idaho, Illinois, Nebraska, and Pennsylvania, sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf, asking the agency to reject premarket tobacco product applications (PMTAs) for all products that contain nicotine not derived from tobacco, also known as non-tobacco nicotine (NTN) or synthetic nicotine.
Continue Reading Bipartisan Coalition of 31 State AGs Urge FDA to Deny Marketing Authorization for Non-Tobacco Nicotine Products