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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.

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.

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.

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.

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.

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.

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.

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.

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…