In Magellan Technology v. United States Food and Drug Administration, the U.S. Court of Appeals for the Second Circuit reviewed the FDA’s decision to deny an application by a manufacturer of electronic nicotine delivery systems to market its fruit-and dessert-flavored replaceable cartridges or “pods.” In a unanimous opinion authored by Circuit Judge Myrna Pérez and joined by Circuit Judges Dennis Jacobs and Sarah Merriam, the court denied the petition for review, agreeing with the FDA that there was insufficient evidence that marketing the flavored pods would appropriately protect public health. 70 F.4th 622 (2d Cir. 2023). The Second Circuit decision is another decision in a line of recent decisions from circuit courts, including the Third, Fourth, Seventh, and District of Columba Circuit, denying petitions for review of FDA decisions regarding e-cigarette products.

Statutory Background

The Family Smoking Prevention and Tobacco Control Act (the TCA), which was enacted in 2009 to combat the public’s use and dependence on tobacco, authorizes the FDA to regulate the manufacture, marketing, and distribution of tobacco products and requires the FDA to conduct a premarket review of “new tobacco products.” To obtain FDA approval, an applicant must show that allowing its product to be marketed would be “appropriate for the public health.” In making this determination, the FDA weighs the benefits of the new tobacco product in promoting smoking cessation against the risk of the product contributing to smoking initiation, which the FDA bases on “well-controlled investigations” or other “existing valid scientific evidence.” The regulatory framework also provides that e-cigarette products already on the market prior to 2009 are subject to the TCA’s premarket authorization framework, and required applicants to submit premarket tobacco applications (PMTAs) for all such products by Sept. 9, 2020.

FDA’s Pre-Deadline Preparation

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