Judge Myrna Perez, nominated by President Biden to the US Court of Appeals for the Second Circuit, wrote a unanimous opinion that was joined by Biden Judge Sarah Merriam rejecting a corporation’s effort to overturn an FDA decision to prevent marketing of flavored e-cigarettes because they would not help protect public health. In fact, the FDA found that marketing the products could endanger public health by encouraging youth smoking. The June 2023 decision was in Magellan Technology Inc. v US FDA.

 

What is this case about?

 Under authority granted specifically by Congress, the US Food and Drug Administration must approve any new tobacco product before it can be marketed. In order to obtain FDA approval, the law specifically requires that a company show that allowing marketing of its products would be “appropriate for the public health.”

Magellan Technology Inc., which sells tobacco-flavored e-cigarette products, asked the FDA for permission to sell “fruit and dessert” flavored products, such as “Pretzel Graham” and “Blue Razz.” After careful review, the FDA denied Magellan’s application as failing to meet the “appropriate for the public health” standard. In particular, the FDA found that the corporation’s studies were inadequate and that it did not have “sufficient evidence” to show that any benefit of the products to adult users in getting them to switch from smoking actual cigarettes would “outweigh the risks to youth” who would begin using tobacco through Magellan’s products. As the court noted, Congress specifically found that youth use of tobacco products is a “pediatric disease of considerable proportions” and that the use of tobacco products remains the “foremost preventable cause of premature death in America.”

Magellan disagreed and sought review of the decision in the Second Circuit. A panel composed of Judges Perez and Merriam, plus George H.W. Bush Judge Dennis Jacobs, considered the case.

How did Judges Perez, Merriam and the Second Circuit Rule and Why is it Important?

Judge Perez wrote a unanimous opinion that rejected the cigarette company challenge and upheld the FDA decision. Contrary to Magellan’s claims, the panel found that the FDA was “well within its statutory authority” to reject the corporation’s application because it did not show that its fruit and dessert flavored products were more effective than tobacco-flavored products in getting people to stop smoking or switch to e-cigarettes. The panel noted that none of Magellan’s studies included “more than two dozen participants” or showed the “actual effectiveness of Magellan’s products at promoting cessation.” The court agreed with the FDA’s evaluation of Magellan’s evidence as “insufficient” to show significant benefits or that the alleged benefits to adults would “outweigh the risks to youth” who would be attracted to the products.

The Second Circuit’s decision is important because of the direct impact of rejecting Magellan’s products on public health, especially for youth. It is also significant because it recognizes the expertise and authority of the FDA, even as corporations and others attack the FDA and other federal agencies. In addition, the ruling provides another illustration of the importance of promptly confirming fair-minded Biden nominees like Judges Perez and Merriam to our federal courts.