American Academy of Pediatrics et al., v. U.S. Food and Drug Administration et al., Nos. 19-2130, -2132, -2198 & -2242, U.S. Court of Appeals for Fourth Circuit (2020)

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Status: Open

Legal Issue

Whether the vape and cigar industries should be allowed to evade the product-by-product review system Congress established in the Family Smoking Prevention and Tobacco Control Act to protect public health from emerging tobacco products.

Overview

With the enactment of the Family Smoking Prevention and Tobacco Control Act, Congress established a product-by-product review process to ensure that new tobacco products entering the market would not exacerbate the existing public health crisis. In 2017, the Food and Drug Administration decided to delay by four to five years the implementation of premarket review for e-cigarettes, cigars, and other products subject to the deeming rule. Public health groups successfully challenged this decision, as the judge found that the FDA had acted outside its authority. The government accepted that decision and had planned to abide by the court-mandated deadlines for premarket review implementation. However, tobacco industry groups filed motions to intervene (some of which were granted and some of which were denied) and are now appealing the lower court’s ruling to the U.S. Court of Appeals for the 4th Circuit.

If the ruling stands, e-cigarette and cigar manufacturers must file their marketing applications by May 12, 2020 and secure marketing authorization by May 12, 2021 in order to continue selling their products. If the industry groups are successful, marketing applications will be due on August 8, 2021 for cigars and other combustible products and on August 8, 2022 for e-cigarettes and other non-combustible products, with no deadline for manufacturers to secure marketing authorization. 

On February 27, 2020, the Public Health Law Center, joined by eleven other nonprofit groups of medical professionals, researchers, and advocacy organizations, filed a motion with the 4th Circuit to submit an amicus brief supporting a rigorous premarket review process for e-cigarettes and cigars. Our brief points out that in the absence of premarket review, e-cigarettes and kid-friendly cigars have caused a public health crisis and argues that the e-cigarette and cigar industries should not be permitted to evade the premarket review system Congress established to protect public health from emerging tobacco products. Cigar industry groups – intervenors in the appeal – opposed our amicus brief, and on March 11, 2020, the Court denied the public health groups’ motion. While the Public Health Law Center and cosigners are disappointed with the Court’s decision, the industry’s opposition to our brief drew the Court’s attention to the significant public health arguments it raised.

Status 

The litigation is ongoing.

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