Health Law Daily FDA overstepped in delaying e-cigarette premarket review requirements
Monday, May 20, 2019

FDA overstepped in delaying e-cigarette premarket review requirements

By David Yucht, J.D.

A federal court found that it had jurisdiction to review an FDA guidance concerning enforcement of the Tobacco Control Act, a law designed to discourage underage smoking, and found that it was not legally issued.

Public health organizations and individual physicians had standing to challenge an FDA guidance that delayed enforcement of the Tobacco Control Act (TCA) (P.L. 111-31), according to the Maryland district court. Moreover, the court had jurisdiction to review this Guidance because it qualified as final agency action for purposes of the Administrative Procedures Act (APA) (5 U.S.C. §§ 500 et seq.). The court also determined that the FDA was required to, but did not, follow the APA’s notice and comment requirements prior to issuing the its guidance. Accordingly, the court denied the manufacturers’ motion for summary judgment, granted the organizations’ motion for summary judgment, and ordered supplemental briefing on an appropriate remedy designed to enable enforcement of the underaged smoking law (American Academy of Pediatrics. v. FDA, May 15, 2019, Grimm, P.).

Tobacco Control Act compliance extension. Congress enacted the TCA to address concerns associated with use of tobacco by minors. The law requires manufacturers of nicotine products, including e-cigarettes, to apply for premarket authorization before introducing new products. However, under the FDA’s guidance, those products can continue to be marketed and distributed pending FDA approval and manufacturers do not have to seek FDA approval until 2021 or 2022 (see New FDA tobacco plan will focus on lowering nicotine to non-addictive levels, July 31, 2017). Several public health organizations including the American Academy of Pediatrics as well as individual physicians filed a complaint for declaratory and injunctive relief against the FDA, claiming that the deferral violated the TCA’s requirement of premarket review of newly deemed products before they were marketed or distributed to consumers. They asked the court to vacate the guidance, claiming that it was unlawful because it exceeded the agency’s statutory authority and was not promulgated pursuant to the APA’s requirements. Both sides filed motions for summary judgment.

Standing and jurisdiction. First, the court determined that there was standing to challenge the FDA’s guidance. The court noted that if one of multiple plaintiffs has standing, then the claim can proceed. Where an organization’s “efforts to carry out its mission” are impeded, that impediment is an injury which may allow for standing. These organizations’ missions centered “on educating the public about the dangers of [new tobacco products].” The guidance’s delay of the submission of tobacco and nicotine manufacturers’ applications for at least five years and its announcement that the FDA will defer enforcement during that period, denied the organizations access to information required to be disclosed by statute. Congress intended for the research provided pursuant to the TCA to be publicly available promptly after product approval. Consequently, the organizations suffered “the type of harm Congress sought to prevent by requiring disclosure.” The court also found that the organizations had a traceable injury which was redressable through court action.

The court next determined that it had jurisdiction to review this guidance, which qualified as final agency action for purposes of the APA. Usually, the actions of an agency such as the FDA “are presumptively subject to judicial review.” However, refusal to take enforcement action is presumptively not subject to judicial review. This presumption of non-reviewability may be overcome by statutory language limiting agency enforcement discretion. Also, an agency’s announcement of its interpretation of a statute, even when that interpretation is advanced in the context of a decision not to take enforcement action, is reviewable. The court found that the language of the TCA required the FDA to act and the FDA did not have discretion to defer action. The court also determined that the guidance was final agency action subject to review because, as a practical matter, it had a binding effect which contributed to a finding that the action was final.

APA. Finally, the court determined that the FDA’s guidance was issued in violation of law. The FDA’s suspension of the TCA’s premarket approval process and enforcement of these requirements, amounted to a rule amendment or revocation, as it was inconsistent with the TCA. The FDA abdicated its statutory duty to review new tobacco products in the prompt fashion dictated by Congress in its premarket review requirement. Here, the guidance was not a policy statement; it was tantamount to an amendment to the TCA. The guidance implemented changes to the statutorily established process. Those changes had legal consequences and the guidance language included commands, requirements, and an order telling manufacturers by when they must submit their applications. The guidance was a rule amendment and therefore a legislative, rather than interpretive, rule. Even if the extension were a rational decision, the FDA could not have made that decision without notice and a comment period as required by the APA. The court will consider a remedy designed to enable enforcement of the nicotine premarket approval process.

The case is No. 8:18-cv-00883-PWG.

Attorneys: C. Andrew Childers (Childers Schlueter & Smith) for Claude R. Knight. Ben J. Scott (Butler Snow LLP) for Boehringer Ingelheim Pharmaceuticals, Inc.

Companies: Boehringer Ingelheim Pharmaceuticals, Inc.

MainStory: TopStory FDCActNews SafetyNews TobaccoNews

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