US Supreme Court hears oral arguments over FDA refusal to approve flavored e-cigarettes News
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US Supreme Court hears oral arguments over FDA refusal to approve flavored e-cigarettes

The US Supreme Court on Monday heard oral arguments in a case in which the Food and Drug Administration (FDA) refused to approve flavored e-cigarettes, citing public health concerns.

The FDA denied applications from two companies — Triton Distribution and Vapetesia — to sell flavored liquids for use in e-cigarettes, also known as vapes. Under the Family Smoking Prevention and Tobacco Control Act, the FDA must authorize new tobacco products before they enter the market; among the necessary criteria, applicants must show the product would be “appropriate for the protection of the public health.”

The FDA appealed a Fifth Circuit court decision, which ruled the agency violated administrative law by misleading the applicant companies about scientific standards and rejecting applications without genuinely considering their efforts to discourage youth smoking. Authoring judge Andrew Oldham accused the FDA of sending vape companies on a “wild goose chase” and engaging in “regulatory switcheroos.”

The arguments Monday focused on whether the agency gave fair notice to applicants regarding the significance of scientific evidence. Eric Heyer, the attorney for the vape companies, argued the FDA unfairly changed its position from a focus on marketing over scientific evidence to a heavy emphasis on scientific evidence and little consideration for marketing. The FDA argued the failure to look over applicants’ marketing plans constituted a “harmless error” because applicants have a statutory requirement to provide scientific evidence. The harmless error doctrine allows courts to avoid overturning agency decisions based on procedural errors if the error did not significantly affect the outcome.

The justices were skeptical of the vape companies’ argument and the lower court’s decision. Justice Brett Kavanaugh pointed to the statutory discretion given to the FDA, and several conservative justices asked questions suggesting support for the agency’s “harmless error” argument. Nonetheless, the bench has not made a decision. The result remains to be seen.

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