On July 26th, in the case of Prohibition Juice Company v. FDA, four e-liquid manufacturers filed a petition for review of the FDA's refusal to authorize the sale of flavored e-cigarettes. The US District Court for the District of Columbia rejected this request.
An electronic cigarette company argues that the FDA lacks the legal authority to require manufacturers to prove that their products have increased public health benefits compared to flavorless e-cigarettes. The manufacturers also claim that the FDA's actions are arbitrary and capricious for three reasons: first, the FDA deviated from earlier guidance. Second, the FDA emphasized the importance of manufacturers, including their methods for limiting young people's exposure to flavored e-cigarettes, but then included this aspect in its considerations. Finally, the FDA failed to consider other important aspects of the issue.
The court acknowledged that the FDA has statutory authority to take action. Additionally, the court maintained that the FDA has not acted arbitrarily or capriciously, nor has it deviated from earlier guidance. E-cigarette manufacturers failed to consider altering their marketing plans to persuade the FDA to revoke its order. The FDA also did not ignore other aspects of the issue.
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