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August 05, 2022

D.C. Circuit Court Rejects Flavored E-Cigarette Manufacturers’ Request to Review FDA Marketing Denial Orders

Decided on July 26, in Prohibition Juice Company v. FDA, the D.C. Circuit Court rejected the petition by four e-cigarette liquid manufacturers to review FDA orders denying authorization to market flavored e-cigarettes. The manufacturers argued that FDA lacked statutory authority to require the manufacturers to demonstrate that their products had increased public health benefits compared to unflavored e-cigarettes. The manufacturers also argued that FDA acted arbitrarily and capriciously for three reasons: First,  that FDA departed from earlier guidance. Second, that FDA emphasized the importance of manufacturers including methods they would use to limit youths’ access to flavored e-cigarettes, but later failed to consider these methods. Lastly, that FDA failed to consider other important aspects of the problem. The court held FDA had statutory authority to act as it did. The court also held that FDA did not act arbitrarily or capriciously, because the agency did not depart from earlier guidance, manufacturers failed to show how agency consideration of their marketing plans would have changed the agency’s decision, and the agency did not fail to consider other aspects of the problem.

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