11th Circuit Court rules against FDA on MDOs

The 11th Circuit Court of Appeals recently ruled in favor of a group of vape companies challenging their Marketing Denial Orders (MDOs) in court. The court ruled that the Food and Drug Administration’s (FDA’s)  “marketing denial orders were arbitrary and capricious” because the FDA “failed to consider the relevant marketing and sales-access-restrictions plan.”

Bidi Vapor, Diamond Vapor, Johnny Copper, Pop Vapor Co., Union Street Brands, and Vapor Unlimited were the vape companies involved with the ruling. Those companies received a stay on their MDOs.

On August 17th, the FDA circulated an internal memo regarding the process of reviewing non-tobacco flavored vapes. The memorandum acknowledges that “[l]imiting youth access and exposure to marketing is a critical aspect of product regulation.” However, the Administration also stated that it was unaware of any restrictions that were sufficient in decreasing the ability of youths to obtain and use electronic cigarettes.

The memorandum ends with “for the sake of efficiency, the evaluation of the marketing plans in applications w[ould] not occur at this stage of review.”

The majority of the MDOs were issued stating that there was not enough evidence products would help adult smokers while keeping vapes out of the hands of youth. The fact that it appears like the FDA did not look at aspects of the Pre-Market Tobacco Applications (PMTAs) that the FDA said was important to controlling youth access was what led to the court ruling.

One of the most notable things to come out of this case is this case causes a circuit split. A circuit split occurs when two circuit courts provide conflicting rulings on the same legal issue. A split generally increases the chance that the Supreme Court will hear a case.

The split occurs between the 11th Circuit Court, and the 5th Circuit Court. Recently, the 5th Circuit Court of Appeals ruled against Triton in a similar case, stating that the FDA did not act arbitrarily or capriciously when issuing Triton’s MDO - the exact opposite of what happened in the 11th Circuit Court.

References: 

• https://media.ca11.uscourts.gov/opinions/pub/files/202113340.pdf
• FDA’s Marketing Denial Order Issued to Bidi Vapor’s Non-Tobacco Flavored ENDS Products are Set Aside and Remanded by the 11th Circuit Court of Appeals for being Arbitrary and Capricious - Lexology 
• Flavored e-cigarette companies lose challenge to FDA marketing denials | Reuters