The 11th Circuit Court of Appeals recently decided against several vape businesses that challenged the validity of their Marketing Denial Orders (MDOs) in the courtroom. 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 affected by the ruling. These companies were granted an extension of their MDOs.
On the 17th of August, FDA released an internal memo on the procedure for reviewing tobacco-free vapes that do not contain tobacco. The memorandum states, “[l]imiting youth access and marketing exposure is a critical aspect of product regulation.” However, the Administration added that it was unaware of any regulations that were sufficient to restrict the capacity of young people to access and utilize electronic cigarettes.
The memorandum concludes by stating that “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 MDOs were issued to state that there was insufficient evidence to suggest that the products would benefit adult smokers and keep cigarettes out of the reach of young people. It appears that the FDA did not examine specific aspects of Pre-Market Tobacco Applications (PMTAs), which the FDA believed were crucial in limiting youth access, which led to the court’s decision.
The most important outcome of this case is the circuit split. A circuit split happens if two courts issue different rulings regarding the same legal issue. A break typically raises the possibility for an appeal to the Supreme Court to hear a case.
The dispute is in the 11th Circuit Court and the 5th Circuit Court. Recently, the 5th Circuit Court of Appeals decided against Triton in the same case, saying it was clear that the FDA didn’t act capriciously or arbitrarily when granting Triton’s MDO, which is the exact opposite of what occurred at the 11th Circuit Court.