On Tuesday, the US Court of Appeals for the 11th Circuit ruled that the US Food and Drug Administration (FDA) should not have denied PMTA review to six e-cigarette companies because it did not consider their marketing and sales plans aimed at reducing youth exposure created in response to tobacco company regulations.
Source: Tanasin
The United States Court of Appeals for the Eleventh Circuit has approved the request for a review submitted by Bidi Vapor, Diamond Vapor, and four other companies questioning the FDA's rejection of their PTMA in a 2-1 vote. According to Chief Judge William Pryor, the agency failed to evaluate the companies' marketing and sales access restriction plan, aimed at minimizing the youth's exposure and access.
The court has deemed FDA's decision "arbitrary and capricious". Any decision made by the FDA must legally consider all relevant factors. In regards to the electronic cigarette manufacturers, the court has ruled that the FDA did not make such considerations.
The court stated in its opinion that "these tobacco companies have submitted information from surveys conducted with their customers about quitting smoking, literature reviews, scientific studies on switching to e-cigarettes, and detailed information about their marketing and youth access plans." "For example, Diamond's online sales use technology that relies on public records to verify the purchaser's age.
Advocates in the e-cigarette industry are welcoming the decision. Gregory Conley, Director of Legislative Affairs and External Affairs at the American Vaping Association, stated that although the court ruling did not order the FDA to grant PMTAs, the agency may still refuse these applications in the future, but these companies may still be in line for review by 2025 and can continue to operate in the meantime.
Conley wrote on Twitter, "Additionally, this opens the door for companies dissatisfied with the PMTA review to file lawsuits. The vague and undefined 'appropriate for the protection of public health' standard of the FDA has long been under attack. This is just the beginning.
Before the 11th Circuit Court ruled, information was disclosed that forced the FDA to acknowledge that evidence was not considered when issuing marketing denial orders (MDOs) to Juul and Turing Point Brands for their e-cigarette products. In the interest of public health, future FDA decisions must include all available evidence, not just evidence that leads to their preferred outcome.
The court recognized a distinction between disposable e-cigarettes and the e-liquids used in open systems. The court also found that the FDA's refusal to review the marketing plan was "wrong and not harmless" (in contrast to the opinions of the Fifth and D.C. Circuit Courts). All petitioners' appeals were approved, the refusal order was vacated, and sent back for reconsideration. Judge Robin Stacy Rosenbaum wrote in dissent that anyone familiar with all the relevant facts of the litigation may have already known how the case would ultimately end.
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