This afternoon, the United States Court of Appeals for the 11th Circuit released opinions in four key cases brought against the U.S. Food and Drug Agency (FDA) by vape product manufacturers who had been issued marketing denial orders (MDOs). In all four cases, the Court found that FDA “failed to consider the relevant marketing and sales-access-restrictions plans” that the manufacturers had submitted when issuing the MDOs.
The Court explicitly labelled FDA’s decision making as “arbitrary and capricious”. Prior legal decisions have determined that FDA action must consider all relevant factors in order to be legally justifiable. In the case of these vape manufacturers, the Court ruled that FDA had not performed such consideration.
Judge Rosenbaum, who dissented from the Court’s opinion, drew heavily upon debunked claims of anti-vaping activists who falsely claim flavored vaping products are spurring a “youth vaping epidemic”, despite youth vaping decreasing 60% over the past two years. In her dissent, she writes that “the evidence did not show that the flavored vaping products made any significant difference to whether existing smokers would quit” but that “those products played the starring role in introducing a whole new generation to the dangers of vaping and smoking”.
Judge Rosenbaum is mistaken, as a study from the journal Nicotine & Tobacco Research found that someone trying to quit smoking with a flavored vape was 43% more likely to quit than someone using unflavored or tobacco-flavored vapes. Access to flavored vaping products increases the likelihood that an adult cigarette smoker will quit the deadly habit of cigarette smoking.
Further, flavors are shown to not increase the likelihood of adolescent vaping. Youth are shown to have the same willingness to try plain versus flavored vaping products.
The 11th Circuit decision comes after embarrassing revelations led FDA to admit to not considering all evidence when issuing MDOs to vape products made by Juul and Turning Point Brands. In the interests of public health, future FDA decision making must engage with all available evidence, not just evidence that leads to their preferred outcomes.