In an unanimous opinion on Tuesday, the 5th US Circuit Court of Appeals said that, when the FDA denied Triton Distribution’s application to sell its flavoured e-cigarettes, the agency did not give sufficient consideration to Triton’s marketing plan to reduce the product’s appeal to young people.
The court said the FDA pulled a “surprise switcheroo” from previous guidance that stated manufacturers would not need longer-term studies to support e-cigarette applications. The FDA declined to approve approximately 55,000 other e-cigarette products earlier this year, after requiring manufacturers to apply their existing products for approval under a 2016 rule which deemed them subject to the same regulations as tobacco products.
Initially, the FDA said it did not expect companies would need long-term studies to support their application. However, in August, the agency announced it would deny the first batch of applications and said manufacturers would likely need studies that followed a cohort of people over time to demonstrate that their product’s role in helping smokers quit cigarettes outweighed the risks to young people.
Triton and several other companies challenged the FDA’s decision, arguing it relied on earlier guidance in its application.
