Triton Distribution can continue selling its flavored e-cigarettes, a federal appeals court has ruled, despite the U.S. Food and Drug Administration’s decision to the contrary.
In a unanimous opinion on Tuesday, the 5th U.S. Circuit Court of Appeals said that when the FDA last month denied the Richardson, Texas-based company’s application to sell its products, the agency did not give adequate consideration to Triton’s marketing plan to reduce the products’ appeal to youth.
The court found the FDA pulled a “surprise switcheroo” from earlier guidance stating that manufacturers would not need long-term studies to support e-cigarette applications.
Triton’s products were among the roughly 55,000 e-cigarettes the FDA earlier this year declined to approve, after requiring manufacturers to apply for approval of their existing products under a 2016 rule deeming them subject to regulation as tobacco products.
A spokesperson for the FDA declined to comment on Tuesday’s decision, as did Triton’s attorney, Eric Heyer of Thompson Hine.
Many e-cigarettes were already on the market at the time of the 2106 so-called deeming rule, and the FDA initially gave manufacturers until 2018 to apply for approval, allowing them to continue selling in the meantime. That deadline was later pushed back to 2022, and then moved up to 2020 amid litigation by anti-smoking groups challenging the delay.
The FDA initially said in guidance accompanying the deeming rule that it did not expect companies would need long-term studies to support their application. However, in an August announcement that it would deny a first batch of applications, the agency said that manufacturers would likely need studies that followed a cohort of people over time to show that their products’ use in helping adult smokers quit cigarettes outweighed the risk to youth.
Triton, along with other companies, challenged the agency’s decision, saying it had relied on the earlier guidance in its application.
The decision, which was written by Circuit Judge Andrew Oldham, joined by Circuit Judges Jennifer Elrod and Cory Wilson, stays the FDA’s decision denying approval to Triton’s flavored products pending a review on the merits.
The case is Wages and White Lion Investments LLC dba Triton Distribution v. FDA, 5th U.S. Circuit Court of Appeals, No. 21-60766.
For Triton: Eric Heyer of Thompson Hine
For FDA: Noah Katzen of the U.S. Department of Justice Civil Division
Brendan Pierson – Reuters – 2021-10-26.
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