Texas company can continue to sell flavored e-cigarettes, 5th circuit rules
- Law firms
- Related documents
- Court finds FDA shot “switcheroo” on manufacturers
- The agency refused around 55,000 applications for electronic cigarettes
The names of companies and law firms shown above are generated automatically based on the text of the article. We are improving this functionality as we continue to test and develop in beta. We appreciate comments, which you can provide using the comments tab on the right of the page.
(Reuters) – Triton Distribution can continue to sell its flavored electronic cigarettes, a federal appeals court has ruled, despite the US Food and Drug Administration ruling otherwise.
In a unanimous opinion on Tuesday, the 5th U.S. Court of Appeals said that when the FDA last month rejected a request to sell its products from the Richardson, Texas-based company, the agency did not not sufficiently taken into account Triton’s marketing plan to reduce revenue. appeal to the youth.
The court found that the FDA had removed a “surprise switch” from previous guidelines indicating that manufacturers would not need long-term studies to support e-cigarette applications.
Triton’s products were among some 55,000 e-cigarettes that the FDA refused to approve earlier this year, after asking manufacturers to seek approval for their existing products under a 2016 rule deeming them to be regulated as tobacco products.
An FDA spokesperson 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 so-called 2106 presumption rule, and the FDA initially gave manufacturers until 2018 to seek approval, allowing them to continue selling in the meantime. That deadline was then pushed back to 2022, then postponed to 2020 amid litigation from anti-smoking groups challenging the delay.
The FDA initially said in the guidelines accompanying the presumption rule that it did not expect companies to need long-term studies to support their claim. However, in an announcement in August that it would turn down a first batch of applications, the agency said manufacturers would likely need studies that track a cohort of people over time to show that their products’ use to help adult smokers quit smoking outweighed the risk of youth.
Triton, along with other companies, challenged the agency’s decision, saying it relied on earlier guidelines in its request.
The ruling, which was drafted by circuit judge Andrew Oldham, joined by circuit judges Jennifer Elrod and Cory Wilson, suspends the FDA’s decision to deny approval of 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 US Circuit Court of Appeals, No. 21-60766.
For Triton: Eric Heyer from Thompson Hine
For the FDA: Noah Katzen of the Civil Division of the US Department of Justice