Dive Brief:
- The U.S. Food and Drug Administration has been ordered to reconsider its decision to ban two e-cigarette manufacturers from marketing their products, according to a recent filing with the U.S. Court of Appeals for the Fifth Circuit.
- This ruling reversed a July 2022 court decision that initially said the manufacturers — Triton Distribution and Vapetasia LLC — lacked scientific evidence that their products offered more benefits to adults than it did risks to youths.
- This continues the broader battle between the FDA and vape manufacturers as the agency has cracked down for several years on flavored e-cigarette products, which it claims are more attractive to children.
Dive Insight:
The court filing notes that over the course of the past several years, the FDA gave vape manufacturers detailed instructions regarding the information federal regulators needed to approve the marketing of e-cigarette products. It notes that the FDA previously said these marketing plans would be critical to the success of companies’ applications.
According to the filing, months after receiving thousands of applications based on its instructions, the FDA shut down about a million of these applications after it “imposed new testing requirements without any notice.”
Regarding the handling of the applications from Triton Distribution and Vapetasia, the court filing notes that the FDA was “arbitrary and capricious” when it came to reviewing their plans to continue marketing their products.
Circuit Judge Andrew Oldham called the FDA’s 2022 ruling for these companies a “regulatory switcheroo,” according to the recent filing.
“FDA will give petitioners the benefit of a full and fair regulatory proceeding on remand, notwithstanding its prior promises to reject their applications no matter what,” according to the filing.
To date, over 275 companies have been issued marketing dental orders from the FDA, according to the agency’s website. As of August 2023, 70% of all vaping products in the U.S. were sold in convenience stores, according to Management Science Associates Inc.
