A federal appeals court ruled on Jan. 3 for the Food and Drug Administration to reconsider the agency’s decision of barring two makers of flavored liquid for e-cigarette from marketing their products.
The ruling of the U.S. Fifth Circuit Court of Appeals, New Orleans, paves the way for the makers to attempt to reverse their marketing denial orders (MDOs).
The court ruled in an opinion by Judge Andrew Oldham that the FDA “sent manufacturers of flavored e-cigarette products on a wild goose chase” regarding the terms necessary for these manufacturers to get approval only to have their applications denied.
Judge Oldham in his ruling wrote: “As of today, FDA has not approved a single PMTA for a single one of the more than 1,000,000 flavored e-cigarette products submitted to the agency.”
The ruling added that the FDA acted arbitrarily and capriciously in rejecting consideration of marketing plans from the following two makers of flavored liquid e-cigarettes, Triton Distribution and Vapetasia LLC.
Oldham called on the FDA to “give petitioners the benefit of a full and fair regulatory proceeding on remand, notwithstanding its prior promises to reject their applications no matter what.”
Eric Heyer, a partner at Thompson Hine LLP, which represents Triton Distribution and Vapetasia LLC,told CSP Daily News that “we are very pleased that the Fifth Circuit has recognized FDA’s procedural failures with respect to its comparative efficacy study demands.” Heyer added: “Going forward, we hope that FDA will focus on communicating with specificity to applicants what study designs the agency finds acceptable and what applicants must show to satisfy the APPH standard for non-tobacco-flavored ENDS products.”
CSP Daily News reached out to the FDA, but the agency declined to comment.
The FDA took charge of regulating e-cigarettes in 2016.
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