The U.S. Food and Drug Administration has rescinded the marketing denial order (MDO) it issued for some Turning Point Brands (TPB) e-liquids. The products that had been denied are now back under review.
In a letter addressed to TPB’s senior vice president of external affairs, Brittani Cushman, the FDA said it had found relevant information that was not properly assessed.
“Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers, current ENDS users, former tobacco users and never users, which require further review,” wrote Matthew Holman, the director of the Office of Science at the FDA’s Center for Tobacco Products.
The agency indicated that it would not initiate enforcement action against the TPB products under review.
The move comes after TPB challenged the MDOs in court. TPB has now withdrawn its appeal.
“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said TPB President and CEO Larry Wexler in a statement. “It is important that the PMTA process is transparent, purposeful and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance.
“We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”
Industry representatives suggest the clerical error is a result of the rush with which the FDA was forced to decide on premarket tobacco product applications. The Sept. 9 deadline was ordered by a court in response to litigation by anti-vaping groups, including the Campaign for Tobacco-Free Kids.
The MDO withdrawal has left some speculating as to whether the rejected applications of other companies would also receive a second look. Several companies, including Triton and Bidi Vapor, are currently awaiting court decisions on their MDO challenges.