FDA Rescinds Marketing Denial Order for Turning Point Brands' Vapor Products
SILVER SPRING, Md. — The Food and Drug Administration (FDA) is taking another look at premarket submissions by Turning Point Brands Inc. (TPB).
According to TPB, the agency rescinded its Sept. 14 Marketing Denial Order (MDO) for certain vapor products with pending premarket tobacco applications (PMTAs) under review.
As a result, all of TPB's proprietary vapor products, including its Solace branded e-liquids, will remain on the market while the FDA continues its review.
In its rescission letter to TPB, the FDA stated, "Upon further review of the administrative record, FDA found relevant information that was not adequately assessed. Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS [electronic nicotine delivery systems] 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."
The letter further clarified that "at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against" the products, TPB said.
In response to the Sept. 14 MDO, the company filed a petition for relief and motion to stay the decision in the Sixth Circuit Court of Appeals. After receiving the notice that the FDA was rescinding the decision, TPB withdrew both the petition and motion on Oct. 8.
"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 Larry Wexler, president and CEO, TPB. "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," he added.
Louisville, Ky.-based TPB is a manufacturer, marketer and distributor of branded consumer products, including alternative smoking accessories and consumables with active ingredients, through its core brands Zig-Zag and Stoker's and its emerging brands within the NewGen segment.