The publicly traded Turning Point Brands says that the FDA has rescinded a previously issued Marketing Denial Order regarding its PMTA applications.
LOUISVILLE, Ky. — Turning Point Brands informed the US Food and Drug Administration (FDA) that a marketing denial order for vapor products it sells pending premarket tobacco application approval has been rescinded and is under new review by the FDA.
The marketing denial order (MDO) was issued on Sept. 14 with tens of thousands of other applications from small to medium-sized vaping manufacturers. Now, the company intends to resume the marketing of its proprietary vaping products and e-liquids while the new regulatory, scientific review is underway.
In response to the Sept. 14 marketing denial order, Turning Point Brands filed a lawsuit against the FDA and the President Joe Biden administration petitioning for relief and a motion to stay the regulatory decision in federal appellate court. With notification of the FDA’s rescission, Turning Point withdrew the legal complaint.
“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 chief executive officer of Turning Point, in an Oct. 11 press 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,” Wexler added.
Turning Point Brands produces the Solace e-liquid brand, the rolling paper brand Zig Zag, Nu-x CBD, and other consumables.