FDA Withdraws MDO for Turning Point Brands Vapor Products

Company’s line will remain on the market while PMTA is under review
Turning Point Brands

LOUISVILLE, Ky. — The U.S. Food and Drug Administration (FDA) rescinded its marketing denial order (MDO) previously issued for certain vapor products from Turning Point Brands Inc., the company said on Oct. 11.

All Turning Point Brands’ proprietary vapor products, including its Solace branded e-liquids, will continue to be marketed while its premarket tobacco product applications (PMTAs) remain under review.

According to the company, the FDA said in its rescission letter that upon further review, it found relevant information that was not adequately addressed. The FDA told Turning Point Brands that its applications contained randomized controlled trials comparing tobacco-flavored electronic nicotine delivery systems (ENDS) to flavored ENDs, as well as several cross-sectional surveys evaluating patterns of use, likelihood of use and perceptions in current smokers.

The letter said that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products, Turning Point Brands said.

After the FDA issued an MDO on Sept. 14, Turning Point Brands filed a petition for relief and motion to stay the decision in the Sixth Circuit Court of Appeals. As a result of the rescission letter, Turning Point Brands said it withdrew both the petition and motion.

“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 of Turning Point Brands. “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.”

While "TPB International LLC" was still on the FDA's online list of companies that have received MDOs as of Oct. 12, an FDA spokesperson confirmed to CSP that the agency had issued a rescission of a denial letter to the company. 

"With this rescission, the company’s tobacco products are placed back into the review process," the FDA said. 

In September 2020, Louisville, Ky.-based Turning Point Brands said it submitted PMTAs to the FDA covering 250 products. The PMTAs covered a broad assortment of products in the vapor category, including proprietary e-liquid offerings, the company said at the time.

The marketer, manufacturer and distributor of branded products including rolling papers, smokeless and vapor products has brands including Solace, VaporFi, South Beach Smoke, HorizonTech and FreeMaX.

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