Turning Point Says FDA Rescinds Marketing Denial Order for Vapor Products

By Michael Dabaie

Turning Point Brands Inc. said the Food and Drug Administration rescinded its marketing denial order for some of its vapor products, with pending premarket tobacco product applications under review.

Turning Point said its portfolio of proprietary vapor products remains under review.

All of Turning Point's proprietary vapor products, including its Solace branded e-liquids, will continue to be marketed while they remain under review, the company said.

Turning Point in mid-September said the FDA issued the marketing denial order in response to a premarket tobacco product application covering some of the company's vapor products.

The company said Monday that in that in its rescission letter, the FDA stated that on review, the FDA "found relevant information that was not adequately 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."

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 said.

"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," Chief Executive Larry Wexler said.

Write to Michael Dabaie at [e-mail]

(END) Dow Jones Newswires

October 11, 2021 08:11 ET (12:11 GMT)

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