Turning Point Says FDA Rescinds Denial-to-Market Order for Vapor Products

By Michael Dabaie


Turning Point Brands Inc. said the Food and Drug Administration had revoked its denial-of-market order for some of its vapor-based products, with pre-market tobacco product applications being reviewed.

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

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

In mid-September, Turning Point said the FDA issued the denial-of-market order in response to a tobacco product pre-market application covering some of the company’s vapor products.

The company said Monday that in its cancellation letter, the FDA said that during the review, the FDA “found relevant information that was not adequately evaluated. Specifically, your requests contained randomized controlled trials comparing tobacco flavored ENDS to flavored ENDS as several cross-sectional surveys assessing patterns of use, likelihood of use and perceptions of current smokers, current NDE users, former tobacco users and never users, which require further consideration.

The letter stated that “at this time, in light of the unusual circumstances, the FDA does not intend to take 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 in reviewing our PMTAs,” said Managing Director Larry Wexler.


Write to Michael Dabaie at [email protected]


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