Turning Point Says FDA Rescinds Marketing Denial Order for Vapor Products
October 11 2021 - 8:26AM
Dow Jones News
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rescinded its marketing denial order for some of its vapor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 michael.dabaie@wsj.com
(END) Dow Jones Newswires
October 11, 2021 08:11 ET (12:11 GMT)
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