Turning Point Brands Down After FDA Denies Vapor Products Application

By Michael Dabaie

Turning Point Brands Inc. shares fell 5% to $45.95 in morning trading after the company said the U.S. Food and Drug Administration denied its application to market some of its vapor products.

Turning Point said it will continue to engage with the FDA and other stakeholders as it considers options, including a formal appeal of the decision and potential legal relief. "While we believe the FDA's current conclusion is misguided, we will continue our dialogue with the agency in search of a path forward," Chief Executive Larry Wexler said.

The company said it stands behind its premarket tobacco product application, which it said established "the products' continued marketing would be 'appropriate for the protection of public health,' the standard established by the Family Smoking Prevention and Tobacco Control Act of 2009."

Turning Point's premarket tobacco product application included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use, the company said.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

September 17, 2021 10:24 ET (14:24 GMT)

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