Turning Point Brands, Inc. Announces FDA Rescinds Previously Disclosed Marketing Denial Order for Turning Point Brands’ Vapor Products
October 11, 2021 at 07:30 am EDT
Share
Turning Point Brands, Inc. was informed by the Food and Drug Administration (“FDA”) that the agency had rescinded its September 14 Marketing Denial Order (“MDO”) for certain of its vapor products with pending Premarket Tobacco Product Applications (“PMTAs”) under review. All of TPB’s proprietary vapor products, including its Solace™ branded e-liquids, will continue to be marketed while they remain under review. In its rescission letter to TPB, the FDA stated, “Upon further review of the administrative record, 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 further clarified that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products. In response to the September 14 MDO, the Company had filed a petition for relief and motion to stay the decision in the 6th Circuit Court of Appeals. On October 8, as a result of the rescission letter, TPB withdrew both the petition and motion.
Turning Point Brands, Inc. is a manufacturer, marketer and distributor of branded consumer products. It sells a range of products to adult consumers consisting of staple products under the brands Zig-Zag and Stokerâs. Its segments include Zig-Zag Products (Zig-Zag), Stokerâs Products (Stokerâs) and Creative Distribution Solutions. Zig-Zag principally market and distribute rolling papers, tubes, and related products; finished cigars and make-your-own cigar wraps, and CLIPPER reusable lighters and other accessories. Stokerâs manufactures and markets moist snuff tobacco (MST) and contract for and market loose leaf chewing tobacco products. Creative Distribution Solutions segment markets and distributes liquid nicotine products and certain other products without tobacco and/or nicotine; distributes an assortment of products to non-traditional retail outlets via Vapor Beast, and markets and distributes an assortment of products to individual consumers via the VaporFi B2C online platform.