Turning Point Brands, the publicly traded company with a presence in multiple segments of the nicotine and tobacco marketplace, confirmed today that some of its Premarket Tobacco Applications (PMTAs) have received Marketing Denial Orders from the FDA.
Other major brands in the independent vaping industry have also received MDOs this week for flavored e-liquids, including AVAIL Vapor. These are believed to be the first MDOs issued to major companies that submitted extensive product-specific scientific evidence in their PMTAs.
“The PMTA denied by this MDO included an in-depth toxicological review, a clinical study, and studies on patterns and likelihood of use,” Turning Point said in a statement. “The data demonstrated that TPB products do not appeal to never users, youth, or former users and that a significant majority of users of TPB products had completely ceased use of combustible cigarettes.”
Turning Point said it will “continue to engage with the FDA and other stakeholders as we consider options moving forward, including a formal appeal of the decision and potential legal relief.” Smaller e-liquid companies that have received MDOs are also considering legal action, although specific strategies are still being discussed.
As of last Friday, Sept. 10, the FDA had issued MDOs to 168 vape manufacturers for almost a million products—most of them flavored bottled e-liquid. The agency announced on Aug. 26 that products in flavors other than tobacco and menthol would be required to meet a higher standard of evidence that they “demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”
Since the Sept. 9 expiration of the grace period for vape manufacturers to continue selling unauthorized products without a marketing order from the FDA, the agency has not authorized a single vapor product.
Turning Point Brands sells the e-liquid brand Solace, and has a major presence in vaping product distribution (Vapor Beast) and online retail (VaporFi, DirectVapor). The company also owns a variety of other non-vapor brands, including nicotine pouches (FRĒ), chewing tobacco and moist snuff, CBD products, and Zig-Zag rolling papers. The company has been a leader in industry lobbying and advocacy for many years.
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