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September 17, 2021

FDA Issues MDOs to Turning Point Brands, Other Large Vape Companies

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.

Smokers created vaping without any help from the tobacco industry or anti-smoking crusaders, and vapers have the right to keep innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I recently joined the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy
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Susan
Susan
1 month ago

I’m getting fed up with what the government says I can and cannot ingest or smoke legally or without taxing it through the roof. They’d never attack alcohol in the same manner because it’s more “socially acceptable” even though it remains appealing to kids and fuels the diseases of alcoholism and addiction. Take this fact with a grain of salt because I can’t site where I’ve heard it but apparently 50% of alcohol sales are to alcoholics. I don’t see the government cracking down on any alcohol manufacturers. But oh, weed is getting legalized for recreational use too. Meanwhile, I… Read more »

R. Keith
R. Keith
1 month ago

These people have no right to disrupt our ability to live and vape. It was 30years I smoked starting at 6 years old finally I was able to use vaping to save what life I have left after the evil of cigarettes. From day one vaping having me my life back and I was able to breathe. I will forever need nicotine as it’s not possible for me to stop and vaping allows me to having it with out all the poison in cigarettes and these evil bastards think there going to take that from me? They better get out… Read more »

Roman
Roman
1 month ago

They should sue take them to the cleaners

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