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September 23, 2021

Turning Point Brands Sues FDA, Challenging PMTA Denials

Turning Point Brands today petitioned a federal court to review the FDA’s marketing denial of its flavored e-liquids. The action represents what could be a wider legal response from the independent vaping industry, challenging the FDA’s effective ban on products in flavors other than tobacco and menthol.

The petition asks the Sixth U.S. Circuit Court of Appeals to review Marketing Denial Orders (MDOs) of Premarket Tobacco Applications (PMTAs) for various flavored e-liquids made by Turning Point Brands (TPB) and sold under the Solace, VaporFi and Vapor Shark brands.

TPB asks the court to review the FDA order “on the grounds that it is arbitrary and capricious, an abuse of discretion, contrary to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act of 2009, and otherwise not in accordance with law.”

The company requests the court “vacate or modify” the FDA order, and asks that TPB be allowed to “continue to market the products subject to the challenged order.”

The link to the petition was shared on Twitter this afternoon by American Vaping Association President Gregory Conley. The link just shows the original filing and contains no legal brief from TPB’s lawyers.

The FDA announced Aug. 26 that it would apply a new standard specifically to vaping products in flavors other than tobacco and menthol. The agency has issued Marketing Denial Orders (MDOs) to 323 companies, representing almost 1.2 million products.

Turning Point Brands sells and distributes vaping products and a variety of non-vaping nicotine, tobacco and cannabis products. In addition to the e-liquid brands named above, the Kentucky-based company owns vape distributor Vapor Shark, online retailers DirectVapor and VaporFi, and nicotine pouch brand FRĒ. TPB has a history of leading and supporting vaping industry lobbying and advocacy.

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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No Cigs
No Cigs
1 month ago

Other juice companies need to do this!! The FDA is out of control, the great majority of people vaping are not teenagers!! I’ve been off cigarettes for over 10 years thanks to flavored ejuice.

Phil Solomon
Phil Solomon
1 month ago

Well I think the companies also need to get together,I don’t know the name of the company that the lady speaker that was in London she said her and her husband started a company 10 years ago and from what she was saying they are big, and they invited her to come and speak and answer questions,anyway I’ve been vaping for over 10 years and vaping flavors helped me quit smoking and I smocked for 35 years thanks Phil

Grady
Grady
29 days ago

Well all know what it is about. It’s about money, The more people that quit smoking the less tax revenue the states and Federal government bring in.

Dennis Michael
Dennis Michael
28 days ago

thank you someone is still fighting hope more still continue.

John Hastings
John Hastings
1 month ago

So they cannot legally sell or distribute any nicotine products until the court decides, right?

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