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September 23, 2021
2 min to read

Turning Point Brands Sues FDA, Challenging PMTA Denials

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Jim McDonald

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.

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Jim McDonald

Vaping since: 12 years

Favorite products:

Favorite flavors: RY4-style tobaccos, fruits

Expertise in: Political and legal challenges, tobacco control haters, moral panics

Jim McDonald

Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue 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’m a member of 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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