U.S. Supreme Court

Did FDA engage in unfair 'regulatory switcheroos' when rejecting flavored vapes? SCOTUS will decide

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The U.S. Supreme Court has agreed to consider the U.S. Food and Drug Administration’s refusal to approve the marketing of new flavored vaping products. (Image from Shutterstock)

The U.S. Supreme Court has agreed to consider the U.S. Food and Drug Administration’s refusal to approve the marketing of new flavored vaping products.

The high court will review a decision by the 5th U.S. Circuit Court of Appeals at New Orleans finding that the FDA was arbitrary and capricious when it denied an application by Wages and White Lion Investments, which does business as Triton Distribution.

Triton Distribution had sought authorization for liquids to be used in e-cigarettes in flavors such as “Jimmy the Juice Man Peachy Strawberry,” “Signature Series Mom’s Pistachio” and “Suicide Bunny Mother’s Milk and Cookies,” according to the cert petition.

The FDA acted under the Family Smoking Prevention and Tobacco Control Act, which imposes special restrictions on “new” tobacco products not commercially marketed before February 2007. Manufacturers must obtain authorization for new products by making a showing that they are “appropriate for the protection of the public health.”

To make that showing, the FDA has to weigh the likelihood that the new products will help existing smokers switch to less dangerous alternatives and the risk that the new products will entice new users.

Since the FDA announced that it would regulate e-cigarettes under the law, it has denied applications to market more than a million flavored products, including products flavored to taste like candy, fruit and desserts.

The en banc 5th Circuit ruled in January that the FDA approval process “was the regulatory equivalent of Romeo sending Mercutio on a wild goose chase—and then admitting there never was a goose while denying he even suggested the chase.”

The Volokh Conspiracy published opinion highlights.

The FDA had given makers of e-cigarettes detailed instructions on information needed for approval while maintaining that the marketing process would be critical, the 5th Circuit said.

“Then, months after receiving hundreds of thousands of applications predicated on its instructions, FDA turned around, pretended it never gave anyone any instructions about anything, imposed new testing requirements without any notice, and denied all 1 million flavored e-cigarette applications for failing to predict the agency’s volte face,” the 5th Circuit said.

The FDA “candidly admitted that it did not read a single word of the 1 million plans,” according to the 5th Circuit, which derided the “regulatory switcheroos.”

The 5th Circuit decision created a circuit split. Seven other federal appeals courts have rejected arbitrary-and-capricious arguments by makers of flavored e-cigarette products, according to the cert petition.

The case is Food and Drug Administration v. Wages and White Lion Investments.

The Supreme Court case page is here.

Law360 and SCOTUSblog covered the cert grant.

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