The Supreme Court is considering the FDA's authority to regulate e-cigarette products


The Supreme Court appeared unwilling Monday to severely limit the Food and Drug Administration's power to ban the sale of new candy-colored e-cigarette products to teens.

Instead, both conservative and liberal justices said Congress gave the agency the power to stop sales of new tobacco products in 2009, and it has used that power in recent years to introduce new e-cigarette flavors with names like ” “Rainbow Road”. and “Peach Strawberry.”

This is exactly the kind of regulatory issue that companies are hoping to win before the conservative Supreme Court, but it wasn't clear they would win this time.

Judge Brett M. Kavanaugh questioned the e-cigarette industry's claim of overregulation by the FDA, saying their objection was based on the law itself.

“They don't agree with the law giving the FDA so much discretion,” he told a lawyer for two companies whose products were denied approval.

Justice Elena Kagan agreed. “I really don't understand what the surprise is here. “Everyone knows that these flavors are particularly dangerous for children who are starting to use smoking products,” she said. “The FDA has been open about this. There’s just not much mystery here.”

The Biden administration defended the FDA's stance.

The agency admitted that it had two related goals. One was to persuade adults to quit smoking by switching to e-cigarettes with appealing flavors, but without encouraging millions of teenagers to start consuming a product containing nicotine.

Eric Heyer, a lawyer for two e-cigarette companies, argued that the FDA had changed direction and surprised his clients by requiring new studies to prove that their products would encourage more adult smokers to switch to e-cigarettes.

His clients won in the conservative 5th Circuit Court in New Orleans, which called the FDA's decisions “arbitrary” and illegal.
But most of the justices sounded Monday as if they favored the FDA's view.

“They're trying to change the law, but the law is very clear,” Justice Sonia Sotomayor said. “Tell us that your product will help adults quit smoking, and show us that youth won’t start.”

Chief Justice John G. Roberts Jr. and Justice Amy Coney Barrett said they were not convinced the FDA misled the companies.

Other conservative justices expressed support for the industry.

Justice Clarence Thomas said the FDA regulations set a “moving target,” and Justices Samuel A. Alito Jr. and Neil M. Gorsuch expressed similar skepticism.

It is unclear whether the court's decision in the coming months will resolve the controversy.

The lawyer for the e-cigarette companies twice pointed to impending change at the FDA with the election of President-elect Donald Trump.

“We have a new administration in office, and the president-elect has been on record saying that I will save flavored e-cigarettes,” Heyer said. “Frankly, we don’t know how the FDA will handle this going forward.”

Kavanaugh said companies were free to try again.

“You can reapply,” he said.

It's also not clear whether the FDA's rejection will have much impact. Numerous e-cigarette flavors are widely available, even if they are not FDA-approved.



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