FDA EFFORTS TO CURB FLAVORED VAPES DRAW SUPREME COURT REVIEW

(Bloomberg) -- The US Supreme Court said it will hear a Biden administration appeal that aims to reinforce the Food and Drug Administration’s power to bar flavored vaping products it concludes are likely to appeal to children. 

The justices will review a federal appeals court decision that said the FDA acted in an “arbitrary and capricious” manner when it rejected applications from two companies seeking to sell e-liquids in such flavors as “Suicide Bunny Mother’s Milk and Cookies” and “Killer Kustard Blueberry.”

The case will test the FDA’s ability to prohibit tobacco products that could be harmful. The agency has denied millions of applications, many of them for flavored vapes, since Congress enacted a 2009 law that requires companies to get FDA approval before selling new tobacco products.

The products would compete with the roughly two dozen that the FDA has authorized, all of them tobacco- or menthol-flavored. The authorized products include those from Altria Group Inc. and R.J. Reynolds Vapor Co., a subsidiary of British American Tobacco Plc. Those companies are also awaiting FDA reviews of their own applications to sell new products and could benefit from any clarity that a court ruling provides.

Flavored Vapes From China Are Overwhelming the FDA’s Resources

The New Orleans-based 5th US Circuit Court of Appeals said the FDA engaged in “regulatory switcheroos” by imposing new testing requirements after companies had submitted their paperwork seeking approval. Other federal appeals courts have upheld the FDA’s actions in similar cases.

The Biden administration told the justices that flavored e-cigarettes “pose a serious risk of enticing young users” and that the 5th Circuit ruling “undermines the agency’s efforts to fight that problem.”

The case involves Wages and White Lion Investments LLC, which does business under the name Triton Distribution. The business makes e-liquids for its own brands as well as another company, Vapetasia LLC. Their proposed flavors also include “Jimmy The Juice Man Peachy Strawberry,” “Signature Series Mom’s Pistachio” and “Iced Pineapple Express,” according to court documents.

Wages and White Lion and Vapetasia said the FDA didn’t provide “fair notice” that it had changed the requirements for authorization of new flavors. The companies urged the Supreme Court not to hear the appeal.

The FDA has declined to comment on the litigation, saying it doesn’t discuss ongoing legal cases. The agency recently said it’s been overwhelmed by lawsuits challenging its denials of some products.

The 2009 law, known as the Tobacco Control Act, says companies must show that products introduced after Feb. 15, 2007,  would be “appropriate for the protection of the public health.” 

The court will hear arguments and rule in the nine-month term that starts in October. 

The case is FDA v. Wages and White Lion, 23-1038.

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2024-07-02T14:00:04Z dg43tfdfdgfd