Supreme Court scrutinizes details of FDA’s rejection of marketing for flavored vapes

Supreme Court justices appeared apprehensive Monday to second-guess the Food and Drug Administration’s rejection of marketing authorization for flavored nicotine products that could be attractive to minors.

Eric Heyer, the lawyer representing the vaping companies Triton Distribution and Vapetasia LLC, argued that the FDA knew that two-thirds of adult users were using the flavored products when it rejected his clients’ products.

The FDA went on to deny applications for more than 250,000 applicants, he added.

“I want to underscore what a massive sea change it was,” Mr. Heyer argued before the court.

But Curtis Gannon, the deputy solicitor general representing the federal government, said the 5th U.S. Circuit Court of Appeals, which sided with the companies against the FDA’s marketing denial, was “alone among the courts of appeals.”

He said that unless the FDA authorized marketing for the products, “the statute made these products unlawful.” The FDA, Mr. Gannon said, has to be persuaded with scientific evidence in the companies’ application for marketing authorization that the product is appropriate for public health.

“Seven percent of youth are still using,” Mr. Gannon said. “The FDA is legitimately concerned that youth are chasing the flavors they want.”

The liberal wing of the court — and some of the Republican appointees — pushed back on the companies’ complaints over how the FDA handled their applications.

Justice Elena Kagan said the FDA was pointed with the companies before the denials and told them they had to persuade the agency that the products were appropriate in light of concerns that flavors are dangerous to kids starting to use them.


“FDA has been completely up front about this and I think that flavors you give people — blueberry vapes — the difficulty with that and the FDA has tried to document that, that blueberry vapes are very appealing to 16-year-olds, not 40-year-olds,” said Justice Kagan, an Obama appointee. “There is just not a lot of mystery here about what the FDA was doing.”

Justice Brett M. Kavanaugh also expressed skepticism about the companies’ legal battle against the FDA denials. He said the fact that the companies claimed flavored vapes could help adult smokers quit cigarettes didn’t outweigh the FDA’s concerns for youth.

“I’m trying to figure out what the legal error is,” said Justice Kavanaugh, a Trump appointee. “You agree at the end of the day, the agency has to make a choice and it is going to be a choice with uncertainty.”

Mr. Heyer said President-elect Donald Trump has said he would save flavored vapes and his administration in the new year could take a different position than the current Biden administration has with its FDA evaluation.

But Justice Kavanaugh said the companies could always reapply at that later time.

The justices are evaluating whether the FDA ran afoul of rule-making procedures in rejecting the flavored vaping products.

The case, Food and Drug Administration v. Wages and White Lion Investments LLC, dba Triton Distribution, et al., involves the FDA’s rejection of marketing authorization for flavored e-cigarettes or vapes by Triton Distribution, which also has products sold by Vapetasia.

The federal government has argued that Congress authorized the executive branch to protect those younger than 18 from tobacco through the Family Smoking Prevention and Tobacco Control Act.

Under the legislation, anyone who wants to introduce a new tobacco product into the market must receive authorization from the FDA. The agency can reject authorization if it finds no evidence that the product would support public health.

Triton wanted to market e-cigarettes with flavors such as Signature Series Mom’s Pistachio, Jimmy the Juice Man Peachy Strawberry and Suicide Bunny Mother’s Milk and Cookies.

The FDA rejected the company’s authorization request, reasoning that the harms outweigh any benefits.

The companies, meanwhile, argue that flavored products can help adults quit using cigarettes.

The companies said the FDA did not notify them of changes in standards for evaluating authorization requests for flavored vapes after issuing a rule in 2016 reclassifying their products and subjecting them to different guidelines.

The 5th Circuit ruled against the FDA’s denial of the companies’ marketing authorizations, reasoning that the agency violated the Administrative Procedures Act.

A Supreme Court decision on flavored vape advertising standards is expected by the end of June.