US Supreme Court Issues Ruling on FDA’s Regulatory Authority

The Food and Drug Administration was handed a win after the Supreme Court declined to hear a challenge to its regulatory authority.

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Supreme Court on Tuesday declined to hear a case challenging the U.S. Food and Drug Administration’s (FDA) regulatory authority.

In an unsigned order on Tuesday, the justices denied an appeal from Avail Vapor, a maker of flavored e-cigarette products, after it lost its challenge against the FDA in a lower appeals court last December.

The 4th Circuit Court of Appeals ruled in December that the FDA has the power to deny applications for e-cigarette products due to its mandate to prevent younger people from smoking tobacco products. It wrote that the FDA has the “daunting task of ensuring that another generation of Americans does not become addicted to nicotine and tobacco products” as it sided with the federal health agency.

E-cigarettes deliver nicotine by vaporizing a liquid, rather than burning tobacco. In 2016, the FDA determined that e-cigarettes were subject to its regulation, like traditional tobacco products, and gave manufacturers until 2020 to apply for approval of e-cigarettes and related products like liquid.

Avail, once a prominent retailer of flavored e-liquids, sought approval for its products in 2020, telling the FDA that they could help smokers quit by switching to e-cigarettes. The company said it had measures in place, including age verification for online sales and limited distribution through specialty shops, that would ensure that its liquids would not be sold to minors.

The FDA denied the application in 2021, saying that the company had not presented long-term studies supporting its claim that its products, which included fruit flavors, were more effective at helping smokers quit than tobacco-flavored liquids, which the agency has said are less appealing to minors. It declined to consider the company’s plans to restrict sales.

Avail’s attorney, Eric Heyer, told CNBC on Tuesday the firm is “disappointed that the Supreme Court declined to review the flawed process by which FDA issued its marketing denial orders to Avail without adequate prior notice of the specific longitudinal comparative efficacy study requirements the agency ultimately imposed.”

In its appeal to the 4th Appeals Court, the firm argued that the FDA had not said it would need to see studies that compare the e-cigarettes with vaping products that taste like tobacco.

“The FDA says Avail and other retailers should have known what they were going to be looking for. Well, virtually nobody in the industry knew,” Mr. Heyer added

He added: “The lack of those comparative efficacy studies was one of the main reasons why the FDA denied these applications. The FDA had five years to communicate this to applicants and they never did. Not a single word.”

Other than Avail, prominent vaping company Juul challenged an FDA application rejection but lost its appeal to overturn the agency’s ban on its products. The company, which had to cut numerous jobs, had argued that the agency conducted an incorrect analysis of its data on vaping.

What the FDA Says

The FDA has denied more than 55,000 applications for e-cigarette products. Those denials have been previously upheld by the D.C. Circuit, 3rd Circuit, and 7th Circuit, according to the Reuters news agency.

Earlier this year, the health regulator said it issued some 6,500 “marketing denial orders” to several firms’ attempts to make and market flavored e-cigarettes, who cannot “market or distribute these products in the U.S., and retailers who sell these illegal products risk FDA enforcement action,” according to a news release.

Any company that wants to legally market a new tobacco product in the United States must receive a written marketing order from the FDA. But if the health regulator deems it unfit for public health, it issues a marketing denial order.

“The premarket tobacco product applications, which were for a variety of flavored e-cigarette products, did not provide sufficient evidence to show that permitting the marketing of these products would be appropriate for the protection of the public health,” the FDA release said. “Flavors of some of the products denied include Citrus, Strawberry Cheesecake, Cool Mint, and Menthol.”

Last year, the 2022 National Youth Tobacco Survey found that some 14.1 percent of high school students and 3.3 percent of middle school students used vaping products at least once in the past 30 days at the time of the survey. About 85 percent used e-cigarettes and 27 percent used menthol-favored e-cigarettes, it found.

Around the same time, the American Association for Cancer Research and the American Society of Clinical Oncology called for a total ban on all flavored e-cigarettes and other vaping products. They said that the “high levels of nicotine can also increase addiction, raise blood pressure, interfere with brain development, and suppress the immune system,” while the “magnitude of long-term health risks will remain unknown until longitudinal studies are completed.”

Reuters contributed to this report.