- Four experts told Insider the
FDA Juul ban could signal a larger trend for the industry. - The decision could be the result of pressure from the
Biden Administration to address teen smoking.
The US ban on
The US Food and Drug Administration (FDA) announced on Thursday that Juul Labs would no longer be able to sell its e-cigarettes and must remove all of its products from the US market immediately. The health group said the decision was part of its campaign to ensure e-cigarettes are "appropriate for the protection of public health."
In its press release, the FDA said Juul Labs was unable to provide sufficient evidence that its vape pods did not leach potentially hazardous chemicals. Juul Labs' chief regulatory officer, Joe Murillo, said in a statement to Insider that the company believes it "provided sufficient information and data based on high-quality research to address all issues raised by the agency" and plans to appeal the decision.
But, four experts told Insider the ban on Juul e-cigarettes could signal a larger upcoming impact on the industry.
"I believe this is just the opening gun," John Bansahf, a lawyer and legal activist who teaches at George Washington University Law School, said. "It seems like Juul was singled out first in large part due to their marketing toward kids."
The e-cigarette brand gained popularity in 2017 following a large social-media campaign. The brand became known for its fruity flavors and faced FDA scrutiny over concerns its marketing campaign was targeting minors. In response, Juul Labs stopped selling fruity-flavored e-cigarettes and cut back on its ad campaign in 2019.
"This ban by the FDA puts electronic-cigarette makers on notice," Alan Holcolmb, a lawyer who focuses on product liability at Turnbull Holcomb, told Insider. "These manufacturers no longer have an unfettered ability to manufacture harmful products and sell them to masses of young people without significant oversight by the government. This is a major win for public health and consumer advocates."
Last year, an FDA study estimated that over 2 million US middle-school and high-school students used e-cigarettes, but the Juul brand has lost much of the popularity it enjoyed during its peak. The company's market share dropped from 75% in 2018 to about 42% last year. Last year, a national survey found over half of high schoolers who vaped preferred Puff Bar.
When asked by Insider about potential FDA action against other e-cigarette brands, the FDA said it was prioritizing application reviews from "manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health."
"As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95% of the e-cigarette market at that time: Fontem (blu), JUUL, Logic, NJOY, and R.J. Reynolds (Vuse)," the FDA told Insider. The FDA has already issued decisions on e-cigarette products from Fontem (blue), Logic, NJOY, and R.J. Reynolds (Vuse) this year, approving some and denying others.
Kenneth Warner, dean emeritus of public health at the University of Michigan, called the reason behind the ban "essentially political."
"There was so much opposition to Juul — from parent groups, organizations like the Campaign for Tobacco Free Kids (the most influential tobacco NGO), and legislators in state legislatures and Congress – that FDA simply could not have authorized the sale of Juul," he told Insider. "The reaction would have been fierce and possibly even threatened the agency's funding."
Bansahf, who founded an anti-smoking group called Action on Smoking and Health, said the decision is likely the result of pressure from the Biden Administration on a larger agenda against the tobacco industry. Earlier this month, The Wall Street Journal reported that the White House plans to dramatically decrease nicotine levels in traditional cigarettes.
"This rebuff to Juul could signal their willingness to remove the nicotine from cigarettes, which will take the addictive sting out of smoking," Robert Proctor, a professor of the history of
However, Eric Lindblom, the former director for tobacco control at the O'Neill Institute at Georgetown University, said he sees the ban as too "product specific" to indicate future bans on other e-cigarette brands, especially in light of the dozens of e-cigarette products the FDA has approved through its Premarket Tobacco Product Application (PMTA) process.
Juul Labs filed its PMTA which was initially accepted nearly two years ago. Every tobacco company is required to file one in order to get approval to continue selling commercially — a process that Warner said allows the FDA to cut many companies out of the market.
Ultimately, experts said the future of the e-cigarette market comes down to whether the brands can prove their company has more benefits when it comes to helping adults quit smoking versus enticing young adults to start vaping.