Vaping’s Legal Battle With FDA to Shift Under ‘Friendlier’ Trump

The vaping industry is counting on President-elect Donald Trump to significantly overhaul how the FDA regulates flavored e-cigarettes, an agency action that came under the scrutiny of US Supreme Court justices this week.

The Trump administration is in line to take up the Food and Drug Administration’s powerful authority to regulate electronic nicotine products, overseeing an authorization process that vaping manufacturers must go through before their product can be legally marketed in the US.

The process has drawn industry resistance over the necessary and sufficient scientific evidence required to prove the products would promote public health. The dispute eventually landed the FDA and members of the industry before the Supreme Court on Dec. 2, where justices took aim at the FDA’s regulation.

Even with the issue up for deliberation before the court, the industry is putting its faith in the Trump administration to revamp the agency’s vaping oversight, calling for relaxed guidelines, timely decisions, and more transparency.

“The incoming administration has a mandate for change,” said Tony Abboud, executive director of the Vapor Technology Association. “They have a desire to eliminate bad regulations. They have a desire to unleash innovation. They believe that consumers should have access to a free market of options.”

Abboud, who met with Trump in September for a “wide-ranging conversation” on vaping, said in an interview he expects the president-elect to “follow through on this promise to save vaping.”

That pledge also became a supporting point for arguments by manufacturers at the Supreme Court.

“We have a new administration coming in,” said Eric Heyer, a partner at Thompson Hine LLP who argued on behalf of the vaping companies. “The president-elect is on record saying, ‘I’m going to save flavored vapes.’”

E-cigarettes deliver nicotine without some of the harmful effects of smoking combustible cigarettes. Many flavored vapes with colorful names that evoke candy and sweets have become appealing to youth, which has prompted the FDA to curb access to the products.

US teenagers’ e-cigarette use dropped by two-thirds over the past five years, according to the annual National Youth Tobacco Survey. About 1.6 million school children currently use the devices, which is just a third of the peak level in 2019, when it was around 5 million.

‘Friendlier’ Administration

The FDA in 2016 determined that e-cigarettes were subject to regulation under the Tobacco Control Act, just like traditional tobacco products. The agency required companies to submit applications by September 2020 for approval, even if they were already on the market.

The FDA received nearly 7 million applications by that deadline, rejecting more than 1 million of them, which prompted the ongoing legal battles.

Industry attacks against the FDA’s premarket tobacco marketing process criticize the agency’s evaluation and the pace of approvals.

The FDA earlier this year said it received applications for nearly 27 million deemed tobacco products and has made determinations on more than 26 million of the applications. To date, the FDA has authorized marketing of 56 products through the Premarket Tobacco Application pathway, including 34 tobacco- and menthol-flavored e-cigarette products and devices, according to a statement from the agency.

Lawsuits seeking to block the FDA’s marketing denial orders claim the agency never gave fair notice that the companies needed to conduct long-term studies on their specific flavored products.

In FDA v. Wages and White Lion Investments on Dec. 2, the FDA said it denied applications because the companies failed to show that the benefits of flavored e-cigarettes to help current smokers quit was greater than the risk of youth becoming addicted to the products.

The Supreme Court will likely issue a ruling by next summer on whether the FDA’s denial orders were arbitrary and capricious.

But regardles of how the court rules, members of the industry are hoping for “fairly dramatic relaxation of the requirements that FDA has imposed on e-cigarettes” under Trump, said Bryan Haynes, a partner at Troutman Pepper Hamilton Sanders LLP.

“The industry could reasonably expect a more transparent process, more timely processing of applications, and better enforcement against non-compliant actors,” Haynes said. “I think this administration will be friendlier to the industry than the Biden administration was.”

The industry is also floating a tobacco product standard, which would establish guidelines for the authorization of products, according to Abboud.

Additionally, manufacturers are eyeing Trump’s support for small businesses and how that will translate into support for vaping sellers.

“The policy ethos that Trump and his team have been advocating all during the campaign is protecting small American businesses, first and foremost, and also enabling American consumers to have the freedom to make choices about their own lives and their own health,” said Jim McCarthy, a spokesperson for the American Vapor Manufacturers.

Trump’s First Term

However, demand for relaxed e-cigarette guidelines should consider Trump’s stance on vaping during his first administration, industry watchers say.

Trump in 2019 threatened to ban most flavored e-cigarettes from the market due to concerns over the appeal to children. He later backed off the ban after it was met with industry resistance.

In 2020, his ban on certain e-cigarette pods made by companies like Juul Labs prohibited flavored e-liquids, but allowed menthol and tobacco products on the market.

He also signed a law that raised the federal legal age for purchasing tobacco from 18 to 21, which vaping proponents say lowered youth vaping numbers.

“These issues are going to be front and center in the new administration,” said Cliff Douglas, CEO of Global Action to End Smoking.

“The court’s decision is going to launch this new phase, because one way or another, it’s going to be issuing a decision and conveying where it stands on how this stuff should be managed.”

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.