CHICAGO — Juul Labs Inc. has hired former Food and Drug Administration employees and is recruiting more researchers as it prepares for a crucial regulatory hurdle that will determine the future of the top US e-cigarette maker.
The company and its peers must submit applications to the FDA by May 12 in order to sell their products. The deadline is a defining moment for the e-cigarette industry, which has been under fire following a surge in teen vaping.
For Juul, securing a swift clearance is critical. Failing to win the FDA’s blessing could shut it out of a market it has dominated.
Roxana Weil, formerly a lead toxicologist at the agency’s Center for Tobacco Products, joined Juul as principal scientific adviser in September. Gabriel Muniz, who worked in an FDA division that inspects tobacco manufacturers, joined Juul last month as a director of regulatory compliance.
Juul is seeking to fill a number of legal, regulatory and science-focused jobs in Washington and San Francisco, according to job listings on its website, after laying off hundreds of people and instituting a hiring freeze as part of a broader reorganization of the company.
Vaping companies are expected to provide studies to the FDA showing their products’ health effects, potential to help smokers quit, and evidence on whether they might appeal to kids and nonsmokers. Regulators have said they want to prevent a new generation from getting hooked on nicotine after decades of progress in reducing smoking rates.
“We are focused on building a company for the long-term,” Juul CEO K.C. Crosthwaite said in a statement.
On Wednesday, Crosthwaite appeared before a House Energy & Commerce subcommittee hearing on vaping and public health.
“Over the past few years, trust in our company and category has eroded,” Crosthwaite said in his remarks. “We know some of our past actions have contributed to that erosion, and we are committed to taking concrete action to re-earn trust.”
To support its application, Juul has run more than 10 clinical trials and more than 100 scientific studies, according to a person familiar with Juul’s plans. Its research is measuring how the nicotine hit from Juul’s devices compares with cigarettes, and which flavors helped people stay away from smoking, among other issues.
Juul will “defer to FDA and others to evaluate the quality on a scientific basis” of its applications, spokesman Austin Finan said.
The company will enter the review after years of taking blame for fueling the teen vaping epidemic.