Big Vape by Jamie Ducharme

Author:Jamie Ducharme
Language: eng
Format: epub
Publisher: Henry Holt and Co.

14

AN EPIDEMIC (SEPTEMBER–DECEMBER 2018)

On September 24, 2018, three FDA investigators arrived on Juul’s doorstep. They informed Kevin Burns that they were there to perform a high-priority inspection requested by the FDA’s Center for Tobacco Products and that they’d need to come inside—now.

The staff was ready for this moment. The FDA routinely dropped by to inspect companies that fell under its jurisdiction, looking for anything that felt amiss or suggested that a company wasn’t following FDA regulations. This time, though the team at Juul didn’t know it yet, the agency’s inspectors were looking for clarity on the things Commissioner Gottlieb felt Juul had been less than forthcoming about over the years: product modifications, health complaints, youth marketing, underage vaping, and more.

The moment Burns let the inspectors inside the building, his employees slipped into a well-rehearsed dance. The receptionist knew to call Juul’s director of compliance, who escorted the investigators to a conference room, where they’d essentially live over the next several days. A team of Juul employees set up in a nearby back room, ready to pull any document the investigators asked for—which totaled thousands over the course of the inspection. The FDA’s inspectors were also free to pull Juul staffers into their conference room to answer questions.

The investigators called in Julie Henderson, Juul’s youth prevention director. She told them about Juul Labs’s youth prevention plans, claiming that the company had distributed educational materials, but never to youth—only to teachers, parents, and principals. If the company ever developed a new curriculum, she promised, it would be through a third-party group. The investigators took notes, requested a few documents on Juul’s curriculum, and let her go.

Chelsea Kania, who’d been with Juul’s marketing team since the company was called Pax, answered questions about Juul Labs’s marketing and advertising. Investigators asked her about Juul’s influencer program and why a company making a product for adult smokers had advertised so heavily on Instagram. Kania calmly told the investigators that Juul had paid only four social media influencers in its entire history, which was true—she just glossed over the unpaid influencers who had posted about Juul after getting vaporizers at a dollar a pop, a company source recalls. She admitted that the company had given out free products right after Juul launched, but she stressed that free sampling had stopped as soon as the FDA’s deeming rule went into effect in 2016. Now, she said, Juul focused on a different kind of marketing: testimonials from adult smokers who felt their lives had been saved by Juul’s products.

As the investigation moved along, Josh Vose, the company’s vice president of medical and clinical affairs, walked the FDA team through the numerous studies that would make up Juul’s PMTA. The FDA’s team also grilled Vose and a few other staffers, including the company’s senior vice president of engineering, hardware, and firmware, Bryan White, about the pod changes FDA inspectors had discovered at a Juul contractor’s facility that spring—but that Juul had failed to report on its own.

White admitted that Juul had, indeed, changed its pod design earlier that year to stop e-juice from leaking out.

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