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19.12.19 7 FEATURE division, acknowledged the popula- tion-wide trends in e-cigarette and cig- arette use. But he pointed out that the FDA's decision on net public health ben- efit will be made on a product-by-prod- uct basis - not across the entire indus- try. He added that Juul has "a significant challenge ahead of them, in overcoming the concerns that exist out there." e FDA declined requests for an in- terview with Mitch Zeller, who heads tobacco regulation at the agency, about its oversight of e-cigarettes. In written answers to questions, the agency did not directly address the population-lev- el data on smoking and vaping trends but said it is "tasked with threading a public health needle" in crafting regula- tions on e-cigarette firms. A Reuters investigation in November detailed how Juul's developers used to- bacco industry research and patents to formulate its smooth but potent "nico- tine salts" blend of liquid nicotine, a key factor in its popularity among teenag- ers. e report showed company lead- ers were aware of the product's popular- ity among teenagers soon after its 2015 launch, contradicting statements that Juul was caught off guard by teenage use last year. Former FDA Commissioner Scott Gottlieb told Reuters that he agreed with public health advocates and tobac- co researchers that whatever benefits Juul may be having for cigarette smok- ers are offset by attracting children who otherwise wouldn't have tried other tobacco products. Before Gottlieb left the department in April, he and his staff explored the option of halting sales of Juul and similar high-nicotine devic- es if their popularity continued rising among teens. "We could take these products off the market tomorrow," he said. "We don't need the applications." Juul and the FDA did not respond to questions on Gottlieb's assertion that the agency should immediately remove Juul and similar products from the mar- ket. Mounting pressure on the FDA E-cigarettes have been available in the United States since at least 2007, but the FDA did not formally get authority over the industry until nine years later, in 2016. e agency initially tried to regulate e-cigarettes as a drug, which would have carried more stringent require- ments for e-cigarette firms, such as ex- tensive clinical trials or animal testing. E-cigarette makers sued the FDA and won, leaving the agency to regulate the devices as tobacco products. FDA officials started crafting a rule to regulate e-cigarettes in 2011, but the industry pushed back and successfully delayed the rule until May 2016, in the final months of the administration of President Barack Obama. During that time, Juul and dozens of competitors introduced products that were grand- fathered into the market because they were already being sold before the regu- lation took effect. e rule extended certain cigarette re- strictions to e-cigarettes, like requiring health warning labels, setting a min- imum sales age of 18 and prohibitions on free samples. A key part of the new rule also re- quired e-cigarette makers to submit ap- plications to the agency by August 2018 - demonstrating why their products provide a net benefit to public health - along with studies and data on potential toxins in the products. When Gottlieb was appointed by President Donald Trump to lead the agency in 2017, one of his first moves was to delay that deadline by four years, a decision public health ad- vocates criticized. Just months later, school administrators, parents and politicians raised alarms about the rap- id rise of vaping among high schoolers, who were particularly transfixed with the Juul device. Some public health advocates feared the new administration's commitment to the Obama-era regulations after an initial three-month delay, as the FDA faced litigation from the industry. Got- tlieb declined to comment on whether the some in the administration wanted to kill the regulations but said his ef- fort to push them forward was "not an easy process." He said he delayed the deadline because the previous adminis- tration had not drafted guidelines that companies could follow for the applica- tion process, leaving the agency open to a legal challenge from the regulated industries. "ey would have sued me, and I would have lost," he said. But today's FDA could – and should – pull Juul and other products from the market, Gottlieb said. "I thought that's where the agency would land," he said. In March, just before he left the agen- cy, Gottlieb said publicly that the FDA was considering prohibiting sales of cartridge-based e-cigarettes like Juul from the market if teen usage rates went up for a second year in a row. Federal youth tobacco survey data first released in September showed that teenage us- age did in fact keep rising, with the percentage of teenagers reporting they used e-cigarettes in the last 30 days growing from nearly 21% to more than 27%. In a statement, the FDA said it has sent more than 1,100 warning letters to retailers selling to minors; issued warning letters to companies market- ing teen-friendly e-cigarette products, such as those with sweet flavors; and launched advertising campaigns aimed at e-cigarette prevention in schools. "Taken together, all of these efforts have had a wide-ranging impact on the manufacturing, marketing and selling" of e-cigarettes, the agency said. "FDA's work is constant in its effort to keep these products out of the hands of kids."

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