Outgoing FDA Commissioner Scott Gottlieb on Tuesday said FDA might consider temporarily removing all pod and cartridge e-cigarettes from the U.S. market if youth e-cigarette use increases this year.
Gottlieb's comments come after FDA last week issued draft guidance intended to restrict where and how flavored e-cigarettes are sold in the United States.
FDA could pull pod and cartridge e-cigarettes off the US market
Gottlieb during a Brookings Institution event on Tuesday said FDA could decide to temporarily pull pod and cartridge e-cigarettes from the market and resume product sales if e-cigarette makers can demonstrate their products are geared toward adults and not aimed at children.
Gottlieb, who will step down from the agency within the month, said he met last week with executives from Altria Group and Juul Labs to discuss Altria's recent decision to take a 35% stake in Juul. Gottlieb said Altria's decision contradicted the commitment the company made in the fall to take steps to help reduce youth e-cigarette use, such as pulling some e-cigarette devices from the market. Gottlieb said Altria did not have any new data on youth e-cigarette use, and he now thinks Altria initially pulled its pod-style e-cigarette products off the market and invested in Juul as a business move, not as an effort address e-cigarette use. Gottlieb called the meeting "difficult," saying there was a "disconnect" between the priorities of health officials and the two companies.
Overall, Gottlieb said, "The e-cigarette industry has been overly dismissive,” considering the United States is "capturing an exploding epidemic right now."
As such, he said, "FDA is going to have to very carefully calculate its action against the entire category of pod-based products." Gottlieb said FDA currently is working to define pod-based products in case the agency needs to take action in the future.
Azar, Gottlieb say youth e-cigarette use is threatening adult use
Separately, Gottlieb and HHS Secretary Alex Azar in an op-ed published Wednesday in the Washington Post wrote that while they "agree with those who believe that e-cigarettes may offer a lower-risk alternative for adult smokers who still want access to nicotine … the continued availability of this opportunity to adults is being endangered by the e-cigarette industry's slowness to address the dangers its products pose to teens." They continued, "While we pursue changes to regulatory policy, we call on the industry—manufacturers and retailers—to step up with meaningful measures to reduce the access and appeal of e-cigarettes to young people."
Azar and Gottlieb said efforts to regulate e-cigarettes must also take into account that e-cigarettes can be used as a cessation tool. They wrote, "We hope that, years from now, we don't look back at this critical point in the history of e-cigarettes as a missed public-health opportunity to help health-concerned smokers addicted to cigarettes. But regulators and public health officials have no choice but to combat the youth trends forcefully and follow available science to guide policy" (Ehley, "Pulse," Politico, 3/20; Edney, Bloomberg, 3/20; Baker, "Vitals," Axios, 3/20; Axelrod, The Hill, 3/20; Azar/Gottlieb, Washington Post, 3/20).
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