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Gottlieb Threatens to Pull ‘Pod’ E-Cigs From Market

As FDA commissioner Scott Gottlieb, MD, prepares to leave office in about 2 weeks, he has expressed optimism that the ambitious policy initiatives aimed at protecting youth and adults from the harms of tobacco will move forward under new leadership.

One possible near-term step, he said in a video interview early this week: the agency may pull Juul and all other “pod” type e-cigarettes from the market if survey data expected in a few months show continued increases in use of the products by teens.

He said results from the 2019 National Youth Tobacco Survey (NYTS) should be available by late July or early August. Survey data from 2018 showed a huge 1-year spike in youth use of e-cigarettes, with use among high school students nearly doubling.

Gottlieb said if the 2019 data show continued increases of 20%, 30%, or 40%, the “FDA is going to have to carefully contemplate action against the category of pod-based products,” which are wildly popular among teens.

“It may be just flavored or the entire pod-based category,” he said at an event held at the Brookings Institution in Washington.

He added that the products will have to undergo regulatory review before they will be allowed back on the market.

“At some point, regardless of your view on whether these products can help currently addicted adult smokers transition off cigarettes, the youth use is so widespread and rampant that whatever redeeming public health value these tools potentially have — and they haven’t demonstrated that yet — is offset by youth use,” he said.

News of Gottlieb’s departure from the FDA sent tobacco company stocks higher earlier this month as Wall Street analysts questioned whether the increased regulation of electronic- and combustible cigarettes he has championed would actually happen under new FDA leadership.

Gottlieb will be replaced on an interim basis by Norman E. Sharpless, MD, who currently serves as director of the National Cancer Institute. President Trump has not yet named his permanent successor, who must be confirmed by the U.S. Senate.

In an op-ed published Wednesday in the Washington Post, Gottlieb and Health and Human Services Secretary Alex M. Azar wrote that while the FDA leadership will change at the end of the month, “the agency’s focus on the dangers to young people from e-cigarettes will carry on with the same vigor.”

Under Gottlieb, the FDA proposed reducing allowed nicotine in combustible cigarettes to non-addictive levels and taking menthol cigarettes off the market altogether.

The FDA commissioner also recently announced moves aimed at addressing the skyrocketing increase in teen vaping, including restricting the sale of most flavored e-cigarettes in convenience stores and other retail establishments, and moving up the date for regulatory review of the products by a year.

At the Brookings Institution event, Gottlieb disclosed that he recently met with representatives from the tobacco giant Altria in what he described as a “difficult meeting.”

He explained that the FDA had received a long letter from Altria in response to a call to tobacco companies to address the youth vaping issue. In that letter, the company acknowledged that the dramatic increase in teen use was driven by pod-based e-cigarettes. It also agreed to pull its own poorly selling pod-based e-cigarette MarkTen products from the market.

But that was followed by the company’s investment of almost $13 billion in Juul Labs, drawing Gottlieb’s ire.

“They made a substantial investment that guaranteed they would expand the market share of the leading pod-based product being used by children,” Gottlieb said. “There seemed to be a disconnect there and I wanted to understand if they had new data [suggesting that youth use was no longer an issue] that was driving that decision.”

He said he heard nothing in the meeting indicating they did.

“I continue to have concerns that some of the activities that [tobacco companies] are taking in the market are not necessarily consistent with what they are telling us,” he said. Those activities “are certainly not consistent with what we think the broader public health objective should be and also what I view as the existential threat to this category.”

Gottlieb said his departure should have little impact on the tobacco initiatives he spearheaded because “there is broad political support across the administration” for them. He noted that the HHS and the White House publicly endorsed the agency’s recent e-cigarette flavoring policy.

But attorney Gregory Conley, head of the American Vaping Association that represents e-cigarette retailers, says it remains to be seen if Gottlieb’s departure from the FDA will derail his tobacco initiatives.

He said a group of Republican senators who oppose new tobacco regulations — including Richard Burr and Thom Tillis of North Carolina and Ron Johnson of Wisconsin — are likely to lobby President Trump to nominate a less activist successor to Gottlieb.

“The next FDA commissioner needs to be confirmed, and presumably [Senate Majority Leader] Mitch McConnell wants somebody who can get Republican votes,” Conley told MedPage Today. “Richard Burr was ready to burn down the FDA over the menthol ban. I’m guessing he will have something to say about the next commissioner.”