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No letup in crackdown on vaping by FDA after Gottlieb resigns

The White House supports a Food and Drug Administration effort to crack down on youth vaping and plans more regulations on tobacco products despite the departure of the agency’s chief, senior White House officials said in an interview on 7 March, write Margaret Talev and Anna Edney for Bloomberg.

FDA Commissioner Scott Gottlieb, 46, is leaving “only on the best of terms,” said Mick Mulvaney, President Donald Trump’s acting chief of staff. “I’m not aware of any policy dispute in the administration regarding Dr Gottlieb.’’

Gottlieb’s resignation on 5 March, which will take effect in about a month, sparked questions about what would happen to his effort to issue sharp new restrictions on e-cigarettes, flavored cigars and other tobacco products.

Limiting flavored e-cigarette sales

This week the FDA’s goal is to officially propose one of Gottlieb’s signature policies: limiting the sales of most types of flavored e-cigarettes, according to a person familiar with the effort.

By formalizing the limits on e-cigarettes before he leaves, the move could make it more likely that Gottlieb’s plan to stem what he called “an epidemic” of youth vaping will survive once an interim head takes over the 17,000-employee agency.

“Everybody agrees that there’s going to be more regulation in the tobacco space,” Joe Grogan, director of the White House Domestic Policy Council, said in the interview with Bloomberg. “We are extremely concerned about the public health consequences of vaping and e-cigarette use in kids.”

Shares of tobacco giant Altria Group Inc., which recently took a $12.8 billion stake in e-cigarette maker Juul Labs Inc., rose 1.1 percent at 10:29 a.m. in New York even as the broader market declined. The stock is up 12 percent this year.

Gottlieb’s resignation had been in the works for some time, according to several people familiar with the matter, and was partly driven by the timing of the release of the administration’s fiscal 2020 budget and subsequent meetings with members of Congress.

He had grown tired of a long commute between his family and Connecticut, and had set in motion much of what he set out to do on tobacco and drugs, according to the people, who asked not to be named because the discussions were private.

The FDA’s longer-term goals are more ambitious. Gottlieb had called for cutting nicotine in cigarettes down to non-addictive, negligible levels. He has also sought to ban menthol, a flavor additive in some cigarettes. Mulvaney and Grogan declined to comment on those efforts.

The goal next week is also for the FDA to propose a policy that would no longer allow some flavored cigars to be sold without marketing clearance from the FDA, according to the person, who wasn’t authorized to discuss agency policy publicly.

Who’s next?

Gottlieb’s abrupt announcement led to speculation about a search for a successor, someone who will need Senate confirmation. An acting commissioner will likely be named soon.

Though Amy Abernethy, principal deputy commissioner, is the current No. 2 at the agency, she won’t be named as acting commissioner, an FDA spokesperson said.

Meanwhile, two potential contenders have emerged to replace Gottlieb, according to two people familiar with the matter:

  • Ned Sharpless, head of the National Cancer Institute. Before being sworn in at NCI in October 2017, Sharpless was the director of the University of North Carolina Lineberger Comprehensive Cancer Center. He got his medical degree from the UNC School of Medicine. He would need Senate approval.
  • Brett Giroir, assistant secretary for health. He was sworn in as assistant secretary in February 2018 and has led the department’s efforts on the opioid crisis. He’s a pediatric critical-care physician and has served as chief executive officer of Texas A&M’s Health Science Center. He already has Senate confirmation, which could be a plus.

Neither of the candidates has a well-known track record on tobacco, though Sharpless has supported Gottlieb’s e-cigarette efforts on Twitter.

Whoever is chosen will have his or her work cut out. Gottlieb, a heavy user of social media to promote his agency, was savvy in navigating the rough terrain of the White House and Congress.

He used his skills to propose increasing restrictions on tobacco in an administration that famously opposes increasing government regulation of industries. Those moves angered conservative lawmakers like Senator Richard Burr of tobacco-producing North Carolina.

Gottlieb also recently hired Doug Andres, former Republican House Speaker Paul Ryan’s press secretary, as a senior adviser. Andres presumably will be able to help any newcomer with the political aspects of the job.

[link url=""]No Letup Seen in Crackdown on Vaping by FDA After Gottlieb[/link]

[link url=""]FDA Chief Resigns After Clearing Slew of Drugs, Wrestling E-Cigs[/link]



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