FDA chief's resignation casts cloud over vaping crackdown

FDA chief's resignation casts cloud over vaping crackdown
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The abrupt resignation of Food and Drug Administration (FDA) Commissioner Scott Gottlieb has raised questions about whether the agency will further pursue its aggressive crackdown on vaping and tobacco companies.

“He is leaving at a uniquely sensitive time,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids. “If his departure means the promises he’s made don’t get adopted, then literally an entire generation of kids is at risk.”

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During his two-year tenure at the FDA, Gottlieb unveiled ambitious proposals that he said were aimed at curbing the youth vaping “epidemic” and reducing the harm and appeal of traditional cigarettes.

But none of the proposals has been implemented, and it’s not known whether his eventual replacement will follow the same strategy. And that’s unsettling to anti-tobacco advocates like Myers.

“I don’t think I ever remember a public official leaving at a time when there is more at stake that will impact whether his legacy is one of extraordinary achievement, or of not doing anywhere near enough,” Myers said. “If they’re not adopted because of the timing of his departure, then the practical effect of his tenure will have been to allow Juul and other e-cigarette manufacturers to threaten the progress that had been made with youth tobacco use.”

Gottlieb, who says he wants to spend more time with family, is slated to leave the agency next month.

One of Gottlieb's proposals that could reshape the industry would sharply limit in-store sales of flavored e-cigarettes. He told The New York Times he thought the guidance would be released before he steps down.

Asked by The Hill on Wednesday if the vaping crackdown would continue after he leaves, Gottlieb said: “I’m very confident of that and I'm very confident that we're going to continue with this policy over the next month, including the policy that we've been formulating.”

Gottlieb has threatened to remove vaping products from the market entirely, limit the nicotine in cigarettes and ban menthol in cigarettes. He has also voiced support for raising the minimum age for buying all tobacco products, from 18 to 21. 

"I wouldn't be surprised if the momentum slows down on those types of issues with Gottlieb out of the role," said Chris Mikson, a partner at law firm Mayer Brown, where he works on FDA regulatory issues.

"He's pushed the bounds of FDA tradition, if not authority, in those areas, and other folks have been hesitant to do that in the past." 

Tobacco stocks went up after Gottlieb’s announcement, and analysts say his departure is likely good for the industry.

“We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cig usage/access, cig nicotine limits and a cig menthol ban given he was the champion behind these initiatives,” Wells Fargo analyst Bonnie Herzog said in an email to clients.

While it’s not clear what approach the next commissioner will take, conservative groups have pressured the White House to block the FDA’s changes, arguing they go against the Trump administration’s anti-regulation agenda.

They see Gottlieb’s departure as an opportunity to reverse course.

Americans for Tax Reform said it formed a coalition of conservative and libertarian groups that was prepared to launch a campaign urging Trump to fire Gottlieb over what it described as a “regulatory assault.”

”I think this is an opportunity to get right what I think the FDA has been doing wrong,” said Paul Blair, director of strategic initiatives at Americans for Tax Reform.

Gottleib’s regulatory approach was completely antithetical to Trump’s promise to cut down regulations, he said.

“The fear-mongering, the overreach and the threats for prohibition has been a lurch in just the completely wrong direction. And it would be a hugely missed opportunity for the president to screw this up by picking someone who was in the mold of Scott Gottlieb when it comes to e-cigarettes and tobacco regulation.”

In particular, they take issue with Gottlieb’s proposal to limit the sales of flavored e-cigarettes in stores, arguing it’s bad for businesses and hurts adult smokers who want to transition away from traditional cigarettes.

“Dr. Gottlieb didn’t protect the public health by preventing youth initiation of e-cigarettes, and he didn’t do enough to help adult smokers quit,” said Jeff Stier, a senior fellow at the Consumer Choice Center, part of the coalition formed by Americans for Tax Reform. “The next FDA commissioner should follow the science and do everything possible to prevent youth initiation of e-cigarettes, while at the same time helping adult smokers switch.”