FDA under pressure to move fast on vaping

FDA under pressure to move fast on vaping
© Greg Nash

The Trump administration is under pressure to implement new restrictions on flavored e-cigarettes.

Lawmakers initially applauded when President TrumpDonald John TrumpLawmakers prep ahead of impeachment hearing Democrats gear up for high-stakes Judiciary hearing Warren says she made almost M from legal work over past three decades MORE and federal health officials made the announcement two weeks ago to restrict the sale of all nontobacco flavors of e-cigarettes but have since called on the Food and Drug Administration (FDA) to move quicker.

Trump cited a massive spike in teen vaping and the spread of a mysterious illness that has sickened hundreds of people across the country.

“We can’t have our youth be so affected,” Trump said at the time. “People are dying with vaping, so we’re looking at it very closely.”

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Youth vaping has skyrocketed in the past year, driven largely by teenagers becoming drawn to sweet and fruit-flavored e-cigarette pods easily accessible in stores. The FDA has struggled to keep up with regulation.

Federal statistics showed a 78 percent increase in e-cigarette use among high school students from 2017 to 2018, and preliminary data showed that number jumped again this year.

During a House Energy and Commerce subcommittee hearing Wednesday, acting FDA Commissioner Ned Sharpless came under attack from Democrats for what they said was the agency’s inability to act.

Lawmakers said the FDA’s reluctance to regulate the e-cigarette industry was responsible for both the youth vaping epidemic and the rash of lung illnesses that have killed nine people.

Rep. Joe Kennedy III (D-Mass.) said the illnesses are the result of a “massive regulatory failure.”

Rep. Diana DeGetteDiana Louise DeGetteDemocrats request info on Google-Ascension partnership Trump health chief declines to detail ObamaCare replacement plan A dozen House Democrats call on EU ambassador to resign amid Ukraine scandal MORE (D-Colo.), chairwoman of the Energy and Commerce Oversight and Investigation Subcommittee, said legislation may be needed to make sure the administration’s actions are being enforced.

“E-cigarettes are only on the market today because FDA has temporarily given them a pass,” DeGette said. “FDA needs to do its job. Examine these products, tell the public what the risks are.”

Energy and Commerce Committee Chairman Frank Pallone Jr.Frank Joseph PalloneKey House and Senate health leaders reach deal to stop surprise medical bills Overnight Health Care — Presented by Johnson & Johnson – House progressives may try to block vote on Pelosi drug bill | McConnell, Grassley at odds over Trump-backed drug pricing bill | Lawmakers close to deal on surprise medical bills Key negotiator says deal close on surprise medical bills legislation MORE (D-N.J.) said he thinks the epidemic could have been avoided.

“I firmly believe that many aspects of the youth vaping epidemic could have been addressed if the FDA had moved forward with reviewing all e-cigarettes on the market when it first had the chance two years ago,” Pallone said.

“While I am pleased by the Administration’s announcement that it plans to pull all flavored e-cigarette products from the market until they undergo full FDA review, I believe that ban should occur immediately,” he said.

Public health officials also blamed lax oversight for the rash of vaping-related illnesses.

“Lack of sufficient regulatory oversight of these vaping products has contributed to the over 500 confirmed or probable cases of severe lung injury associated with vaping across the country,” Dr. Joneigh Khaldun, Michigan’s chief medical executive, said in prepared remarks.

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“We support the FDA’s current proposal to not allow these products on the market unless their safety has been proven,” she added.

Sharpless acknowledged that the agency “should have acted sooner” to stop the epidemic of youth vaping.

“In retrospect, the FDA should have acted sooner, we should have begun regulating these devices sooner,” Sharpless told lawmakers. “But we’re going to catch up.”

Sharpless said the agency is working to finalize a guidance that will force e-cigarette manufacturers to submit their flavored products for agency review. When that happens, all current flavored e-cigarettes — except tobacco — will be removed from the market.

The FDA gained the authority to regulate tobacco products in 2009, but it wasn’t extended to vaping products until 2016.

When the Trump administration took over in 2017, then-FDA Commissioner Scott Gottlieb enacted a plan to reduce nicotine levels in traditional cigarettes and saw e-cigarettes as a potential tool to help people quit.

“We must remember the goal was to help currently addicted adult smokers quit. It was a package deal, with regulation of nicotine at its center. The legitimate e-cigs, while not safe, are less harmful than smoking,” Gottlieb tweeted Wednesday.

As a result, the agency decided to delay enforcing the laws until 2022, much to the frustration of public health groups.

In response to a federal lawsuit, the agency moved that timeline up again, to next spring, though companies can file applications sooner.

“Now we are open for business to receive these applications,” Sharpless said.

Sharpless noted that no e-cigarette product in the United States is on the market legally but pushed back on the notion that the administration is instituting a ban.

“FDA is not banning flavors. Rather FDA intends to enforce existing law,” Sharpless said. “It is important to note that this does not mean flavored e-cigarettes can never be marketed—if companies think they can show that specific products meet the standards established by Congress, then FDA would authorize that product for sale.”