- The Washington Times - Wednesday, June 23, 2021

Members of Congress on Wednesday pressed the acting chief of the Food and Drug Administration to clear the market of flavored vapes and tobacco products that they said entice kids into the habit.

The lawmakers also slammed the regulators for failing to prove claims that the flavored products help adults wean off smoking.

“This is the Super Bowl for the FDA’s tobacco effort. I’m afraid they’re not ready for prime time. I hope they prove me wrong,” Sen. Richard J. Durbin, an Illinois Democrat at the forefront of the anti-vape effort, told members of the House Oversight Committee.

Rep. Raja Krishnamoorthi of Illinois and other Democrats on the committee said the FDA’s crackdown on cartridge-based e-cigarettes under the Trump administration didn’t go far enough. Too many loopholes remain, he said, including the availability of menthol flavors and disposable products.

The use of e-cigarette among high school students remains high, he noted, while regulators spend their time conducting an exhaustive review of what’s on the market.

“It’s time to reevaluate the public health threats that are entirely within our ability to control,” Mr. Krishnamoorthi said.

The FDA, under a court order, required e-cigarette and tobacco companies to submit applications by September 2020 to keep their vaping products on shelves. Regulators must decide by Sept. 9 whether the products are targeted at kids and if they bolster public health by helping adults to quit smoking — a key talking point for vape-product makers who say their products are beneficial.

Acting FDA Commission Janet Woodcock said her agency received 6.5 million marketing-authority applications for e-cig products and will determine whether they have a net benefit.

Dr. Woodcock repeatedly assured Mr. Krishnamoorthi, who chairs an oversight subcommittee on the economy and consumer policy, that she will use her authority to protect kids.

“We are working furiously on application review in order to move on from sort of a Wild West, unregulated marketplace,” she said.

Dr. Woodcock said that if products entice minors to take up vaping, they won’t be allowed on the market. And she said regulators will continue to take action against companies that market products that resemble toys or seem designed to be concealed in backpacks.

JUUL, a company whose pods are exceedingly popular and drew the ire of vaping critics, said it withdrew flavors on its own ahead of the 2020 crackdown and its premarket tobacco product application (PMTA) should meet the FDA’s criteria.

“In order to earn a license to operate in society, we need to be a science and evidence-based company, engage in open and transparent dialogue with our stakeholders, and take methodical and responsible actions to advance the potential for harm reduction for adult smokers while combating underage use. Our PMTA submission is a key part of that approach,” Juul Labs CEO K.C. Crosthwaite said at the time of its submission last year.

The Vapor Technology Association, a key lobbying group, said Congress shouldn’t grandstand on the issue after they granted the FDA the legal authority it is using to scrutinize vaping products.

“Under no circumstances should lawmakers be interfering with that law or the FDA‘s science-based regulatory process by asking FDA to replace science with their own emotions, anecdotes and speculation about e-cigarettes as they did at today’s hearing,” said VTA Executive Director Tony Abboud said.

“The PMTA is a rigorous and complex scientific regulatory process that must balance the needs of millions of adults who are trying to save their own lives by quitting smoking with the unfortunate reality that some youth may regrettably experiment with nicotine products. And, to that end, we can and must continue to take other meaningful actions to address the issue of teen vaping.”

Vaping has been a source of concern for Capitol Hill for years, though the issue is coming into focus again as the coronavirus pandemic eases.

“There was a youth vaping epidemic in this country before the coronavirus, before this subcommittee was created, and before Acting Commissioner Woodcock took the helm at FDA. And the youth vaping epidemic continues today,” Mr. Krishnamoorthi said.

Mr. Durbin said one in five high school students use e-cigarettes, so the FDA must step in.

“These alarming trends are erasing the historic progress we’ve made reducing youth tobacco use,” he testified. “Who’s the cop on the beat to whom we entrust our children? It’s the Food and Drug Administration, and this agency has been timid and reluctant for way too long.”

The lawmakers said kids are migrating to menthol vapes and disposable e-cigs, so broader actions are needed.

“Kids get it. If we don’t take this seriously across the board, they will find those loopholes and continue their addiction,” Mr. Durbin said.

Mr. Durbin said the fight is personal. His father, a long-time smoker, died at age 53 from lung cancer.

During the hearing, some GOP members said if Democrats are so concerned about vaping, they should also stop liberalizing policies around marijuana.
Rep. Andrew Clyde, Georgia Republican, said the gradual legalization of marijuana is a “very, very dangerous path” to go down.


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