Key Democrats slam FDA for failing to crack down on Juul

WASHINGTON — Congressional Democrats openly pressured acting Food and Drug Administration Commissioner Janet Woodcock to crack down on e-cigarette manufacturers Wednesday, with one powerful lawmaker blasting the agency for what they say is inaction on the issue.

“Who is 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,” said Sen. Dick Durbin (D-Ill.), the second most powerful Democrat in the Senate, who was testifying before the House hearing as a witness. “I worry the agency is going to fail again.”

The hearing comes as the FDA begins deciding in earnest which e-cigarette manufacturers can stay on the market, as part of a congressionally mandated process. Manufacturers like Juul, Blu, and Njoy were required to submit marketing applications to the FDA in September but are allowed to stay on the market until at least September 2021, while the agency reviews those applications.

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Rep. Raja Krishnamoorthi (D-Ill.), the chair of the House Oversight subcommittee that called the hearing, also used his opening statement to push the FDA to ban all products similar to Juul.

“Commissioner, no matter what your decision is on Juul’s [application], you know that the problem does not end there. To end the youth vaping epidemic, you’ll have to deny the applications for all products with the same characteristics that made Juul so popular with a generation of children,” Krishnamoorthi said, per prepared remarks.

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The committee also played a video of youth and parent testimonies sharing their experiences with e-cigarette addiction.

“I, along with many other kids in my generation, got addicted to nicotine and these products in that time that you allowed these companies to sell their products. What do you have to say now to me and everyone else who got addicted?” said one testimonial from a woman identified as Alyssa, 20 years old.

Woodcock’s opening statement did not provide any hints as to how the agency will come down on Juul or any other company. Instead, she emphasized that the agency is prioritizing certain applications that represent a large portion of the e-cigarette market. While Woodcock did not name Juul directly, the company’s application is widely expected to get that priority.

“FDA pulled several applications into a separate review queue and dedicated resources to their review. By identifying and ensuring review of these applications, we believe we can achieve the greatest public health impact most quickly,” Woodcock said, according to prepared remarks.

The Oversight Committee also released half a dozen internal documents from its investigation of Juul on Wednesday. The committee says they show Juul knew its products were addictive for kids.

The documents include an internal memo from a Juul-run focus group in 2018 where young people were asked directly why the product is “so attractive to kids in Middle and/or High School.” Several of the young people responded that the product’s high nicotine content kept kids hooked.

Tobacco control advocates have continually argued that Juul’s high nicotine content has had an outsized impact on the company’s popularity with young vapers. Juul pods contain 5% nicotine, roughly the amount found in a pack of cigarettes. The company has said it chose the high nicotine level to lure adult smokers to quit combustible cigarettes.

The Oversight Committee’s investigation also revealed that Juul began receiving complaints that its products’ nicotine levels were too high in 2016, roughly one year after the company launched.

Juul also sought to skirt rules in the European Union that would have required it and other e-cigarette makers to lower their products’ nicotine levels, according to the congressional report.  Congressional investigators uncovered an internal email where Juul’s regulatory experts discussed developing a new product that more efficiently delivered nicotine “to make up for EU low-pod nicotine.”


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