Commentary

Fed Judge Orders FDA To Speed Up E-Cig Reviews As NC Sues Juul

E-cigarettes were under fire yesterday as a federal judge ruled the Food and Drug Administration has been lax in reviewing the impact of the nicotine delivery systems on vapers’ health, and North Carolina’s attorney general filed a lawsuit against Juul, accusing it of using “unfair and deceptive” marketing practices that has led to an “epidemic” among young people. 

North Carolina is the first state to take legal action against Juul, which is the dominant brand in the U.S. e-cigarette market, with an estimated market share of 74%, according to  Nielsen. The global e-cigarette market was worth $11.26 billion in 2018, and is projected to reach $18.16 billion by 2024, according to  Mordor Intelligence.

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“In the complaint  made in Durham Superior Court, [DA Josh] Stein wants a judge to require Juul to: cease selling e-cigs to N.C. minors; limit the flavors sold in the state; stop advertising and marketing practices that are intended to or likely to appeal to minors; and delete all data for customers whom Juul cannot confirm are at least 18,” Richard Craver writes for the Winston-Salem Journal.

“Juul’s business practices are not only reckless, they're illegal. And I intend to put a stop to them. We cannot allow another generation of young people to become addicted to nicotine,” Stein says in a release announcing the action.

“Juul said in a statement that it has not seen the complaint yet. It said the company shares Stein’s concerns about youth vaping, 'which is why we have been cooperating with his office and why we have taken the most aggressive actions  of anyone in the industry to combat youth usage,'” CNBC’s Ashley Turner reports.

“The complaint cited data that said in 2017 nearly 17% of North Carolina high school students and more than 5% of the state’s middle school students reported that they had used an e-cigarette in the previous 30 days. It also said e-cigarette use among high school and middle school students across the nation skyrocketed by 78% and 48%, respectively, from 2017 to 2018,” Turner continues.

“Several of the state’s requests overlap with existing Food and Drug Administration policies, including prohibiting the sale of Juul and other e-cigarette products to minors. But the state’s complaint goes further: FDA guidelines restrict the sale of fruit or candy flavors in stores, allowing menthol, tobacco and mint to be sold. North Carolina’s request would bring mint off the market in that state, in addition to popular flavors like mango and cucumber,” writes Deanna Paul for the Washington Post.

But the FDA itself was under attack yesterday for what a federal judge characterized as “an abdication of its statutory responsibilities.”

Judge Paul Grimm of the U.S. district court for the district of Maryland ordered the FDA  “to speed up its reviews of thousands of electronic cigarettes currently on the market, siding with public health groups that sued the agency,” reports Nathanal Weixel for The Hill

The lawsuit was filed last year by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups. “They argued that the FDA's delay in regulating e-cigarette products led a spike in underage vaping,” Weixel adds.

“The FDA gained authority to regulate the products in 2016, but it has allowed thousands of products to remain on the market without formal rules or product standards. The agency says that both FDA staff and manufacturers need more time to prepare for regulation,” writes the AP’s Matthew Perrone. 

“Under President Donald Trump’s FDA commissioner, Scott Gottlieb -- who departed last month -- the FDA said it would not require e-cigarette manufacturers to submit their products for review until 2022. Shortly before stepping down Gottlieb moved the deadline up to 2021,” he adds.

“In a meeting w/Acting FDA Commish Sharpless yesterday it became clear he has no intention of taking legal action he’s empowered to take to protect children from the addiction of e-cigarettes. No action would be taken to ban kid-friendly vaping flavors during this President’s term,” Illinois Sen. Dick Durbin, who is the Democratic whip, tweeted  yesterday morning before the decision was handed down.

Meanwhile, Juul yesterday filed a notice with the San Francisco Department of Elections “indicating that it intends to collect signatures for a ballot initiative that aims to impose additional restrictions on online and brick-and-mortar e-cigarette retailers,” Catherine Ho reports fo r the San Francisco Examiner.

"Say what?” you may be saying.

“It might seems strange that an e-cigarette maker would seek restrictions on the use of its product. But tobacco policy experts say it would render other existing or planned city restrictions on tobacco -- like the flavored-tobacco ban and the pending legislation to ban the sale of e-cigarettes -- unenforceable,” Ho explains.

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