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Judge rules in favor of AAP, partners in FDA e-cigarette lawsuit :

May 16, 2019

The AAP and its partners have achieved a major victory in their legal battle to speed up federal health authorities’ review of e-cigarettes.

A federal judge ruled Wednesday the Food and Drug Administration (FDA) cannot delay the review for several more years as planned, saying it gave “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”

“The AAP applauds the judge’s ruling,” said AAP President Kyle E. Yasuda, M.D., FAAP. “The FDA oversight over the sales and marketing of these harmful products has languished for too long. With the epidemic of e-cigarette use by teens, it is incumbent on the FDA to act expeditiously to hold manufacturers accountable for products that contain nicotine and harmful chemicals.”

In 2016, the FDA expanded its authority to regulate tobacco products to include e-cigarettes and cigars. A year later, it announced manufacturers would not have to provide information about cigars until 2021 and e-cigarettes until 2022. In the meantime, the products can stay on the market.

In March 2018, the AAP, its Maryland Chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Truth Initiative and five pediatricians sued the FDA, Department of Health and Human Services and the heads of both agencies saying the decision to allow manufacturers to keep selling e-cigarettes without proper review puts children at risk.

The U.S. surgeon general has concluded e-cigarettes are addictive and harmful to developing brains, and the National Academies of Science, Engineering and Medicine has found users are at increased risk for switching to traditional cigarettes.

Youths often are attracted to e-cigarettes due to their wide array of flavors like bubble gum, cotton candy and chocolate. Products like Juul, which look like USB flash drives, also are easy to hide.

While awaiting FDA review, teen use of e-cigarettes has skyrocketed. More than 3 million high school students and 570,000 middle school students were current e-cigarette users in 2018, spikes of 78% and 48%, respectively over 2017, according to a Centers for Disease Control and Prevention study.

U.S. District Judge Paul W. Grimm of Maryland admonished the FDA for delaying review.

“Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market, at which time the youth are likely to switch to one of the other thousands of tobacco products that are approved — results entirely contrary to the express purpose of the Tobacco Control Act,” he wrote.

He has given the AAP and its partnering health groups two weeks to recommend a remedy and then the FDA will have a chance to respond.

“It is now the FDA’s responsibility,” the health groups said, “to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market, including products like Juul that have fueled the youth e-cigarette epidemic.”

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