The epidemic of e-cigarettes: Judge rules FDA must implements regulations, sides with public health groups

An increase of underage vaping has created an epidemic of e-cigarette use by teens. Without any warning or information about e-cigarettes, the FDA have given manufacturers a free pass to sell and market “these harmful products” a lawsuit filed by several public health groups said.

On Wednesday, a federal judge sided with the groups behind the lawsuit requiring the Food and Drug Administration was responsible for regulating e-cigarettes and cigars much sooner than the agency planned. The lawsuit, which was filed by 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 in 2018, “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.”

United States District Judge Paul W. Grimm of Maryland ruled the FDA has a legal obligation to hold manufacturers accountable, but instead gave “manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”

“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,” Judge Grimm wrote.

The Center for Disease Control and Prevention concluded in a study that currently there are more than 3 million high school students and 570,000 middle school students using e-cigarette, this was a rise of 78 percent and 48 percent, respectively, since 2017.

“It is now the FDA’s responsibility 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.”

While the FDA pushed back it’s authority to regulate manufacturers of e-cigarettes and cigars until 2022 and 2021, respectively, the products remained on the market. But Wednesday’s ruling will now make the FDA have to “act expeditiously to hold manufacturers accountable for products that contain nicotine and harmful chemicals.”

“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.”