FDA Orders Juul E-Cigs Off Shelves

Posted on Posted in Juul

By Emily Field 

Law360 (June 23, 2022, 11:12 AM EDT) — The U.S. Food and Drug Administration on Thursday officially said it was ordering e-cigarette giant Juul‘s products off the market, capping off a two-year review process of its tobacco and menthol-flavored vaping products.

Previously, the agency had delayed making a decision on the market titan, which has about 40% of the roughly $15 billion e-cig market. It rejected almost 950,000 flavored vaping products in September because their applications didn’t have sufficient evidence that their benefit to adult smokers outweighed the public health risk of teens vaping their products.

But Juul has long been a target of the agency since the Trump administration, when the previous FDA Commissioner Scott Gottlieb made youth vaping a high priority.

Since the agency expanded its authority to regulate e-cigarettes in May 2016, the FDA has been concerned that candy-like or fruity flavors are too attractive to young people ever since it expanded its authority to regulate the already-booming industry in May 2016. Eight out of 10 juvenile vapers use flavored products, and 3.6 million middle and high schoolers used e-cigarettes in 2020, according to the agency.

Juul bowed to pressure in November 2018 and took its mango, fruit, crème and cucumber flavors off the market, while also scrubbing its social media campaigns, shortly after the FDA pressed the company for its marketing information.

In its decision on Juul’s products, the FDA said that the company’s applications didn’t have sufficient evidence about their toxicology to show that marketing them would be appropriate for protecting public health. The FDA said it had concerns about the company’s study due to insufficient and conflicting data, including potentially harmful chemicals leaching from Juul e-liquid pods. That insufficient data stopped the FDA from finishing a full toxicological risk assessment of Juul products, according to the agency.

“The FDA is tasked with ensuring that tobacco products sold in this country meet the standard set by the law, but the responsibility to demonstrate that a product meets those standards ultimately falls on the shoulders of the company,” Michele Mital, acting director of the FDA’s Center for Tobacco Products, said in a statement. “As with all manufacturers, Juul had the opportunity to provide evidence demonstrating that the marketing of their products meets these standards. However, the company did not provide that evidence and instead left us with significant questions. Without the data needed to determine relevant health risks, the FDA is issuing these marketing denial orders.”

The products comprise the Juul e-cigarette devices and its four types of pods with tobacco and menthol concentrations at 3% and 5%.

Representatives for Juul could not be immediately reached for comment.

–Editing by Alyssa Miller.