Scientists Sound Alarm on Potentially Dangerous JUUL Chemicals as FDA Deadline to Keep E-Cigarettes on the Market Looms

Newsweek | Alexandra Hutzler | U.S. | August 1, 2019

Scientists are sounding the alarms on the chemicals inside of Juul e-cigarettes and other vaping products after a study suggested that certain flavors could make it more difficult for users to breathe.

Researchers from Yale and Duke University released a study this week that found the “vape liquid” inside Juuls could produce harmful acetals when heated. The chemical compound could irritate throats and even damage lungs.

The chemists in the study detected acetals in crème brûlée Juuls, one of the eight flavors available. Researchers said that other flavors could also contain acetals and aldehydes, but they did not test all the possible aldehydes in this study. These chemicals are not listed on the e-cigarette’s label.

Juul fired back at these findings, saying that the researchers “failed to take into account real world conditions.” The company also argued that the study overestimated how much people consume its products.

The report comes as Juul and its e-cigarette rivals have less than a year to submit applications to the Food and Drug Administration for market approval. E-cigarettes were able to enter the U.S. market without government approval until 2016, when the FDA announced it was extending its regulatory jurisdiction over tobacco products to e-cigs and vape pens.

Originally, manufacturers had until 2018 to submit applications to continue selling e-cigarettes and other vaping products. But then-FDA Commissioner Scott Gottlieb extended the deadline until 2022.

But this month, a federal judge determined the agency needed to impose a 10-month deadline for the applications. In his ruling, U.S. District Judge Paul W. Grimm wrote that “the record before me shows a purposeful avoidance by the industry of complying with the premarket requirements.”

Companies that do not file by the May 2020 deadline may have their products pulled from the shelves. Judge Grimm also said the FDA needed to act on the applications within one year or the products that were not reviewed would have to come off the market.

Acting FDA commissioner Ned Sharpless called the federal court’s ruling “an important step forward for public health and validates FDA’s commitment to accelerate review of these products, particularly the ones that are most attractive to youth.”

Gottlieb, the former chief of the FDA, told CNBC in June that these companies, and Juul in particular, were “in a hard spot to ever get their product approved.”

Published by Tobacco Stops With Me on August 15, 2019