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September 20, 2019

FDA investigates more than 450 cases of disease after e-cigarette use, and issues warnings to JUUL

The FDA warned e-cig manufacturer JUUL Labs Inc., on Sept. 9, 2019, regarding the company’s marketing of its unauthorized modified risk tobacco products, including marketing to youth that claimed e-cigarettes are “totally safe.”

In the warning letter sent to the company, the FDA requested information detailing JUUL’s marketing practices targeting students, tribes, health insurers and employers. The company marketed the devices “without an appropriate FDA order in effect,” according to the agency, and did so in such a way that would lead consumers to believe that the products presented a lower risk of tobacco-related diseases and were less harmful than traditional cigarettes.

The letter specified concerns regarding several statements allegedly made by the company, including referencing testimony from a July 2019 Congressional hearing in which JUUL representatives were accused of telling students during a school presentation that JUUL was “totally safe” and that the “FDA would approve it any day.”

“Regardless of where products like e-cigarettes fall on the continuum of tobacco product risk, the law is clear that, before marketing tobacco products for reduced risk, companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful. JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Acting FDA Commissioner Ned Sharpless, M.D., said in a statement.

E-cig health risk warning from the FDA

The warning follows the FDA’s announcement last month that it was reviewing at least 215 cases of severe respiratory diseases and pulmonary illness from 25 states as part of its investigation into possible health risks associated with e-cigarettes. Reports of injuries allegedly caused by e-cigarettes have since grown to more than 450 cases in 33 states, including at least six deaths.

According the FDA, many of the patients reported a gradual start of symptoms, including:

  • breathing difficulty
  • shortness of breath
  • and/or chest pain before hospitalization.

Some patients also reported mild to moderate gastrointestinal illness including:

  • vomiting
  • diarrhea
  • other symptoms such as fevers or fatigue.

Several state’s Attorneys General have also launched their investigations as reports of injuries and deaths continue to climb. Michigan is the first stated to ban flavored e-cigarettes, with its Governor stating, “As governor, my number one priority is keeping our kids safe . . . And right now, companies selling vaping products are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe. That ends today.”