The U.S. Food and Drug Administration sent a warning letter to Juul Labs Inc. after reviewing testimony from two days of hearings in the U.S. House on Juul in July.
FDA investigators found the company broke the law, according to CNBC, “by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution.”
According to CBC Canada, the FDA alleges that Juul’s labeling and marketing of the e-cigarette devices lead consumers to believe they are safer than regular cigarettes and pose less of a risk for tobacco-related diseases.
“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,” Acting FDA Commissioner Ned Sharpless said in the letter.
“JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation’s youth,” Sharpless said.
Particularly disturbing, according to the FDA was a letter from the CEO that appeared on JUUL’s website, and also in an email that JUUL sent to a parent in response to her complaint that the company sold JUUL products to her child.
The letter states: “[JUUL’s] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it.”
But the FDA also warned the e-cigarette industry as a whole – “We’ve also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we’ll take even more aggressive action.”
In a separate letter sent on Monday to Juul CEO Kevin Burns, the FDA requested more information about the company’s marketing practices. Specifically, the agency is looking for any scientific evidence or data that shows whether its use of words like “switch” and “alternative” give people the idea that Juul’s e-cigarettes are less harmful than cigarettes.
The letter specifically refers to Juul’s “Make the Switch” campaign that conveys the idea that switching to JUUL is a safer alternative to cigarettes, in that using JUUL products poses less risk or is less harmful than cigarettes.
The FDA is giving Juul 15 days to respond to the letter and failure to do so can result in a fine, injunctions or seizure of the company’s products.
