The FDA issued a letter warning Juul on Monday that the company may face sanctions for illegally advertising Juul as a safer alternative to cigarettes. In the letter, the FDA warned that it will fine the company or even seize Juul’s products if the e-cigarette manufacturer does not revoke its unsubstantiated claim that Juul is a safer alternative to cigarettes.

The letter was sent to Juul CEO, Kevin Burns.

The warning letter was prompted by FDA findings after reviewing testimony presented in Congressional hearings on Juul in July. From the testimony, the FDA determined that, by selling or distributing Juul products as modified risk tobacco products without an FDA order in effect that permits such sale or distribution, the company had committed illegal marketing practices.

Federal law states that companies are not allowed to market tobacco or nicotine products as safer than cigarettes without presenting evidence to the FDA. After reviewing the evidence, the claims must be approved by the FDA. The FDA has never validated claims that Juul is a safer alternative to cigarettes.

“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,” explained Acting FDA Commissioner Ned Sharpless.

The letter addressed numerous instances where Juul violated these federal laws, citing one particular instance in which a Juul representative told students at a school presentation that Juul “was much safer than cigarettes,” and “totally safe”.

The FDA also cited a statement written by Burns that appeared on the company’s website, which stated that Juul is designed to “heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and hard associated with it.”

The FDA sent an additional letter, inquiring about Juul’s marketing practices. The agency requested any scientific evidence or data that shows whether certain phrasing used in Juul advertisements gives consumers the idea that Juul is less harmful than traditional cigarettes.

Juul has recently begun a new advertising campaign which tells smokers to “make the switch” from cigarettes to Juul and features personal stories of adult smokers who have switched over to Juul. The FDA is concerned that these advertisements deceive smokers into believing that by making the switch, they are choosing a safer option.

Juul was asked to turn all materials presented in the July congressional hearings into the FDA. The FDA is now investigating whether Juul failed to comply, and withheld some materials from the agency.

Federal health officials and the FDA both have expressed growing concerns for Juul’s advertising practices, which seem to make Juul appear as less harmful than cigarettes.

Juul has undergone major rebranding in wake of numerous investigations into the company’s marketing tactics which revealed that Juul was marketing to youth.

The FDA warning letter is a dark mark on Juul’s rebranding efforts and a reminder that there is validated evidence that Juul is less dangerous than cigarettes.

 

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