Juul 'has ignored the law': FDA slams company over marketing practices
Federal health officials issued a warning letter to Juul Labs Inc. Monday, slamming the e-cigarette maker for claims that its products were a safer alternative to smoking and ordered the company to stop making unproven claims for its products.
The latest move by the Food and Drug Administration increases the legal pressure on the nation’s best-selling vaping company, which has been besieged by scrutiny from state and federal officials since a recent surge in underage vaping.
In the letter, the Food and Drug Administration determined the company marketed its products as "modified risk tobacco products without an appropriate FDA order in effect."
The FDA also upped its scrutiny of a number of key aspects of Juul’s business, telling the company to turn over documents on its marketing, educational programs and nicotine formula.
Juul marketed its products as having "a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products, contain a reduced level of a substance or present a reduced exposure to a substance," the agency said.
“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," said acting FDA Commissioner Ned Sharpless, M.D. "JUUL has ignored the law, and very concerningly, has made some of these statements in school to our nation's youth."
Concern over vaping products has grown as the Centers for Disease Protection and Control are investigating hundreds of lung illness cases and five deaths that may be linked to chemical exposure while vaping.
According to the CDC, the illnesses span 33 states.
Just recently, a high school in Alabama, began taking measures in their own hands in order to protect their students.
Wilson High School, located roughly 130 miles southwest of Nashville, Tennesee, removed some of the stall doors in the school’s bathrooms in an effort to stop students from vaping.
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And now, the company accused of fueling a vaping craze among youth, has 15 days to respond.
In their response, the FDA requests that Juul describe its plan for maintaining compliance with the United States Federal Food, Drug, and Cosmetic Act (FD&C) and how they plan to prevent future violations of the same or similar nature.
If not, the FDA says the e-cigarette maker must provide “reasoning and provide any and all scientific evidence and data, if any, that support that your statements and representations do not explicitly or implicitly convey that JUUL products pose less risk, are less harmful, present reduced exposure, or are safer than other tobacco products.”
A Juul spokesman said the company is reviewing the FDA comments and “will fully cooperate.”
The Associated Press contributed to this report.