The Atlanta Journal-Constitution
FDA warns Juul about its ad claims
Juul Labs, the dominant e-cigarette company, violated federal regulations by selling its vaping products as a safe alternative to traditional tobacco cigarettes without approval from the Food and Drug Administration, the agency said in a warning letter Mo
Happening now
The FDA issued its warning amid a public health crisis with more than 400 cases of vaping-related lung illnesses that have hospitalized many teenagers and adults, and possibly five deaths. Public health investigators have yet to determine a specific cause, but have cited the use of both cannabis-related and nicotine vaping products from a number of companies as possible suspects
Previously
The agency’s warning letter to Juul follows a lengthy inquiry into the company’s marketing and sales practices, as well as a review of congressional testimony from Juul executives, consumers — including students and parents — and anti-smoking advocates.
Claims not proven
Under federal law, companies are not permitted to market products as safer than cigarettes or a safe alternative without proving those claims to the FDA.
The FDA also said it was especially concerned that testimony before Congress indicated that company representatives had appeared at schools, telling students that its e-cigarettes (electronic nicotine delivery systems) were safer than tobacco products.
The FDA stated that company “has engaged in labeling, advertising, and/or other activities directed to consumers, in which JUUL explicitly and/or implicitly has represented that JUUL products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products.”
What’s next
In a statement, a company spokesman said, “We are reviewing the letters and will fully cooperate.”
The agency ordered the company to submit its plan to correct the regulations within 15 days.