FDA criticizes Juul for telling students its e-cigs are ‘totally safe’
FDA criticizes Juul for telling students its e-cigs are ‘totally safe’
FDA Says Juul Violated Regulations, Sold Vaping As Safer Than Smoking
11 September, 2019, 10:56
Vaping market leader Juul Labs received a harsh warning today from federal health officials over claims that its e-cigarette products are less harmful than conventional tobacco use.
"In addition, we're troubled about several issues related to JUUL's outreach and marketing practices that came to light in a recent Congressional hearing".
Juul says it discontinued its school programs - which were meant to discourage underage use - last September. The FDA has been investigating Juul for months but had not previously taken action against the company.
Under federal regulations, such "modified-risk claims" must be authorized by the FDA.
The FDA told Juul that parts of its "Make the Switch" marketing campaign that encourages smokers to use its device convey that they're safer than cigarettes.
Meredith Berkman, a New York City resident and co-founder of Parents Against Vaping e-cigarettes (PAVe), testified that she and other mothers formed their advocacy group after a Juul representative gave a deceptive presentation to their children in school without teachers present, school administrator knowledge, or parental consent.
"We are reviewing the letters and will fully cooperate", according to Ted Kwong, a Juul Labs spokesperson.
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However, vaping has reportedly been linked to at least five deaths and 450 illnesses across the nation.
Although officials said the definitive cause of the illnesses remains unknown, "the severity of the illness and the recent increase in the incidence of this clinical syndrome indicates that these cases represent a new or newly recognized and worrisome cluster of pulmonary disease related to vaping", according to a report by health officials in Wisconsin and IL. Numerous samples contain vitamin E acetate that experts said could cause lung injury. The agency is also concerned that a company representative told students its e-cigs were "totally safe", according to the students' testimony before Congress.
The warning said Juul wrongly painted its devices as safer than cigarettes and marketed them intentionally to young people.
"While this investigation is ongoing, people should consider not using e-cigarette products", the Centers for Disease Control (CDC) and Prevention said in a statement.
The agency wants answers to those questions within 30 days. There were also additional concerns cited over the company's marketing that focused on Native American tribes, health insurers and students.
In response to Durbin's criticism, FDA spokeswoman Stephanie Caccomo said in an emailed statement on Friday that the agency looks forward to "engaging with Senator Durbin, along with all members of Congress, on this ongoing and very serious situation".
In a statement, acting FDA commissioner Norman "Ned" Sharpless said "companies must demonstrate with scientific evidence that their specific product does in fact pose less risk or is less harmful" than conventional cigarettes.
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