Juul warned by FDA over marketing practices

FDA Says Juul Illegally Pitched E-Cigarettes as Safer Alternative to Smoking, Including in Presentation to Schools

The FDA is putting the pressure on Juul Labs.

Juul Labs violated U.S. rules against marketing to teens by telling a group of NY high school kids that its wildly popular e-cigarettes were "totally safe", according to the Food and Drug Administration.

"Referring to your ENDS [electronic nicotine delivery system] products as "99% safer" than cigarettes, "much safer" than cigarettes, "totally safe", and "a safer alternative than smoking cigarettes" is particularly concerning because these statements were made directly to children in school".

On Monday, the Food and Drug Administration (FDA) sent a letter to Juul stating that if it did not take corrective actions within the next 15 days, it could face fines or a seizure of its products.

The FDA, in a second letter sent to Kevin Burns, Juul chief executive officer, on Monday, asked the company for documents and information about several marketing and outreach practices detailed in the July congressional hearing.

"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", said Acting FDA Commissioner Ned Sharpless in a statement.

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The agency said Juul's labelling and advertising of its vaping devices can lead to consumers believing that the products present a lower risk of tobacco-related diseases or are less harmful than other commercially marketed tobacco products.

FDA warning letters are not legally binding, but regulators can take companies to court if they don't comply with the government's requests.

The letter says Juul "should immediately correct the violations".

Juul Labs Inc. was warned by US health officials that it may have violated the law by making claims its e-cigarette devices are safe. E-cigarette makers have until next May to submit their products to the FDA for health reviews. Juul officials who testified said they had ended the school programs and that the company no longer sold many types of e-flavored cigarettes in retail stores.

Most experts agree the aerosol from e-cigarettes is less harmful than cigarette smoke because it doesn't contain most of the cancer-causing byproducts of burning tobacco. In that presentation earlier this year, Juul said its device is "a smart, really well thought-out alternative to smoking" that will improve "the lives of the world's one billion adult smokers".

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". "With respect to our work to tackle the youth e-cigarette epidemic, we remain committed to our oversight of e-cigarettes and to keeping them out of the hands of youth".

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