Economy

U.S. FDA warns Juul over its marketing practices

U.S. FDA warns Juul over its marketing practices”

JUUL Labs co-founder and Chief Product Officer James Monsees is sworn in to testify before a House Oversight and Government Reform subcommittee on Capitol Hill during a hearing on the youth nicotine epidemic. "We've also put the industry on notice: If the disturbing rise in youth e-cigarette use continues, especially through the use of flavors that appeal to kids, we'll take even more aggressive action".

Under federal regulations, such "modified-risk claims" must be authorized by the FDA.

Juul and other vape manufacturers were initially given an August 2018 deadline by the FDA to present proof of the health benefits of e-cigarettes, but FDA commissioner Dr. Scott Gottlieb pushed that deadline back four years, to 2022. The students said a Juul representative was invited to address the school as part of an assembly on mental health and addiction issues.

A spokesperson for Juul Labs says the company is reviewing the letters and will fully cooperate.

At least five deaths nationwide have been linked to vaping and federal health officials warned people against using e-cigarettes until the probe is complete.

In addition, the agency said it is examining more than 450 cases of lung illnesses.

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. A large number of the victims seem to have used marijuana products, though a small number said they used nicotine vapes.

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.

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.

"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".

In the a year ago, Juul has tried to position its e-cigarettes as a tool to help adult smokers stop smoking, using the tagline "Make the switch".

"[Juul] has engaged in labeling, advertising, and/or other activities directed to consumers, in which JUUL explicitly and/or implicitly has represented that JUUL products are free of a substance", the letter reads.

The agency wants answers to those questions within 30 days. According to a warning letter from the FDA, Juul improperly sold its vaping products as safer alternatives to traditional tobacco cigarettes.

The letter also criticizes the company for apparently turning over more documents to congressional investigators than to the agency "despite previous document requests from FDA".



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