Sci-tech

Feds rip Juul for claiming its e-cigarette is safer than smoking

The letter indicates the FDA has determined that the San Francisco-based company, a top maker of electronic nicotine delivery systems, has marketed its products as modified risk tobacco products, that is, as a safer alternative to traditional cigarette smoking, without FDA approval.

Juul Labs violated United States 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. The CDC and the FDA on Friday said they continue to investigate the illnesses and aren't sure what products are responsible.

The agency's warning letter highlights an incident recounted by two NY high school students during a congressional hearing in July. The administration highlighted specific instances where Juul made these claims, including a school presentation at which a company representative told students that their products were safer than cigarettes and "totally harmless". The agency is also concerned that a company representative told students its e-cigs were "totally safe", according to the students' testimony before Congress.

Juul said it discontinued its school programs last September.

"We are reviewing the letters and will fully cooperate", Ted Kwong, a Juul spokesman, said.

In addition, the agency said it is examining more than 450 cases of lung illnesses. The letter cites congressional testimony that Juul's advertising "saturated social media channels frequented by underage teens" and "used influencers and discount coupons to attract new customers".

Last year, Juul closed down its social media sites.

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 FDA is putting the pressure on Juul Labs. Juul has 15 business days to respond with a plan for fixing the problems. "The CEO's letter stated: "[Juul's] simple and convenient system incorporates temperature regulation to heat nicotine liquid and deliver smokers the satisfaction that they want without the combustion and the harm associated with it". 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. The industry is under mounting scrutiny due to a surge in teenage vaping and recent deaths that public-health officials have connected to inhaling vapor from e-cigarettes.

E-cigarettes have been on the US market for more than a decade, but the FDA didn't gain the authority to regulate them until 2016. But it said the company apparently provided Congress more documents than it gave the FDA.



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