Juul warned by FDA over marketing practices

Juul warned by FDA over marketing practices

The FDA on Monday gave the company 15 working days to respond to the warning letter, and demanded a description of corrective actions and a plan for maintaining compliance with the law.

"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".

"T$3 hat testimony revealed JUUL engaged in a wide variety of promotional activities and outreach efforts to persuade potential customers, including youth, to use JUUL products", the agency wrote in its letter of concern.

During the congressional hearing in July, two NY high school students testified that a Juul representative who gave a presentation on addiction at their school allegedly told them that the company's product was "totally safe".

"Juul has ignored the law, and, very concerningly, has made some of these statements in school to our nation's youth", said Acting FDA Commissioner Ned Sharpless.

During a House subcommittee hearing last month on Juul's role in the "youth nicotine epidemic," lawmakers listened to testimony from several individuals who said Juul's marketing said its e-cigs were safer than tobacco. Juul has pitched its sleek, USB-like vaping device as a way for adults to quit smoking - though the FDA said that the company also targeted students.

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

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.

The FDA action comes as federal health authorities investigate five deaths from a mysterious lung illness tied to vaping. Public health experts have said that Juul has largely propelled the rise, commanding about 75% of the e-cigarette market in the United States.

In the previous year, Juul has tried to position its e-cigarettes as a tool to help adult smokers stop smoking, using the tagline "Make the switch". But there is virtually no research on the long-term effects of vaping.

In the letter to Juul CEO Kevin Burns, FDA regulators said they were "troubled" by a number of other points raised at the congressional hearing. And under pressure, it also voluntarily removed its fruit and dessert flavors from retail stores.

A 2017 report from the US Surgeon General found a 900 percent increase in e-cigarette use among young people between 2011 and 2015.

After the seminar, Caleb said he approached the Juul rep and told him that he had a friend struggling with a nicotine addiction.

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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