Juul warned over claims e-cigarette safer than smoking

Andrew Cummings
September 10, 2019

United States regulators have sent a warning letter to Juul Labs, saying the e-cigarette company violated United States law by promoting its products as safer than traditional cigarettes.

Krishnamoorthi's letter followed a two-day hearing in July, after which the committee concluded that "JUUL appears to be violating FDA regulations against making unapproved express and implied claims that its product helps users stop smoking cigarettes and is safer than cigarettes". In a separate letter to the company, the FDA said it is "concerned" that its campaign suggests "that using Juul products poses less risk or is less harmful than cigarettes".

The FDA highlighted an incident recounted by two NY high school students during a congressional hearing in July.

"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".

Juul said it discontinued its school programs last September. The letter increases pressure on the richly valued company at the same time a mysterious lung ailment is raising new questions about the health effects of vaping.

Recently, San Francisco issued a ban on all non-FDA approved e-cigarette products, MI issued a ban on e-cigarettes in general and New York Governor Andrew Cuomo proposed a state-wide ban on all flavored e-cigarette products today. Responding Monday to the FDA's letter, Juul said in a statement that "We are reviewing the letters and will fully cooperate".

In addition, the agency said it is examining more than 450 cases of lung illnesses. Juul and similar small, discrete e-cigarettes have become a scourge in US schools nationwide.

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.

The reprimand could foreshadow a tough road for Juul's efforts to gain FDA clearance to continue selling its products, which all e-cigarette makers must do starting next year. There were also additional concerns cited over the company's marketing that focused on Native American tribes, health insurers and students. "Witnesses testified, for example, that JUUL advertising saturated social media channels frequented by underage teens and that JUUL used influencers and discount coupons to attract new customers".

In the past year, Juul has tried to position its e-cigarettes as a tool to help adult smokers stop smoking, using the tagline "Make the switch". E-cigarettes generally heat liquid containing nicotine.

The company, which has long promoted its nicotine pods as a safer alternative to traditional cigarettes, must provide a written response to the FDA within 15 days.

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