E-cig company runs afoul of two administration no-nos

Feeling Sorry?

Poor JUUL. JUUL is the e-cigarette company with the highest public profile, but its undeniable success has been leavened by almost constant scrutiny from public advocates and regulators alike.

The feds began regulating e-cigarettes as one tobacco product among many three years ago. Since then, JUUL’s been on the radar of regulators and watchdog groups, despite some gestures it made to limit advertising.

There was a state attorney general investigation. And the FDA’s public scientific workshop, which aimed tobacco cessation efforts straight at e-cigarette use. And the open letter from the Campaign for Tobacco-Free Kids and the American Cancer Society Cancer Action Network (among others) urging the administration to investigate the company.

And now, earlier this month, the FDA hit the company with not one, but two strongly worded letters (there must be a chief correspondent position at these big government agencies).

Can JUUL ever catch a break?

Curriculum

The first letter shakes its finger at the company for “marketing unauthorized modified risk tobacco products by engaging in labeling, advertising, and/or other activities directed to consumers.” According to the letter, these activities included a school presentation where the company made claims that its products were “modified risk tobacco products” – products that claim to reduce the harm or risk of tobacco-related disease associated with conventional tobacco products. The FDA maintains that a JUUL spokesperson, presenting to children in a school, made statements to the effect that JUUL “was much safer than cigarettes” and that “FDA would approve it any day.”

The FDA gave the company 15 days to straighten out the marketing.

The second letter expresses concern “about several issues raised in a recent Congressional hearing regarding JUUL’s outreach and marketing practices, including those targeted at students, [Native American] tribes, health insurers and employers.” Here, the administration is scrutinizing several marketing statements made by the company as part of its “make the switch” campaign, including that its products were “The alternative for adult smokers” that promised to “Improve the lives of the world’s one billion adult smokers.”

The Takeaway

The executive summary of the letters calls them “the latest development in the FDA’s ongoing investigation related to JUUL.” If you want to know what the rest of the investigation looks like, the administration is happy to brag on it.

“The agency previously requested documents from JUUL Labs in April 2018 to examine the reportedly high rates of youth use and the youth appeal of JUUL products,” the summary claims. “The FDA has also conducted an unannounced inspection of JUUL’s corporate headquarters” and “inspections of several of JUUL’s contract manufacturing facilities to determine compliance with all applicable FDA laws and regulatory requirements.”

There doesn’t seem to be any letup. Which raises the question: How will JUUL adapt when its main selling point – the difference between conventional cigarettes and its own products – seems to be constantly blurred by regulators? Not to mention the FDA’s planned ban on flavored e-cigarettes (at the president’s urging), various state- and citywide measures to address recent deaths relating to vaping, and a recent ban on e-cigarette advertising announced by three large media companies …