• by Thom Forbes  @tforbes, September 10, 2019

After reviewing testimony presented at a congressional hearing in July and other evidence, the U.S. Food & Drug Administration yesterday sent a warning letter to Juul Labs CEO Kevin Burns stating the company is violating federal regulations in its marketing by claiming its electronic nicotine delivery system (ENDS) is “much safer than cigarettes” and the “FDA would approve it any day.”

Specifically, “our review of testimony from the July 24-25, 2019 House Subcommittee hearing, documents from FDA’s inspection of Juul’s headquarters, Juul’s submissions to the agency, and Juul’s website, revealed that your firm 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, have a reduced level of or exposure to a substance, and/or that Juul products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products,” states the letter signed by Anthony Villa, senior regulatory counsel for the FDA Center for Tobacco Products.

“The FDA’s action dealt a setback to the company’s efforts to rebrand itself after public outrage erupted over a surge in teenage vaping,” write  Sheila Kaplan and Matt Richtel for The New York Times.

“And it served as a reminder that the health effects of e-cigarettes are not established at a time when more than 400 people have been sickened by vaping-related illnesses. Five deaths have been linked to vaping, and hundreds of people have been hospitalized. Public health investigators have yet to determine a specific cause, but they have cited the use of cannabis and nicotine vaping products as possibilities. No one product or company has been implicated,” Kaplan and Richter continue.

The FDA “also sent a letter to the company ‘expressing concern and requesting more information’ about its outreach and marketing practices, especially to students, tribes, health insurers and employers,” Jayne O’Donnell reports  for USA Today. 

“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,” a letter, signed by Center for Tobacco Products director Mitchell Zeller, states.

“These marketing techniques were common and well documented, says Robert Jackler, a researcher at Stanford who studies e-cigarette marketing,” writes  Sara Harrison for Wired.

“‘This has been going on for years,’ says Jackler, who also testified at the two-day congressional hearing. … He speculates the FDA is reacting to pressure from U.S. representative Raja Krishnamoorthi (D-Illinois), who chaired the hearing, and from Sen. Dick Durbin (D-Illinois). Both Krishnamoorthi and Durbin have urged the FDA to take action in recent weeks to curb the youth vaping epidemic,” Harrison adds.

“Juul has maintained that its products are intended to convert adult smokers to what it described in the past as a less-harmful alternative. In other communications, the company says it cannot make claims its products are safer, in line with FDA regulations,” write&n bsp; CNN’s Jamie Gumbrecht and Jacqueline Howard.

“We are reviewing the letters and will fully cooperate,” Ted Kwong, a Juul Labs spokesperson, tells them.

“Agustin Rodriguez, counsel at Troutman Sanders in Richmond, Virginia, said when vaping companies receive a letter like this, it is in their best interest to have their in-house counsel organize a team to respond to the claims in the letter,” Dan Clark writes  for Law.com.

“It is critical that the organization engage in a thorough process to review the facts and assess the allegations of the warning letter. This will lead to the writing of an equally thorough and complete response,” Rodriguez, who previously served as an in-house attorney at Altria Group Inc., tells Clark. He added that both internal and external stakeholders should be involved in that review.

In The Guardian this morning, Jessica Glenza writes  about the “rising tide of lawsuits being filed against America’s dominant vape manufacturer.” She cites, in particular, the case of a 20-year-old woman who says she started “Juul-ing” when she was 16 and quickly began vaping the equivalent of eight packs of cigarettes a week.

“An estimated 9 million adults and 3.6 million US teenagers vape, including 20% of high school students, making the potential plaintiff pool enormous. Juul commands three-quarters of the U.S. e-cigarette market, with sales growing 783% between June 2018 and this year to $942.6 million, Wells Fargo reported. In less than one year, Juul’s valuation rose from $16 billion in the summer of 2018 to $38 billion in December 2018,” Glenza reports.

The way things are going on the medical, legal and political fronts, however, that may all go up in vape.