A day after the FDA announced a crackdown on sales to minors, the maker of the top-selling electronic cigarette JUUL outlined steps the company plans to take to combat underage use of its product.
Those steps include support of state and federal initiatives to make it illegal to purchase JUUL and other e-cigarettes before the age of 21, and funding "independent research, youth and parent education and community engagement" aimed at curtailing e-cigarette use among teens.
On Tuesday, FDA Commissioner Scott Gottlieb, MD, outlined steps the agency is taking to keep JUUL e-cigarettes out of the hands of minors, acknowledging that the brand and similar e-cigarettes have become "wildly popular" with high school-age teens and young adults.
In less than three years JUUL has become the best selling e-cigarette in the U.S., commanding more than 50% of sales, according to figures released early this month by market research group Nielsen.
In a press statement, the company pledged to spend $30 million over the next three years on research, education and engagement efforts aimed at curtailing youth use of the product.
"Our company's mission is to eliminate cigarettes and help the more than one billion smokers worldwide switch to a better alternative," said JUUL Labs CEO Kevin Burns.
"At the same time, we are committed to deterring young people, as well as adults who do not currently smoke from using our products. We cannot be more emphatic on this point: No young person or non-nicotine user should ever try JUUL," he added.
Business Insider reported that JUUL Labs earned more than $224 million in retail sales in 2017.
It is not clear what percentage of those sales were made to smokers using the product to kick the habit and what percentage were to non-smoking teens and young adults.
Popularity Among Teens Evident on YouTube
In his announcement earlier this week, Gottlieb revealed that the FDA sent a letter to JUUL Labs directing the company "to submit important documents to better understand the the reportedly high rates of youth use and the particular appeal of these products."
"We don't yet fully understand why these products are so popular among youth. But it is imperative that we figure it out, and fast. These documents may help us get there," Gottlieb said.
With its boxy-sleek design, JUUL looks more like a flash drive than a typical e-cigarette and it even plugs into a computer's USB port for charging. Critics say the design makes it easy to hide from parents and teachers, and the e-cigarette is also offered in flavors like Creme Brulee, Mango and Cool Cucumber, which may appeal to younger users.
Robert K. Jackler, MD, of Stanford University Medical Center, Stanford, California, says anyone who doubts the popularity of the JUUL brand among teens need only visit the website YouTube.
Resent searches of the site by Jackler and his research team turned up more than 137,000 videos related to the product, with 43 videos having 100,000 or more views.
Jackler told MedPage Today that a search of the term "Hiding JUUL" turned up 3,010 videos and a search of "JUUL in school bathrooms" turned up 789 videos. A search for "Hiding JUUL at home" linked to more than 1,000 videos.
"Social media is a big part of this company's marketing, so they have to be aware of these videos," Jackler said. "They have viral sales and they know very well that a big part of that is from young people."
Jackler said the very characteristics that may benefit smokers who want to quit -- high nicotine content coupled with a delivery system facilitating rapid nicotine absorption -- make JUUL uniquely dangerous for nicotine-naive teens.
"We don't yet know how many young people who never smoked a cigarette have become addicted to nicotine through this product," he said.
Company, FDA Efforts Not Enough, Critics Say
Jackler said JUUL Labs' is following Big Tobacco's playbook in vowing to combat teen use of its product through company-sponsored research, youth programs and community outreach.
He noted that tobacco company-sponsored research has a decades-long history of not being truly independent.
"Many universities will not accept tobacco money for research," he said. "Some granting organizations, such as the American Cancer Society, will not accept applications for funding from researchers who have accepted tobacco money."
He added that tobacco company-sponsored youth tobacco programs "have a long and disreputable history of intentionally using ineffective methods which often had the effect of actually promoting tobacco use."
"And I would worry about any highly profitable tobacco company engaging the community. The motivation will be a public relations campaign to burnish the company's image," he said.
Campaign for Tobacco-Free Kids president Matthew Myers expressed skepticism about the company's efforts in a press statement released Wednesday. And he was also highly critical of the FDA for its decision to delay key provisions of e-cigarette regulation until the summer of 2022.
"The popularity of JUUL with kids is due in part to how the product was designed and marketed, but it is also a result of the FDA's failure and delay in enforcing critical regulations," Myers noted. "Other manufacturers are already taking advantage of this regulatory gap and introducing JUUL knock-offs that threaten to make the problem worse."
Myers called on the FDA to enforce its own rules by preventing the introduction of look-alike products and "subjecting e-cigarettes to FDA review of their public health impacts, as required by law."