Juul Labs Inc. needed less than a day to agree to take significant steps to address federal and state regulatory concerns about the popularity among youths of its top-selling electronic cigarette.
The company said Wednesday it will “actively support” state and federal initiatives to raise the minimum age to at least 21 to purchase tobacco products. Juul began in August requiring purchasers of Juul on its website to be at least 21.
Juul also pledged an initial investment of $30 million over three years dedicated to independent research, youth and parent education, and community engagement efforts.
On Tuesday, The Food and Drug Administration expanded and tightened its oversight over Juul products, including taking steps to halt online sales to youths on eBay.
Although the four steps announced by FDA Commissioner Scott Gottlieb in a new youth tobacco prevention plan apply to other e-cigs, the focus clearly was on Juul.
“It’s imperative that we make sure children and teenagers aren’t getting hooked on more novel nicotine-delivery products,” Gottlieb said in a statement.
“The troubling reality is that electronic nicotine delivery systems, such as e-cigarettes, have become wildly popular with kids.”
Juul, based in San Francisco, entered the mainstream retail marketplace in 2015. It is sold in the form of a pen or a USB flash drive that’s easy to use — and hide — because the vapor typically does not have a smell and quickly dissipates.
Officials with Winston-Salem/Forsyth County Schools have said they are aware of students using Juul — which is in the shape of a pen or USB flash drive — even though vaping and smoking are not permitted on campus.
Juul said its focus has been on assisting adult smokers on limiting, if not stopping, smoking traditional cigarettes.
“We also recognize that young people have become aware of and gained access to its products,” the company said in a news release.
Juul to work with tobacco control groups
Dr. John Spangler, professor of family and community medicine at Wake Forest Baptist Medical Center, said his primary concern about Juul is the way that nicotine "hard-wires addition circuits in the developing adolescent brain."
"I am not sure if Juul's suggestions will work."
Spangler said it is possible to propose using Juul similarly to Accutane for severe acne, which he said is "dangerous, but so indispensable that it remains on the market."
"Pharmaceutical companies that make these extremely dangerous drugs have developed 'hard stop' ways to prevent dispensing prescriptions without serious controls in place."
"Perhaps, some less-intrusive, but still serious constraints, can be placed on Juul," Spangler said.
Juul said it will work with Tom Miller, Iowa’s attorney general and a support of the continuum of risk initiative with tobacco products, and his coalition of public officials and tobacco control individuals. Their goal is to limit youth access to Juul.
Miller and his coalition also will work with Juul “to develop a transparent and effective framework for independent research focused on the scientific and societal implications of vapor products.”
Juul chief executive Kevin Burns said his company’s products “have the potential over the long-term to contribute meaningfully to public health in the U.S. and around the world.”
“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.”
Juul said its initiative will include: expanding enforcement of its “secret shopper” program at retail and online outlets of its products; calling on social media platforms to remove content showing youth consumption of Juul; and enhancing efforts to promote educational material of its products at retail outlets.
Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, called the Juul steps “very positive and can help pave the way for better cooperation and civil engagement between all stakeholders, including the FDA, tobacco control organizations, policy makers and manufacturers.”
“We can, with all stakeholders working together, significantly reduce the illegal sale and distribution of these products by youths.”
However, Matt Myers, chairman of the Campaign for Tobacco-Free Kids, said the steps being taken by Juul "are not a substitute for effective FDA regulation ... history has shown over and over again that voluntary actions by tobacco manufacturers doesn't work."
Study shows Juul popularity among youth
A 2017 study by Yale University researchers found that teen smokers experimented with four styles of e-cigs: traditional e-cigs, such as Vuse by R.J. Reynolds Vapor Co. and blu eCigs; a hookah pen with a liquid vapor tank; a modified vaporizer with a customizable battery and tank; and Juul.
Among teens who used all four products, Juul was used the most at 77.9 percent.
A Juul starter kit costs $49.99 online and is available nationwide at convenience stores. It includes a re-chargeable Juul device, a USB charger, a warranty, and a four-pack of the flavored Juul pods.
After ramping up production in 2017, Juul overtook Vuse in November and has since sped away to a 54.6 percent market share in March, according to Nielsen data.
In recent months, there have been imitators of Juul to enter the marketplace, such as myblu, affiliated with ITG Brands LLC of Greensboro, and KandyPens.
Democratic senators in Congress and a coalition of anti-tobacco advocacy groups have prodded the FDA to tighten marketing standards for Juul. The coalition recently filed a lawsuit to compel the FDA to act quicker in implementing regulations on innovative tobacco and nicotine products.
The FDA is requesting from Juul Labs: documents related to product marketing; research on the health, toxicological, behavioral or physiologic effects of the products, including youth initiation and use; whether certain product design features, ingredients or specifications appeal to different age groups; and youth-related adverse events and consumer complaints associated with the products.
“We appreciate that Juul Labs has already expressed recognition of this problem and has reached out to the FDA and other stakeholders to discuss these concerns,” Gottlieb said Tuesday,
Gottlieb said eBay responded to the FDA request by removing Juul listings from its website and voluntarily implementing measures to prevent new listings.
“We are planning additional enforcement actions focused on companies that we think are marketing products in ways that are misleading to kids,” Gottlieb said.
Gottlieb said the new steps do not represent a change from the continuum-of-risk strategy announced in July that has a role for e-cigs and other innovative nicotine-reduction products to help adult smokers to quit traditional cigarettes.
“But we’ve got to step in to protect our kids,” he said.
Gregory Conley, president of American Vaping Association, said his coalition “are reluctant to support policies that would deny harm-reduction alternatives to adult smokers, including 18- to 20-year-olds.”
“However, it is hard to blame Juul when they are facing off with well-funded opponents who ultimately want to see all products, like Juul, removed from the U.S. market.”
Conley said having Miller, the Iowa attorney general, involved, “should send a signal to genuine public-health advocates that Juul is very serious about preventing youth access to its products.”