FDA Commissioner Scott Gottlieb has revealed his plans to combat underage use of e-cigs and nicotine, which has grown 78 percent among high school students from 2017 to 2018.
The commissioner today announced a plan that would remove all flavored electronic nicotine delivery system products — with the exception of tobacco, mint, menthol, or non-flavored products — from any store where children under the age of 18 can see them.
So what does this mean for Juul, a company that reached a $10 billion valuation 4x faster than Facebook and currently owns more than 70 percent of the e-cig market?
One result is that Juul Labs is likely now just as desperate for minors to quit vaping as the FDA. The commissioner has made it abundantly clear that if he doesn’t see a significant decrease in underage use, he’s willing to pull the plug on the e-cig industry.
“I could take more aggressive steps,” Gottlieb said in a written statement. “I could propose eliminating any application enforcement discretion to any currently marketed ENDS product, which would result in the removal of ALL such products from the marketplace. At this time, I am not proposing this route, as I don’t want to foreclose opportunities for currently addicted adult smokers. But make no mistake. If the policy changes that we have outlined don’t reverse this epidemic, and if the manufacturers don’t do their part to help advance this cause, I’ll explore additional actions.”
Yes, it seems remarkable that we may live in a world where cigarettes, the country’s leading cause of preventable death, are available at grocery stores but e-cigarettes, which are said to be 95 percent less dangerous, are illegal. But that’s exactly what might happen if the government, e-cig manufacturers, and consumers don’t work together to end underage use of nicotine.
Though some critics would argue otherwise, Juul has maintained that it never intended to sell to minors. Which doesn’t change the fact that the company’s revenue is largely dependent on the nicotine addicted as a category.
The American economy was essentially created upon the back of Big Tobacco. And 50 years ago, the industry got away with marketing to young people and creating several generations of addicted adults to what may have been the most successful consumer product ever. To say that it was lucrative would be an understatement. It still is.
Fiscally, would Juul enjoy being the next Philip Morris? Undoubtedly. But it would rather be the next Nicoderm CQ or Nicorette than be illegal. Hell yes! Right now, the company is still hanging in there. But the only way to prevent the company from being officially banned in the U.S. is to find a way to get kids to stop vaping.
For this reason, Juul Labs is going a few steps further than the FDA’s new policy. Not only is the company removing non-tobacco flavors from convenience stores or other stores where people under 18 can shop, but it’s also removing all non-tobacco flavors from vape shops and age-restricted specialty stores. From here on out, the only place to buy Cucumber, Creme, Fruit and Mango (the most popular flavor) Juul pods is on the Juul website.
The company will also increase its secret shopper program from 500 visits/month to 2,000 visits/month at the more than 90,000 stores where Juul products are sold.
Juul’s plan, announced Tuesday, also includes removing the company’s Instagram and Facebook channels, and limiting its Twitter account to non-promotional information.
Alongside cracking down on flavored ENDS products, Gottlieb is also looking into banning combustible menthol cigarettes and all flavored cigars from the market. Mint and menthol ENDS products could also be on the chopping block.
“I’m deeply concerned about the availability of menthol-flavored cigarettes,” said Gottlieb in a written statement. “I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes.”
Not only does the masking effect of menthol make combustible menthol cigarettes more attractive to youth, but Gottlieb went on to say that “they exacerbate troubling disparities in health related to race and socioeconomic status” and “disproportionately and adversely affect underserved communities.”
For these reasons, the FDA is taking a hard stance on menthol combustible cigarettes and flavored cigars, a move that will surely mobilize big tobacco in yet another battle in their decades-long war against regulators. Until restrictions can be enforced on these combustible products, however, the FDA is allowing menthol and mint flavored ENDS products to be sold in convenience stores as well as vape shops.
But Gottlieb will be keeping a close watch on it:
“I’m also aware that there are potentially important distinctions even between mint- and menthol-flavored e-cigarette products,” he wrote. “I’m particularly concerned about mint-flavored products, based on evidence showing its relative popularity, compared to menthol, among kids. So, I want to be clear that, in light of these concerns, if evidence shows that kids’ use of mint or menthol e-cigarettes isn’t declining, I’ll revisit this aspect of the current compliance policy.”
In response to the FDA’s announced plan, a Juul Labs spokesperson had this to say:
Commissioner Gottlieb has made it clear that “preventing youth initiation on nicotine is a paramount imperative.” As we said earlier in the week, the numbers tell us underage use of e-cigarette products is a problem that requires immediate action. That is why we implemented our action plan. We are committed to working with FDA, state Attorneys General, local municipalities, and community organizations as a transparent and responsible partner in this effort.
The FDA statement, which is more than 4,000 words, thoroughly explains that the agency is trying to strike a balance between ensuring adult smokers have an alternative through ENDS and protecting a generation of young people from becoming addicted to nicotine.
In light of the FDA’s opposition to menthol, Gottlieb addresses the distinction between allowing menthol/mint and tobacco flavored ENDS into convenience stores opposed to other flavors:
This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age-restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking.
As far as online sales go, the FDA is looking to ensure that all flavored ENDS products sold online go through a rigorous age-verification process.
Gottlieb also addressed the potential for new products to reverse the growth of underage ENDS use, and said that the agency would work to make the application review process more efficient.
“In the coming months, CTP plans to issue additional policies and procedures to further make sure that the process for reviewing these applications is efficient, science-based and transparent,” said Gottlieb. “We’ll also explore how to create a process to accelerate the development and review of products with features that can make it far less likely that kids can access an e-cigarette.”
Juul Labs has briefly discussed its vision for a next-generation e-cig, which the company has been working on for a year. The device would incorporate Bluetooth, letting users monitor and control their nicotine intake. However, Bluetooth might also allow for geofencing to prevent kids from using the product at school, as well as a smartphone-based lock that would only allow the Juul to be used by someone who has verified they’re over 21.
Source: Tech Crunch Startups | What the FDA’s restriction of e-cig flavors means for Juul
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