By Scott Gottlieb / For The Washington Post
When regulations are contemplated to address an epidemic of teenagers using e-cigarettes, vaping advocates complain loudly. The restrictions will obstruct adult access to these products, they say, foreclosing the opportunity for smokers to use the devices to quit cigarettes.
Another complaint: Regulatory action to ban flavored e-cigs, which appeal to children, could end up forcing the shutdown of small vape stores that cater to adults.
The Washington Post reported Sunday that the opposition has succeeded in stalling a Trump administration plan to implement a universal ban on flavored vaping products as a way to stem the youth epidemic. If the concern is the impact on vape stores, as The Post reported, there are ways to address that while still taking tough steps to reduce kids’ access to e-cigs and reduce the products’ appeal to them.
As a study published in the New England Journal of Medicine last winter made clear, vaping almost certainly contributes to accelerating declines in smoking rates. E-cigs aren’t safe, but when used properly they are not nearly has harmful as lighting tobacco on fire and smoking it.
Yet providing adult smokers with a safer alternative to cigarettes cannot come at the expense of addicting a generation of young people to nicotine with these same products. New data from the Food and Drug Administration shows almost a third of teens now vape. And according to a study published in February in the Journal of the American Medical Association, young people who start out using nicotine through e-cigs are more likely to become long-term smokers.
The solution is to get e-cigs out of the hands of kids but preserve the devices’ potential to help adult smokers fully quit cigarettes.
It starts with differentiating between sleek, mass-produced e-cigarettes that use pre-filled, flavored pods of nicotine, as with Juul’s products, and hardware that requires nicotine to be poured into open tanks.
The open-tank products typically have larger batteries and are sold at higher prices. Since they produce sizable plumes of hard-to-conceal vapor, they aren’t popular with teenagers. With data now supporting the distinction between young people’s use of cartridge-based and open-tank vapes, the devices can be treated differently under the FDA’s enforcement policy.
The FDA can immediately remove from the marketplace the cartridge-based e-cigs that kids use. Teens like the devices’ sleek form, but also the big nicotine buzz that they offer. It’s not just about the flavors. Even with Juul recently committing to ending sales of its kid-friendly mint flavor, we should expect teens to switch to the company’s mild tobacco flavors.
Once the cartridge-based e-cigs are swept from the market, under current law, companies that want to relaunch them would need to file FDA applications showing that they provide a net public health benefit. The review process would allow the agency to impose additional restrictions to prevent their use by young people.
Meanwhile, open-tank vapes (and flavors mixed for individual customers inside vape stores) could continue to be sold in adults-only vape shops that can prove they effectively enforce age restrictions. These products would have until next year’s existing deadline to file applications with the FDA seeking market authorization; they could remain on the market in adults-only shops while the agency conducts its review.
Next, the FDA could make the process for completing and filing those applications more efficient for small and the sometimes individually owned vape stores. The big tobacco companies, with their mass-produced cartridge products, have the money and consultants to meet the regulatory requirements. The vape shops may struggle to do the same.
To address that concern, the agency could allow vape stores that follow a common manufacturing process for mixing e-liquids to pool their data and resources to file a shared application for market approval. If the application is approved, the FDA could issue individual approvals to each vape shop.
These steps would need to be backed with tough enforcement of age restrictions. The vape shops want to cast themselves as victims of regulation. But many shirk their duty to keep these products out of the hands of kids. One recent survey found that among young e-cig users, 14.8 percent obtained them from vape shops, and only 8.4 percent from gas stations or convenience stores.
Political considerations may dictate that vape shops be given some accommodation, but there are public-health arguments for targeting the products most widely abused by young people. If we delay action altogether, we’ll leave an entire generation of kids mired in a lifetime of nicotine addiction.
Scott Gottlieb, a resident fellow at the American Enterprise Institute, was commissioner of the Food and Drug Administration from May 2017 to April 2019. He consults for and invests in biopharmaceutical companies.