Vaping has now been linked to at least 11 deaths, and more than 500 people have hospitalized with vaping-related lung illness.
Here in Massachusetts, Governor Charlie Baker has declared a public health emergency and a four month ban on the sale of all e-cigarettes.
The Centers for Disease Control and Prevention have recently warned against vaping. Ned Sharpless, acting commissioner of the FDA, told a House Committee hearing this past week that “We don’t consider the products safe. We think they have harm.”
It all begs the question: how did we get here? How could e-cigarettes be on the market if the FDA says they are not safe?
Law and Policy Specialist Lauren Lempert of the Center for Tobacco Control Research & Education University of California, San Francisco walked us through e-cigarette regulation – past, present, and future. Here’s what you should know.
E-cigarettes have not been approved by FDA
FDA received a mandate to regulate e-cigarettes in 2016, and the Agency gave manufacturers until 2018 to submit applications for authorization.
However, that deadline has moved around several times in the intervening three years. First, it was pushed back to 2022. Then, as the number of vaping-related cases of lung damage began to increase, FDA pulled it up to 2021. Finally, under pressure from a lawsuit, FDA set a May, 2020 deadline.
In the meantime, manufacturers have been given permission to continue selling their products.
E-cigarettes are regulated as tobacco products, not a way to stop smoking
FDA’s authority to regulate e-cigarettes and other tobacco products is separate from its authority to regulate medicines. Therapies that help people quit smoking fall into the latter category.
Although it is frequently implied – by both e-cigarette manufacturers and the FDA – that e-cigarettes are a safer alternative to smoking and could help people quit smoking, no manufacturer has ever requested that designation. If they did, it would trigger the need for the same kind of safety and efficacy testing required for medicines.
In addition to concerns about the safety of vaping, there is reason to be skeptical about the idea of using e-cigarettes to get off cigarettes. Statistics show that most adults are not quitting when they start vaping, but rather, using both e-cigarettes and conventional cigarettes. And there is some evidence to suggest that the combination is more dangerous than either smoking or vaping, alone.
FDA has options
Ideally, FDA regulations for e-cigarettes would be based on studies that show the long-term effects of vaping.
In the meantime, the FDA could restrict the sale of flavored products, which young people have reported as being part of the appeal of e-cigarettes. FDA has said that new rules about flavors will be finalized in a matter of weeks.
FDA also has the authority to set marketing provisions, and could use that to push back on the sleek appearance of e-cigarettes – making them less “sexy” to teens.
Warning labels are another option, but on that front, Lempert expresses skepticism. She says research has shown that labels about nicotine’s addictive nature are not effective, especially for young consumers, who think they’ll be able to quit whenever they want.
“FDA would have would have to come up with better warning labels to make them effective,” she said.