In Case You Haven't Heard…

Abstract

Scott Gottlieb, M.D., former commissioner of the Food and Drug Administration (FDA) and now a fellow at the conservative think tank the American Enterprise Institute, wants to establish rules for vaping, and these could include setting up a system for e‐cigarettes to be over‐the‐counter (OTC) medicines, nicotine‐replacement tools like gum and patches. In a June 24 opinion piece in The Wall Street Journal, he writes that e‐cigarettes can be a tool to help adult smokers quit, while also keeping teens away from smoking, but he says this will be a “tough job” for the FDA. He said while e‐cigarettes are “less harmful” than combustible cigarettes, they aren't safe; they can damage the lungs, and they can lead to nicotine addiction. There are medical products to treat nicotine addiction: gum and patches that are so safe they can be bought over the counter. E‐cigarettes are not that safe. He thinks that the JUUL‐type systems that are favored by minors and sold in convenience stores should be regulated differently from the open systems primarily used by adults, which have refillable cartridges. “The FDA could allow vape stores that follow common manufacturing processes for e‐liquids to band together to file a common application for market approval,” he writes. Still, there could be a more specific path altogether, in which e‐cigarettes could be approved as OTC drugs, like gum and patches. “The e‐cig manufacturers would need to run clinical studies to prove that their products don't create undue risks relative to their ability to help smokers quit cigarettes,” he writes. “The OTC pathway would treat cartridge‐based e‐cigs similarly to nicotine gums and patches, requiring them to clear a higher bar to prove they are effective smoking‐cessation tools. But it also would provide more‐stringent safeguards against products that appeal to kids but don't help adults.”