The FDA Warms to Vaping

In July, the Food and Drug Administration (FDA) extended the deadline for e-cigarette manufacturers to seek regulatory approval of their products. On the face of it, the change was merely a four-year stay of execution. But the agency also signaled a new receptiveness to vaping as a harm-reducing alternative to smoking, which suggests the reprieve could turn into a commutation.

That would be good news for smokers who want to quit. For too long, American public health officials have been unreasonably hostile to e-cigarettes, which deliver nicotine in an aerosol that is far less hazardous than tobacco smoke and offers a closer simulation of the real thing than nicotine gum or patches do.

FDA Commissioner Scott Gottlieb seems to appreciate the public health potential of this innovation. "The overwhelming amount of death and disease attributable to tobacco is caused by addiction to cigarettes," he said in a press release. "Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts."

The FDA said "a key piece" of its new approach is "demonstrating a greater awareness that nicotine—while highly addictive—is delivered through products that represent a continuum of risk and is most harmful when delivered through smoke particles in combustible cigarettes." The agency wants to strike "an appropriate balance between regulation and encouraging development of innovative tobacco products that may be less dangerous than cigarettes."

Toward that end, the FDA is giving e-cigarette companies until August 8, 2022, to apply for permission to keep their products on the market under regulations published last year. The agency says it will use the extra time to seek additional public comment and develop clearer guidance for the industry.

The regulations require manufacturers of vaping equipment and e-liquids to demonstrate that approval of their products "would be appropriate for the protection of the public health." It is not clear what that means in practice, but the FDA projected that applications would cost hundreds of thousands of dollars per product, and many observers thought that was an underestimate. The burden was expected to drive most companies out of business.

If the FDA is serious about promoting "less harmful sources" of nicotine, it will develop transparent, straightforward, and practical criteria for approving current and new vaping products. Standing between smokers and products that can save their lives is surely not "appropriate for the protection of the public health."