The regulation of e-cigarettes is a crucial aspect of public health efforts to combat smoking-related diseases and nicotine addiction. The U.S. Food and Drug Administration (FDA) is at helm of these regulatory efforts through its Premarket Tobacco Product Applications review process. This evaluation process is designed to ascertain whether new commercial tobacco products are suitable for the market according to standards to protect public health. As of now, the FDA has authorized the sale of 23 e-cigarette products, a decision that merits further discussion from a public health viewpoint.

Understanding FDA Authorization

It is important to differentiate between FDA "authorization" and "approval." Approval is what the FDA does with respect to food, drugs, and devices, whereas it “authorizes” tobacco products. Authorization by the FDA only implies that the agency has deemed these products marketable in the U.S. It does not indicate that these products are safe or that, in the case of e-cigarettes, they present a reduced harm alternative to combustible tobacco products. This distinction is vital for making informed decisions regarding e-cigarette use.

Details on the 23 Authorized E-Cigarettes

The FDA's website offers the list of 23 FDA authorized e-cigarette products available for sale in the U.S. as of January 2024. All other e-cigarettes besides these listed products are unauthorized. What do these 23 products have in common? The authorization of these e-cigarettes brings to light several important public health themes:

  • No Flavors: None of the 23 authorized e-cigarettes are flavored. The decisions to authorize these products reflect a strategy to diminish the attractiveness of flavored e-cigarettes. They also suggest that it might be the FDA’s policy never to authorize a flavored e-cigarette. By restricting the available flavors to tobacco only, the aim is to deter young people from initiating nicotine use. Flavored e-cigarettes, especially menthol, have been particularly appealing to teenagers and young adults, contributing to the rise in youth vaping. It's important to emphasize this point: despite the widespread availability of flavored e-cigarettes in the market, none of these flavored e-cigarettes are authorized.

  • Not Modified Risk: None of the 23 authorized e-cigarettes have been authorized as modified risk tobacco products, nor have their companies applied for that designation.  There is a lack of evidence to prove that e-cigarettes are a safer alternative to traditional cigarettes or that they serve as effective tools for quitting smoking, especially when used outside a counseling setting. 

  • Environmental Impact: None of the 23 authorized e-cigarettes are so-called "disposable" or "single-use vapes."  This distinction underscores the importance of addressing both public health and environmental concerns associated with vaping products. The proliferation and discarding of e-cigarettes present significant environmental challenges.  Often advertised as "disposable vapes," these products are disposed of once the e-liquid runs out, and they contain lithium-ion batteries glued into the product, which makes them nearly impossible to safely remove or recycle.  The environmental toll of these products has sparked considerable concern. 

Looking Ahead

The primary public health objective of e-cigarette regulation is to minimize harm and shield future generations from nicotine addiction. The FDA's application of the Premarket Tobacco Product Applications review process underscores this commitment. It's imperative that state registry bills are not seen as a substitute for this evaluation process, and legislators should be wary of allowing unreviewed products within their jurisdictions.

As the e-cigarette industry changes, product regulations need to continue to be based on reliable scientific evidence with the goal of protecting public health. We urge the FDA to persist in its stance of not approving e-cigarettes that are flavored, labeled as lower-risk alternatives, or equipped with non-recyclable, fixed lithium-ion batteries. Regulatory actions moving forward must prioritize the safeguarding of public health.

Willow Anderson, Staff Attorney
March 5, 2024