If the FDA Wants People to Stop Smoking, it Should Stop Meddling in the Vaping Market

An article featured in Annals of Internal Medicine highlights an ongoing effort by the Food and Drug Administration to bring more nicotine replacement therapies (often called NRTs) to market. Although rates have plummeted over the past several decades, smoking remains one of the most common causes of preventable death in the U.S. 

The article’s call to action is far from the FDA’s first attempt to promote NRT innovation. In 2019, the agency began revisiting older guidelines and adjusting prior regulatory requirements “to assist sponsors in the clinical development of nicotine replacement therapy (NRT) drug products intended to help cigarette smokers stop smoking.”  After years of seeking public feedback and revising older policies, the agency released new guidelines in 2023.  

It has been an ambitious project with little to show for it. After four years of promotion, revising standards, and receiving public feedback, the FDA has only approved three NRTs. Each of them strongly depends on other behavioral interventions (which have their own limitations).

At best, NRTs remain a work in progress. Fortunately, e-cigarettes provide ready and reliable help. But we already knew that. 

Peer-reviewed research finds e-cigarette use is a reliable and relatively easy aid to help users give up cigarettes. Harvard Health Publishing of Harvard Medical School finds vaping and e-cigarettes are among the most reliable options to reduce tobacco use. The National Health Service of the United Kingdom promotes vaping as a way to quit smoking (even providing designated vaping spots in hospitals). 

Vaping is also considerably safer than smoking. Since 2020, vaping has been linked to 68 deaths. The FDA itself has approved dozens of vaping products, certifying they are safe for public consumption. 

Ironically, the FDA is almost single-handedly responsible for keeping vaping products away from those hoping to quit smoking. 

Dating back to 2018, the agency underwent a massive regulatory crackdown to curb the so-called “vaping epidemic” among high school middle school aged users. The crackdown included raiding vaping facilities, confiscating corporate documents, banning pod flavors, running industry leaders out of the market, and issuing countless warning letters to intimidate vaping producers. 

Again, the FDA’s efforts have come up short. Research finds no discernable difference in teenage vaping use since the FDA began. If anything, teens were vaping less before the FDA gained authority to regulate vaping products. 

Repeated and numerous efforts to thwart the vaping market aside, the FDA remains cautiously open to approving these goods as smoking cessation treatments. Having e-cigarettes approved for this use would require the agency’s full approval. That always takes considerable time and financial resources. 

First and foremost, letting vaping goods reach their full potential to reduce smoking first requires the FDA to stop its six-year crusade against them. Judging by the predicament the FDA finds itself in now, I do not even think it realizes it has a problem.