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The New FDA Commissioner Has the Chance to Help Smokers

The opinions expressed by columnists are their own and do not necessarily represent the views of
AP Photo/Frank Franklin II, File

Across the country, teens are turning away from cigarettes in large part thanks to e-cigarettes. Yet, all that progress could be lost, as many e-cigarettes could be pulled off the market by next year. Because of the Food and Drug Administration’s (FDA) rigorous application process, many companies are predicted to close, thus reducing the access to e-cigarettes.


Yet there is hope, as the new FDA commissioner, Stephen Hahn, has the potential to ensure that e-cigarettes remain an available option for those that need them.

Currently, e-cigarettes companies have been able to sell their products without needing FDA approval, yet that will change as firms must submit a Premarket Tobacco Product Applications (PMTA) by May of next year. While in theory the application process should be straightforward enough to allow most companies to pass approval, in reality few companies will actually submit an application.

The FDA reports that each application for an e-liquid can run up to $130,000 while each delivery system can cost $466,000. With expenses running so high, the FDA concludes by saying that industry can expect to pay anywhere from $320 to $520 million to comply with the FDA. Yet due to the excessive costs, the FDA openly admits that many businesses will choose to “cease to sell products in the U.S. rather than bear the cost of complying with this final rule.”

As e-cigarettes are pulled off the market, smokers are the ones that are ultimately left with the short end of the stick. Seventy percent of smokers want to quit smoking, and while options like quitting “cold turkey” and nicotine patches are somewhat successful, e-cigarettes are found to be the most effective option for people to ditch the deadly habit. However, as options to vape become limited, many people will simply return to smoking.


Yet, hope is alive as Hahn was approved by the Senate Committee on Health, Education, Labor and Pensions on Tuesday. Having said in a Senate confirmation hearing he will use “science and data to guide [his] decisions” when it comes to regulating e-cigarettes, perhaps Hahn will be able to recognize the evidence-based e-cigarettes’ role in helping public health.

But what can be done to ensure e-cigarettes remain accessible to smokers?

For starters, Hahn can ensure that the application process isn’t excessively restrictive that it pushes safe e-cigarettes out of the market. Hahn could also extend the PMTA deadline. This would ensure companies are given enough time to properly comply with all of the requirements requested by FDA.

The ramifications of such changes could be lifesaving.

Over 480,000 people annually lose their lives due to cigarettes, while 34 million Americans smoke every year. As the new director of the FDA, it is his responsibility to ensure the public has access to products that reduce harm and promote health. E-cigarettes are an essential product that have already saved lives and continue to help people transition off from smoking.


While it’s important to ensure that vaping products are safe to use, e-cigarettes are widely known to be much safer than cigarettes. As Hahn’s nomination still has to pass the Senate’s vote, hopefully he can bring along the changes needed to ensure e-cigarettes remain a viable option for smokers across the country.

Janson Quinlan Prieb is a policy analyst at the American Consumer Institute, a nonprofit educational and research organization.

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