FDA’s anti-smoking strategy ignores millions of Americans

Published May 7, 2026 9:00am ET



Across the country, a quiet negotiation is happening inside American families: If you’re still smoking, you can’t be around the grandkids.

For many older people, that carries more weight than any warning label ever could. After decades of trying to quit, it becomes less about abstract health risks and more about missing birthdays, holidays, or simple outings. 

Policymakers have focused on preventing young people from starting to smoke. That effort has saved lives. But somewhere along the way, we pushed the people who already smoke, many of them older, to the margins of the conversation.

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There are roughly 25 million adults in the United States who continue to smoke cigarettes, per 2026 New England Journal of Medicine data. Many have tried to quit more than once. Many have used the tools doctors recommend: gums, patches, and lozenges — or all of the above. For many, those options have not worked, resulting in a familiar and discouraging cycle. 

These are the adults we are ignoring, and public health policy continues to reinforce that blind spot.

This is the kind of blind spot Food and Drug Administration Commissioner Marty Makary has spent his career calling out. In his book Blind Spots, he challenges stale thinking in medicine and argues that institutions tend to cling to established beliefs long after the evidence has shifted. Few areas illustrate that dynamic more clearly than how quickly nicotine products have evolved compared to how slowly our thinking about them has changed.

As Makary prepares to face questions on Capitol Hill, he has the opportunity to confront a system that is not delivering enough on its core objective of reducing smoking. That starts with acknowledging a basic reality: Millions of Americans still smoke, and many have not been well served by the existing tools.

Our policy framework has not kept pace with that reality. Originally designed to protect families, the Family Smoking Prevention and Tobacco Control Act now focuses largely on preventing youth use, leaving current tobacco users without a clear path forward.

At the same time, new nicotine alternatives that do not rely on combustion have emerged, curbing the harm caused by the thousands of chemicals released when tobacco burns. And yet, the false assumption that nicotine causes cancer continues to shape how patients think, how doctors advise, and how policymakers regulate. A recent study of U.S. healthcare providers found that many still misunderstand the relative risks of nicotine products, with roughly half not believing that switching from cigarettes to non-combustible alternatives reduces health risks. 

Millions of Americans have already turned to those nicotine alternatives to help them quit smoking. Yet, federal policy has struggled to keep up. The FDA’s Premarket Tobacco Product Application process for these products has been slow and extremely difficult to navigate. Many applications remain unresolved or have been denied with limited clarity. 

But adults — our parents and grandparents — who have spent years trying to quit will continue to suffer the consequences if we fail to offer better options.

Other countries have adopted the approach at the core of tobacco harm reduction: helping people move away from cigarettes and toward lower-risk nicotine alternatives. The U.S. has been slower, often caught between timid regulators and loud advocacy groups clinging to outdated assumptions. The result is a growing black market that is difficult to corral. 

The FDA’s current intransigence is hurting millions of people. The public needs much clearer communication about the role of nicotine in smoking-related disease, the availability of alternative products, and consistent enforcement against illegal products that undermine public health and regulatory credibility.

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The adults we’re ignoring are not abstractions, and they deserve a public health strategy that reflects their realities, not endless moralizing or a one-size-fits-all quitting script. 

Are we willing to meet people where they are, or are we going to keep pursuing a strategy that quietly writes off millions of adults?

David Oliveira is a partner at Scrimshaw Strategies and a former senior staffer at the Food and Drug Administration, where he spent six years working on tobacco control policy. Drawing on his firsthand experience inside the agency, he has publicly highlighted gaps in enforcement and regulatory strategy, particularly around illicit nicotine products and tobacco harm reduction.