FDA’s fantasy modeling doesn’t justify ban on cigarettes

The Food and Drug Administration (FDA) is proposing to mandate the removal of 97 percent of the nicotine in cigarettes, meaning almost every cigarette currently sold in America would be banned. And it’s not just cigarettes in the FDA’s line of fire. Most cigars and pipe tobacco will have to meet the FDA’s new nicotine standard.

The economic and employment impacts of the FDA’s rule could be devastating for many. The FDA is justifying this rule with a model of projected benefits that claims to prevent 48 million youth and young adults from starting smoking by the year 2100 and lead to 12.9 million Americans quitting smoking one year after the rule is implemented.

So, is such a radical and unprecedented policy worth it to achieve such enormous public health benefits, and is it likely to be as successful as the FDA projects? In a word, no.

America’s youth smoking rate is already one of the lowest in the world. Only 1.4 percent of middle and high school students tried a cigarette in the past month, a decline of almost 60 percent from 2020, which was the year the FDA chose to derive its inputs on youth smoking for its model of projected benefits. The FDA’s model, primarily based on eight experts guessing what they believe will happen in response to the policy, assumes the policy will be implemented in 2027, a year in which it’s not unrealistic to assume youth smoking could already be statistically indistinguishable from zero. If that is indeed the case, then the FDA’s model will have massively overshot the projected benefits of preventing youth from picking up smoking, and the policy will be focused entirely on removing choice from adult smokers.  

However, there are still further assumptions in the FDA’s plan that are unlikely to materialize. According to the FDA, when the ban on regular cigarettes comes into effect, around half of smokers will switch to safer nicotine alternatives like e-cigarettes, nicotine pouches, and heated tobacco. The success of the FDA’s plan in large parts depends on a competitive market in these products that consumers find satisfying and know are safer than smoking cigarettes.

“The FDA also recognizes the importance of ensuring broad and equitable access to all the tools and resources that can help smokers quit,” Brian King, head of the Center for Tobacco Products at the FDA, told journalists in a press conference announcing the rule.

The deep irony is that for the last four years, the FDA has been denying smokers access to the most effective tools for quitting, namely e-cigarettes, by banning most of the domestic vape market. A flood of vapes from China has come to fill the gap, which the FDA is now desperately trying to interdict with the help of other agencies.

Despite an overwhelming amount of evidence on both the relative safety of e-cigarettes and their effectiveness in helping smokers quit, the majority of the public still believes these products are no different from regular cigarettes.

The gap between reality and public misperception indicates the FDA’s failure to communicate accurate information, especially when understanding such information is critical to the success or failure of the biggest prohibition in the agency’s history and the largest in America since the 1970s.

The FDA’s model gives short shrift to the idea there will be a substantial illicit market for cigarettes. With almost 30 million smokers and a market worth tens of billions, the FDA is betting that criminals won’t capitalize on an opportunity to meet demand as they have with vapes and illicit drugs. It’s a bold assumption that goes against the grain of history and experience. When South Africa banned cigarette sales during the COVID-19 pandemic, most smokers continued using cigarettes smuggled in from neighboring countries despite prices soaring 240 percent.  

Hopefully, the incoming Trump administration will force the FDA to detach itself from abstract models based on guesswork and instead pursue tried and proven strategies to help those smokers who wish to quit do so.

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