Please let the FDA follow the science instead of blowing in the political winds

By Cheryl K. Olson, MPH, Sc.D.

Hasn’t everyone who smoked cigarettes quit by now? Since you’re reading this, you probably don’t have a pack in your pocket or purse. It’s likely you count few, if any, smokers among your colleagues. Back in 1965, when 42% of U.S. adults inhaled tobacco, college grads were about as likely to indulge as the less-educated. That’s far from the case today.

In fact, over thirty million of our fellow Americans are still smoking, says the Centers for Disease Control and Prevention. Twenty-five of every 200 adults. Why don’t you know them? Because smoking is increasingly concentrated in what my public health colleagues call “vulnerable populations.” Traumatized, poor, chronically ill, older, incarcerated, uninsured or on Medicaid. The more of these disadvantages, the more likely they are to smoke. Smokers die earlier, from a wide range of diseases; quitting saves years of life. But smokers from vulnerable groups quit far less easily. Simply put, the easy wins against smoking are over.

A recent analysis in the journal Preventive Medicine shows current quit-smoking medications can’t solve our smoking problem. Prescription patches and pills work in ideal clinical trial conditions, but barely budge the needle in the real world. As study coauthor Vaughan Rees, of Harvard’s School of Public Health, said at the 2022 E-Cigarette Summit, “The best evidence-based interventions are dated, overrated and cannot meet the challenge of reducing tobacco-related harm in this century.”

It’s easy but useless to keep blaming smokers for not liking and using these products. We may want smokers to take their medicine. But to truly save lives, reduced-risk products must satisfy. A growing number of researchers are calling for new options that are “attractive to smokers.”

Fortunately, the Food and Drug Administration has a Center for Tobacco Products tasked with reviewing novel nicotine alternatives. Companies must submit reams of studies, called Premarket Tobacco Product Applications (PMTAs) to the FDA. As Mitch Zeller, the longtime director of the CTP, said, “The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of public health.’” Will the health benefit to tobacco users outweigh potential risks to tobacco non-users, especially youth?

Some novel options will fail that balance test. In a recent press release, FDA Commissioner Robert M. Califf called nicotine gummy products “a public health crisis just waiting to happen.” He announced a crackdown on a maker that didn’t file a PMTA, saying “The FDA will not stand by as illegal products infiltrate the marketplace.”

Kudos to the FDA for taking action against bad actors who flout the rules. However, the release also cited an article in the September issue of the journal Pediatrics fueling fears about teen use of a wider range of flavored oral nicotine products. It’s crucial to monitor youth tobacco use trends. But a tiny percentage of teens ever trying these products in a Los Angeles sample should not be overinterpreted.

In July, Califf announced an external review of the FDA’s Center for Tobacco Products (as well as the food safety program). This likely stems at least in part from a recent premature crackdown and embarrassing retreat by CTP regarding JUUL e-cigarettes. Several years ago, JUUL became the poster child of underage nicotine use, during its temporary reign as the most popular vaping product for youthful experimenters.

That past behavior implies that the FDA’s nicotine product reviewers feel pressure to prevent youth use above all, however low the risk. After years of fighting Big Tobacco, advocates and researchers are hyper-attuned to nefarious intent with any novel products. Multiple academic papers have tagged flavored smokeless products created for adult smokers (including nicotine gums and pouches) as “the next JUUL.”

The public, and even most physicians, already misperceive nicotine as the cause of cancer and see non-combustible alternatives such as vaping as just as risky if not more dangerous than smoking. FDA campaigns meant to deter youth vaping unfortunately fed these misperceptions.

If we agree job one is to save lives, we have got to move these vulnerable 21st century smokers off combustible cigarettes. This means following the science in public education, and following the science in reviewing new nicotine products that could save the lives of millions of smokers. As Kenneth E. Warner of the University of Michigan School of Public Health put it in his article, How to Think–Not Feel­–About Tobacco Harm Reduction: “Lives are at stake…. We need to assess the evidence in a fair and objective manner, and move forward together toward the elimination of tobacco’s harms.”

Suppose you are dead set against anything that benefits companies that still make cigarettes. Many companies submitting PMTAs have no links to Big Tobacco. These innovators need predictability to risk investing hundreds of thousands of dollars in the science FDA wants.

Perhaps the external review of CTP through the Reagan-Udall Foundation will help. Founded by Congress to advance the mission of the FDA, its vision stresses “regulation informed by science.”

Otherwise, FDA will in effect clear the market for companies that flourish by ignoring the rules.

Cheryl K. Olson is a behavioral scientist working in tobacco harm reduction and is also a member of PPI’s Mosaic network.