It’s FDA’s moment to lead with purpose on nicotine

The U.S. tobacco and nicotine marketplace is in a state of dysfunction. Combustible cigarettes — the most harmful way to consume nicotine — still dominate the back wall at retail.¹ Adult consumers hear inconsistent messages from a variety of sources about tobacco and nicotine products. Retailers are confused about what products are legal to sell to adults 21 and older — and a patchwork of conflicting federal and state laws only deepens the disorder. 

Coordinated policy action is urgently needed to restore order, protect public health and ensure that both adult consumers and youth are safeguarded by a clear and enforceable regulatory framework. 

As Chief Underage Prevention Officer at PMI U.S. — the U.S. businesses of Philip Morris International — I see firsthand how regulatory uncertainty and enforcement gaps for tobacco and nicotine products are undermining the legal market and underage-access prevention efforts. 

Incredibly, smoking remains the leading preventable cause of death in the U.S. today.² More than 70 percent of money spent on tobacco products at retail goes toward combustible cigarettes.³ Quitting smoking altogether is the best choice, but most continue each year. We think better alternatives are available, but adult consumers are not getting clear and consistent information about these smoke-free products, and retailers are not given sufficient information to understand FDA’s rules and what products they are allowed to sell to adults 21 and older.  

The result is a poorly regulated marketplace for what is supposed to be a highly regulated industry — one where illicit trade is growing and untested products bypass regulatory channels that enforce critical safeguards like quality standards, marketing restrictions and age verification.⁴ And what we consider the most concerning of all — the risk of underage appeal and access increases. 

There is reason for optimism. According to the most recent National Youth Tobacco Survey, 8.1 percent of youth reported using any tobacco product in the past 30 days — a 50 percent drop over the past five years and the lowest rate recorded in the survey’s 25-year history.⁵ At the same time, many of the nearly 30 million adults who continue to smoke show interest in trying smoke-free alternatives.⁶ 

After recent announcements, the FDA seems poised to authorize more products that meet its rigorous scientific standards — and with greater speed and transparency. More FDA-authorized products will help discourage demand for illicit products. But authorization alone is not enough. The FDA must also invest in education and communications for adult consumers, retailers, manufacturers and state regulators about its role as lead regulator, its scientific reviews and what we view as the potential benefits of authorized smoke-free products for the almost 30 million smokers in the U.S. 

A well-regulated market is not a utopian ideal — it is essential to supporting responsible business, preventing underage access and restoring lost tax revenue. We think timely FDA action, paired with consistent education, oversight and enforcement will clarify the regulatory landscape and close the door on illicit trade. 

Now is the time for the FDA to lead with purpose. A transparent, science-based regulatory framework is not just good policy — we believe it’s the foundation for promoting harm reduction and improving public health. 

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