Why U.S. Nicotine Policy Needs a Reset

U.S. smoking rates have fallen dramatically over the past several decades, but progress is slowing and major disparities remain. A new editorial published in Cureus argues that further reductions will depend on a more practical, person-centered approach that better reflects how adults who smoke actually make decisions.

In 2000, the U.S. adult smoking rate was 23.3%. Today, it is less than 10%. But millions of Americans still smoke cigarettes, and those who remain are increasingly concentrated among people facing financial stress, limited access to healthcare, and other challenges. These groups often get less support from current policies.

The Cureus editorial, “Closing the Harm Reduction Gap: EMPOWERing People Who Smoke,” asks whether a more practical, person-centered approach could help reduce smoking further while also addressing the inequalities that persist under current policy. Two of the authors work for Haypp Group, the parent company of Nicokick.

As someone who used to smoke and now uses nicotine pouches, I’ve seen how adult access to other options can help people move away from cigarettes. That experience shaped how I think about harm reduction.

Lindsay Reese

Senior Scientific Content Manager

In the UK, strong tobacco control policies together with access to alternatives have helped reduce smoking. A balanced approach can reach people who are not benefiting from current strategies.

Marina Murphy

Senior Director of Scientific Affairs

Tobacco control follows a familiar playbook: raise taxes and make cigarettes less appealing or less available. These measures have contributed to major declines in smoking and should not be dismissed.

But the traditional playbook is producing diminishing returns and may slow progress when it limits access to lower-risk alternatives. For adults who have continued smoking despite decades of warnings, taxes, restrictions, and cessation campaigns, further progress may depend on making lower-risk alternatives available and regulating them in proportion to their risks.

• Bans and restrictions remain a common response to new nicotine products.
• Higher taxes are often treated as the fastest way to discourage use.
• Clear and achievable regulatory pathways for products such as e-cigarettes and nicotine pouches have lagged behind market developments. 

This imbalance is reflected in the federal regulatory agenda. In January 2025, FDA proposed reducing nicotine in cigarettes and other combusted products, an ambitious undertaking that could take years to finalize and implement. Meanwhile, many modern noncombustible products have already spent years waiting for final decisions under the Premarket Tobacco Product Application process.

Making cigarettes less addictive may help, but adults who still smoke also need a clear path to regulated, lower-risk alternatives. Delaying those decisions leaves that path incomplete.

The result is a regulatory gap. Adults who smoke are told cigarettes are uniquely harmful, but the pathway for authorizing alternatives has often been slow, unclear, and uneven.

The e-cigarette market illustrates the consequences. FDA spent years reviewing and denying large numbers of applications while many popular products remained unauthorized. During that period, illicit and unauthorized flavored products became more popular and captured an enormous share of the market.

• Nicotine pouches now face a similar challenge. FDA launched a pilot program in September 2025 intended to streamline its reviews of nicotine pouch applications. Nine months later, most applications included in the pilot are still awaiting final decisions. FDA has improved communication with applicants, but that has not yet translated into faster decisions for most of them. The smoking rate has fallen, but 25 million U.S. adults still smoke.
• Illicit markets can grow when lawful regulatory pathways are too slow or uncertain.
• Adults need accurate information and access to regulated alternatives, not just another round of bans and delays.

The proposed EMPOWER framework offers a counterpoint. Instead of relying mainly on prohibition and pressure, it begins with a practical question: How can regulation and policy help move adults away from cigarettes while maintaining strong protections against youth use?

For the United States, that could include:

• Evaluating products based on relative risk and evidence of real-world switching.
• Modernizing PMTA guidance for categories such as e-cigarettes and nicotine pouches.
• Prioritizing enforcement against illicit products while creating a clearer route for lawful ones.
• Communicating honestly about the differences between combustible and noncombustible products.

Smoking is now strongly associated with socioeconomic and health inequalities.

In the U.S., cigarette smoking has declined substantially, but disparities remain. CDC data show that 11.6% of U.S. adults smoked cigarettes in 2022, with higher smoking rates among adults with lower education levels, lower household incomes, public insurance coverage, disability, and serious mental health conditions.

These differences are large. In 2022, current cigarette smoking was reported by 30.7% of adults with a GED and 20.1% of adults without a high school diploma, compared with 5.3% of adults with an undergraduate degree and 3.2% of those with a graduate degree. Smoking also remained higher among adults with annual household incomes below $35,000 than among those in higher-income groups.

The 2024 U.S. Surgeon General’s report similarly concluded that tobacco-related disparities persist by income, education, geography, occupation, behavioral health status, and disability status. People in these groups often face greater barriers to quitting, including less access to healthcare and cessation support. Combined with persistent effort to socially shame people who smoke, these factors have made this population invisible and easy to ignore.

Cigarettes remain widely available, while many governments restrict alternative nicotine products through flavor bans and product prohibitions.

Restricting noncombustible products while cigarettes remain widely available gets the risk hierarchy backward. Cigarettes burn tobacco and produce smoke with thousands of chemicals. Nicotine pouches and e-cigarettes generally expose users to fewer harmful chemicals because they do not involve combustion.

They are not risk-free, and nicotine is addictive. But treating all nicotine products as equally harmful limits informed decision-making.

Many adults who smoke:

• Lack clear advice about relative risk.
• Misunderstand nicotine.
• Overestimate the risks of alternatives
• Live in areas where alternatives are restricted or unavailable.

The U.S. has declined to follow international public health frameworks when they conflict with American law, science, or policy priorities. Tobacco regulation should be evaluated on the same basis.

The World Health Organization’s MPOWER framework emphasizes bans, taxes, restrictions, and pressure. Those policies have value, but the Cureus editorial argues that they should be complemented by an EMPOWER framework focused on adults who continue to smoke. 

EMPOWER does not replace proven tobacco-control measures. It adds practical tools for reaching adults who continue to smoke despite them.

• Support switching away from cigarettes
• Help people who are not ready to quit nicotine
• Provide clearer information about relative risk
• Reduce smoking-related health inequalities

Cigarette smoking in America has declined, but progress is slowing. Building on what has worked while giving adults more realistic options could help accelerate it.

Important Disclaimer: This article is provided for informational and policy commentary purposes only. It discusses relative risk, smoking cessation, and harm reduction at the level of broad product categories and public policy. It does not make an FDA-authorized modified-risk claim for any specific nicotine pouch or claim that any nicotine pouch is approved by FDA as a smoking-cessation treatment.

Nicotine is addictive and intended only for adults age 21 and over who currently use tobacco or nicotine. Adults considering changes to their tobacco or nicotine use should consult a qualified healthcare professional.