How bureaucracy stalls the battle against smoking

The latest U.S. vaping statistics highlight a changing tobacco landscape in which vaping is on the rise and smoking is declining. However, FDA regulations have not kept pace with these market shifts, particularly in allowing safer smoking alternatives to reach the market. The FDA’s regulatory processes are limiting harm reduction options for American adults and underscore the need for urgent congressional action to amend tobacco control laws to better protect public health.

A recent report from the Substance Abuse and Mental Health Services Administration, using data from the 2023 National Survey on Drug Use and Health, shows a 13.3% increase in nicotine vaping among Americans ages 12 and up, from 8.3% in 2022 to 9.4% in 2023. Encouragingly, underage use (Americans ages 12 through 20) of vapor products fell by 4.1%, from 12.2% in 2022 to 11.7% in 2023. In 2023, 26.6 million Americans were vaping, of whom 4.5 million (16%) were underage.

The FDA’s regulatory processes for introducing safer alternatives to cigarettes are overly cumbersome, repetitive, and inadequate for the growing number of adults using e-cigarettes.

SAMHSA also documented an ongoing decrease in combustible cigarette use. In 2023, only 13.7% of Americans 12 years or older smoked, totaling 38.7 million people, with 1.2 million (3.3%) being underage. This 13.7% smoking rate shows a 6.2% decrease from 2022, when the smoking rate was 14.6%. More importantly, this reduction represents 2.4 million fewer Americans smoking compared to the previous year.

SAMHSA’s findings align with recent financial reports from tobacco manufacturers showing steep declines in U.S. cigarette sales. British American Tobacco reported a 13.7% drop in U.S. combustible cigarette volumes in its mid-year financial report, attributing the decrease to economic pressures on consumer spending and the rise of unregulated disposable e-cigarette products. Similarly, Altria’s second-quarter report for 2024 indicated a 13% decline in domestic cigarette volumes, acknowledging macroeconomic pressures and the “growth” of disposable e-cigarettes led to these declines.

Efforts to limit disposable vapor products by tobacco manufacturers and regulators continue. To date, the FDA has authorized only 34 e-cigarette products, 32 tobacco-flavored and two menthol-flavored — the first non-tobacco-flavored products permitted in the United States. All are owned by three companies: Altria, BAT, and Japan Tobacco International.

The FDA’s regulatory processes for introducing safer alternatives to cigarettes are overly cumbersome, repetitive, and inadequate for the growing number of adults using e-cigarettes. This situation presents a significant paradox in that since the e-cigarette application deadline four years ago, only the largest tobacco manufacturers have received FDA authorization but also profit from combustible cigarette sales.

What’s more, these manufacturers have spent billions of dollars on research and development and incurred substantial costs related to FDA authorization processes. Yet they are losing sales of both their e-cigarette products and traditional cigarettes to companies that have not even applied for FDA approval, nor have they disclosed their products to the FDA for sale in the United States. Despite the presence of these unregulated products, smoking rates continue to decline, while vaping has increased — a trend reflected in adult survey data and declining sales numbers from tobacco manufacturers.

The FDA’s marketing order application process needs significant reform. Despite the FDA’s claim of commitment to using all available regulatory tools to address illegal products, the agency resists endorsing less harmful alternatives to cigarettes. As adult vaping increased in 2023, the FDA did not issue any new marketing orders for e-cigarette products but authorized more than 660 orders for combustible cigarettes — in a year when adult smoking rates fell. This inaction is unacceptable for an agency granted congressional authority to regulate tobacco products two years after the introduction of safer alternatives like e-cigarettes.

Ranging from e-cigarettes to oral nicotine and a limited rollout of heated tobacco products since 2007, American adults have been exposed to a variety of safer alternatives, many which are non-FDA-approved. Despite this, the percentage of adults, including medical professionals, who are unaware of the health benefits of tobacco harm reduction products continues to rise. This ongoing issue stems directly from the FDA’s ineffective regulatory approach, which appears to favor traditional cigarettes and smoked tobacco products over safer alternatives.

The FDA’s focus on youth usage hinders its efforts to enhance the market for safer tobacco alternatives, despite reports showing a decrease in youth e-cigarette use and a slight increase in youth smoking. A recent SAMHSA report shows that the percentage of youth ages 12 to 20 years old reporting current cigarette use rose by 6.5% from 2022 to 2023. While still below 2021 rates, this uptick is concerning, with several states reporting increases in youth smoking rates in recent Youth Risk Behavior Surveys.

The FDA is not fully using its regulatory capabilities to eradicate outdated smoking habits and promote access to regulated tobacco harm reduction products. The approval of only 34 e-cigarette products from three manufacturers is grossly inadequate to meet the needs of over 20 million adults who vaped in 2023. This limitation not only stifles free market competition but also contradicts American values. Congress must address and revise the restrictive 2009 tobacco law, which currently impedes tobacco harm reduction efforts for American adults who smoke.