The latest statistics on e-cigarettes in the United States highlight the changing tobacco landscape, with e-cigarette use increasing and smoking declining. However, FDA regulations have not kept pace with these market changes, particularly in allowing safer alternatives to smoking to come to market. FDA’s regulatory process is limiting harm reduction options for American adults and highlights the need for urgent Congressional action to reform 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 that nicotine vape use among Americans aged 12 and older will increase by 13.3%, from 8.3% in 2022 to 9.4% in 2023. Encouragingly, underage (Americans ages 12-20) use of vape products will decrease by 4.1%, from 12.2% in 2022 to 11.7% in 2023. In 2023, 26.6 million Americans will be vaping, of which 4.5 million (16%) were minors.
The FDA’s regulatory process for introducing safer alternatives to cigarettes is overly burdensome, repetitive, and inadequate for the growing number of adults using e-cigarettes.
SAMHSA also documents a continuing decline in combustible tobacco use. In 2023, only 13.7% of Americans ages 12 and older will be smokers, totaling 38.7 million people, of whom 1.2 million (3.3%) are minors. This 13.7% smoking rate represents a 6.2% decrease from 2022, when the smoking rate was 14.6%. More importantly, this decrease represents 2.4 million fewer Americans smoking compared to the previous year.
SAMHSA’s findings coincide with recent financial reports from tobacco manufacturers showing a steep decline in tobacco sales in the U.S. British American Tobacco reported that its sales of combustible cigarettes in the U.S. fell 13.7 percent in 2015. Interim Financial ReportThe company blamed the decline on economic pressures on consumer spending and the rise of unregulated disposable e-cigarette products. 2024 Q2 Report The company reported a 13% drop in domestic cigarette sales, acknowledging that macroeconomic pressures and the “growth” of disposable e-cigarettes led to the decline.
Efforts by tobacco manufacturers and regulators to restrict disposable e-cigarette products continue. To date, the FDA has approved 34 e-cigarette products32 tobacco flavors and two menthol flavors, are the first non-tobacco flavored products permitted in the U.S. All are owned by three companies: Altria, BAT, and Japan Tobacco International.
The FDA’s regulatory process for introducing safer alternatives to cigarettes is too cumbersome and repetitive to keep up with the growing number of adults using e-cigarettes. This situation presents a major paradox: since the deadline for e-cigarette applications four years ago, only the largest tobacco manufacturers have received FDA approval, and they also profit from the sale of combustible tobacco products.
Additionally, these manufacturers have spent billions of dollars on research and development and incurred significant costs associated with the FDA approval process. However, they are losing sales of both e-cigarette products and traditional cigarettes to companies that have not applied for FDA approval and have not disclosed their products to the FDA for sale in the United States. Despite the existence of these unregulated products, smoking rates continue to fall and e-cigarette use is on the rise. This trend is reflected in adult survey data and declining sales by cigarette manufacturers.
The FDA’s marketing order application process needs significant reform. Although the FDA claims to be using all available tools, Regulatory Tools To combat illegal products, the FDA has resisted promoting less harmful alternatives to cigarettes. As e-cigarette use among adults increased in 2023, the FDA did not issue any new marketing orders for e-cigarette products, but 660 orders The adult smoking rate FellTwo years after the introduction of safer alternatives like e-cigarettes, this inaction from an agency empowered by Congress to regulate tobacco products is unacceptable.
From e-cigarettes to oral nicotine to the limited availability of heat-not-burn products since 2007, American adults have been exposed to a variety of safer alternatives, many of which are not approved by the FDA. Nevertheless, a large proportion of adults, including health care workers, use e-cigarettes. Ignorant of the health benefits Use of tobacco harm reduction products continues to increase. This ongoing problem is a direct result of the FDA’s ineffective regulatory approach, which prioritizes traditional cigarettes and smoked tobacco products over safer alternatives.
The FDA’s focus on youth use has hindered efforts to expand the market for safer tobacco alternatives, despite reports of a decline in youth e-cigarette use and a slight increase in youth smoking. A recent SAMHSA report found that the percentage of youth ages 12-20 who report current tobacco use is increasing by 6.5% from 2022 to 2023. While still lower than the 2021 rate, this increase is concerning, and recent Youth Risk Behavior Surveys have reported rising youth smoking rates in several states.
The FDA is not fully utilizing its regulatory capacity to eradicate outdated smoking habits and promote access to regulated tobacco harm reduction products. The approval of just 34 e-cigarette products from three manufacturers is clearly insufficient to meet the needs of the more than 20 million adults who will vape in 2023. This restriction not only hampers free market competition, but also runs counter to American values. Congress must address and reform the restrictive 2009 Tobacco Act, which currently impedes efforts to reduce tobacco harms for American adults who smoke.
