The Food and Drug Administration’s (FDA) announcement arrives during the concluding days of President Joe Biden’s administration, which diminishes the chances of the measure being enacted. The President-elect, Donald Trump, along with his health-related nominees, have not provided commentary on the initiative. A previous initiative in this area, which was aimed at reducing nicotine by former FDA Commissioner Dr. Scott Gottlieb, was halted during Trump’s initial term.
Trump’s nominee for health secretary, Robert F. Kennedy Jr., has not articulated his views on how tobacco regulation fits within his broader strategy to combat chronic illness. Should the initiative continue under a Trump administration, major tobacco corporations such as Reynolds American and Altria are likely to contest it legally, potentially hindering its execution.
According to multiple studies conducted over the years, the FDA stated that decreasing nicotine levels could enable nearly 13 million current smokers to quit within one year. Furthermore, it is projected that approximately 48 million more young individuals would likely refrain from starting the habit, as cigarettes may become effectively nonaddictive.
FDA Commissioner Robert Califf emphasized during a press briefing that finalizing this rule could significantly save lives and alleviate the burden of serious health issues. The proposal specifies that the nicotine content in cigarettes should be capped to levels that no longer foster addiction among smokers. Companies would be granted a two-year timeframe to adjust their products in accordance with any finalized regulations. The FDA has made its extensive 334-page proposal available online and plans to seek public feedback over the next nine months before proceeding further.
This initiative has garnered extensive support from antismoking advocates, who are encouraging Kennedy to assist in its implementation, should he gain confirmation. Chrissie Juliano, representing the Big Cities Health Coalition, noted that managing tobacco is integral to achieving goals related to chronic disease prevention and is a crucial aspect of the necessary discourse in the country.
Smoking is responsible for over 480,000 annual deaths in the U.S., attributed to severe health conditions such as cancer, heart disease, and stroke. These adverse effects often develop over many years and persist, even as smoking rates decline among adults and teenagers.
The motivation behind limiting nicotine stems from the comprehensive authority granted to the FDA by Congress in 2009 to oversee the tobacco sector. However, the FDA’s progress on nicotine regulation and other tobacco-related measures—such as the introduction of warning labels on cigarette packaging—has frequently faced setbacks due to lawsuits from the tobacco industry.
Califf acknowledged that anticipating industry litigation accounts for the deliberate pace of the FDA’s progress on the proposal, asserting that “the research has to be airtight to survive the challenges that we know we’ll get in court.” Under existing law, the agency holds the power to regulate nicotine but cannot eliminate it entirely. The proposed restrictions would pertain to cigarettes, cigars, and pipe tobacco, but not to electronic cigarettes, nicotine pouches, or other risk-reduced products. While many e-cigarette brands have undergone limited testing, the FDA has recognized certain leading brands like NJOY and Vuse as safer alternatives for smokers.
Brian King, the FDA’s tobacco director, indicated that around 50% of smokers are expected to shift to alternative products, such as e-cigarettes or other non-combustible options. Currently, no legal limits on nicotine exist in the U.S., despite its natural occurrence in tobacco plants. Techniques do exist to extract nicotine, including chemical extraction and hybridizing plants.
The recent FDA announcement coincides with a consistent decline in smoking rates across the United States. Last year, the smoking prevalence reached a new low, with only 1 in 9 adults reporting current smoking habits.
The concept of low-nicotine cigarettes is not a novel approach; various companies, including Philip Morris, attempted to market such products during the 1980s and 1990s without significant success. In 2019, the FDA sanctioned a cigarette containing 95% less nicotine than standard offerings.
The FDA has funded studies indicating that smokers who switch to very low nicotine cigarettes tend to smoke less and demonstrate a greater likelihood of attempting to quit. This research is vital in proving that smokers will not compensate by increasing their cigarette intake or inhaling more deeply—issues that arose with previously marketed “light” and “low tar” cigarettes, which were ultimately banned for being misleading.
