WASHINGTON — On Wednesday, federal authorities unveiled a comprehensive proposal to curb nicotine levels in cigarettes, a long-standing objective of anti-smoking advocates, though its implementation remains uncertain.
This Food and Drug Administration (FDA) initiative emerges in the waning days of the Obama administration, significantly diminishing its chances of enactment. President-elect Donald Trump and his health appointees haven’t addressed the measure, but a previous initiative led by Trump’s first FDA commissioner, Dr. Scott Gottlieb, was unsuccessful.
Trump’s nominee for health secretary, Robert F. Kennedy Jr., has offered limited insight into how tobacco regulation aligns with his plans to reform the government’s chronic disease strategy. Even with continued effort under the Trump administration, tobacco companies such as Reynolds American and Altria are expected to challenge the proposal in court, delaying its implementation.
Following years of research, the FDA stated Wednesday that reducing nicotine could help almost 13 million smokers quit within a year. The agency projects that approximately 48 million young people would never start smoking due to cigarettes essentially losing their addictive qualities.
“This action, if finalized, could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money,” FDA Commissioner Robert Califf stated.
The agency’s plan involves capping nicotine levels in cigarettes to a point where they would no longer create or sustain addiction. Companies would have several years to reformulate their products following the publication of final regulations. The agency released its 334-page proposal online Wednesday and will accept public comments for nine months before proceeding.
Anti-smoking advocates strongly support the proposal and urged Kennedy to facilitate its implementation upon confirmation.
“Tobacco regulation is crucial for achieving his stated goals of reducing chronic disease and is a vital component of the national dialogue,” said Chrissie Juliano of the Big Cities Health Coalition, which represents over 30 metropolitan health departments.
Smoking accounts for over 480,000 U.S. deaths annually due to cancer, heart disease, stroke, and other smoking-related illnesses. Despite decreases in adult and teen smoking, these conditions remain prevalent due to their long latency periods.
The nicotine limitation concept stems from the extensive authority granted to the FDA by Congress in 2009 to regulate the tobacco industry. However, the FDA’s efforts regarding nicotine and other tobacco measures—like adding graphic warnings to packaging—have been hindered by legal challenges.
The law permits the agency to regulate, but not eliminate, nicotine. The proposed nicotine limits apply to cigarettes, cigars, and pipe tobacco, but not e-cigarettes and other lower-risk products. Although many e-cigarettes lack comprehensive testing, the FDA has classified some, including NJOY and Vuse, as less harmful alternatives.
Currently, there are no U.S. limits on nicotine, which is naturally present in tobacco plants. Several methods exist for its removal, including chemical extraction and plant cross-breeding.
The latest FDA announcement coincides with a continued decline in U.S. smoking rates. Last year, the smoking rate reached a record low, with only 1 in 9 adults reporting current smoking.
Low-nicotine cigarettes are not a novel concept. Several companies, including Philip Morris, experimented with these products in the 1980s and 1990s with limited success. In 2019, the FDA approved a cigarette containing reduced nicotine.
FDA-sponsored studies demonstrate that smokers switching to very low nicotine cigarettes smoke less and are more likely to attempt quitting. This research is crucial in establishing that smokers won’t compensate by smoking more or inhaling more deeply, a phenomenon observed with “light” and “low tar” cigarettes marketed in the past, which were later banned as misleading.