WASHINGTON – On Wednesday, federal authorities unveiled an extensive proposal aimed at decreasing the addictive nature of cigarettes by imposing a cap on their nicotine content. This initiative has been a longstanding objective for tobacco control advocates; however, its implementation is unlikely to occur in the near future.
This initiative from the Food and Drug Administration (FDA) arrives during the concluding days of President Joe Biden’s administration, considerably diminishing the chances that it will be enacted. No comments have been made regarding this measure from President-elect Donald Trump or his health nominees, although a previous effort led by Dr. Scott Gottlieb, Trump’s initial FDA commissioner, was stalled during his first term.
Robert F. Kennedy Jr., the nomination for health secretary under Trump, has not provided substantial remarks about how tobacco regulation fits into his broader strategy for addressing chronic diseases. Even if the proposal moves forward under Trump’s administration, major tobacco corporations like Reynolds American and Altria are likely to contest it legally, potentially postponing its execution.
The FDA has dedicated years to researching this matter and stated that limiting nicotine would aid nearly 13 million existing smokers in quitting within a year. Furthermore, about 48 million young individuals would likely avoid the habit altogether, as cigarettes would become effectively non-addictive, according to projections from the agency.
“This action, if finalized, could save numerous lives and significantly alleviate the burden of serious illnesses,” remarked FDA Commissioner Robert Califf during a press briefing. Under their plan, nicotine in cigarettes would be restricted to levels that “could no longer create and sustain this addiction among people who smoke.” Tobacco companies would receive a two-year period to reformulate their products following the release of a final regulation. The FDA made its extensive 334-page proposal available online and plans to accept public comments for the next nine months before proceeding further.
The proposition has gained overwhelming support from anti-smoking advocates who are urging Kennedy to help implement it, should he be confirmed. Chrissie Juliano, representing the Big Cities Health Coalition, emphasized that regulating tobacco is essential for meeting goals related to chronic disease reduction in the U.S.
Tobacco use results in over 480,000 deaths annually in the U.S. due to ailments like cancer, heart disease, and stroke. Although smoking rates have decreased among both adults and teenagers, the health consequences from years of smoking often manifest much later in life.
The concept of regulating nicotine traces back to significant regulatory power granted to the FDA by Congress in 2009, allowing it to oversee the tobacco sector. However, the FDA’s initiatives, particularly regarding nicotine limits and other tobacco regulations, such as enhanced graphic health warnings on cigarette packaging, have been hindered for years owing to litigation from the tobacco industry.
Califf noted that the anticipated legal challenges from the industry contribute to the methodical pace at which the FDA is navigating this proposal. “The research needs to be thoroughly substantiated to withstand the legal scrutiny we expect,” Califf stated. According to current laws, while the FDA does have the authority to regulate nicotine levels, it cannot ban nicotine altogether. The proposed nicotine restrictions would pertain to cigarettes, cigars, and pipe tobacco, but they would not extend to e-cigarettes, nicotine pouches, or other lower-risk options. The FDA has recognized several alternative major e-cigarette brands, including NJOY and Vuse, as safer choices for smokers.
“About half of smokers are expected to shift towards these alternative products, which may include e-cigarettes or other non-combustibles,” stated Brian King, the FDA’s tobacco director. Altria, which markets both Marlboro cigarettes and NJOY e-cigarettes, criticized the FDA’s nicotine reduction plan, predicting it would lead to the emergence of illegal markets. According to spokesperson David Sutton, the proposal is “fundamentally flawed.”
Currently, there are no regulations in the U.S. concerning nicotine levels, which are naturally present in tobacco plants. Various methods exist to extract nicotine, including chemical processes and plant breeding techniques.
The latest FDA proposal emerges as smoking rates in the U.S. continue to decline. Last year marked another record low, with only 1 in 9 adults identifying as current smokers. The concept of low-nicotine cigarettes isn’t new; several companies, including Philip Morris, attempted to market these products during the late 1980s and 1990s but faced limited success. In 2019, the FDA approved a cigarette variant that contains 95% less nicotine compared to conventional options.
Studies sponsored by the FDA have demonstrated that when smokers transition to very low-nicotine cigarettes, they tend to smoke less and show an increased willingness to quit. This research plays a crucial role in affirming that smokers won’t compensate for the lower nicotine by merely consuming more cigarettes or inhaling more deeply. This phenomenon was notably seen in previous “light” and “low tar” cigarettes, which were ultimately banned due to their misleading claims.
