Is Biden Banning Cigarettes in the 11th Hour? FDA’s Nicotine Plan Could Be the Start

WASHINGTON D.C. — The Food and Drug Administration (FDA) released a proposed regulation on Wednesday to significantly reduce nicotine levels in cigarettes and other combustible tobacco products. This measure aims to make cigarettes less addictive, discourage youth smoking, and encourage adults to quit or switch to less harmful alternatives.

The proposed rule would limit nicotine in cigarettes to 0.7 milligrams per gram of tobacco, a drastic reduction from the current average of 17.2 milligrams per gram. The FDA stated the change could yield “significant public health benefits for all age groups” by reducing tobacco addiction and preventing smoking-related illnesses. The regulation would also apply to cigars, pipe tobacco, and roll-your-own products but excludes e-cigarettes and nicotine pouches.

"This proposed product standard would limit the addictiveness of the most toxic and widely used tobacco products," the agency wrote in its announcement. FDA Commissioner Robert Califf emphasized the importance of the proposal, describing it as a critical step in addressing tobacco-related deaths and illnesses. “If there is a goal to make America healthy again, I can’t imagine anything more important to get done than this,” he said during a press briefing.

Potential Public Health Impact

Smoking remains the leading cause of preventable death in the United States, with over 480,000 fatalities annually. The FDA estimates the new rule could prompt more than 19 million smokers to quit within five years of implementation, significantly lowering the nation's rates of cancer, heart disease, and respiratory illnesses.

Califf highlighted the extensive research supporting the proposal, citing studies demonstrating that reduced nicotine levels curb addiction and smoking prevalence. The FDA noted that while some illicit trade of high-nicotine cigarettes may occur, it expects the public health benefits to outweigh potential risks.

Implementation and Industry Reaction

If finalized, tobacco companies would have two years to comply. While the regulation does not ban cigarettes outright, tobacco industry representatives have voiced opposition, arguing that the rule would disrupt the market and fuel a black market for high-nicotine products.

Luis Pinto, a spokesperson for Reynolds American Inc., criticized the measure, stating that reducing nicotine content will not make cigarettes less harmful. The proposal has also drawn concerns over potential economic impacts on farmers and retailers reliant on tobacco sales.

Challenges and Timeline

The proposed rule now enters a public comment period ending September 15, 2025. Following this, the FDA will evaluate feedback before submitting the final regulation for approval. The Trump administration, which returns to office later this month, will determine whether to finalize or dismiss the proposal.

The rule builds on efforts initiated during Donald Trump’s first term, when then-FDA Commissioner Scott Gottlieb championed nicotine reduction as a pivotal public health initiative. Progress stalled after Gottlieb’s departure in 2019 but resumed under the Biden administration in 2022.

Califf acknowledged the delay, citing the need to ensure the regulation could withstand legal challenges. “The research has to be airtight to survive the challenges that we know we’ll get in court,” he said.

Long-Term Goals

This initiative aligns with the Biden administration’s broader efforts to combat chronic diseases and reduce U.S. cancer rates by 50%. Despite setbacks in implementing other tobacco control measures, including a menthol cigarette ban, advocates view this regulation as a landmark opportunity to curb smoking-related deaths.