Nicotine levels in cigarettes, cigars, and pipe tobacco in the United States could be dramatically decreased if a new rule from the Food and Drug Administration is finalized, significantly lowering the addictiveness of combustible tobacco products.
“Today’s proposal envisions a future where it would be less likely for young people to use cigarettes and more individuals who currently smoke could quit or switch to less harmful products,” FDA Commissioner Robert Califf said in a press statement announcing the proposal of the rule Wednesday. “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.”
Nicotine levels largely depend upon the brand of cigarette, but the average is usually about 13 milligrams of nicotine per unit. The proposed rule would decrease the amount of nicotine by 95% to 0.07 milligrams for all combustible tobacco products.
The proposed rule has been in the works for a significant period of time, with the Office of Management and Budget concluding its review of the proposal on Jan. 3.
Brian King, FDA’s Center for Tobacco Products director, told reporters in a press call Wednesday that by reducing the level of nicotine in tobacco products, “the cycle of exposure to these toxic chemicals can be broken.”
Cigarette smoking kills over 480,000 people in the U.S. each year, according to the Centers for Disease Control and Prevention. In 2018, the agency estimated that smoking cost the U.S. more than $600 billion, including $372 billion in lost productivity and $240 billion in healthcare spending.
The agency projected that nearly 13 million people would quit smoking within one year of the rule taking effect, including those who would completely switch to noncombusted tobacco products.
The model also estimated that the new product standard would result in the prevention of 1.8 million tobacco-related deaths by 2060 and 4.3 million prevented deaths by the end of the century.
Smoking rates are already at an 80-year low, according to an August Gallup poll, which found that only 11% of U.S. adults reported having smoked a cigarette within the past week. The current smoking rate is half of what it was a decade ago and only one-third as large as it was in the late 1980s.
Criminal justice experts, though, are concerned that the new rule would effectively act as a ban that would drive users to purchase black-market alternative products, creating a lucrative opportunity for criminal networks.
Richard Marianos, former assistant director of the Bureau of Alcohol, Tobacco, Firearms, and Explosives, previously told the Washington Examiner that the proposal is “a ridiculous push” and “a gift that Biden is giving to criminals out there.”
“Prohibition, or any type of change in a product like this, never works. It never will work. It hasn’t worked in the past, and it’s going to create problems,” said Marianos.
Trump is expected to implement a sweeping “Make America Healthy Again” agenda along with his nominee for Health and Human Services secretary, Robert F. Kennedy Jr. Califf told reporters that he “can’t imagine anything more important to get done” to achieve MAHA.
“Multiple administrations have acknowledged the immense opportunity that a proposal of this kind offers to address the burden of tobacco-related disease,” Califf said in the press release, adding that he hopes “we can all agree” that reducing preventable death and disease “is an admirable goal we should all work toward.”
The new nicotine level rule will have an open comment period until Sept. 15, leaving ample time for industry and community stakeholders to comment.
A report published in December by Chmura Economics & Analytics found that the proposed rule could yield an annual $24 billion loss in federal, state, and local taxes as well as a loss of more than 150,000 agriculture and retail jobs across the country.
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The FDA has issued multiple last-minute proposals in the last week of the Biden administration, including banning Red Dye No. 3 in processed foods due to its carcinogenic properties.
On Tuesday, the agency also proposed a new rule to add front-of-package nutrition labels to processed foods highlighting their levels of sodium, added sugars, and saturated fats.