Tobacco companies will be required to reduce the amount of nicotine in cigarettes in order to make them less addictive, according to a notice posted on a U.S. government website.
A maximum nicotine level in cigarettes and certain finished tobacco products is a proposed rule. F.D.A. would reduce addictiveness to tobacco products in order to give addicted users a better chance of quitting.
The United States would be at the forefront of global antismoking efforts if the proposal were to become a reality. New Zealand is the only nation that has done this. With a powerful tobacco lobby already indicating any plan with significant reductions in nicotine would be intolerable and with conservative lawmakers who would consider government overreach that could spill over into the mid-term elections, it's not hard to see why.
The White House press secretary reminded reporters that agenda plans for the Office of Management and Budget can be found on the website. She said no decision had been made.
An announcement has been expected and few details were released on Tuesday. The commissioner of the F.D.A., Robert Califf, told an audience last week that he would be speaking more about nicotine addiction.
Americans are addicted to products that coat the lungs with tar, release thousands of chemicals and lead to cancer, heart disease and lung disease. E-cigarettes, chews, patches and lozenges are available with or without nicotine.
The director of the F.D.A. tobacco center said that the rule could have the greatest impact on public health. Tobacco use is still the leading cause of preventable disease and death.
According to the Centers for Disease Control and Prevention, about 480,000 deaths are caused by smoking every year.
It will take a long time to overcome the obstacles. The amount of nicotine in cigarettes would need to be reduced by 95 percent. 30 million smokers in the US could be thrown into nicotine withdrawal if that happens. The proposal does not include alternatives such as e-cigarettes.
High-nicotine cigarettes can be purchased on illegal markets in Mexico and Canada, according to experts.
The F.D.A. would have to overcome opposition from the tobacco industry in order to succeed. The agency may give the industry five or more years to make the changes.
Major tobacco initiatives outlined in the Tobacco Control Act have not taken off yet. Tobacco companies were supposed to put warnings on cigarette packs. It will take up to another year for the agency to make a decision on which e-cigarettes should stay on the market.
The F.D.A. would be overstepping its authority by requiring a product that is impossible to produce or unacceptable to consumers, according to cigarette makers.
Both an express and a defacto ban would eviscerate Congress's stated purpose of permitting the sale of tobacco products to adults.
The effort to lower nicotine levels follows a proposed rule that would ban the sale of cigarettes with flavors that are popular with black smokers. Tens of thousands of people have commented on the proposal, which was hailed as a potential landmark advance for public health. The F.D.A. is bound to address the comments it receives before making a final rule.
Five years ago, the agency's commissioner released a plan to cut nicotine levels in cigarettes. The proposal didn't lead to a rule during the Trump administration.
According to the F.D.A., a model predicted that five million people would stop smoking if nicotine was slashed.
Retailers, wholesalers and tobacco companies were among the 8,000 people who commented on the proposal. According to the Florida Association of Wholesale Distribution, the proposal could result in new demand for black-market products and increase crime.
The F.D.A. did not have evidence that the plan to cut nicotine levels would improve public health. In a letter to the F.D.A., the agency said it had no power to force tobacco farmers to grow low-nicotine tobacco.
A cigarette ban that would violate tobacco control laws would be considered a cigarette ban by the tobacco company.
The tobacco control law gave the F.D.A. broad powers to regulate tobacco products with standards that were appropriate for the public health.
Consumers are already able to buy low-nicotine cigarettes. The 22nd Century Group began selling a reduced-nicotine cigarette that took 15 years and tens of millions of dollars to develop. Five percent of the nicotine level of conventional cigarettes is contained in the company's brand, VLN.
He said that this is not some far off technology.
In order to earn its F.D.A. designation, VLN was subjected to a number of testing and clinical trials.
VLN is being sold at Circle K convenience stores in Chicago. The proposed F.D.A. rule is likely to accelerate plans for a national roll out in the coming months. He said that the company's long-range business plan was dependent on licensing its technology to Big Tobacco.
Dr. Neal Benowitz proposed the idea of removing nicotine from cigarettes in 1994.
He was concerned about whether smokers would hold on to their cigarettes for a longer period of time or if they would use more cigarettes to compensate for the lower nicotine level. The lowest-nicotine version of the cigarette was the one that prevented those behaviors.
A professor of Psychiatry at the University of Minnesota who studies the relationship between nicotine and smoking behavior said a growing body of evidence suggested that a rapid and significant reduction of nicotine in cigarettes would provide greater public health benefits.
A study led by Dr. Hatsukami found that people who had been randomly assigned cigarettes with ultra-low nicotine smoked less and exhibited less signs of dependency than people who had been given cigarettes with nicotine levels that were gradually reduced over the course of 20 weeks.
The gradualist group experienced more intense nicotine withdrawal than the participants and they dropped out more frequently. They turned to their regular brands.
She said that if you reduce nicotine, the experience of smoking will be less satisfying and people will try to quit.
Lawmakers can expect a degree of public health benefit from tobacco-control policy. There is no other nation that has experience with a low nicotine cigarette mandate.
Alex Liber, an assistant professor in Georgetown University's School of Medicine who studies tobacco control policy, looked at Poland's experience with a ban on menthol cigarettes.
The study he and others wrote found that the ban did not lead to a decrease in cigarette sales.
He said that they will make more and more if they have wiggle room. I don't expect anything else.
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