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The U.S. Food and Drug Administration (FDA) is proposing a new rule that, if finalized, would make cigarettes and certain other combusted tobacco products minimally or nonaddictive by limiting the level of nicotine in those products.
Smoking cigarettes, which contain nicotine, an addictive chemical, is estimated to kill nearly half a million people in the U.S. each year.
The proposed rule aims to make cigarettes less addictive, prevent young people from starting smoking, and promote quitting smoking among all groups.
The FDA wants your comment on the proposed rule.
You can submit a model comment created by Salud America! urging the FDA to make cigarettes and other tobacco products less addictive.
This comment period is open until Sept. 15, 2025.
Submit This Model Comment to Reduce the Addictiveness of Tobacco Products
Greetings,
I’m writing in support of the FDA’s proposed rule to limit the amount of the addictive additive of nicotine in certain tobacco products.
I strongly believe that instituting a limit on nicotine could improve the health of millions of Americans, including many Latinos, who continue to be disproportionately impacted by cancer due to smoking (https://bit.ly/3AHF38j).
Cancer remains a top cause of death for Latinos (https://bit.ly/42iucgM ) and other people of color, with smoking being a leading risk factor for the disease (https://bit.ly/3KMrPcx).
What’s more, I believe that this rule will help Latinos and all people to quit smoking and keep young people from starting smoking or getting addicted.
While Latinos smoke fewer cigarettes, they are more prone to start smoking making it more difficult to quit later (https://bit.ly/3CiUKnt). Latino youth among those who are most susceptible to start smoking at a younger age (https://bit.ly/4g1wOUI).
This rule would have the added benefit of protecting young Latino youth and all youth from becoming addicted at an early age, and it gives them a better chance at living healthier lives into adulthood.
In all, reducing the amount of nicotine in tobacco products could have a positive impact on the health of Latinos and all people for generations to come.
Please take this under advisement as you continue to weigh the benefits that creating a maximum nicotine standard would have on the health of Americans.
How Does the Proposed Rule Work?
If finalized, the rule would establish a maximum nicotine standard that cigarette manufacturers must abide by.
The standard would cover the following tobacco products:
- Cigarette tobacco
- Roll-your-own (RYO) tobacco
- Cigars (including little cigars, cigarillos, and large cigars)
- Pipe tobacco
The proposed rule would limit the nicotine yield to 0.70 milligrams per gram of tobacco contained in those products.
That would be a significant reduction in the average nicotine content used in the top cigarette brands as of 2017 (17.2 mg/g).
As a result of the lower dosage of nicotine, tobacco products contained under the proposed rule would not “create and sustain addiction, users would be able to quit when they would like, something many who use these products currently do not have the ability to do,” according to the FDA.
“This [rule] could save many lives and dramatically reduce the burden of severe illness and disability, while also saving huge amounts of money. I hope we can all agree that significantly reducing the leading cause of preventable death and disease in the U.S. is an admirable goal we should all work toward,” said FDA Commissioner Dr. Robert M. Califf, in a statement.
Nicotine Addiction
When researching the potential benefits of a nicotine limit, investigators “knew early on in their research that if a cigarette did not deliver a certain amount of nicotine, new smokers would not become addicted, and ‘confirmed’ smokers would be able to quit,” according to the proposed rule.
What’s more, tobacco companies have been operating at “any level of nicotine desired” since the 1960s.
“These companies sought to identify the ‘optimum’ dose needed to ‘satisfy’ people who smoke cigarettes and, thereby, assure their continued smoking,” according to the rule.
The FDA is hoping that limiting the amount of nicotine in tobacco products will also help with impressionable youth, who may become addicted to the substance when experimenting.
“Reducing the number of people who experiment with cigarettes or certain other combusted tobacco products who then transition to regular use of these products would prevent severe adverse health consequences of long-term smoking at the individual level and result in public health benefits at the population level,” according to the FDA.
An estimated 49.2 million (19.8%) or nearly 1 in 5 adults reported using tobacco products in 2022, according to the Centers for Disease Control and Prevention’s (CDC) analysis of the 2019-2022 National Health Interview Survey (NHIS).
The FDA estimates that the proposed rule could prevent 48 million youth and young adults “who would have otherwise initiated habitual cigarette smoking” from beginning the habit by the year 2100.
It’s also estimated an additional 12.9 million would quit smoking a year after the standard has been implemented. Within 5 years, that number increases to 19.5 million.
This intervention could result in saving the lives of 1.8 million from tobacco-related deaths by 2060 and by 2100, 4.3 million deaths, according to an FDA research model included in their report for the proposed rule.. Every year, a reported 480,000 people die prematurely from disease caused by smoking, making tobacco use one of the leading causes of disease and death in the US.
What’s more, the reduced number of premature deaths could result in 19.6 million life years gained by 2060 with 76.4 million gained by 2100.
Benefit to Public Health
In all, the proposed rule is poised to improve medical cost savings, productivity loss savings, reduce secondhand and thirdhand smoke, and help with environmental impacts of cigarette smoke.
By reducing the addictiveness of cigarettes, the rule aims to cut down on risk factors for serious disease and death.
In fact, smoking or tobacco use is one of the biggest modifiable risk factors for cancer, including bladder, stomach, liver pancreas, colon, and kidney cancers.
It’s also the number one risk factor for lung cancer.
According to the CDC, smoking causes almost 9 out of every 10 cases of lung cancer.
Lung cancer is a disease that disproportionately affects Latinos and other people of color.
While Latinos smoke fewer cigarettes than their white peers, Latinos suffer from higher rates of lung cancer due to non-medical drivers of health such as limited access to healthcare, equitable housing and education, and healthy food.
These non-medical drivers of health can influence the type of medical care someone receives, including preventative care such as cancer screenings resulting in later and more costly diagnoses.
The rule also seeks to help people quit smoking.
Right now, smoking one cigarette can shave 20 minutes off your life span, according to a recent Salud America! report.
What’s more, the mortality rate among those who smoke cigarettes is 2 to 3 times higher than those who haven’t smoked, according to the FDA’s proposed rule.
So quitting smoking can have a positive impact on your health.
Within a year of quitting, your risk of heart disease is cut in half. Those who quit before turning 40 can benefit from a 90% drop in the risk for premature death, according to a Salud America! report.
How Does the Policy Impact the Economy?
While there are many health benefits, including decreasing risk for cancer, manufacturers may stand to feel the financial weight of the change.
If passed, the FDA anticipates that the tobacco industry will need to adjust to meet the new standard.
Economic impacts include the repurposing of land and labor while capital could affect consumers, according to the proposed rule.
Federal and state governments could also see a decrease in tax revenue.
In addition, firms could experience a loss in income and sales.
The FDA estimates that the annualized benefits of the proposed rule, primarily from improved public health and reduced smoking-related illnesses, would amount to over $1.1 trillion per year over a 40-year period, while the annualized costs to implement the rule would be $2.07 billion per year over the same period.
Cigarette smoking cost the US over $600 billion in 2018. The majority of that was spent on healthcare ($240 billion).
What’s more, the US lost $185 billion was lost in productivity due to smoking-related illnesses and other health conditions, $180 billion in productivity due to smoking premature deaths, and $7 billion was lost due to productivity from secondhand smoke exposure leading to premature death.
Quit Smoking with Quitxt
Need help to kick the smoking habit?
Fortunately, Quitxt can help!
Quitxt is a bilingual service from UT Health San Antonio and the Cancer Prevention and Research Institute of Texas that sends texts messages to smartphones to help South Texas adults quit smoking. Messages help with motivation to quit, setting a quit date, handling stress, and using nicotine replacement, if needed.
To join Quitxt in English, text “iquit” to 844-332-2058.
For Spanish, text “lodejo” to 844-332-2058.
More than 1 in 5 Quitxt users fully quit smoking after completing the English version of the program, according to a 2017 study.
“There’s no better time than now to stop smoking with help from Quitxt,” said Dr. Amelie Ramirez, director of Salud America! at UT Health San Antonio. “Quitting smoking is proven to improve your health, increase your life span, and save money.”
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