https://www.cnn.com/2025/01/15/health/nicotine-limits-cigarettes-tobacco-fda/index.html

According to the article, the U.S. Food and Drug Administration (FDA) is proposing limits on the level of nicotine in cigarettes and some other types of tobacco products to make them less addictive.

“If finalized, the United States would be the first country globally to take such a bold, life-saving action to prevent and reduce smoking-related disease and death,” the FDA said in a statement.

Nicotine is highly addictive, and studies show that a policy that lowers nicotine levels in products would help millions of people quit smoking or smoke less. Most smokers surveyed have said they regret starting and want to quit.

Most people who smoke started as kids, studies show, even though the legal age to buy tobacco was 18 for many years and raised to 21 in 2019. If nicotine levels were lowered, experts say, young people may still try tobacco products out of curiosity, but they would be less likely to form a lifelong habit.

“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. 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. 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,” FDA Commissioner Dr. Robert Califf said in the statement.

Capping Nicotine Levels

Nicotine levels would be capped at 0.7 milligrams per gram of tobacco in cigarettes, according to the proposal. Dr. Brian King, director of the FDA’s Center for Tobacco Products, said recently that would lower the average concentration in products on the market today significantly – by about 95 percent.

“By reducing the nicotine level of cigarettes and certain other combusted tobacco products to a level low enough to no longer create or sustain addiction, that cycle of exposure to these toxic chemicals can be broken,” King said on a call with reporters.

Tobacco Products Impacted

The proposal would apply to cigarettes, cigarette tobacco, roll-your-own tobacco, most cigars — including little cigars, cigarillos and most large cigars — and pipe tobacco, the agency said. The rule does not include e-cigarettes, nicotine pouches, non-combusted cigarettes such as heated tobacco products, waterpipe tobacco (hookah), smokeless tobacco products or premium cigars.

The Trump Administration

The FDA initially explored nicotine limits under the first Trump administration. When asked why it took so long to get the proposal out, King said that when the FDA first issued notice that they were considering proposing this rule in 2018, the agency got 7,000 submissions during the public comment period and it took time to collect the information and to review the science. Califf, who was also on the recent media call, said that his agency had to anticipate lawsuits from the tobacco industry.

“I think everyone on this call is aware of the fact that we will be sued on anything that comes into action,” Califf said, adding, “The research has to be airtight to survive the challenges that we know we’ll get in court.”

“We have to do everything just right in order to succeed.”

The Relevant Data

Although the number of people who smoke has been declining for more than a decade, about 28 million U.S. adults are considered current smokers.

Cigarette smoking is still the leading cause of preventable death, disease and disability in the United States, according to the US Centers for Disease Control and Prevention. The country loses 490,000 people a year to tobacco-related disease, according to a report from the U.S. surgeon general, and more than 16 million Americans are living with a smoking-related illness.

Health-care costs associated with smoking totaled more than $240 billion in 2018, according to the CDC.

“This is a truly game-changing proposal that would accelerate declines in smoking and save millions of lives from cancer, cardiovascular disease and other tobacco-related diseases if it is implemented,” Yolonda C. Richardson, president and CEO of Campaign for Tobacco-Free Kids said in an emailed statement Wednesday. “Given these enormous benefits, we urge the incoming Trump Administration to move forward in finalizing and implementing this rule. Few actions would do more to fight chronic diseases such as cancer and cardiovascular disease that greatly undermine health in the United States and that the incoming Administration has indicated should be a priority to address.”

The FDA projects that more than 12.9 million people who smoke cigarettes will stop one year after the rule comes effective, and 19.5 million people would stop within five years. By 2100, the change could prevent approximately 48 million children and young adults from starting smoking.

“We know that tobacco use is not a choice. It is an addiction. It is not a habit; it is an addiction. And really, the rule is significant,” Erika Sward, the assistant vice president of national advocacy for the American Lung Association, said this week.

Input from the American Heart Association

The CEO for the American Heart Association, Nancy Brown, characterized the proposal as “one of the most significant in FDA history to curb tobacco use,” but also added that she hopes the rule would be expanded to include all nicotine products. E-cigarettes are the most commonly used tobacco products among youth, followed by nicotine pouches, neither of which would be impacted by this proposed rule.

“We will continue to work closely with the agency toward the goal of making this policy a reality,” Brown said in an emailed statement.

The public can make comments on the rule starting this week through mid-September. It could take years for the rule to be finalized.

 

Discussion Questions

1. Do you foresee that this regulatory action will be finalized during the second Trump administration? Why or why not?

This is, in essence, an opinion question, so student responses may vary.

In your author’s opinion, the finalization of this regulatory action could potentially be impacted in terms of the second Trump administration. An incoming president has the authority to appoint a new FDA head, and Donald Trump has nominated Dr. Marty Makary, a Johns Hopkins surgical oncologist, to lead the FDA. Dr. Makary has not publicly stated his position regarding the FDA’s proposed regulation to limit nicotine in cigarettes.

It is important to note that there were efforts to reduce nicotine in cigarettes during the first Trump administration. The FDA, under then-Commissioner Dr. Scott Gottlieb, proposed a plan to limit the amount of nicotine in cigarettes to make them less addictive. However, this effort faced significant challenges and was sidelined during Trump's first term. The proposal aimed to cap nicotine levels in cigarettes, cigars, and pipe tobacco, but it faced potential legal challenges from tobacco companies.

The outgoing head of the FDA under the Biden administration, Dr. Robert Califf, is a noted advocate of reducing cigarette nicotine levels. He has publicly supported the FDA's proposal to cut nicotine levels in cigarettes to nonaddictive levels. Dr. Califf believes that reducing nicotine in cigarettes could help prevent addiction and significantly decrease smoking-related diseases and deaths

 

2. What is the justification for limiting nicotine levels in cigarettes and other tobacco products?

As indicated in Article 2 and in response to Article 2, Discussion Question Number 1 above, science supports the conclusion that reducing nicotine in cigarettes could help prevent addiction and significantly decrease smoking-related diseases and deaths.

The following information from the article bears emphasizing:

    a) Cigarette smoking is the leading cause of preventable death, disease and disability in the United States.

    b) The U.S. loses 490,000 people a year to tobacco-related disease.

    c) Over 16 million Americans are living with a smoking-related illness.

    d) Health-care costs associated with smoking totaled more than $240 billion in 2018.

    e) The FDA projects that more than 12.9 million people who smoke cigarettes will stop within one year after the rule becomes effective, and 19.5 million people will stop within five years.

    f) By 2100, nicotine regulation could prevent approximately 48 million children and young adults from starting smoking.

 

3. In your reasoned opinion, is the FDA’s decision to limit nicotine in cigarettes and other tobacco produces an example of “good government,” or is it an example of the so-called “nanny state” (defined as a government or its policies that are perceived as overprotective or interfering excessively with personal choice)? Explain your response.

 

This is an opinion question, so student responses may vary. As mentioned in response to Article 1, Discussion Question 3 of this newsletter, your author favors the “good” that can come about by government regulation, including greater safety for consumers. If the FDA does not act on reducing the level of nicotine in cigarettes and other tobacco products, it is highly doubtful that tobacco companies will self-regulate. They have already had generations to do so.