FDA Plan to Reduce Nicotine in Cigarettes: Implications for Public Health

The US Food and Drug Administration (FDA) has recently announced a plan to reduce nicotine levels in cigarettes, a move addiction experts believe could have a major impact on public health in the United States. Smoking remains the leading preventable cause of death and disease, with the latest statistics showing that 480,000 people in the country die annually due to smoking.

Although there has been a decrease in the number of smokers over the years - many young people are turning to e-cigarettes instead of smoking - "We still have a lot of people with a long history of smoking, despite efforts in tobacco public health," said Dr. Lisa Fucito, director of tobacco treatment services at Smilow Cancer Hospital.

Approximately 70% of the 31 million adult smokers in the country express a preference for not smoking, according to government statistics. Over half of the population tries to quit smoking every year, but only 7.5% of these attempts are successful.

Although there are several steps between the FDA's announcement in late June and a new law, reducing the amount of nicotine in cigarettes could bring significant change for smokers.

Fucito and other Yale medical experts explained the plans of the FDA and their potential impact.

What is the plan to reduce nicotine and why is FDA proposing it now?

Reducing nicotine in cigarettes is part of the Biden administration's Cancer Moonshot program, which aims to reduce cancer deaths by 50% within 25 years. The FDA announcement in June came after a proposal in April to ban menthol cigarettes and flavored cigars.

A recent plan will require tobacco companies to reduce the level of nicotine in cigarettes to a point that is no longer considered addictive. This will not affect other nicotine-containing products such as smokeless tobacco, e-cigarettes, nicotine pouches, or nicotine replacement therapy (such as nicotine lozenges and patches).

This is not a new idea - it has been discussed since 1994. The 2009 Family Smoking Prevention and Control Act ultimately provided the FDA with regulatory control over tobacco and the ability to lower nicotine levels (although not to zero). However, the agency still requires scientific evidence to support taking action.

Since then, federally-funded research has provided ample evidence to support this strategy. A notable study published in the New England Journal of Medicine in 2015 showed that reducing nicotine in cigarettes could lead to reduced smoking and more successful attempts to quit.

How quickly will the nicotine reduction plan be implemented?

Experts predict that the task of reducing nicotine is unlikely to happen soon. The FDA's intention is to propose a standard by May 2023. The agency must first publish the regulations, allow public comments, and then issue the final regulations. Tobacco companies that do not agree with the regulations may face obstacles, and some say the entire process could take several years.

Nevertheless, according to Fucito, this is an important step towards controlling major health hazards.

Will reducing nicotine in cigarettes make smoking safer?

Even with a significant reduction in nicotine, cigarettes remain harmful. "Tobacco is very dangerous," says Fucito. "The leaf form of tobacco contains many toxic chemicals. When you burn it, it creates new toxins that can cause harm.

Cigarettes contain 600 ingredients and when burned, produce over 7,000 chemical compounds. At least 69 of these compounds, such as ammonia, benzene, formaldehyde, and lead, are known to be carcinogenic. Tar, which is produced during tobacco combustion, contains most of the cancer-causing and other harmful chemicals. Tar coats the inside of the lungs, forming a sticky layer that can lead to cancer, emphysema, and other serious illnesses.

Nicotine may have significant negative effects on health, according to animal studies. It has been shown to cause problems with brain function, resulting in difficulties with attention, learning, and memory that may persist for a long time.

The true issue with nicotine lies in its addictive nature. This is why it is difficult for people to quit smoking. Dr. Nii Addy, an expert in neuroscience and addiction, explains that just like any other drug, nicotine hijacks the brain's reward system. It does this by binding to receptors in the brain and sending signals to release dopamine, a neurotransmitter that contributes to creating a "feel-good" sensation. This trains the brain to repeat the action, so when nicotine leaves the body, the brain craves more.

Is it really possible to reduce nicotine addiction in a "non-addictive" way?

Concerning the issue of how much nicotine needs to be reduced in cigarettes to decrease addiction, some research suggests that people who smoke cigarettes with 95% less nicotine content notice a decrease in dependency and smoke less. However, a less drastic reduction of nicotine can lead to increased inhalation or smoking.

It is important to note that there are various methods to reduce the nicotine content in cigarettes. Nicotine can be removed from tobacco leaves, cigarette manufacturers can adjust the blend of tobacco they use, or they can use genetically engineered tobacco to produce low-nicotine cigarettes.

Does reducing nicotine really help people quit smoking?

Fucito works directly with those who want to quit smoking, often because they have health conditions and their doctors have advised them to quit, or because they are preparing for surgery and smoking increases the risk of surgical infections and complications. "I know it can be difficult to quit smoking because nicotine is highly addictive, and cigarettes deliver nicotine to the brain within seconds," she says. Because the reward is so quick, the habit persists.

She added that medication can help interrupt this process, but one issue is that they cannot replicate the sensory experience of smoking, aside from nicotine. Smoking itself can also be beneficial. "The benefits of reducing nicotine cigarettes are that you still have the habitual experience of smoking, but overall cigarettes are less addictive and less enjoyable, which is important in helping people to reduce and eventually quit smoking.

What impact does reducing nicotine have on public health?

This will have a significant impact," stated Fucito, adding that she anticipates more individuals struggling with smoking will quit. According to CDC statistics, nearly 13 out of 100 American adults smoked in 2020. A study published in the New England Journal of Medicine in 2018 found that reducing nicotine levels could save millions of lives and millions of life years in the coming decades.

Reducing smoking levels can have a positive impact on the health of smokers, as their habit puts them at a higher risk for health issues compared to non-smokers. These health issues include, but are not limited to, cancer, stroke, respiratory diseases, cataracts, macular degeneration, and type 2 diabetes. Smoking also increases the risk of erectile dysfunction and decreased fertility in men, and low bone density, menstrual cycle changes, pregnancy complications, and danger to unborn babies in women.

According to Fucito, it will also help the "priority population who cannot quit smoking." "Different groups are disproportionately affected by smoking and tobacco-related harms." These groups include low-income individuals, those with low levels of education, identified minority group members or those diagnosed with mental health issues. "For example, it is estimated that smokers with schizophrenia will die prematurely by 25 years due to smoking," Fucito said.

Will reducing nicotine have an impact on mental health?

Quitting smoking can cause a range of negative psychological symptoms such as anxiety, irritability, restlessness, and mood swings. It can also lead to physical withdrawal symptoms, which are most severe during the first few days of quitting. Some symptoms may persist for a longer period of time, such as changes in sleep, appetite, or diet. However, it is important to note that these symptoms typically resolve within a few weeks, according to Fucito.

She added that this helps to understand the effects of smoking and quitting on the body. "The effect of nicotine is temporary: when you smoke, you quickly release nicotine, which feels good and may improve your mood. But after 1 to 2 hours, these effects will disappear and you will experience withdrawal unless you smoke another cigarette," she said. "This cycle throughout the day makes it difficult to quit smoking. However, after a few weeks of quitting smoking, these mood changes will normalize. Medication can make this process more comfortable.

How can quitting smoking become a more tolerable experience?

Individuals who want to quit smoking can start by talking to their primary care physician. The tobacco treatment services at Smilow Cancer Hospital offer personalized consultations with FDA-approved nicotine replacement therapies such as patches, gum, lozenges, inhalers, and other approved tobacco-use medications, including Chantix and Zyban.

They also recommend that patients adopt potential tobacco harm reduction strategies, such as switching to alternative tobacco products (e-cigarettes, oral nicotine products) as a replacement for cigarettes. The Smilow Plan and many other smoking cessation programs also offer clinical trials, with a focus on testing new drugs and behavioral strategies.

According to Fucito, quitting smoking may be unpleasant, but it does not pose a threat to one's life. "Remember, the withdrawal symptoms are most severe in the first few days, which can be helpful. But after about four weeks, the situation will normalize for most people," she said.

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