Cigarettes with ultralow nicotine levels are now being called the game-changer in the fight against smoking. If you are having trouble in quitting smoking, then, it is for you, that soon the Biden White House is expected to formally propose a plan that will order cigarette nicotine levels to be reduced, reports The Washington Post. For now though, it has been a failure, as these cigarettes, also known as VLN cigarettes that stands for very low nicotine are only available in 5,100 stores in 26 states. This is a very small fraction of the overall market for cigarettes. The company that makes it, 22nd Century, is struggling not because of the low supply, but also from the advocates who have long believed slashing nicotine levels altogether.

The Advent and ideation

Nicotine is a chemical that is produced naturally from tobacco that makes the cigarette and also keeps people hooked. While it is believed that it makes people alert, and get the "hit" to keep them going, it exposes the users to harmful substances, carcinogens, and increases the risk of heart disease, lung cancer, and other illness.

Ultralow-nicotine cigarettes, like the VLN brand, contain about 95% less nicotine than the regular cigarettes. The idea is quite simple: without the addictive grip of nicotine, smokers will find it easier to quit. Research too has shown some promise. For instance, the studies funded by the National Institute on Drug Abuse revealed that very low nicotine cigarettes reduced addiction potential significantly without having users to increase their smoking frequency. However, the problem is, why would anyone choose for a low-nicotine that does not make them feel the same way, when the high-nicotine cigarette is right next to it, making them feel the same way, with the same alertness, sold at the same price.

“It’s very hard to imagine someone actively choosing to continue to use a low-nicotine product for the same price when a high-nicotine product is right next to it,” said Eric Donny, a Wake Forest University School of Medicine nicotine researcher.

No wonder, the experiment with low nicotine product by Philip Morris' Next cigarettes in the 1980s and Vector Tobacco's Quest brand in the early 2000s, flopped.

FDA's Role in the Push

The Food and Drug Administration (FDA) has supported the development of such products, even allowing VLN cigarettes to be marketed as lower-risk options. However, these products remain a niche market, available in only a fraction of U.S. stores.

Recently, the Biden administration has considered a bold step—mandating a dramatic reduction in nicotine levels for all cigarettes sold in the United States. Supporters believe this move could save millions of lives, while critics, including tobacco companies, warn of potential unintended consequences.

What Could Be The Challenges?

Resistance from Big Tobacco Companies: They could argue that slashing nicotine levels could backfire. Their claim is, smokers will turn to black markets or smoke more to satisfy their cravings, which may lead to greater exposure to harmful substances.

Consumer Reluctance: History is proof to the instances of smokers being hesitant to embrace the low-nicotine products.

Political Hurdle: It may face political roadblocks, as under the Trump administration, plans to cut nicotine were shelved.

Could Low-Nicotine Cigarettes Be The Solution?

Advocates believe that ultralow-nicotine cigarettes could be a game-changer, comparing them to decaf coffee or non-alcoholic beer—products that reduce harm while offering a similar experience.

Some experts warn that a black market for traditional cigarettes could undermine these efforts. They also stress the need for safer alternatives, such as vaping products, to support smokers transitioning away from traditional cigarettes.

GLP-1 drugs such as Ozempic and Wegovy can reduce cardiovascular events and deaths in people with type 2 diabetes (T2D) and some people with obesity. However, stopping treatment may affect these benefits.

Around 20–50% of patients discontinue GLP-1 therapy within the first year. Previous studies have linked discontinuation to weight regain and worsening blood sugar, blood pressure and cholesterol levels.

Now, a study published in The Lancet Regional Health has found that people with type 2 diabetes and no previous cardiovascular disease who stopped GLP-1 treatment had nearly twice the risk of heart attack, stroke or death from any cause compared with those who continued.

"In people with T2D and without previous cardiovascular disease, interrupting a therapy with GLP-1RA was associated with a higher risk of a composite of myocardial infarction, stroke, or death from any cause compared to those continuing the treatment," said researchers from IRCCS MultiMedica in Milan, Italy.

However, the observational study cannot establish that stopping GLP-1 drugs directly caused the increased risk. Researchers also did not know why patients discontinued treatment, which could have been due to side effects, cost or underlying illnesses such as frailty or cancer.

What Did The Study Find?

Researchers analysed electronic medical records from more than 300 diabetes clinics in the Italian Association of Clinical Diabetologists (AMD) database, covering 2004–2024.

They identified more than 80,000 people with type 2 diabetes and no established cardiovascular disease who had started GLP-1 treatment.

Those who continued treatment took the medication for nearly three years on average, compared with just over one year among those who stopped.

The combined risk of non-fatal heart attack, non-fatal stroke or death from any cause was nearly twice as high among those who discontinued treatment.

• Those who stopped: About 4 events per 100 people per year.
• Those who continued: About 2 events per 100 people per year.

People With Obesity Had Higher Risks

Among those who discontinued treatment, the risks of adverse outcomes were higher in people with obesity (body mass index of 30 or above) than in those without obesity.

Interestingly, changes in weight, blood sugar and blood pressure after stopping treatment were modest and similar among those who subsequently experienced a heart attack, stroke or death and those who did not.

This suggests that changes in these risk factors may not fully explain the higher rates of adverse outcomes.

Should You Stop Ozempic Or Wegovy?

Lead author Antonio Ceriello, head of diabetes research at IRCCS MultiMedica, said the association between stopping GLP-1 receptor agonists and poorer cardiovascular outcomes was "not a complete surprise". However, he noted that the scale of the association was significant, ABC News reported.

The researchers said long-term GLP-1 use may be important for maintaining health benefits in people with type 2 diabetes, but further studies are needed to establish whether stopping treatment directly increases cardiovascular risk or reflects worsening underlying health.

People taking Ozempic, Wegovy or other GLP-1 medications should discuss any decision to stop treatment with their doctor.

Eli Lilly's oral weight-loss drug Foundayo, that received FDA approval in April 2026, has shown promise in reducing the severity of obstructive sleep apnoea (OSA) in a recent trial.

OSA is a condition in which breathing repeatedly gets interrupted during sleep. In a late-stage clinical trial, the medicine reduced the repeated starting and stopping of breathing by up to 44% over 52 weeks in adults with moderate-to-severe sleep apnoea and overweight or obesity.

The findings from the phase 3 ATTAIN-OSA clinical programme were presented at the American Heart Association's Scientific Sessions 2026 on November 9 and published simultaneously in JAMA. The study included 712 participants, divided into two groups based on whether they were using positive airway pressure (PAP) therapy.

Eli Lilly plans to submit the findings to the US Food and Drug Administration (FDA) by the end of 2026 to seek approval for Foundayo as a treatment for moderate-to-severe obstructive sleep apnoea in adults with overweight or obesity.

Foundayo Reduces Sleep Apnoea Episodes

Also read: Lancet Study Says Obesity Drug Mazdutide Shows 18% Weight Loss In 32 Weeks: How Does It Compare To Wegovy?

The trial evaluated Foundayo, also known by its generic name orforglipron, in two separate studies. One involved 363 adults who were not using PAP therapy, while the other included 349 participants who continued using it.

After 52 weeks, the drug reduced the number of breathing interruptions per hour, measured using the apnoea-hypopnoea index (AHI).

The findings included:

• Participants not using PAP therapy: Breathing interruptions fell by 43.8% compared to a 6.3% reduction in the placebo group.
• Participants using PAP therapy: Breathing interruptions fell by 27.5% compared to a 3% reduction in the placebo group.
• Better oxygen levels: Sleep apnoea-related oxygen deprivation, measured through hypoxic burden, fell by 55.9% in the group not using PAP and 45.8% in the group using PAP.

The drug also helped some participants reach remission or mild disease. According to Lilly's reported efficacy analysis, this included 31.5% of participants not using PAP therapy and 19.6% of those using it.

Can Foundayo Replace CPAP Therapy?

Also read: Ozempic, Mounjaro Users Report Burning Skin Sensation: What Is Allodynia?

Continuous positive airway pressure (CPAP), a form of PAP therapy, remains a standard treatment for obstructive sleep apnoea. It uses a machine to deliver a steady flow of air through a mask, keeping the airway open during sleep.

The ATTAIN-OSA programme included participants who were not using PAP therapy as well as those who continued using it. The results suggest that Foundayo could benefit both groups, but they do not establish that patients can stop using CPAP.

Vaishnavi Kundel, the study's presenting author and Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, said, “If approved to treat obstructive sleep apnea, orforglipron could be a promising oral pharmacologic option for people with overweight or obesity and this condition. A convenient daily pill may help expand access to treatment for sleep apnea, and it could potentially be used with CPAP or other therapies to better meet individual patient’s needs.”

More About Foundayo

Also read: Ozempic, Zepbound: US FDA Orders New Warning Over Rare Eye Risk

Foundayo is an oral glucagon-like peptide-1 (GLP-1) receptor agonist. It is taken once daily and works by mimicking the GLP-1 hormone, which helps regulate appetite, calorie intake and blood glucose levels.

By reducing appetite and supporting weight loss, the drug may help address one of the important risk factors of obstructive sleep apnoea.

Excess weight, especially around the neck and upper airway, can increase the likelihood of airway narrowing or collapse during sleep. When the airway repeatedly becomes blocked, breathing interruptions occur and blood oxygen levels can fall.

Participants taking Foundayo lost an average of 11.5% of their body weight in the study group not using PAP therapy and 11.2% in the group using it.

Why Is Obstructive Sleep Apnoea A Concern?

Obstructive sleep apnoea is a breathing disorder related to sleep in which the muscles and soft tissues of the upper airway relax during sleep, causing the airway to narrow or become temporarily blocked.

This results in repeated pauses in breathing or episodes of shallow breathing, disrupting sleep and reducing oxygen levels. Common symptoms include:

• Loud and constant snoring
• Episodes of gasping or choking during sleep
• Waking up frequently during the night
• Morning headaches
• Excessive daytime sleepiness
• Difficulty concentrating and irritability

Amid increasing reports of a rare form of sudden vision loss called nonarteritic anterior ischemic optic neuropathy (NAION) following the use of drugs such as Ozempic, Wegovy and Mounjaro, the U.S. Food and Drug Administration (FDA) has ordered GLP-1 drugmakers Novo Nordisk and Eli Lilly to add warnings about the potential eye risk to their drug labels.

NAION can cause sudden, painless vision loss in one eye and, in some cases, permanent impairment.

In a Drug Safety Communication, the FDA informed patients and healthcare providers about the potential increased risk associated with these medicines. It is requiring manufacturers to include information about NAION in the Warnings and Precautions section of their drug labels.

The agency said it evaluated clinical trial data, animal studies and post-marketing evidence, including observational studies and case reports.

GLP-1 Users File Lawsuits Over Vision Loss

Also read: Hundreds Of American GLP-1 Users Sue Novo Nordisk, Eli Lilly Over Vision Loss: What Is NAION?

The FDA action comes amid lawsuits filed by people who allege they developed NAION after taking GLP-1 drugs such as Ozempic and Wegovy.

According to The Wall Street Journal, US law firm Weitz & Luxenberg has filed more than 90 lawsuits in New Jersey state court since 2025 on behalf of people who say they developed the condition while taking these medicines.

Separate federal lawsuits in Philadelphia accuse Novo Nordisk and Eli Lilly of failing to provide adequate warnings about the potential eye risk. The cases are pending. The allegations do not establish that the medicines caused the condition.

Regulators in Europe and Australia have also required warnings about a possible increased risk of NAION with some GLP-1 medicines.

In the US, vision problems are listed as possible side effects, but NAION had not previously been included as a specific risk in FDA-required labelling. The FDA's Sentinel Initiative is also reviewing the possible safety signal.

What Is NAION?

NAION is the most common acute optic neuropathy in people over 50, according to the Mayo Clinic. It occurs when blood flow to the optic nerve is reduced, damaging the nerve that carries visual information from the eye to the brain.

The condition typically causes sudden, painless vision loss in one eye. While some patients may experience partial improvement, the damage can be permanent. There is currently no proven treatment to reverse the vision loss.

Diabetes itself increases the risk of NAION, independent of GLP-1 use. Other risk factors include low blood pressure during sleep and having a small optic nerve cup.

What Does Research Say About The Risk?

Read More: Wegovy More Likely To Cause Rare Blindness Than Ozempic And Other Similar Drugs, Recent Study Finds

The potential association between GLP-1 medicines and NAION has been under regulatory review internationally.

Last year, the European Medicines Agency's safety committee said NAION may affect up to one in 10,000 people taking semaglutide for at least one year. Semaglutide is the active ingredient in Ozempic, Wegovy and Rybelsus.

The Danish Patient Compensation Association also granted compensation to four patients who experienced vision loss after using Novo Nordisk's GLP-1 medicines.

A large study published in 2025 tracked nearly 175,000 people with diabetes taking semaglutide and an equal number taking non-GLP-1 medicines. It found that the risk of NAION was more than twice as high after two years of treatment with semaglutide compared with other diabetes medicines.

However, an observed association does not establish that the medicines directly caused the condition.

The FDA routinely monitors medicines after they enter the market, evaluates potential safety signals and takes regulatory action when appropriate.