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.

The US Food and Drug Administration (FDA) has approved Tivicay PD tablets for oral suspension (dolutegravir) to treat HIV infection in babies.

Developed by ViiV Healthcare, Tivicay and Tivicay PD were previously approved for adults and children older than four weeks.

Now, Tivicay PD has been approved for newborns from birth up to four weeks of age weighing at least 2 kg, in combination with other antiretroviral agents.

How Does Tivicay Work?

Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor used in combination with other antiretroviral agents to treat HIV.

Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle.

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What’s The Evidence For Tivicay PD In Newborns?

The FDA approval was based on data from the IMPAACT 2023 study, in which 48 newborns exposed to HIV-1 and weighing at least 2 kg received Tivicay PD from birth for up to six weeks, in combination with standard-of-care antiretroviral medications to prevent mother-to-child HIV transmission.

The newborns were followed for 16 weeks. Results showed that Tivicay PD drug levels in newborns were similar to those associated with efficacy in adults.

Importantly, the drug’s safety profile in newborns was also similar to that observed in older pediatric and adult patients.

FDA Priority Review

Read More: Reducing Mother-To-Child HIV Transmission To Zero Key To End AIDS In India: Experts

In June, the FDA accepted a supplemental new drug application (sNDA) for Tivicay PD that would extend its use to newborns from birth. The agency granted the application Priority Review with a PDUFA action date of August 25, 2026.

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," said Jean van Wyk, chief medical officer at ViiV Healthcare, at the time.

Who Should Avoid Tivicay or Tivicay PD?

Patients should not receive Tivicay or Tivicay PD if they have had previous allergic reactions to the drug or if they are also receiving dofetilide.

Serious allergic reactions have been reported. Patients should be monitored for liver damage. Immune reconstitution syndrome has also been reported in patients treated with combination antiretroviral therapy.

Taking Tivicay or Tivicay PD with certain other medications may cause the drug to stop working against HIV or lead to serious side effects. Patients or their caregivers should tell their healthcare provider about all medications they are taking before starting Tivicay or Tivicay PD.

Tivicay tablets and Tivicay PD tablets for oral suspension are not substitutable on a milligram-per-milligram basis.

What Is HIV?

HIV (human immunodeficiency virus) attacks the body's immune system, increasing the chances of developing serious infections or cancer. Without treatment, HIV can lead to AIDS (acquired immunodeficiency syndrome).

There is no cure for HIV, but prevention and treatment options are available.

Preventing Mother-to-Child HIV Transmission

Pediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. The latest statistics show there are 1.7 million children living with HIV, and the majority of AIDS-related deaths among children still occur during the first five years of life.

Major obstacles persist for children, such as continued mother-to-child transmission, the availability of HIV testing, slow initiation of treatment, and poor availability of optimized pediatric formulations of antiretrovirals, according to UNAIDS.

An HIV-positive mother can pass the virus to her baby during pregnancy, labor, delivery, or breastfeeding, but proper medical care lowers this risk to less than 1%.

The deaths of three patients in experimental gene-editing and cell-therapy trials in China, including two children, have raised grave concerns about patient safety, transparency and oversight in the country's clinical-trial system.

The three deaths occurred in separate investigator-initiated trials (IITs), which are studies led by researchers or medical institutions rather than conducted through the conventional drug-development pathway.

The cases have come to light only months after the deaths, prompting US lawmakers to ask the FDA to scrutinise clinical data generated in China more closely.

Three Patients Died In Separate Experimental Trials

One case involved a 6-year-old girl with Snijders Blok-Campeau syndrome, a rare neurodevelopmental disorder. She died seven days after receiving an experimental gene-editing treatment at Xinhua Hospital in Shanghai in May 2025.

Reports said the treatment was delivered into the spinal fluid, and the hospital's ethics board later determined that the death was definitely related to the treatment.

A second death involved a boy with Duchenne muscular dystrophy (DMD) who received HuidaGene Therapeutics' experimental CRISPR-based therapy. He died in August 2025 after developing acute respiratory distress syndrome (ARDS) during a severe immune reaction following a high dose of the viral-vector treatment. The company disclosed the death in August 2026 after questions from reporters.

The third case involved a man in his 50s with scleroderma, who died in March 2026 after receiving RiboX Therapeutics' experimental in-vivo CAR-T therapy.

RiboX had announced FDA clearance to begin testing the treatment in the US shortly before the death became public.

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Why Gene Therapy Can Trigger Serious Reactions?

High doses can further increase this risk. In the HuidaGene case, the child developed ARDS during what the company described as a severe immune reaction. Such reactions can cause widespread inflammation and damage organs, making them potentially life-threatening.

Gene editing also carries another category of risk: the treatment is intended to alter genetic material, so researchers must carefully assess whether editing occurs only at the intended target and whether the delivery system itself creates additional risks.

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Bigger Concern Is Trial Oversight

The deaths have attracted particular attention because they occurred in trials initiated by investigator, which have historically offered researchers a faster route to testing experimental therapies.

Unlike conventional clinical trials, these studies have operated under a different regulatory framework in China. Reports have raised concerns about whether independent safety monitoring was adequate in some cases.

For example, the HuidaGene trial did not have an independent data safety monitoring board, according to reporting by STAT. The study enrolled four boys, and the child who died was the fourth participant to receive treatment and received the highest dose administered in the trial.

US Lawmakers Are Calling For Greater Scrutiny

The cases have prompted Representatives John Moolenaar and Ben Cline to ask the FDA to stop accepting Chinese clinical-trial data for US drug applications unless the agency has recently inspected the trial site.

In a letter to Acting FDA Commissioner Kyle Diamantas, the lawmakers said, “American families deserve confidence that the treatments approved in our country are supported by data produced with rigor, ethics, and accountability.”

At least 1 in 4 former NFL players who died between 2016 and 2021 had chronic traumatic encephalopathy (CTE), according to a new study published in the BMJ. Researchers say the figure may be a conservative estimate, raising concerns about the long-term effects of repeated head impacts in American football.

The study examined 878 former NFL players who died during the six-year period. Of them, 235 had donated their brains for research, and 215, or 91.5%, were found to have CTE.

As brain donation was not available for everyone who died, researchers calculated that at least 24.5% of the entire group had CTE. Researchers say the actual number could be substantially higher.

What Is CTE?

Repeated head impacts can cause abnormal accumulation of tau protein in the brain. Over time, these changes can damage and kill brain cells, particularly in areas involved in memory, thinking, mood and behaviour.

The damage is not always caused by one dramatic concussion. Researchers focus on the cumulative burden of repeated head impacts, including hits that may not cause obvious concussion symptoms.

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Brain Damage Can Build Up Over Years

CTE can be associated with symptoms including memory problems, confusion, impaired judgement, depression, anxiety, aggression and difficulties controlling impulses.

The new study also found a strong relationship between more advanced CTE and dementia. Among players with the most severe, Stage IV disease, dementia was particularly common.

Dr Daniel Daneshvar, a neurologist at Mass General Brigham and lead author of the study, said, "Former NFL players had about a fourfold higher risk of dying from neurodegenerative disease compared with the general population."

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The Risk May Begin Before The NFL

One important finding is that the brain injury associated with CTE does not necessarily begin during an NFL career.

Players may accumulate thousands of head impacts during childhood, high school and college football, before ever reaching the professional level.

Researchers therefore say prevention needs to focus on reducing repetitive head impacts throughout a player's sporting career, rather than concentrating only on professional football.

This also explains why researchers distinguish between concussions and repetitive head impacts. A player can experience numerous hits without being diagnosed with a concussion, yet the cumulative exposure may still have a lasting impact in long term.

Can CTE Be Detected Or Treated While Someone Is Alive?

One of the biggest challenges is detecting CTE while someone is alive. There is currently no definitive test that can diagnose CTE during life and no cure that can reverse the underlying brain changes.

Researchers are studying biomarkers and brain-imaging techniques that could eventually make diagnosis possible without an autopsy. The treatment focuses on managing symptoms like depression, sleep problems, headaches, cognitive difficulties and behavioural changes.