The U.S. Food and Drug Administration (FDA) has taken a significant step in the evolving landscape of tobacco harm reduction by authorizing the marketing of 20 ZYN nicotine pouch products. The agency released this decision following comprehensive scientific review under the PMTA pathway, marking the first time FDA has authorized nicotine pouches. This move, while bringing to light debates concerning public health, could fundamentally shape the future of nicotine consumption and alternatives to tobacco use in the United States.
ZYN nicotine pouches are innovative products designed as alternatives to traditional tobacco. Unlike cigarettes or smokeless tobacco, these small synthetic fiber pouches contain nicotine but no tobacco. Users place them between the gum and lip, where nicotine is absorbed into the bloodstream. Available in various flavors, including cinnamon, citrus, and cool mint, ZYN offers two nicotine strengths- 3 milligrams and 6 milligrams.
This new product category targets adult smokers who would like to switch to less harmful alternatives compared to traditional tobacco. FDA's authorization marks a landmark moment for this emerging segment of the tobacco market in the United States.
The FDA decision anchors from the Family Smoking Prevention and Tobacco Control Act of 2009, which obligates all new tobacco products to comply with strong public health standards. The agency review found that the ZYN pouches involve substantially lower risks compared to cigarettes and smokeless tobacco products, such as snuff or snus.
The pouches contain far fewer harmful constituents associated with cancer and other life-threatening diseases. In addition, studies submitted by the manufacturer showed that many adult smokers and users of smokeless tobacco switched entirely to ZYN, indicating its potential as a harm-reduction tool.
"These nicotine pouch products meet that bar by benefiting adults who use cigarettes or smokeless tobacco products," said Matthew Farrelly, Ph.D., director of the FDA's Office of Science at the Center for Tobacco Products.
This is a clear FDA warning: ZYN is not risk-free, nor is it "FDA-approved." Although the agency said that low use levels of nicotine pouches among youths remain at 1.8% of middle and high school students in the United States who reported using any tobacco product, according to the 2024 National Youth Tobacco Survey, the agency emphasized preventing youth exposure.
The FDA did this by applying stringent marketing restrictions, including the following:
- Ban mass-market advertising on TV and radio.
- Require actors/models in ads to appear at least 35 years old.
- Avoid themes, characters, or imagery appealing to youth.
The agency will also closely monitor marketing practices and suspend or withdraw authorizations if products no longer meet public health standards.
ZYN pouches don't contain any tar and the carcinogenic chemicals present in cigarette smoke and in the majority of smokeless tobacco products. Unlike snus, a popular form of pasteurized tobacco widely used in Scandinavian countries, ZYN contains no tobacco at all. In fact, that positions it like the nicotine gum or lozenge, releasing controlled doses of nicotine to eliminate craving.
For decades, tobacco companies have been looking for alternatives to traditional cigarettes, as smoking rates in the U.S. and around the world have declined. E-cigarettes became popular in the early 2010s but were later criticized for underage vaping. ZYN nicotine pouches could be a safer alternative, but critics fear they may follow the same path if youth use increases.
ZYN, marketed by Philip Morris International acquisition target Swedish Match through 2022 for a cost of $16 billion. While Philip Morris invests massively into nicotine pouches, huge demand from customers bolsters the business segment in the most phenomenal way in U.S. tobacco. Already nicotine pouches emerge as a pace-setter that could set to be at the core of industry's future prospects.
Also Read: 3 Science-Backed Methods To Quit Smoking For Good
However, controversies run rampant in the history of tobacco alternatives. For example, e-cigarette giant Juul Labs was sued for marketing to minors, settling in 2023 for $462 million without admitting wrongdoing. Critics are now beginning to scrutinize ZYN flavored products, including citrus and peppermint, arguing they may attract younger users.
That benefit, however – the FDA seems poised to acknowledge adult smokers will use nicotine pouches – underscores much-needed responsible marketing and rigorous oversight. Public health advocates caution, however, there is no such thing as winning when it has to be over youth uptake first and close to long-term effects on health.
Supporters say that ZYN is a genuine substitute for smokers looking to quit or reduce their reliance on devastating tobacco products. Indeed, as Brian King, Ph.D., FDA's Center for Tobacco Products director, noted, "It is imperative that the maker of these products does so responsibly so that youth will not take up their use".
The FDA's approval of ZYN nicotine pouches is part of a larger effort to regulate and innovate within the tobacco industry. Over the past decade, the agency has received applications for nearly 27 million products, authorizing only those that meet rigorous health standards.
This also goes with recent suggestions to limit nicotine content in cigarettes, marking a step toward harm reduction and prioritization of public health. However, challenges remain, but the ZYN authorization is reflective of a growing recognition of alternative nicotine products' role in reducing tobacco-related disease and mortality.
The FDA's approval of ZYN nicotine pouches marks a turning point in tobacco harm reduction. As a less harmful alternative to cigarettes and smokeless tobacco, ZYN has the potential to benefit adult smokers while reducing risks to public health. However, the success of this initiative will depend on strict regulatory oversight, responsible marketing, and continued vigilance against youth use.
Smoking cessation is one of the best heart-healthy lifestyle choices you could ever make and minimize the risk for developing conditions like A-Fib. While quitting smoking might not be an easy task, its benefits can be felt at once and significantly. Here is how to quit smoking successfully.
Set a quit date and be firm about it. This will give you ample time to mentally and physically prepare for the transition.
Share your decision with your family, friends, or support group. This will make it easier for you because you have people to motivate and hold you accountable.
Consider using nicotine patches, gum, or lozenges to manage withdrawal symptoms and reduce cravings. Seek the advice of a healthcare professional.
Identify situations or emotions that make you want to smoke, such as stress, boredom, or social settings. Develop healthy coping strategies, like journaling or engaging in a hobby, to navigate these triggers.
Engage in regular exercise. Exercise not only diverts your mind from excessive hunger and craving but also improves moods and overall well-being.
Drinking water will help to flush out nicotine from your system, and the level of your craving will decrease.
People often smoke when their stress is too high. Try to engage in some relaxing activities like yoga, meditation, or deep breathing.
Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024
E-Cigarette and Nicotine Pouch Use Among Middle and High School Students — United States, 2024
Just when the world seemed to settle into a post-pandemic rhythm, a new COVID-19 variant—NB.1.8.1, nicknamed Nimbus—is gaining ground and rattling global health authorities. With its hallmark symptom being an agonizing sore throat that patients describe as feeling like “swallowing razor blades,” the variant has already led to a noticeable rise in infections across several countries.
First identified in early 2025, this Omicron subvariant is making headlines as cases spike across Asia and begin to surface in North America, Europe, and Australia as well. With international mobility returning to pre-pandemic levels, global health experts are closely monitoring its trajectory.
NB.1.8.1 is a mutated form of the Omicron variant, it is continuing the trend of subvariants that are more transmissible but, so far, not necessarily more severe. It was first detected and quickly spread through densely populated regions of China and Hong Kong.
By late April, the World Health Organization (WHO) reported that NB.1.8.1 accounted for approximately 10.7% of globally submitted genomic sequences—up from just 2.5% a month earlier. This rapid expansion prompted the WHO to designate it as a “variant under monitoring” on May 23.
What sets NB.1.8.1 or Nimbus, apart from earlier COVID-19 variants is its unique set of symptoms, most notably the intense sore throat.
Patients across various countries, including Thailand, Indonesia, and the UK, have described a "razor blade" sensation in the throat, far more painful than the sore throats associated with previous variants.
Virologists, including Australia’s Dr. Lara Herrero of Griffith University, believe this new variant has a higher transmission potential and increased immune evasion capabilities, meaning it can more easily bypass natural or vaccine-induced immunity, contributing to its rapid spread.
While the classic COVID symptoms like fever and fatigue remain present, NB.1.8.1 adds a painful twist to the mix. Here’s what patients have been reporting:
Healthcare professionals caution that these symptoms can be confused with the flu or seasonal allergies, making early detection more challenging without testing.
Despite its painful symptoms and swift spread, current data suggests that NB.1.8.1 is not more deadly than prior variants. The WHO has emphasized that existing COVID-19 vaccines remain effective at preventing severe disease and hospitalization caused by this strain.
A pre-print study (still pending peer review) also indicates that although the variant demonstrates high immune evasion, the severity of illness appears consistent with previous Omicron variants. That said, under-testing in many parts of the world means the actual scale of spread may be underreported.
Several factors contribute to the rise in COVID cases globally:
Reduced testing and complacency: Fewer people are getting tested for COVID-19 compared to the height of the pandemic, making tracking more difficult.
Seasonal mobility: Increased travel and fewer restrictions may be aiding the variant’s spread.
Vaccine fatigue and rollback of mandates: Recent policy changes, such as the rollback of vaccine recommendations for children and pregnant women in the U.S., could affect future immunization rates.
Dr. Robert F. Kennedy Jr., Health and Human Services Secretary under the Trump administration, recently stated a controversial shift in vaccine recommendations, despite evidence supporting vaccination—especially for pregnant women—to protect both mother and baby.
Health experts explain that COVID-19 vaccines continue to be a first and most important aspect of defense and protection, including against NB.1.8.1. There is no current evidence that the variant undermines vaccine effectiveness against severe illness.
The American College of Obstetricians and Gynecologists (ACOG) also urges pregnant women to stay up to date on their COVID vaccinations, citing strong data showing that vaccinated mothers pass antibodies to their newborns, offering early protection.
While NB.1.8.1 isn’t considered a “variant of concern” yet, its rapid rise in numbers and severe sore throat symptoms have placed it on the global radar. The good news is that existing public health measures—vaccination, hygiene, mask-wearing in high-risk settings—still work.
Individuals who experience persistent throat pain, especially if accompanied by other flu-like symptoms, are advised to get tested and isolate as necessary.
The present guidance from public health officials mirrors what the international community has collectively embraced as received wisdom:
If your sore throat feels unusually painful—like swallowing glass or razor blades, it might be time to test, mask up, and protect those around you.
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The U.S. Health Secretary Robert F. Kennedy Jr. on Wednesday unveiled eight new members to the Advisory Committee on Immunization Practices (ACIP), days after abruptly dismissing the previous 17-member panel. Health and Me had previously reported on the JFK Jr.'s decision to 'retire' the existing members of the ACIP.
This move has stirred concern among doctors, scientists, and public health groups, who fear Kennedy is steering federal vaccine policy in a direction driven more by ideology than science.
The new appointments include individuals known for their skepticism about mainstream vaccine science, including critics of COVID-19 vaccines and public health measures implemented during the pandemic.
Among the new advisers is Dr. Robert Malone, a scientist who once worked on mRNA vaccine technology and later gained notoriety for promoting conspiracy theories about COVID-19 vaccines. Malone has suggested that Americans were “hypnotized” into taking vaccines and claimed the shots cause a form of AIDS—both statements widely debunked by scientific communities.
Also joining the panel is Dr. Martin Kulldorff, a co-author of the controversial Great Barrington Declaration that argued against pandemic lockdowns, and Dr. Cody Meissner, a pediatric infectious disease expert who previously served on both ACIP and the FDA’s vaccine advisory panel.
Vicky Pebsworth, a regional director for the National Association of Catholic Nurses and former board member of the National Vaccine Information Center—often cited for spreading vaccine misinformation—was also appointed.
Public health experts expressed alarm over the new composition. “The previous ACIP was made up of technical experts who have spent their lives studying vaccines,” said Abram Wagner, a University of Michigan public health researcher. “Most people on the current list don’t have the technical capacity we expect from those making complex, science-driven decisions.”
Wagner added that the inclusion of Pebsworth was “incredibly problematic,” due to her association with groups accused of spreading vaccine misinformation.
Despite public concerns, Kennedy stated the committee would not be composed of “anti-vaxxers” but of “credentialed scientists.”
ALSO READ: RFK Jr. Removes Entire CDC Vaccine Advisory Committee
Other appointees include:
The ACIP, created in 1964, advises the CDC on how to use FDA-approved vaccines. While Kennedy promised during his Senate confirmation to uphold the vaccination schedule, he has since overridden ACIP’s guidance. In May, he independently altered COVID-19 vaccine recommendations for children and pregnant women.
On Monday, he dismissed all 17 existing ACIP members, pledging to install a new team before the committee’s next meeting in late June. The upcoming agenda includes key decisions on vaccinations for flu, COVID-19, HPV, RSV, and meningococcal disease.
Kennedy, long a polarizing figure in the vaccine debate, has accused the former panel of being too aligned with pharmaceutical companies. Critics warn that his restructured committee may prioritize politics over public health science.
At just 14 years old, Siddharth Nandyala is already changing the face of modern medicine. A native of Anantapur in Andhra Pradesh in India, living in Frisco, Texas, this young genius is causing global waves with the development of CircadiaV, a revolutionary AI-powered mobile app that can diagnose heart disease within a record seven seconds. With nothing more than a smartphone and sophisticated machine learning, Siddharth's invention has the potential to transform cardiovascular disease screening—one of the globe's top causes of death.
With certification from international tech giants such as Oracle and ARM, Siddharth is officially the world's youngest AI-certified professional but behind the titles and accolades, it's his vision for affordable, early healthcare interventions that really sets him apart. While most teenagers are at the age playing around with social media and video games, Siddharth is addressing medical challenges on a global scale.
Heart disease remains the primary cause of death in the world, resulting in more than 17.9 million deaths annually, as reported by the World Health Organization (WHO). A significant portion of those deaths are avoidable if diagnosed early enough. Unfortunately, the absence of medical diagnostic infrastructure in remote and underprivileged regions—particularly in developing nations—is an enormous challenge.
What sets CircadiaV apart is its non-invasive, fast, and precise method for early detection of heart disease. The app can capture heart sounds by holding a smartphone against a patient's chest. It removes ambient noise, analyzes the audio data through a cloud-based machine learning model, and provides results in seven seconds.
The program can identify various cardiac anomalies, such as:
And it's amazingly precise—with a detection accuracy of more than 96%, as confirmed through testing on over 15,000 patients in America and another 700 in India, including at the Guntur Government General Hospital (GGH).
This application does not substitute for the EKG but is used as a quick, scalable pre-screen," Siddharth said to the Smithsonian Magazine. That clarification is important—it is not intended for consumer use at home or consumer diagnostics, but is designed to assist medical personnel, especially in impoverished environments where full cardiac diagnostics might not be within reach.
That is where CircadiaV comes in. Its low-cost, cloud-based, and portable nature makes it a perfect device for community clinics and frontline health workers. The application can be utilized in rural areas to give an early diagnosis, leading to early referrals and possibly cutting long-term morbidity and mortality.
An initial potential diagnosis in patients otherwise unlikely to have had access to medical treatment may in the end save long-term morbidity and mortality from this disease.
That is, this app could literally be a lifesaver—particularly for patients in rural towns, refugee camps, or even wartime zones where cardiologists and expensive diagnostic technology are scarce.
Siddharth's foray into innovation had not begun with CircadiaV. Prior to this, he had created a low-cost prosthetic arm, a innovation to enhance mobility for individuals with limb loss in underprivileged communities. He also had started STEM IT, a company that creates science and technology kits for children, enabling experiential STEM learning across socioeconomic barriers.
His success has already seen him receive national and international acclaim, including a Certificate of Recognition from the US House of Representatives and a congratulatory letter from President Joe Biden.
And although he is as old as some of his classmates are young, Siddharth has just become a computer science major at the University of Texas. And his goals don't end there. He hopes to make CircadiaV capable of not just detecting lung diseases like pneumonia and pulmonary embolism, but also of analyzing recordings of lung sounds just like the app presently analyzes heart sound recordings.
Clinically, prompt detection is the key to success with cardiovascular treatment. Most terminal cardiac illnesses—such as congestive heart failure or severe coronary artery disease—are salvageable if detected early. But when symptoms intensify, choices narrow, and survival rates plummet.
By providing healthcare professionals with an advantage with CircadiaV, Siddharth is delivering:
Consider the following: a community health worker in a remote village in India uses a smartphone to identify early-stage heart failure in a 55-year-old man. Rather than waiting weeks for a cardiology visit, that patient can be expedited for further testing and treatment—saving his life.
The app is particularly useful for terminal heart patients whose survival chances raise significantly if the condition is detected at the asymptomatic or initial phases. With correct warnings regarding the development of arrhythmias or valve malfunctions, the technology enables physicians to act before it is too late.
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