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
Credits: Canva
The United States Food and Drug Administration has recently approved cabozantinib (Cabometyx) for patients with previously treated advanced neuroendocrine tumors. This is an oral tyrosine kinase inhibitor, which is offering a new standard for care of this patient group. This has been announced by the Dana-Farber Cancer Institute.
The approval came on the bases of the results from the phase 3 CABINET study. The study compared cabozantinib to a placebo in patients with advanced pancreatic neuroendocrine tumors.
As per the National Cancer Institute, neuroendocrine tumor grows from neuroendocrine cells. These cells receive and send messages through hormones to help the body function. These cells are found in organs throughout the body. The neuroendocrine tumor was called carcinoid tumor
These tumors grow very slowly and are mostly found in appendix, also known as appendiceal neuroendocrine tumors. When found in lungs, they are also called bronchial tumors. These areas are more common in children and young adults. Whereas for adults, it is mostly found in the digestive tract, called the GI neuroendocrine tumor. What makes it concerning is that it can also spread to other parts of the body but does so more in adults than in children.
They are rare in children and more common in adults, affecting up to 4 in 100,000 adults.
The drug which FDA has approved based on the phase 3 CABINER study's results have been published last September in the New England Journal of Medicine. Patients who were treated with cabozantinib survived significantly longer with no worsening of their disease compared with patients who received placebo. This also improved the efficacy as was observed in the interim analysis. The trial was in fact terminated early and unblinded in August 2023.
The reported side effects of cabozantinib were similar to those found in other studies of the drug. They include:
"Patients with neuroendocrine tumors often face a difficult journey," lead author of the CABINET study, Jennifer Chan, M.D., M.P.H., of the Dana-Farber Cancer Institute, said in a statement. "Despite advances in recent years, there has remained a critical need for new and effective therapies for patients whose cancer has grown or spread. Cabozantinib significantly improved outcomes in this patient population and this FDA approval provides new hope."
While some people have symptoms, others may do not have any symptoms. These symptoms depends on where in your body the tumor has grown.
Patients who have appendiceal neuroendocrine tumors may have symptoms of appendicitis, such as pain in abdomen. They could also be later diagnosed with carcinoid tumor in case the doctor removes the appendix and finds a tumor. Patients with carcinoid tumor in other parts of the digestive tract may have symptoms such as:
Other ways to detect is by lab tests, imaging, and biopsy.
For most women, this reality is what menopause feels like, a time when hormonal changes impact everything from sleep routines to mood stability. Oprah Winfrey recently shared her own personal battle with menopause, exposing how it left her unable to read her favorite books or even host her famous book club. In a candid conversation, Winfrey explained how the overwhelming symptoms—especially heart palpitations and an inability to concentrate—left her feeling like she was “literally going to die every single night.”
It’s a topic that’s often kept behind closed doors, but menopause affects millions of women globally. According to the National Institute on Aging, menopause is reached when a woman has had no period for 12 months in a row, normally between the ages of 45-55, and may create a variety of symptoms ranging from hot flashes to emotional upset. Oprah's announcement of her own menopause experience highlights the not-so-well-known symptoms and raises awareness of the need for greater information and support. Let's take Oprah's journey and see how we can learn more about and cope with this natural but too-often-misunderstood phase of life.
But media mogul Oprah Winfrey is breaking that. In a recent interview, Winfrey, 71, spoke candidly about her own menopause experience, describing an ordeal so overwhelming that she thought she was "going to die every single night."
Winfrey's confession is not simply another celebrity revelation—it's a wake-up call for millions of women across the globe who suffer from menopausal symptoms in ignorance, without proper medical attention, or public support.
Menopause, that phase of life when a woman's menstrual cycle permanently ceases because of the decrease in estrogen and progesterone levels, is usually coupled with symptoms of hot flashes and night sweats. But in Winfrey's case, it was different—though no less unsettling.
One of the most surprising and disturbing symptoms that she experienced was one of inattention. An avid reader since childhood and the face of Oprah's Book Club, she discovered that she couldn't read.
The worst for me, this is when I realized I really was in trouble, is when I couldn't focus reading," Winfrey explained to ABC News' Kayna Whitworth. "I adore reading so much, but I abandoned the book club because I could not focus when I was reading. I could no longer complete a book.
It wasn't until she began hormone therapy with estrogen that she regained her concentration. "I brought back [the book club] when I began taking estrogen because I could concentrate again, but I actually never mentioned that before," she confessed. "It makes me want to cry."
Although night sweats and hot flashes are universally acknowledged as symptoms of menopause, other physical and psychological consequences tend to go unmentioned. Winfrey felt palpitations of the heart—a symptom she never correlated with menopause.
"I did not have night sweats, and I did not have hot flashes, but I had never heard that palpitations [were] a symptom of menopause," she explained. "When I was going through it, there was nothing. There was nobody."
This absence of knowledge concerning the entire range of menopausal symptoms is a crucial concern. Menopause influences each woman uniquely, with some suffering from anxiety, depression, insomnia, mental fogginess, or even arthritis, says the National Institute of Health (NIH). And though it touches everyone equally, menopause has been among the least talked about and most under-studied topics in women's health.
Committed to making sure that other women do not have to endure in silence, Winfrey is leveraging her platform to ignite a long-overdue discussion. Her new Hulu special, An Oprah Winfrey Special: The Menopause Revolution, seeks to inform and empower women on menopause, offering expert advice and real-life stories to guide them through this stage of life with confidence.
She also tweeted to highlight how crucial it was to discuss menopause. "When I underwent menopause, I couldn't sleep for two years. I couldn't concentrate. I couldn't read my favorite books. I had heart palpitations. Nobody informed me about this. Now we're discussing it, so no woman suffers," she posted on Facebook.
Winfrey's advocacy is part of a larger effort to make menopause conversations mainstream and better healthcare responses. Women should have access to proper information and healthcare providers who seriously consider their symptoms.
Winfrey's experience teaches an important lesson: women need not be afraid to get a medical consult when they are experiencing symptoms of menopause. "Because it hits every cell in your body, the first time you have any of the symptoms, that's when you need to go go find a doctor who will hear you, listen to you, and take action for you," she encouraged.
Far too frequently, women's menopausal symptoms are downplayed, and they must cope with the changes by themselves. Professionals advise going to see a gynecologist or a menopause specialist as early as perimenopause—the pre-menopause phase—so that possibilities such as hormone therapy, lifestyle modifications, and other forms of treatment can be discussed.
Oprah Winfrey's honest narrative about her battle with menopause is a call to change the way society understands and responds to this natural phenomenon. It's about tearing down the taboo and myth surrounding menopause so that future generations of women will be better equipped and empowered.
With powerful voices such as Winfrey at the forefront, menopause is no longer a silent battle—it's a dialogue that must be heard.
(L to R) Lt Gen Dr Vimal Arora; Rakesh Sharma with Soyuz T-11 crew (source: Russian House, New Delhi)
In an exclusive interview with Health and Me, Lt Gen Dr. Vimal Arora who is the Chief Clinical Officer (CCO) at Clove Dental talked about his experiences of treating the former Presidents of India and the time when he served as one of the doctors at the Air Force Institute of Dental Sciences in Bengaluru.
In 1982, Rakesh Sharma was selected as a cosmonaut for a joint Soviet-Indian spaceflight. With him, ex IAF Pilot Ravish Malhotra was also selected who was trained to fly on that mission as a backup for Rakesh Sharma. For this mission, Sharma was rigorously trained at Moscow's Yuri Gagarin Cosmonaut Training Center for two years. He also underwent a test for claustrophobia in Bengaluru's Indian Air Force facility with being locked in a room for 72 hours for the test.
It was there only when Dr Arora had come across the case. "I was young in Bengaluru, and we had these India astronauts who would go along with Russian astronauts and the medical were also going on. At that time, I distinctly remember Rakesh Sharma and Ravish Malhotra and only one of them were supposed to go," he shares.
It was there when Dr Arora got caught in a debate with regards to their medical checkup. It was on whether the astronauts should have their wisdom tooth removed.
"Their dental checkups were done and we were told that their wisdom teeth had to be taken out. We were fighting with them (Russian doctors)," Dr Arora shares.
"I said, 'they are perfectly fine, why is there a need to extract their tooth? It is not going to cause any trouble.' But it was made very clear from the Russians and their team of doctors and dentists that wisdom teeth must be removed."
The reason for this was, as Dr Arora explained, the astronauts, the mission and everyone else who have invested in the spaceflight could not let a wisdom tooth ache become a issue to cancel the trip. Even if there is a chance that this may cause tooth pain, the trip had to be called back and the team could not afford that.
"This is when I learned the wisdom tooth has to go away. It was a different lesson for me at that time," he shares.
After that, Dr Arora says that many more things had enlightened him, including the first intra oral full mouth x-ray machines which had also been imported there.
He says that dentistry has changed unimaginably. The amount of technology that dentists used is not used in any other health sector.
His experiences do not just end there. He has also treated the former Presidents of India including Dr APJ Abdul Kalam and Dr Pranab Mukherjee.
"What makes them stand apart was the simplicity with which they treated the doctor. I remember that I was more nervous when I had to talk to Dr Kalam. But he always had this child-like simplicity and child-like curiosity. He always left with some kind of messages and it gave me a different lesson in my life."
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