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Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months

In the News, News Stories & Editorials, We're In the News

Tristan Manalac, BioSpace, March 9, 2026

The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.

The FDA’s Oncologic Drugs Advisory Committee will meet at the end of April to discuss two of AstraZeneca’s cancer drug applications—one seeking approval in breast cancer and another requesting a label expansion in prostate cancer.

The panel of outside experts is scheduled to convene on April 30, according to a Federal Registry posting, breaking what will be more than nine months of silence for the Committee. The ODAC, as the board is more commonly known, last met in July 2025.

The April meeting will be a whole-day affair, according to the registry notice. The morning session will focus on AstraZeneca’s new drug application for the oral SERD drug camizestrant, in combination with a CDK4/6 blocker such as Pfizer’s Ibrance or Novartis’ Kisqali, for HR-positive, HER2-negative breast cancer in the first-line setting.

[….]

Despite acing its target outcomes, analysts at Leerink Partners expressed concerns about how SERENA-6 was designed. “Importantly, the trial does not answer if intervening earlier, leveraging serial diagnostics to detect the early emergence of [ESR1 mutations], provides a longer-term benefit to patients rather than front-loading a benefit that could have eventually occurred in a later line,” they wrote in a note to investors on Friday.

In addition, while oral SERDs have become the standard of care for second-line therapy in ESR1m breast cancer patients, SERENA-6 “did not have an oral SERD widely used in the 2L and crossover to [camizestrant] was not permitted.”

[….]

During the afternoon session on April 30, the FDA’s cancer committee will discuss AstraZeneca’s bid to expand its AKT inhibitor Truqap to treat metastatic hormone-sensitive prostate cancer. Data from the Phase 3 CAPItello-281 trial showed that the drug plus abiraterone significantly improved radiographic progression-free survival versus placebo plus abiraterone.

The Phase 3 CAPItello-280 study of Truqap was halted in April 2025, however, as an independent data monitoring committee concluded that a combination regimen of the drug with docetaxel and androgen-deprivation therapy would miss its primary endpoints of overall survival and progression-free survival in patients with metastatic castration-resistant prostate cancer.

The ODAC meeting in April comes amid mounting criticism of FDA panels, which according to experts, have grown increasingly unbalanced and devoid of nuance.

In a September 2025 interview with BioSpace, for instance, Diana Zuckerman, president of the nonprofit National Center for Health Research, blasted a July 2025 expert panel on the use of selective serotonin reuptake inhibitors in pregnancy, which she said put too much emphasis on the potential harms of these drugs and not enough on their benefits.

“They didn’t want any nuance. It seemed they didn’t want any real difference of opinion,” she said.

To read the entire article, click here Two AstraZeneca Drugs To Be Scrutinized in First FDA Cancer Advisory Panel in 9 Months – BioSpace

Prasad Out At FDA, Turning Critics’ Focus Back To Makary

In the News, News Stories & Editorials, We're In the News
Jessica Karins and Maaisha Osman, Inside Health Policy, March 06, 2026

FDA’s polarizing and high-profile biologics chief Vinay Prasad is leaving the agency for the second time since his tenure began a year ago, and this time his departure may be permanent, after yet another controversy over rare disease approvals spilled into public view and cast new doubts on Prasad and Commissioner Marty Makary’s leadership. Makary’s next pick to run the biologics center is viewed as a make-or-break decision for his commissionership.

A House Energy & Commerce Committee Democrat who is vocal on FDA issues told Inside Health Policy the next goal for the agency’s critics could be ousting the commissioner. “Prasad is Makary’s man and Makary’s failure. Makary’s seat is hot and now we need a hearing to make it hotter,” Rep. Jake Auchincloss (MA) said.

In a social media post, Makary spun the departure as a planned return to Prasad’s family and academic committees after a one-year leave of absence from the University of California San Francisco, saying he has accomplished lasting reforms at the agency. Prasad had not previously mentioned plans to spend only a year at FDA.

The latest controversy for the Center for Biologics Evaluation and Research was its decision not to approve a Huntington’s disease gene therapy from UniQure, followed by anonymous statements from FDA officials to the media that left industry fuming. But that was one in a string of rare disease decisions under Prasad that angered industry and other FDA stakeholders. He also made several decisions on vaccines that were unpopular with regulated industry and public health stakeholders, including refusing to review Moderna’s mRNA influenza vaccine. He made headlines for claiming FDA had linked COVID-19 vaccines to multiple pediatric deaths, then never publicized promised data.

[….]

Many members of Congress have already criticized the agency under Makary’s leadership for what they see as inconsistent or inappropriate demands placed on rare disease drugmakers. Auchincloss said at an event earlier this week that Makary and Prasad should both be fired.

The dispute with UniQure centers around FDA asking the company to do a follow-up trial of its gene therapy that would require placebo surgery. FDA officials say the surgery isn’t risky or invasive; but UniQure and many Huntington’s disease patient advocates say it is. The anonymous FDA official said on the call with press UniQure’s original trial offered a “distorted or manipulated comparison,” and an HHS spokesperson told the Washington Post UniQure “lied” about what FDA wants from a second trial.

[….]

The dispute was viewed as not boding well for Prasad’s leadership at the biologics center. He had already left FDA for a short period once, amid controversy over a different gene therapy, before rejoining the agency. Another Makary appointee, George Tidmarsh, was accused of using his position to pursue a “bizarre personal vendetta” against a regulated company and left the agency permanently.

The backlash to the UniQure situation from rare disease stakeholders also isn’t a good sign for buy-in to FDA’s plausible mechanism pathway, which Makary has touted as evidence of a flexible regulatory flexibility but appears to offer more flexibility in theory than the agency is offering in practice.

Diana Zuckerman, president of the National Center for Health Research, told IHP Prasad’s departure from CBER represents a setback for efforts to strengthen scientific rigor in the agency’s regulatory decisions. She said Prasad brought a focus on scientific evidence that many researchers and policy experts have long argued has been missing at senior levels of FDA.

Zuckerman said that across several administrations, the agency has increasingly emphasized “customer service,” with industry too often treated as the primary customer rather than patients and public health. While she acknowledged that Prasad’s decisions and outspoken criticism of the agency drew opposition from industry groups, some rare disease advocates and even FDA staff, she said independent researchers have repeatedly raised concerns that FDA has approved costly medical products that are ineffective or unsafe.

In her view, the agency’s reliance on more “flexible” approval standards for products that lack clear evidence of benefit is contributing to rising health care costs and straining federal programs such as Medicare and Medicaid. “I think Dr. Prasad leaving is a loss for the FDA, for patients, and for Medicare and Medicaid,” Zuckerman said. 

To read the entire article, click here: https://insidehealthpolicy.com/inside-drug-pricing-daily-news/prasad-out-fda-turning-critics-focus-back-makary

Divisive F.D.A. Vaccine Regulator Is Resigning

In the News, News Stories & Editorials, We're In the News

Christina Jewett, The New York Times (and syndicated at many other media outlets), March 6, 2026

Dr. Vinay Prasad, a polarizing figure at the Food and Drug Administration who oversaw vaccines, is leaving the agency at the end of April, according to a Health and Human Services spokesman.

As the agency’s chief science and medical officer, Dr. Prasad had wide-ranging authority over vaccines, drugs and gene therapies. He issued several controversial decisions, including overruling career scientists on some vaccine approvals and cracking down on a biotech company linked to two teenagers’s deaths.

In one of the most highly publicized moves, Dr. Prasad refused to accept Moderna’s application for a new mRNA flu vaccine, causing an uproar among companies and some experts who complained he was too often moving the goal posts on studies that had been OK’d by the agency. Within days, Dr. Marty Makary, the agency’s commissioner, reversed the decision after the company agreed to conduct another study.

And in recent months, he had issued a series of rejections for treatments of rare diseases, increasingly upsetting patients who have few options and biotech companies invested in developing cures.

Many of those decisions were made with little warning. He shied way from public advisory panel meetings on drugs under review, rebuffing calls for greater transparency. Dr. Prasad has criticized those forums, saying that the drug industry manipulated public opinion.

[….]

“[His]reforms represented a tremendous body of work achieved in a remarkably short period of time,” Dr. Makary wrote. “They are substantive, durable changes that will shape the agency’s approach for years to come and stand as part of Vinay’s lasting legacy here.”

Leaders in the biotech and investor communities had long pressed the White House for his ouster.

However, Diana Zuckerman, a close observer of the F.D.A. and president of the nonprofit National Center for Health Research, said Dr. Prasad’s decision to leave was a loss to independent researchers who had “hoped he would help strengthen the public health mission of the F.D.A.”

“F.D.A.’s ‘flexible’ standards for approving products that are not proven to work are resulting in an unsustainable health care system,” she said, noting the cost of failed therapies to Medicare and to patients.

Before joining the agency, Dr. Prasad was an academic at the University of California, San Francisco. He was known for criticizing the F.D.A., saying its drug review officials were too permissive in issuing approvals.

He has also been described as a Covid contrarian after complaining on podcasts and on his YouTube channel about public health measures that he deemed ill-informed by medical evidence.

But he and Dr. Makary broke with Mr. Kennedy on whether pregnant women should get the vaccine, including pregnancy as a condition warranting vaccination, in an article in The New England Journal of Medicine.

[….]

Last summer, after a second teenager died from liver-related complications from a therapy for Duchenne muscular dystrophy, Dr. Prasad demanded that the manufacturer, Sarepta, stop distributing the drug. The company pushed back, and the agency settled on keeping the drug from older children who were more likely to be harmed by it.

[….]

The Department of Health and Human Services held a background briefing on Thursday about the latest controversial decision, against a treatment for Huntington’s disease.

[….]

In a social media post Friday evening, Dr. Makary said that Dr. Prasad would be resuming his work in California and that a successor would be announced before he leaves.

To read the entire article, click https://www.nytimes.com/2026/03/06/health/fda-prasad-resigns.html?nl=breaking-news&segment_id=216275

Are Prostate Cancer Screenings Necessary? The Pros and Cons

Prostate Cancer

Farmin Shahabuddin, MPH, Shahmir H. Ali, ABD, Brandel France de Bravo, MPH, and Nicholas J. Jury, PhD

Prostate cancer is the second leading cause of cancer deaths for men in the United States, after lung cancer. One in every eight men will be diagnosed with prostate cancer in his lifetime.1 Most cases are in men 65 and older, and most deaths occur in men 75 and older.2 Annual screenings would seem to be an important way to prevent prostate cancer. However, it may surprise you that many experts, including the U.S. Preventive Services Task Force (USPTF), do not recommend men over 70 to get screened for prostate cancer.3 For men ages 55 to 69, it doesn’t recommend for or against screening, but instead recommends talking to their doctor about whether screening is right for them.

In fact, even if screening leads to a diagnosis of prostate cancer, it often does not require any treatment. That is why there is a hot debate within the medical community: Are prostate cancer screenings a good idea, and if so, for which men? This article discusses the available tests and the benefits and harms of getting tested for prostate cancer. It also describes a study published in 2026 that may help guide PSA screenings.

Are Prostate Cancer Screenings Accurate?

Prostate cancer occurs when small tumors develop in the prostate gland, which is an important part of the male reproductive system. Screening can be performed quickly and easily in a physician’s office using either of two tests: a blood test, called prostate-specific-antigen (PSA) test, and the digital rectal exam (DRE), a manual exam of the prostate area.

Unfortunately, prostate tests are often inaccurate. Both the PSA and DRE result in many false positives (when the test shows a man has prostate cancer who does not have prostate cancer) and false negatives (when a test shows a man does not have prostate cancer but he actually does have prostate cancer). Using both screening methods together will miss fewer cancers but also increase the number of false positives, which then results in more testing, such as biopsies that involve inserting a needle through the rectum.  Biopsies can possibly result in medical complications.

Researchers are also trying to determine if other types of testing might be more accurate in detecting prostate cancer.  One study of more than 5,500 men examined whether the rate of change in PSA levels when a man has multiple tests over time (also called “PSA velocity”) could improve cancer detection compared to standard (single blood test) PSA and DRE screening tests.4 They found that high PSA velocity often resulted in biopsies that did not improve cancer detection.

A New Way to Consider PSA Test Results

A study published in 2026 may help men and their physicians decide to rely on one PSA test in their 50’s to decide whether or not to have PSA tests after that. The researchers reported that one-tenth of 1% (0.1%) developed cancer within 5 years, just over half a percent (0.6%) within 10 years, and 3.3% within 20 years.  This clearly suggests these men can safely avoid PSA tests for many years.  Prostate cancer rates were also low for the 958 men with intermediate PSA levels (1.00-3.00 ng/mL): 1.4% at 5 years, 5.0% at 10 years, and 11.8% at 20 years.  In contrast, the 211 men with PSA levels greater than 3.00 ng/mL were much more likely to be diagnosed within 5 years (14.5%), 10 years (28.3%) and 20 years (34.8%).16

Do Prostate Cancer Screenings Save Lives?

Given these results, most men would feel comfortable waiting at least 5 years for another PSA test if the initial test was below 3.00 ng/,=mL). But as those test scores increase, you might think screening every few years would lead to earlier detection, earlier treatment, and a lower chance of death, since prostate cancer is usually curable (90% or better) if detected early. Surgery or radiation aim to remove or kill all cancerous cells in the prostate. If not detected and treated early, the cancer may spread beyond the prostate and can be fatal.

However, research has shown conflicting conclusions.  We examined the best research and found that whether prostate cancer screening saves lives depends on how exactly “screening” is defined, as well as how survival is measured. For example, a study of 76,000 American men aged 55-74 found that men who screened for prostate cancer every year were not any less likely to die of prostate cancer during the 7 years of the study than those receiving “usual care” (defined for most as at least one screening during those years).5,6

In contrast, a different study of 182,000 European men aged 50-75 found that men who received “regular screening” (every 2-4 years, depending on the European country) were less likely to die of prostate cancer during the 13 years of the study than those who did not have any screening.7,8  And yet, the men who were regularly screened did not live longer than those who didn’t, because they died of other causes.  That’s important to know, because the goal of screening is to live longer, not to prevent death from just one particular disease.

Newer research provides additional important information. In a study published in The New England Journal of Medicine in 2025, researchers in Europe followed more than 160,000 men for 23 years to see whether PSA screening saves lives. The study found that 14% of men who underwent an average of 2 PSA tests were diagnosed with prostate cancer, compared to 12% who did not have any screening PSA tests. Only 1.6% of the men who did not have PSA screening died of prostate cancer, compared to 1.4% who had PSA screening. 9

The researchers pointed out that deaths from other causes were much higher: about 49% of men in both groups died of other causes, showing that many men who develop prostate cancer may ultimately die from something else. This is why experts point out that prostate cancer is rarely fatal, and many men who develop prostate cancer will die from something else. That raises the question of whether screening does more harm than good.

Why don’t PSA Screening Programs save more lives?

As the 2026 study of one PSA screening of men between 45-70 (median age of 54) shows that most men will not benefit from frequent PSA screenings. A compromise could be for men to have one PSA test around age 45-70 and decide whether to continue PSA screenings for the next 10-20 years depending on the results of that test.

Prostate cancer usually grows so slowly that it is often equally safe to screen only when there are symptoms, rather than screening based on PSA or DRE results.  Symptoms of prostate cancer can include urinary problems, difficulty having an erection, or blood in the urine or semen. If a man has prostate cancer without any symptoms, he may not need to be treated. In fact, experts estimate that half the men who are diagnosed with prostate cancer would not have any symptoms in their lifetime, and 80-85% would not die of the disease within 15 years of diagnosis, even if they were not treated.10 

The New England Journal of Medicine study researchers point out that the complications of prostate cancer treatment, which include erectile dysfunction and incontinence, continue to be a concern, given the relatively small chances that PSA screening will save a man’s life.  The study also found that for every 1,000 men who were screened, about 27 more were diagnosed with prostate cancer that may never have caused symptoms or shortened their lives. The numbers probably would have been higher if the men had undergone more frequent PSA tests, since most of the men in the study only underwent two. More frequent PSAs would be expected to result in more unnecessary biopsies and treatments that carry their own risks, as noted above.

That’s exactly why experts do not agree that screening with a PSA or DRE test saves lives. For men who were diagnosed with prostate cancer, the chances of dying from the prostate cancer within 10 years of diagnosis were about 3 in 10,000 (that’s less than half of one percent), whether the men had a PSA screening or not.11 This means that although a PSA test will detect prostate cancers before any symptoms appear, often those cancers would never have become harmful. Experts say the findings show that PSA screening can save more lives but should be used carefully, focusing on men who are most likely to benefit while avoiding unnecessary testing in those at low risk.  Having one PSA test in one’s 50’s can help determine who is most likely to benefit from frequent PSA screenings and those who will not.

Can Prostate Cancer Screenings Do Harm?

Aside from not providing a significant benefit to many men, prostate cancer screening may be harmful. These harms can include 1) inaccurate results leading to unnecessary biopsies and complications, 2) complications and high costs associated with unnecessary treatment, and 3) serious side effects from treatments (such as urinary incontinence and impotence).12 In fact, a 2018 study based on data from 721,718 men across 5 clinical trials estimated that for every 1000 men screened for prostate cancer, screening-related complications will result in 1 person being hospitalized for sepsis, 3 requiring pads for urinary incontinence, and 25 reporting erectile dysfunction.13

These serious side effects from prostate cancer treatment are the reason why many men with prostate cancer choose “active monitoring” instead of treatment.  Active monitoring usually involves visiting a doctor for a PSA test every 6 months and a DRE at least once a year. However, even being asked to actively check on your symptoms during the years after being diagnosed with prostate cancer can have a detrimental psychological impact.  Men who were diagnosed with low-risk prostate cancer who were asked to monitor their symptoms reported significantly higher anxiety than those without cancer or those currently in treatment.14

It is also important to acknowledge that the harms of prostate cancer screening are disproportionately impacting some communities more than others. A 2018 study revealed that Black men were more likely to receive a false-positive PSA test and undergo a biopsy than white men.15 For more information on racial differences in prostate cancer, read our article linked here.

The Bottom Line

Based on the current evidence, U.S. experts continue to conclude that prostate cancer screenings often provide very little benefit and can be harmful.  Doctors and scientists are searching for better tests, such as using family history of prostate cancer to influence the time and frequency of recommended PSA screenings. However, the impact of such efforts on reducing deaths from prostate cancer remains unknown, and so do the likely harms. Therefore, the best thing to do is talk with your doctor about whether getting a prostate cancer screening is truly right for you.

References

  1. Key Statistics for Prostate Cancer | Prostate Cancer Facts. Accessed June 29, 2022. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
  2. Cancer of the Prostate – Cancer Stat Facts. SEER. Accessed June 29, 2022. https://seer.cancer.gov/statfacts/html/prost.html
  3. US Preventive Services Task Force, Grossman DC, Curry SJ, et al. Screening for Prostate Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2018;319(18):1901. doi:10.1001/jama.2018.3710
  4. Vickers AJ, Till C, Tangen CM, Lilja H, Thompson IM. An empirical evaluation of guidelines on prostate-specific antigen velocity in prostate cancer detection. J Natl Cancer Inst. 2011;103(6):462-469. doi:10.1093/jnci/djr028
  5. Andriole GL, Crawford ED, Grubb RL, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-1319. doi:10.1056/NEJMoa0810696
  6. Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO). Division of Cancer Prevention. Published July 1, 2014. Accessed July 19, 2022. https://prevention.cancer.gov/major-programs/prostate-lung-colorectal-and-ovarian-cancer-screening-trial
  7. Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate cancer mortality: results of the European Randomised Study of Screening for Prostate Cancer (ERSPC) at 13 years of follow-up. The Lancet. 2014;384(9959):2027-2035. doi:10.1016/S0140-6736(14)60525-0
  8. Schröder FH, Hugosson J, Roobol MJ, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360(13):1320-1328. doi:10.1056/NEJMoa0810084
  9. Bassett, M. (2025, October 29). PSA screening reduces prostate cancer deaths, long-term data show. MedpageToday. https://www.medpagetoday.com/hematologyoncology/prostatecancer/118218
  10. Mulhem E, Fulbright N, Duncan N. Prostate Cancer Screening. afp. 2015;92(8):683-688.
  11. Ilic D, Djulbegovic M, Jung JH, et al. Prostate cancer screening with prostate-specific antigen (PSA) test: a systematic review and meta-analysis. BMJ. 2018;362:k3519. doi:10.1136/bmj.k3519
  12. Sanda MG, Dunn RL, Michalski J, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008;358(12):1250-1261. doi:10.1056/NEJMoa074311
  13. Ruane-McAteer E, Porter S, O’Sullivan J, Dempster M, Prue G. Investigating the psychological impact of active surveillance or active treatment in newly diagnosed favorable-risk prostate cancer patients: A 9-month longitudinal study. Psychooncology. 2019;28(8):1743-1752. doi:10.1002/pon.5161
  14. Miller EA, Pinsky PF, Black A, Andriole GL, Pierre-Victor D. Secondary prostate cancer screening outcomes by race in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Screening Trial. The Prostate. 2018;78(11):830-838. doi:10.1002/pros.23540
  15. Miller, E. A., Pinsky, P. F., Black, A., Andriole, G. L., & Pierre-Victor, D. (2018). Secondary prostate cancer screening outcomes by race in the Prostate, Lung, Colorectal, and Ovarian (PLCO) Screening Trial. The Prostate, 78(11), 830–838. https://doi.org/10.1002/pros.23540

  16. Lindholz M, Bülow R, Schoots IG, et al. Clinical and Liquid Biomarkers of 20-Year Prostate Cancer Risk in Men Aged 45 to 70 Years. JAMA Netw Open. 2026;9(2):e2556732. doi:10.1001/jamanetworkopen.2025.56732

Sleep Better Tonight: A Guide for Cancer Patients and Survivors

Diet, Habits, & Other Behaviors, Quality Of LIfe

Farmin Shahabuddin, MPH, National Center for Health Research

Many cancer patients (and their loved ones) experience insomnia, which is defined as having trouble falling and/or staying asleep.1 If this is a problem for you, you are not alone. Lack of sleep can make us tired, make it difficult to concentrate, and make it difficult to deal with any issues that arise, and can increase our chances of developing other health problems.2 Most cancer patients with insomnia are prescribed sleep-aid medications, which can have unpleasant side effects, such as memory problems and other health risks.1 Before reaching for the medicine cabinet, there are natural strategies that can help you get the rest you need. This guide combines the latest research and expert recommendations to help cancer patients and survivors sleep without the need for pills.

Your Plate Is Your Sleep Aid: How Diet Affects Rest

One of the simplest and most overlooked ways to improve sleep is already in your kitchen. Research shows that foods and dietary patterns that improve sleep tend to be lower in sugar and saturated fat and higher in fiber.3

The Sleep-Friendly Menu

A Mediterranean-style diet, which is rich in fruits and vegetables, lean meat, olive oil, vegetable fats, and whole grains, has shown promising results for sleep. A 2020 study followed more than 400 women based on a sleep questionnaire that measured overall sleep quality and found that those who followed this eating pattern most closely had 30% fewer sleep problems as measured by a sleep questionnaire than those who did not.3

Foods that promote better sleep:3,4

  • Fruits and vegetables (promote relaxation)
  • Beans and lentils (the more servings, the better the sleep quality)
  • Whole grains
  • Nuts, seeds, and leafy greens
  • Lean meat, olive oil, and vegetable fats

Your gut and your brain work as a team. When you eat more fruits, vegetables, nuts, and other plant-based foods that are high in fiber, the good bacteria in your gut stay balanced and healthy. This helps your body relax and know when it is time to sleep, which may help you sleep better.3

Sleep Disruptors: What to Skip

Research found that eating more sugar, refined carbs, and saturated fat made people take longer to fall asleep and spend less time in deep, restorative sleep.4

Foods and drinks that disrupt sleep:3,4

  • Sugary snacks and drinks
  • Highly processed packaged foods
  • Chocolate (contains caffeine)
  • Alcohol (it makes you drowsy initially but disrupts sleep later)
  • Acidic foods like citrus, which can cause heartburn
  • Spicy foods

A study of almost 500 women found that those who took more than an hour to fall asleep consumed over 400 calories more per day and consumed more sugar, more saturated fat, and less fiber compared to those who fell asleep within 15 minutes.3

Creating the Perfect Sleep Environment

Cool, Dark, and Quiet

Your bedroom directly affects your sleep quality. Ideally, you want a quiet, dark, cool environment, all of which help you fall asleep more quickly.4 Temperatures between 65-70 are usually ideal, but keep in mind that biological differences mean that men tend to like cooler temperatures than women.

Wear Socks To Bed?

This may seem like a strange idea, but it works. As our body makes more melatonin near the end of the day to prepare us for sleep, our body temperature starts to drop. Wearing socks can help a natural process that increases the flow of blood to your hands and feet, warming them. The nonprofit Sleep Foundation points out that socks can help you fall asleep more quickly and even help you stay asleep.5 Of course, your socks should not be tight (you don’t want to cut off circulation!), and to prevent sweating feet, we recommend sleeping in cotton socks (100% cotton if possible) that are relatively lightweight.

The Light Fight: Winning the Battle Against Blue Glow

Melatonin is a hormone that is naturally released in the brain a few hours before we feel a sense of sleepiness. Light from phones, laptops, and TVs prevents melatonin from being released, making it hard to fall asleep.4 If you use your computer, smartphone, or tablet before bedtime, the blue and green light from these devices can neutralize melatonin’s effects. If you watch television, be sure you are at least six feet away from the screen.6 Even going to the bathroom in the middle of the night can make it harder to go back to sleep, so try using a flashlight to reduce the impact of the light. Unfortunately, if you wake up for a bathroom break, it is completely normal to take up to 30 minutes to drift back to sleep.6

Clock Work: Timing Your Way to Better Sleep

Harness the Power of Daylight

You can help program your body to produce melatonin for sleep at the right time of day by getting exposure to daylight during the morning and afternoon. Take a walk outside or sit beside a sunny window.4 Morning activity that exposes you to bright daylight will help your natural circadian rhythm.6

The Goldilocks Rule for Eating

Going to sleep hungry can keep you awake, but so can eating before bedtime. Avoid eating a big meal within two to three hours of bedtime. If you are hungry right before bed, eat a small, healthy snack (such as an apple with a slice of cheese or a few whole-wheat crackers) to satisfy you until breakfast.4

Rituals That Rock You to Sleep

When you were a child, and your mother read you a story and tucked you into bed every night, this comforting ritual helped lull you to sleep. Even in adulthood, a set of bedtime rituals can have a similar effect. Rituals help signal to the body and mind that it is time for sleep. Drink a glass of warm milk. Take a bath. Or listen to calming music to unwind before bed.4

Move It to Snooze It: Exercise and Sleep

Physical activity, even gentle movement like a short walk, can help you sleep better at night. Exercise boosts the effect of natural sleep hormones such as melatonin.4 However, timing matters: aerobic exercise releases endorphins, which are chemicals that keep people awake. If you are having trouble sleeping, try to avoid vigorous activity within two hours of bedtime.6 Of course, check with your doctor about what level of physical activity is right for you during treatment or recovery.

Breaking the Sleep Anxiety Cycle

One of the most effective ways to overcome sleep problems is cognitive behavioral therapy for insomnia. This type of therapy helps people understand how their thoughts, habits, and routines affect their sleep.7 It focuses on changing behaviors that interfere with sleep, such as spending too much time in bed awake with unhelpful thoughts, whether worrying about your health or the health of a loved one, or even worrying that not getting enough sleep will make you feel worse the next day.

A review of studies found that cognitive behavior therapy is effective for reducing insomnia in cancer survivors.8 In addition, a 2019 study from Memorial Sloan Kettering Cancer Center found that the therapy helped reduce insomnia in cancer survivors, and also helped patients reduce their use of sleep aids even 20 weeks after finishing treatment. About 25% of patients were using at least one prescription sleep aid at the beginning of the study, but only 17% used the medication 20 weeks after treatment.9 Twenty weeks after completing the therapy, participants fell asleep an average of 24 minutes faster. That may not seem like much, but it is comparable to the small benefit of sleeping pills.9

The study also evaluated acupuncture for insomnia and found it to be less effective than cognitive therapy at falling asleep but more effective at staying asleep. almost as effective as cognitive behavioral therapy. Acupuncture is a traditional Chinese treatment where a trained acupuncturist places special needles into the skin at specific points on the body, which are associated with different aspects of health, such as pain or insomnia. Those who received acupuncture fell asleep an average of 11 minutes faster than before treatment. Right after completing treatment, participants who had acupuncture slept for an average of 62 more minutes a night, which was 27 more minutes than those treated with cognitive behavioral therapy. That is much more additional sleep than is typical of sleeping pills.9

Most cognitive behavioral therapy programs for insomnia last about six to eight weeks. If it is difficult to find a trained CBT-I therapist where you live, online therapy options are becoming more available. Acupuncture is a good alternative, especially for those who also experience pain, since acupuncture can also provide short-term pain relief.9,10

For more information about cognitive behavioral therapy or acupuncture for cancer patients with insomnia, see link.

Quiet the Mind: Tackling Stress Before Bed

When you are dealing with cancer, it is natural for worries to bubble to the surface at night, concerns about your health, upcoming appointments, treatment side effects, costs, or what the future holds. Stress activates the fight-or-flight hormones that make it hard to sleep.4

Give yourself time to wind down before bed. To relax, try deep breathing exercises: The simple one is to inhale slowly and deeply, and then exhale. Or try the 4-7-8 breathing exercise, which, in addition to a breathing technique, helps you concentrate on something other than whatever is worrying you.11

In addition to relaxation techniques, small changes to your sleep environment can also help. A sleep mask can block out light from streetlights, electronics, or early morning sun, helping your body stay in sleep mode. White noise, such as a fan, sound machine, or app, creates a steady background sound that covers up sudden noises that can disrupt your sleep. This can help your brain relax and make it less likely that you will wake up during the night.

If you are curious about which sleep masks, white noise machines, and other sleep products work best, Consumer Reports has tested and reviewed many of them. You can check out their recommendations.12 In addition, there are free cell phone apps that provide a choice of soothing repetitive sounds, such as waves, babbling streams, and rain, such as the Soothing Sleep Sounds for iPhones.

The Melatonin Question: What You Need to Know

If you try melatonin supplements, experts recommend buying the same brand consistently since supplements are not tested by any unbiased government agencies, and dosages vary between manufacturers. For most people, it is safe to take melatonin nightly for one to two months. After that, you should stop and see how your sleep is.6

Important caution: Talk to your oncologist or health care provider before taking melatonin or any supplement, as it may interact with your cancer treatment. Do not use melatonin if you are pregnant or breastfeeding or have an autoimmune disorder, a seizure disorder, or depression. Also, talk to your provider if you have diabetes or high blood pressure.6

Red Flags: When to Talk to Your Doctor

Pain or discomfort, an urge to move your legs, snoring, and a burning pain in your stomach, chest, or throat are symptoms of common sleep disrupters, including restless legs syndrome, sleep apnea, and gastroesophageal reflux disease (GERD). If these symptoms are keeping you up at night or making you sleepy during the day, talk to your doctor.4 Many cancer patients experience sleep problems related to their treatment or medications, so do not hesitate to bring up sleep concerns with your care team.

The “Magic Food” Myth

You may have heard that specific foods like tart cherries or kiwifruit can ease you into slumber. While some small studies suggest benefits, there is no single “miracle” food that works for everyone.3

The Bottom Line

Better sleep does not come from any single trick; it comes from building healthy habits throughout your day. Start with one or two changes that feel manageable. Eat more fruits and vegetables, get some gentle movement when you can, dim the lights in the evening, find ways to quiet your mind through breathing exercises or therapy, and permit yourself to rest.

If sleep problems persist, talk to your care team about cognitive behavioral therapy or acupuncture; both have been shown to help cancer survivors sleep better without the side effects of sleeping pills. Small improvements add up over time, and better sleep can help you feel better each day.

References

  1. Savard, J., Ivers, H., Villa, J., Caplette-Gingras, A., & Morin, C. M. (2011). Natural course of insomnia comorbid with cancer: An 18-month longitudinal study. Journal of Clinical Oncology, 29(26), 3580–3586.
  2. Harvard Health Publishing. (2023, November 20). 8 secrets to a good night’s sleep. Harvard Health. https://www.health.harvard.edu/newsletter_article/8-secrets-to-a-good-nights-sleep
  3. Wadyka, S. (2025, January 10). Foods to eat for better sleep. Consumer Reports. https://www.consumerreports.org/health/nutrition-healthy-eating/foods-to-eat-for-better-sleep-a7781483547/
  4. Johns Hopkins Medicine. (n.d.). Natural sleep aids: Home remedies to help you sleep. Johns Hopkins Medicine. https://www.hopkinsmedicine.org/health/wellness-and-prevention/natural-sleep-aids-home-remedies-to-help-you-sleep
  5. Sleep Foundation. (n.d.). Sleeping with socks on. Sleep Foundation. https://www.sleepfoundation.org/sleep-hygiene/sleeping-with-socks-on
  6. Harvard Health Publishing. (2023, November 20). 8 secrets to a good night’s sleep. Harvard Health. https://www.health.harvard.edu/newsletter_article/8-secrets-to-a-good-nights-sleep
  7. Tagle, A. (2026, January 15). 4 ways to beat the anxiety of insomnia—and get back to sleep. NPR Life Kit. https://www.npr.org/2026/01/15/nx-s1-5611117/beat-anxiety-insomnia-get-back-to-sleep
  8. Johnson, J. A., Rash, J. A., Campbell, T. S., Savard, J., Gehrman, P. R., Perlis, M., Carlson, L. E., & Garland, S. N. (2016). A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Medicine Reviews, 27, 20–28.
  9. Garland, S. N., Xie, S. X., DuHamel, K., Bao, T., Li, Q., Barg, F. K., Song, S., Kantoff, P., Gehrman, P., & Mao, J. J. (2019). Acupuncture versus cognitive behavioral therapy for insomnia in cancer survivors: A randomized clinical trial. Journal of the National Cancer Institute, 111(12), 1323–1331.
  10. Yin, X., Gou, M., Xu, J., Dong, B., Yin, P., Masquelin, F., Wu, J., Lao, L., & Xu, S. (2017). Efficacy and safety of acupuncture treatment on primary insomnia: A randomized controlled trial. Sleep Medicine, 37, 193–200.
  11. Young, M. (2022, September 6). How to do the 4-7-8 breathing exercise. Cleveland Clinic. https://health.clevelandclinic.org/4-7-8-breathing
  12. Consumer Reports. (2026, January 9). 12 products that help us get a good night’s sleep. Consumer Reports. https://www.consumerreports.org/health/sleeping/products-that-help-us-get-a-good-nights-sleep-a8894453489/

NCHR Written Comment to FDA on Modified Risk Tobacco Product (MRTP) Applications for ZYN Nicotine Pouch Products

Testimony & Briefings

January 21, 2026

Re: Docket number FDA-2025-N-0835
Modified Risk Tobacco Product Applications for ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A., Inc.

The National Center for Health Research (NCHR) appreciates the opportunity to submit this public comment regarding the Modified Risk Tobacco Product (MRTP) applications submitted by Swedish Match U.S.A., Inc. for ZYN nicotine pouch products.

NCHR is a nonprofit research organization that bridges the gap between scientific evidence and public policy to ensure that medical products and consumer health technologies are evaluated through rigorous, independent analysis. Our staff have medical, scientific, statistical, public health, and FDA policy expertise and we carefully reviewed the relevant research on ZYN.

We explain below why our scientific analysis concludes that the available evidence does not support granting Modified Risk Tobacco Product authorization for ZYN nicotine pouches. The application lacks the long-term evidence required to demonstrate reduced risks of oral cancer or serious cardiovascular and cerebrovascular concerns. In addition, the smoking habits of many adults, adolescents and children who are also using tobacco pouches, the rising popularity of ZYN among children, teens, and young adults and the documented harm shown in the Poison Control Centers data provides additional evidence that the statutory population-health standard has not been met.

Our analysis below focuses on population-level impact, youth use patterns, limitations of the clinical and epidemiologic evidence, evidence of oral and cardiovascular health risks, documented pediatric exposures, and the evidentiary standards for reduced-risk authorization.

  1. Under Section 911 of the Tobacco Control Act, Modified Risk Tobacco Product (MRTP) authorization requires evidence that a product will benefit the health of the population as a whole, not simply reduce exposure to selected toxicants in individual users. That population standard has not been met in the data provided to the FDA. 

ZYN use by children and adults is rising rapidly. According to the 2024 National Youth Tobacco Survey, approximately 480,000 middle and high school students reported current nicotine pouch use. This is often not experimental or occasional use: over 22% reported daily use, and nearly 30% used pouches on 20 or more days in the past month (NYTS 2024). A study published last year reported increasing middle and high school students’ use and frequent co-use with e-cigarettes and/or cigarettes, rather than substitution for cigarettes, directly undermining the population benefit required for MRTP claims (JAMA Network Open, 2025).

In prior MRTP reviews, the U.S. Food and Drug Administration has cautioned that epidemiologic trends observed in Sweden cannot be directly extrapolated to the U.S. context because of differences in social, cultural, and market conditions. This is a particular problem because the data was of a different product and there are substantial differences between General Snus and ZYN.  In addition,  the Swedish studies were focused on adults and in the U.S. ZYN is especially popular with children and teenagers. For all these reasons, reliance on the Swedish epidemiologic research results is not appropriate for evaluating ZYN’s population-level impact.

  1. The proposed claims of lower risks of serious diseases are unsubstantiated and inappropriate because of the lack of long-term data in Sweden and the lack of long-term U.S. health outcomes data. Swedish Match seeks to claim reduced risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, but these diseases are associated with decades of exposure, not with the short-term use of a product that was not nationally available in the U.S. until 2019. It is well established that most adult smokers started smoking in their teens or early adulthood, and yet they rarely are diagnosed with lung cancer, COPD, cardiovascular diseases, or other serious diseases until they are middle aged or older. It is therefore inappropriate to base claims of lower risks on Swedish data of 20 years or less of a different product and the available evidence is short-term on U.S. nicotine pouch users and limited to  toxicant comparisons, biomarkers, perceptions, and brief observational follow-up,  which cannot support reduced-risk claims for diseases that typically develop decades after exposure.

Oral health is of particular concern. Published studies of Swedish nicotine pouch users have reported a higher prevalence of oral mucosal lesions, evidence of local inflammation with elevated inflammatory biomarkers, and findings consistent with microbial dysbiosis and periodontal effects. In contrast,  some industry-cited findings claim safety by focusing on the absence of plaque acidogenesis, which does not measure oral cancer risk and cannot support claims of reduced malignancy. These findings represent short-term biologic signals of tissue irritation and altered oral ecology, which are incompatible with claims of safety and do not constitute clinical or epidemiologic evidence of reduced risk for long-latency outcomes such as oral cancer or other serious diseases. In addition, most are not based on ZYN users. Taken together, the available evidence, which is relatively short-term and based on surrogate endpoints, does not demonstrate that ZYN nicotine pouches, as actually used, reduce the risk of oral cancer or other serious disease outcomes.

  1. Being “tobacco-free” does not mean harmless, and this is particularly important for cardiovascular and cerebrovascular risk. Both the European Society of Cardiology and the American Heart Association have emphasized that nicotine itself is toxic to the heart and blood vessels, regardless of delivery form. In addition, the American Heart Association and other experts warn that modern oral nicotine products remain addictive, may adversely affect cardiovascular risk pathways, and lack long-term outcome data, while noting that nicotine can raise blood pressure, increase heart rate, and impair vascular function-mechanisms directly relevant to myocardial infarction and stroke.

Moreover, independent chemical analyses of nicotine pouches have identified dozens of non-nicotine constituents per product, including compounds with known toxicologic concern, underscoring that reduced combustion does not equate to safety. In the absence of long-term statistically significant evidence demonstrating reduced cardiovascular or cerebrovascular events among nicotine pouch users, allowing claims of reduced risk of heart disease or stroke misleads consumers and fails to meet the MRTP population health standard.

  1. In addition to concern about the popularity of ZYN among children and teens that potentially results in a life-threatening nicotine addiction, there are short-term, real-world harms for children of all ages. FDA safety communications and national poison center surveillance show sharp increases in nicotine pouch exposures, with approximately 70 percent occurring in children under five years of age, most commonly through unintentional ingestion (FDA consumer update, 2025; Pediatrics, 2025). Young children are uniquely vulnerable to nicotine toxicity because of their low body weight and immature physiology, and even small amounts of nicotine can cause vomiting, seizures, cardiovascular instability, and other serious adverse effects. These exposures are not theoretical; they are occurring in real-world household settings as flavored nicotine pouches become more widely available. These pediatric harms occur whether or not an adult smoker in the house switches from cigarettes and therefore must be included in FDA’s population-level MRTP assessment. Authorizing reduced-risk claims will inevitably increase household exposures as well as parents’ perceived safety of these products for their children.
  1. ZYN’s marketing practices and product design are inconsistent with Section 911’s public health standard. Under Section 911 of the Tobacco Control Act, Modified Risk Tobacco Product authorization requires evidence that marketing a product with reduced-risk claims will advance public health, including by reducing nicotine addiction and supporting cessation among current tobacco users without increasing uptake or dependence among non-users.

Rather than promoting nicotine de-escalation or cessation, ZYN’s rewards programs (described on zyn.com and in social media) and 2 different nicotine strengths appear designed to maximize continued use and dependence. The shift from lower-dose to higher-dose products, combined with loyalty and rewards incentives, is fundamentally inconsistent with the public health intent of harm reduction and undermines any claim that these products advance public health.

These concerns are reinforced by market data demonstrating that ZYN’s growth reflects rapid commercial expansion rather than smoking cessation or complete switching. A peer-reviewed analysis published in JAMA Network Open found that overall U.S. nicotine pouch sales increased 10-fold from 126.06 million units during the 5 months between August and December 2019 to 808.14 million units in the first three months of 2022. During those years, ZYN accounted for 58.8% of total unit share, far exceeding competing brands.

Taken together, ZYN’s program rewarding more purchases (which is especially popular with students), offering both a lower and higher dose of  nicotine, and dominant market growth pattern indicate it is increasing and sustaining nicotine exposure. Importantly, the applicant has not demonstrated that this rapid growth corresponds with reductions in cigarette smoking, increased cessation, or decreased overall nicotine dependence at the population level. These real-world use patterns are incompatible with the statutory requirement that MRTP authorization advance public health. The evidence does not support granting reduced-risk claims for ZYN nicotine pouch products. Compared to current use, which has increased dramatically in recent years, advertising claims of lower risk that is allowed with MRTP authorization is expected to increase ZYN use and nicotine addiction, especially among children and teens, since research clearly shows that the label encourages a misperception of safety.

In conclusion, the evidence submitted in support of the MRTP applications for ZYN nicotine pouch products does not meet the statutory standard under Section 911 of the Tobacco Control Act. ZYN’s growing popularity among middle school and high school students is similar to the early stages of the vaping epidemic among children and teens that occurred prior to the COVID pandemic restrictions that reduced such use.  There are no long-term data supporting the claims that these products are safer than combustible cigarettes in terms of cancer, cardiovascular disease, stroke, or other serious health outcomes among U.S. users. At the same time, data suggesting likely risks of oral cancer, the cardiovascular and cerebrovascular toxicity of nicotine regardless of delivery form, and preventable harms to young children through accidental exposure represent population-level risks independent of any potential individual benefit among adult smokers. We therefore strongly urge that the FDA help reduce nicotine-addiction among children, teens and adults by not granting Modified Risk Tobacco Product authorization for ZYN nicotine pouch products.

Respectfully submitted,
National Center for Health Research
Washington, D.C.

 

References:

  1. S. Food and Drug Administration. (n.d.). Modified risk tobacco products (MRTP).
    https://www.fda.gov/tobacco-products/advertising-and-promotion/modified-risk-tobacco-products
  2. Gentzke, A. S., Cornelius, M., Jamal, A., et al. (2024). E-cigarette and nicotine pouch use among middle and high school students—United States, 2024. MMWR Morbidity and Mortality Weekly Report, 73(35). https://www.cdc.gov/mmwr/volumes/73/wr/mm7335a3.htm
  3. Han, D. H., Lee, S., & Seo, D. C. (2025). Trends in nicotine pouch use and co-use with e-cigarettes among U.S. adolescents, 2023–2024. JAMA Network Open, 8(1), e2333311.
  4. S. Food and Drug Administration. (2026). Modified risk applications for ZYN nicotine pouches now under FDA scientific review. https://www.fda.gov/tobacco-products/ctp-newsroom/modified-risk-applications-zyn-nicotine-pouches-now-under-fda-scientific-review
  5. S. Food and Drug Administration. (2016). Technical project lead review and decision summary: Modified risk tobacco product application for General Snus. https://www.fda.gov/tobacco-products/ctp-newsroom/modified-risk-applications-zyn-nicotine-pouches-now-under-fda-scientific-review
  6. Barrington-Trimis, J. L., Liu, F., Unger, J. B., et al. (2025). Oral nicotine product use and vaping progression among adolescents. Pediatrics, 155(6), e2024070312.
  7. Rungraungrayabkul, D., Gaewkhiew, P., Vichayanrat, T., Shrestha, B., & Buajeeb, W. (2024). What is the impact of nicotine pouches on oral health: A systematic review, vol. 24. BMC Oral Health. BioMed Central Ltd.
  8. European Society of Cardiology. (2025). Vapes, pouches, heated tobacco, shisha, cigarettes: Nicotine in all forms is toxic. https://www.escardio.org/The-ESC/Press-Office/Press-releases/vapes-pouches-heated-tobacco-shisha-cigarettes-nicotine-in-all-forms-is-tox
  9. Stokes, A., Auer, R., Goodman, M., et al. (2025). Smokeless oral nicotine products: A scientific statement from the American Heart Association. Circulation.
  10. American Heart Association. (2025). Triple threat: E-cigarettes, oral nicotine pouches, and heat-not-burn products. https://www.heart.org/en/healthy-living/healthy-lifestyle/quit-smoking-tobacco/triple-threat-e-cigarettes-oral-nicotine-pouches-and-heat-not-burn-products
  11. S. Food and Drug Administration. (2025). Store nicotine pouches safely to prevent accidental exposure to children and pets. https://www.fda.gov/consumers/consumer-updates/properly-store-nicotine-pouches-prevent-accidental-exposure-children-and-pets
  12. S. Food and Drug Administration. (2025). FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review
  13. Lyu, J. C., Ozga, J. E., Stanton, C. A., Hrywna, M., Ganz, O., Ross, J. C., … & Ling, P. M. (2025). Advertising the leading US nicotine pouch brand: a content analysis of ZYN advertisements from 2019 to 2023. Tobacco Control.
  14. Majmundar, A., Okitondo, C., Xue, A., Asare, S., Bandi, P., & Nargis, N. (2022). Nicotine pouch sales trends in the US by volume and nicotine concentration levels from 2019 to 2022. JAMA Network Open, 5(11), e2242235-e2242235.
  15. La Capria, K., Hamilton-Moseley, K. R., Phan, L., Jewett, B., Hacker, K., Choi, K., & Chen-Sankey, J. (2024). Perceptions of FDA-authorized e-cigarettes and use interest among young adults who do not use tobacco. Tobacco prevention & cessation, 10, 10-18332.
  16. Wackowski, O. A., Rashid, M., Greene, K. L., Lewis, M. J., & O’connor, R. J. (2020). Smokers’ and young adult non-smokers’ perceptions and perceived impact of snus and e-cigarette modified risk messages. International journal of environmental research and public health, 17(18), 6807.

 

Click here to read our oral testimony to the FDA on the Modified Risk Tobacco Product applications for ZYN nicotine pouch products.

Testimony of Dr. Akashleena Mallick at the FDA TPSAC Meeting on ZYN Nicotine Pouch Products Submitted by Swedish Match U.S.A, Inc.

Testimony & Briefings

January 22, 2026

I am Dr. Akashleena Mallick. I am a physician and public health researcher with the nonprofit National Center for Health Research.

A modified-risk authorization requires a clear benefit to public health. That standard is not met here. I will explain why.

I want to begin by supporting the concerns previously raised by UCSF and Tobacco Free Kids about the use of nicotine pouches by about half a million U.S. middle and high school students. I will now focus on the medical, pediatric, and public health harms of ZYN.

A modified-risk order requires proof of less disease. The FDA found no data on the health impact of ZYN. Relying on General snus data is inappropriate because these products differ in use, toxicology, and marketing. We agree with the FDA that data on Swedish adults do not apply to U.S. teenagers. That’s why FDA’s General Snus MRTP is not a valid precedent for ZYN.

Claims of reduced risk for cancer, heart disease, and stroke would require decades of follow-up to make them comparable to the risks of cigarettes. No such data exists. Short-term biomarkers and toxicant comparisons cannot prove disease reduction. Nicotine itself harms the heart and blood vessels, as concluded by the American Heart Association and the European Society of Cardiology. Nicotine raises blood pressure and heart rate and worsens vascular function- key pathways for heart attack and stroke. Without long-term data showing fewer cancers, heart attacks, or strokes, any claim of reduced risk is misleading and probably incorrect.

US poison center data show nicotine pouch exposures rose dramatically, from 181 cases in 2022 to over 900 cases by early 2025. Nearly three-quarters of these cases involved children under age five, mostly from accidental ingestion. A peer-reviewed national study found that nicotine pouch ingestions in young children rose more than 760 percent in just three years and were more likely than other nicotine products to cause serious harm or hospital admission. These injuries are happening now.

ZYN has a record of aggressive marketing with a rewards program that encourages more frequent use, including in children and adolescents. If the goal of ZYN was to give a safer alternative to smoking, why is ZYN successfully focusing its marketing on children and teens, most of whom don’t smoke?

Independent research shows that modified-risk claims are often misunderstood as “safe.” Leading to dual use, delayed quitting, and use by non-smokers who then become addicted. Some states apply lower taxes to MRTP products, and companies push for those cuts. Lower prices increase use among both smokers and non-smokers.

The FDA said e-cigarettes would help adults quit. Instead, they helped fuel a youth nicotine epidemic. Nicotine pouch sales have already risen more than 10-fold, from 126 million units in 5 months in 2019 to over 800 million units in 3 months in early 2022.

There is no long-term evidence that ZYN reduces mouth cancer, lung cancer, heart disease, or stroke. But there is clear evidence of pediatric poisonings, likely cardiovascular harm, problematic marketing, and increasing risks to public health.

For these reasons, ZYN nicotine pouches do not meet the legal standard for modified-risk authorization.

Thank you.

Click here to read our written comment to the FDA on the Modified Risk Tobacco Product applications for ZYN nicotine pouch products.

5 topics to watch as MDUFA negotiations restart

Uncategorized

Elise Reuter, MedTech Dive, January 14, 2026

Medtech lobbyists and the Food and Drug Administration’s medical device center began negotiations last year on an agreement that sets a significant portion of the center’s budget. The Medical Device User Fee Amendments, or MDUFA, determine how much the FDA can raise in industry fees over a five-year period, supplementing taxpayer funding.

The FDA and industry must come to an agreement before September 2027, when the current MDUFA agreement is set to expire, although stakeholders expect an agreement to go to Congress this year. Device lobbyists called for a renewal of the current agreement, with a similar funding amount and structure, while patient groups emphasized the need for increased safety and transparency. Many stakeholders also raised concerns about the FDA’s capacity after staff cuts that took place last year.

Here are five topics to watch as the FDA and industry near a deal:

  1. Negotiations are moving quickly

The medtech industry and the FDA meet multiple times per month to hammer out an agreement for MDUFA VI, which must go to Congress for approval before the current program expires in September 2027. Those meetings take place behind closed doors, and sparse meeting minutes provide an indication of where the discussions are headed. Patient and physician groups, and other stakeholders, participate in separate, monthly meetings.

Diana Zuckerman, president of the National Center for Health Research, a nonpartisan think tank, told MedTech Dive that the FDA and industry aim to bring a commitment letter to Congress this year, possibly before the midterm elections this fall. Zuckerman and other stakeholders said an agreement could come as early as the first quarter of 2026.

“They seem to be moving quickly,” Zuckerman said. “They’re happy with the way things are. Industry is happy. FDA is happy.”

Medtech lobbying groups AdvaMed and the Medical Device Manufacturers Association, or MDMA, declined to comment on the negotiations. When asked about the timing and amount of funding the FDA hopes to see in the next agreement, Department of Health and Human Services spokesperson Andrew Nixon pointed to meeting minutes.

In broad summaries of their discussions, the FDA described a need for more resources, while the medtech industry called for similar terms to the current user fee agreement. The current program, MDUFA V, allows the FDA’s Center for Devices and Radiological Health to receive $1.78 billion to $1.9 billion over five years, with the final tally depending on whether the agency meets certain performance and hiring goals.

The MDMA noted a “significant ramp up in user fees under MDUFA V, especially in the last two years of the program,” according to a summary of an Oct. 29 meeting. 

Bottom of Form

In the same discussion, AdvaMed called for the FDA to keep the current MDUFA V framework, adding that the program has reached a “steady state.” The FDA had been considering a simpler fee structure without adjustments for hiring goals and add-on payments for performance.

  1. Patient groups and industry are worried about staff cuts

After the Trump administration slashed the FDA’s workforce last year, industry and patient groups alike have been raising concerns about the impact. While the FDA has never stated how many people were cut, the HHS said last spring that it would cut 3,500 FDA workers, and a ProPublica analysis in August found that the CDRH had lost more than 20% of its staff due to cuts and attrition.

“The FDA clearly has expressed to us, stakeholders outside the industry, that they’re shorthanded,” said Michael Abrams, a senior health researcher at consumer advocacy nonprofit Public Citizen. “They’re feeling stressed for obvious reasons. The FDA has received huge, nondiscriminate [Department of Government Efficiency] cuts.”

In discussions with industry, the FDA’s device center has acknowledged challenges. For the majority of 2025, “staff have been focused solely on review work, which has created some system strain,” the agency said in an Oct. 29 meeting.

[….]

The CDRH committed to “maintaining or achieving appropriate staffing levels” to meet its goals in a Dec. 2 meeting. A week later, industry groups called for confirmation that new hires funded under MDUFA V will be realized by the end of fiscal 2027, according to meeting notes.

Madris Kinard, a former FDA public health analyst and CEO of Device Events, said it may be challenging to hire people, adding that it can take six months to a year to hire at the FDA.

“The people that were let go are in a real bind and may not be willing to go back to something that’s unsure,” Kinard said.

  1. The FDA’s proposals include changes to user fee triggers, higher fees overseas

The FDA proposed changes to “triggers” that determine whether the agency can continue to collect user fees. Currently, there are two triggers intended to ensure that user fees supplement the FDA’s budget rather than replacing congressional funds. Congress must provide a certain level of funding for CDRH, and CDRH must spend a certain amount of non-user-fee funding on device reviews and other costs.

[….]

In the Dec. 2 meeting, the FDA proposed changing the appropriation and budgetary spending thresholds, including increasing both thresholds and the operating reserve to cover extended lapses in funding. Industry representatives said a week later that they were open to discussions on the spending trigger but opposed changing the appropriations trigger.

Another big change proposed by the FDA is to levy more fees from medical device companies overseas than in the U.S.

The agency said the changes would account for the additional resources needed to oversee foreign firms, adding in a Dec. 12 meeting that companies operating within the U.S. may see flat or decreased fees.

  1. Patient groups call for more focus on safety and effectiveness

Patient advocates called for more FDA funding to go toward ensuring devices are safe and effective, rather than emphasizing speed of reviews. Some people, including Public Citizen’s Abrams, called for more funding from Congress to support postmarket reviews and recalls.

Abrams also raised concerns about fast-track programs for medical devices. Last year, the FDA and the Centers for Medicare and Medicaid Services announced a pilot where device makers can ask the agency to waive premarket authorization and investigational device requirements for some digital health products while they collect real-world data.

“[HHS Secretary Robert F. Kennedy Jr.] and [FDA Commissioner Martin Makary] say they want gold standard evidence, but are also calling for lowering standards and fast-track approvals,” Abrams said.

Alexander Naum, policy manager for Generation Patient, a nonprofit representing young adults with chronic health conditions, said he was also worried about fast-track programs, and called for more postmarket monitoring of medical devices. For implants in particular, Naum would like to see reporting requirements to help patients better understand how a medical device is going to age and mature with them.

“We’re just really concerned when that innovation isn’t coming with appropriate safeguards needed to protect patients,” Naum said.

Stakeholders also called for more user-friendly adverse event reporting and more enforcement to ensure device companies report malfunctions, injuries and deaths in a timely fashion. They noted a recent government watchdog report found the FDA needs more staff and authority to oversee medical device recalls.

  1. Without access to industry meetings, public input is limited

Patient groups told MedTech Dive that it was difficult to provide input on the negotiations with industry because they are denied access to those meetings and have to rely on vague minutes to understand what the FDA and device lobbyists are discussing.

During the previous round of user fee negotiations in 2022, the FDA’s device center received criticism from senators after neglecting to post meeting minutes for months. In the current negotiation, minutes are posted weeks after meetings and include few details on the meat of what was discussed.

[….]

This has been a “major barrier” in keeping track of where the FDA and industry are at in negotiations, said Isabella Xu, a policy associate at the Center for Science in the Public Interest.

[….]

Patient advocates also said that sometimes the topics presented by the FDA at stakeholder meetings don’t match what patients care about. The Patient, Consumer and Public Health coalition, a group of more than two dozen nonprofits focusing on medical and consumer products, said in an emailed statement that the scope of the meetings is limited and many of the topics focus on making reviews faster and offering industry more access to FDA staff and expertise. 

“There’s just nothing about issues that a lot of the patient groups really care about,” NCHR’s Zuckerman said. “Yes, patient groups care about access, but they also care about safety and they also care about effectiveness.”

Top drug regulator Richard Pazdur set to leave the FDA

News Stories & Editorials, We're In the News
STAT News
December 2, 2025. Lizzy Lawrence

WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency.

Pazdur informed leaders at the FDA’s drug center of his intention to leave the agency at a meeting on Tuesday, according to two agency sources familiar with the matter. The move comes less than a month after he took the role of top drug regulator at the urging of FDA Commissioner Marty Makary.

A spokesperson for the FDA confirmed the news and said Pazdur’s decision is final. Pazdur did not respond to a request for comment.

“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the FDA spokesperson told STAT. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients.”

Pazdur is the fourth person to lead the Center for Drug Evaluation and Research this year. The previous director, George Tidmarsh, left the agency in November amid allegations that he used his position to advance a personal vendetta against a business associate, and amid conflict with Center for Biologics Evaluation and Research Director Vinay Prasad.

Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave.

The elevation of Pazdur, a longtime FDA staffer who was previously the director of the cancer center, was intended to stabilize the agency. Biotech stocks gave up gains after STAT reported on Pazdur’s plan, with the S&P Biotech ETF sliding 1%.

“Really bad news here,” John Maraganore, the founder of Alnylam Pharmaceuticals, posted on social media. “Rick Pazdur has been a National Treasure for efforts in bringing safe and effective cancer medicines to patients.”

[….]

Even patient advocates who sometimes disagreed with Pazdur’s decisions to approve certain cancer drugs expressed dismay at the news.

“Dr. Pazdur’s retirement is a huge loss for the FDA and for patients across our country,” said Diana Zuckerman, president of the National Center for Health Research. “Many of us appreciate that he was willing to express his concerns about FDA’s recent plans to speed up the approval process at a time when FDA had lost staff and expertise.”

Pazdur took the job on assurances that he would be protected from political influence, sources close to him previously told STAT. Political pressure has increasingly affected science at the agency, especially for products of particular interest to health secretary Robert F. Kennedy Jr., like vaccines, antidepressants, and autism treatments.

But it seems that Pazdur ran into issues almost immediately. The Washington Post reported that Pazdur raised concerns about a new program spearheaded by Makary to offer expedited review to drugs that align with national priorities. He noted that the program, called the Commissioner’s National Priority Voucher, was not transparent and could be illegal. Tidmarsh also raised concerns about the program on his way out of the FDA.

[….]

Experts told STAT that the personnel drama at the FDA threatens to undermine the credibility of the agency, which is charged with protecting and promoting public health.

To read the entire article, click here 

Menopause and Hormones

Prevention

National Center of Health Research

Lower hormone levels in menopause may lead to hot flashes, trouble sleeping, vaginal dryness, and fragile bones.

What is Hormone Therapy for Menopause?

Like all medicines, hormone therapy has advantages and disadvantages. The evidence about risks and benefits is complicated, and some health professionals are more knowledgeable than others, so it’s important to read articles like this one before you talk to your doctor, nurse, or pharmacist about hormones.

What are the Symptoms of Menopause?

  • Thinning of your bones, Bones become more fragile, which may lead to loss of height, and bones are more likely to break (osteoporosis)

What are the Benefits of Using Hormones for Menopause?

  • Hormone therapy is the most effective FDA-approved medicine for the relief of hot flashes, night sweats, or vaginal dryness.
  • While you are taking hormones, they may reduce your chances of your bones becoming fragile and more likely to break (osteoporosis). However, when you stop taking the hormones, your bones will become more fragile, so it is important to improve your bone health through diet (calcium) and exercise.

What are the Risks of Using Hormones for Menopause?

The risks of oral hormones (pills) for menopause tend to be greater for older women (over 60) than for women in their 50s, but regardless of age, on average, long-term hormone use tends to cause harm that outweighs the benefits. The more you know, the more likely you are to make the decision that is best for you. For example, combined hormone therapy has been found to increase the chances of dementia, while estrogen alone increases the chances of developing ovarian cancer and decreases the chances of developing breast cancer. For a woman with a uterus, taking estrogen alone increases her chances of developing endometrial cancer (cancer of the uterine lining), while adding progestin to estrogen lowers the risk of endometrial cancer.

As you can see, the advantages and disadvantages vary depending on which hormones, your age, and your medical history.

Research on combined estrogen and progestin shows it probably can increase the chances of cognitive impairment (early Alzheimer’s or dementia) in women older than 65.

Will Hormone Therapy Protect the Heart and Prevent Strokes?

The evidence is mixed on heart disease, but hormones seem to increase the risk of strokes.

 

All articles are reviewed and approved by Dr. Diana Zuckerman and other senior staff.

The National Center for Health Research is a nonprofit, nonpartisan research, education, and advocacy organization that analyzes and explains the latest medical research and speaks out on policies and programs. We do not accept funding from pharmaceutical companies or medical device manufacturers. Find out how you can support us here.