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  • Calling the Shots: Tracking RFK Jr. on Vaccines

    It was one of President Donald Trump’s more audacious picks for his Cabinet: anti-vaccine activist and alternative health advocate Robert F. Kennedy Jr. to helm the nation’s health department.

    Kennedy, however, won over the senators needed to confirm him to lead the Department of Health and Human Services, promising not to remove government website statements pointing out that vaccines do not cause autism and to keep current vaccine approval and safety monitoring systems intact. Ahead of being tapped by Trump for the role, he said he wouldn’t take vaccines away from those who wanted them while stressing a desire for individual choice.

    Since his confirmation, Kennedy has toed the line between backing vaccination as a preventive public health tool and making statements or overseeing developments that threaten to undermine that tool. His moves have played out against the backdrop of an explosion in vaccine-preventable measles cases in West Texas and an intense flu season that resulted in high rates of hospitalization, along with bird flu outbreaks that have raised the specter of another pandemic.

    Here’s a look at notable vaccine-related moves and remarks made by Kennedy or under his authority since he was sworn in as head of HHS on Feb. 13:

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    • Dec. 16, 2025 – The CDC ended the long-standing recommendation for all newborns to receive the hepatitis B vaccine at birth after its revamped committee of outside vaccine experts voted 8-3 to scrap it. The agency now recommends parents consult with a healthcare provider to decide whether infants born to hepatitis B-negative mothers should get the vaccine. “We are restoring the balance of informed consent to parents whose newborns face little risk of contracting hepatitis B,” CDC acting Director Jim O’Neill said in a statement.
    • Nov. 28, 2025 – Dr. Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, said in a memo to agency staff that a review “found that at least 10 children have died after and because of receiving COVID-19 vaccination.” In the memo, which was first reported by The New York Times, Prasad said the true number could be higher and accused the agency of ignoring safety concerns. He did not include information like the ages of the kids, whether they had health problems or how the agency staff determined the vaccine-death link. Prasad said he would propose new oversight and review of vaccines.

    • Sept. 18-19, 2025 – The CDC’s Advisory Committee on Immunization Practices held a chaotic meeting where it voted to weaken COVID-19 shot recommendations, saying that individuals should consult with their healthcare provider about whether they should get the shot. They decided against a prescription requirement for the shot in a narrow vote. The panel also voted against recommending a combination jab against measles, mumps, rubella and chickenpox, or MMRV, for children under the age of 4 and postponed a vote on the hepatitis B vaccine for newborns.

    • July 7, 2025 – Several medical groups sued Kennedy and HHS over his changes to federal vaccine policies, including his decision to remove healthy children and pregnant women from the COVID-19 vaccine schedule, which the plaintiffs asked the court to vacate. The lawsuit accuses Kennedy of working “to dismantle the longstanding, Congressionally-authorized, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans.”

    • Aug. 27, 2025 – Kennedy announced that emergency use authorizations for COVID-19 shots were rescinded, instead issuing full marketing authorization for the shots – but only for those who are at “higher risk” of severe COVID-19. The FDA authorization is for adults 65 and older as well as for children and adults with at least one medical condition that puts them at risk of severe illness.

    • July 22, 2025 – Kennedy accepted a recommendation from the CDC’s ACIP to remove the mercury-based preservative thimerosal from all influenza vaccines distributed in the U.S. “Injecting any amount of mercury into children when safe, mercury-free alternatives exist defies common sense and public health responsibility,” Kennedy posted on social media. However, many studies have shown that the small amount of thimerosal used in vaccines is harmless. The move is not expected to impact many Americans, as the vast majority of flu vaccines distributed in the U.S. do not contain the preservative.  

    • May 27, 2025 – Kennedy announced via social media that the CDC was no longer recommending the COVID-19 vaccine for healthy pregnant women and children, citing a “lack of clinical data” to support administering repeat shots for those populations. The move came despite the agency listing pregnancy as a health risk factor for developing complications from COVID-19.

    • July 29, 2025 – Democrats on the Senate Health Committee announced that they would investigate Kennedy’s overhaul of the CDC’s ACIP, which makes vaccine recommendations for Americans. “By removing all 17 of ACIP’s members and replacing them with eight individuals handpicked to advance your anti-vaccine agenda, you have put decades of non-partisan, science-backed work – and, as a result, Americans’ lives – at risk,” the Democrats wrote in a letter to Kennedy. 

    • June 25, 2025 – HHS officials missed a self-set deadline to release ethics forms for new members of the committee before a June meeting. Eventually, Kennedy’s conflict-of-interest database was updated with significantly less information on the new members than prior members. 

    • June 11, 2025 – Kennedy announced eight new ACIP members. At least half of the picks had spoken out against vaccination in some way, according to The New York Times. Infectious disease experts accused Kennedy of breaking his pledge not to appoint “ideological anti-vaxxers” to the panel.

    • June 9, 2025 – Kennedy announced that he was removing all 17 members of the CDC’s ACIP, which makes vaccine recommendations for Americans. “A clean sweep is necessary to reestablish public confidence in vaccine science,” Kennedy said in a statement. The removal went against a promise Kennedy made to GOP Sen. Bill Cassidy of Louisiana to gain the senator’s vote for Kennedy’s confirmation. 

    • Nov. 19, 2025 – The CDC revised its long-held stance that vaccines don’t cause autism, now saying on its website that the consensus is “not an evidence-based claim.” It continues: “Studies supporting a link have been ignored by health authorities.” The change sparked outcry from public health groups as well as Cassidy, who voted for Kennedy’s confirmation after gaining several commitments from him, including one to not remove language on the CDC website pointing out that vaccines do not cause autism. “What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism,” Cassidy posted on social media after the website was updated. 

    • Sept. 22, 2025 – Kennedy joined Trump at a White House event where the president claimed that vaccines should “be taken separately” rather than as a combined shot and that “it seems when you mix them, there could be a problem.” Trump also promoted claims about vaccines and autism, saying, “I think I can say that there are certain groups of people that don’t take vaccines and don’t take any pills that have no autism.” Kennedy added that the Trump administration will be “closely examining” vaccines as it seeks to find the cause of autism, which the HHS secretary had previously promised would come by September. 

    • March 25, 2025 – The Washington Post reported that HHS had hired David Geier to study potential connections between vaccines and autism – a debunked theory he has previously promoted that again drew the spotlight after Kennedy refused to reject the claim during his confirmation hearings. Geier faced disciplinary action from state regulators more than a decade ago for practicing medicine without a license and was listed as a data analyst in the HHS employee directory, according to the Post. 

    • Jan. 5, 2026 – The CDC announced a revamped childhood vaccine schedule that decreased the number of vaccines recommended for children, nixing shots for flu, rotavirus, hepatitis A, hepatitis B, some forms of meningitis and RSV. Vaccines for those diseases are only recommended now for certain groups deemed high risk. The Trump administration said that all shots would continue to be covered by insurance companies. “This decision protects children, respects families and rebuilds trust in public health,” Kennedy said in a statement. The American Academy of Pediatrics and other public health organizations sued over the move, calling it “harmful and unlawful.”
    • Sept. 9, 2025 – A new MAHA strategy report said that HHS and the White House Domestic Policy Council will develop a framework focused on “ensuring America has the best childhood vaccine schedule.”

    • Feb. 18, 2025 – In his first address to agency staff after taking over as HHS secretary, Kennedy said a commission would investigate the childhood vaccination schedule, questioning whether it was among “possible factors” tied to poor health in the U.S. Kennedy said the Make America Healthy Again commission – created by a Trump order – would convene “representatives of all viewpoints” to examine potential causes behind a “drastic rise in chronic disease,” including some issues that “were formerly taboo and insufficiently scrutinized.” 

    • Aug. 27, 2025 – The White House fired CDC Director Susan Monarez less than a month into her new role after she clashed with Kennedy over vaccine policies. Kennedy reportedly asked Monarez to fire career agency officials and commit to backing his own advisers, which she refused to do. Four high-ranking officials resigned in support of the former director. 

    • July 2025 – Prasad, the FDA’s top vaccine official and Trump’s replacement for Dr. Peter Marks, left the post after less than three months on the job. Prasad “did not want to be a distraction,” an HHS spokesperson said in a statement, adding that he was leaving the role to “spend more time with his family.” But less than two weeks after his ouster, Prasad was rehired to the same role. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” HHS spokesperson Andrew Nixon said.

    • March 28, 2025 – The Wall Street Journal reported that Marks – the FDA’s former top vaccine official and head of the Center for Biologics Evaluation and Research – submitted his resignation after being forced to either resign or be fired. In a resignation letter, Marks said he’d been “willing to work to address (Kennedy’s) concerns regarding vaccine safety and transparency,” but accused the HHS chief of merely wishing for “subservient confirmation of his misinformation and lies.”

    • May 14, 2025 – Kennedy, in his testimony to lawmakers on Trump’s budget proposal that would slash the HHS budget by more than a quarter, said that his “opinions about vaccines are irrelevant.” He added that he doesn’t think “people should be taking medical advice from me.” When Kennedy was questioned about whether he would hypothetically vaccinate a child of his for measles, he said, “probably, for measles.” He wouldn’t answer the same question about vaccines for chicken pox or polio. 

    • April 2025 – Kennedy told CBS News after the second measles death in an unvaccinated child in the U.S. that people should get the measles vaccine but that the “government should not be mandating those.” Despite his endorsement of the vaccine, Kennedy said in the same interview that “we’re always going to have measles, no matter what happens, as the vaccine wanes very quickly.” However, according to the CDC, most people who are vaccinated against measles “will be protected for life.”

    • March 11, 2025 – In an interview with Fox News’ Sean Hannity, Kennedy said the measles vaccine “does cause deaths every year … so people ought to be able to make that choice for themselves.” According to the Infectious Diseases Society of America, no deaths have been found to be related to the measles, mumps and rubella vaccine among healthy people, while “there have been rare cases of deaths from vaccine side effects among children who are immune compromised.” The CDC recommends such individuals not get the MMR vaccine or wait to get it.

    • March 4, 2025 – In an interview with Fox News, Kennedy stressed nutrition and exercise as ways to avoid being severely impacted by measles: “It’s very, very difficult for measles to kill a healthy person.” He said the area in West Texas undergoing a measles outbreak is “kind of a food desert” and that malnutrition “may have been an issue” for a child who died of measles in that outbreak. State health officials said the child, who was not vaccinated, “had no known underlying conditions.”

    • March 2, 2025 – Kennedy wrote in a Fox News op-ed that “studies have found that vitamin A can dramatically reduce measles mortality.” He pointed to a CDC recommendation, updated after he took office, supporting the use of vitamin A to treat measles infections. While health experts acknowledge that vitamin A can be beneficial for patients with a measles infection, they’ve also emphasized it is not a replacement for vaccination and warned that it can cause dangerous health complications when given in excess.

    • December 2025 – HHS terminated millions in grant money for the American Academy of Pediatrics because the initiatives “no longer align with the Department’s mission or priorities,” according to an HHS spokesman. The group has criticized the changes Kennedy has made to federal vaccine policies. “The sudden withdrawal of these funds will directly impact and potentially harm infants, children, youth and their families in communities across the United States,” said Mark Del Monte, the academy’s chief executive and executive vice president.
    • Aug. 5, 2025 – HHS announced it will pull contracts and cut funding for 22 vaccine development projects totaling nearly $500 million. “After reviewing the science and consulting top experts at NIH and FDA, HHS has determined that mRNA technology poses more risks than benefits for these respiratory viruses,” Kennedy said in a video announcement on social media, referring to the vaccine technology used in COVID-19 and flu shots. But infectious disease experts argued the decision puts the U.S. at risk for future pandemics, crediting mRNA technology for the fast turnaround of the COVID-19 vaccines. 

    • March 2025 – The Trump administration targeted NIH grants aimed at studying vaccine hesitancy and how to improve immunization levels. According to NPR, more than 40 grants related to vaccine hesitancy were canceled. 

    • January 2026 – Kennedy removed at least four members of the Advisory Commission on Childhood Vaccinations, which reviews issues relating to the Vaccine Injury Compensation Program. The committee suggests which vaccines and what conditions should be covered by the program, which Kennedy plans to revamp.
    • Sept. 9, 2025 – In its MAHA strategy report, the Trump administration said that HHS and NIH will “investigate vaccine injuries with improved data collection and analysis, including through a new vaccine injury research program at the NIH Clinical Center that may expand to centers around the country.”

    • July 28, 2025 – Kennedy posted on social media his plan to revamp the federal system to compensate people harmed by vaccines. Kennedy said that the Vaccine Injury Compensation Program “is broken, and I intend to fix it.” According to Kennedy, the program has paid out $5.4 billion to 12,000 petitioners since its inception in 1986. He accused the program of dismissing cases that have merit and slow-walking others. “I will not allow the VICP to continue to ignore its mandate and fail its mission of quickly and fairly compensating vaccine-injured individuals,” Kennedy said. The program “is a no-fault alternative to the traditional legal system for resolving vaccine injury petitions,” according to the Health Resources and Services Administration. 

    • Aug. 14, 2025 – HHS announced it is reinstating the Task Force on Safer Childhood Vaccines – a panel created by Congress to improve safety and oversight – in a move requested by Children’s Health Defense, the anti-vaccine advocacy group Kennedy previously led. The task force, which was disbanded in 1988, will now work with the Advisory Commission on Childhood Vaccines to produce regular recommendations. The move comes after Children’s Health Defense sued Kennedy in July for failing to establish the task force. 

    – Former U.S. News writer Steven Ross Johnson contributed to this report

    Cecelia Smith-Schoenwalder

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  • Sea moss recall sparks nationwide warning to customers

    Diva Fam Inc. is voluntarily recalling all lots and flavors of Sea Moss Gel Superfood due to a “lack of required regulatory authorization and temperature monitoring records for pH-controlled food products,” the U.S. Food and Drug Administration (FDA) said in an alert.

    Newsweek reached out to the company via email for comment on Tuesday night.

    Numerous recalls have been initiated this year due to potentially damaged products, foodborne illness, undeclared food allergens or the potential for bacteria.

    Millions of Americans experience food sensitivities or food allergies every year. According to the FDA, the nine “major” food allergens in the United States are eggs, milk, fish, wheat, soybeans, Crustacean shellfish, sesame, tree nuts and peanuts.

    According to the alert, the recall impacts all flavors, sizes and batch numbers of True Sea Moss brand Sea Moss Gel Superfood in 16-ounce glass jars that were manufactured before January 9, 2026. The product was sold nationwide through select retailers and via website.

    There have been no reported illnesses in connection to the recall, the FDA alert says.

    The alert lists recalled flavors and corresponding UPC numbers for customers to cross-reference.

    “The matter was identified during a California Department of Public Health inspection that raised questions regarding regulatory authorization and related production records for certain distributed products. The Company is cooperating fully with regulatory authorities and has initiated this voluntary recall to ensure regulatory alignment,” the FDA alert says in part.

    Consumers in possession of any recalled Sea Moss Gel Superfood should immediately discontinue use and follow instructions from the retailer regarding product return or disposal. For further details, customers may contact Diva Fam via phone at 818-751-3882 from 9 a.m. to 5 p.m. Pacific Time weekdays or email support@divafam.com.

    In an email to Newsweek last year the FDA said, “Most recalls in the U.S. are carried out voluntarily by the product manufacturer and when a company issues a public warning, typically via news release, to inform the public of a voluntary product recall, the FDA shares that release on our website as a public service.

    “The FDA’s role during a voluntary, firm-initiated, recall is to review the recall strategy, evaluate the health hazard presented by the product, monitor the recall, and as appropriate alert the public and other companies in the supply chain about the recall.

    “The FDA provides public access to information on recalls by posting a listing of recalls according to their classification in the FDA Enforcement Report, including the specific action taken by the recalling company. The FDA Enforcement Report is designed to provide a public listing of products in the marketplace that are being recalled.”

    Additional information on recalls can be found via the FDA’s Recalls, Market Withdrawals, & Safety Alerts.

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  • Bariatric Weight-Loss Surgery and Mortality | NutritionFacts.org

    Today, death rates after weight-loss surgery are considered to be “very low,” occurring in perhaps 1 in 300 to 1 in 500 patients on average.

    The treatment of obesity has long been stained by the snake-oil swindling of profiteers, hustlers, and quacks. Even the modern field of bariatric medicine (derived from the Greek word baros, meaning “weight”) is pervaded by an “insidious image of sleaze.” Beguiled by advertising for fairy tale magic bullets of rapid, effortless weight loss, people blame themselves for failing to manifest the miracle or imagine themselves metabolically broken. On the other end of the spectrum are overly pessimistic practitioners of the opinion that “people who are fat are born fat, and nothing much can be done about it.” The truth lies somewhere in between.

    The difficulty of curing obesity has been compared to learning a foreign language. It’s an achievement virtually anyone can attain with a sufficient investment of energies, “but it always takes a considerable amount of time and trouble.” And, of those who do stick with it, most will regain much of the weight lost. To me, this speaks to the difficulty, rather than the futility. It may take smokers an average of 30 attempts to finally kick the habit. Like quitting smoking, curing obesity is just something that has to be done. As the chair of the Association for the Study of Obesity put it, it doesn’t take “will power” to do essential tasks like getting up at night to feed a baby; it’s just something that has to be done.

    Our collective response doesn’t seem to match the rhetoric or reality. If obesity is such a “national crisis” reaching alarming proportions, dubbed by the post-9/11 Surgeon General as “every bit as devastating as terrorism,” why has our reaction been so tepid? For example, governments meekly suggest the food industry take “voluntary initiatives to restrict the marketing of less healthy food options to children….” Have we just given up and ceded control?

    Our timid response to the obesity epidemic is encapsulated by a national initiative promulgated by a Joint Task Force of the American Society for Nutrition, Institute of Food Technologists, and International Food Information Council: the “small-changes approach.” Since “small changes are more feasible to achieve,” suggestions include “using mustard instead of mayonnaise” and “eating 1 rather than 2 doughnuts in the morning.” Seems a bit like bringing a butter knife to a gunfight. Proponents of the small-changes approach lament that, unlike other addictions—for example, alcohol, cocaine, gambling, or tobacco—we can’t counsel our obese patients to give up the addictive element completely, as “[n]o one can give up eating.” But just because we have to breathe, doesn’t mean it has to be through the end of a cigarette. And just because we have to eat doesn’t mean we have to eat junk.

    What about bringing a scalpel to the gunfight instead? The use of bariatric surgery has exploded from about 40,000 procedures noted in the first international survey in 1998 to hundreds of thousands performed now every year in the United States alone. The first technique that was developed, the intestinal bypass, involved carving out about 19 feet of intestines. More than 30,000 intestinal bypass operations were performed before we recognized “catastrophic” and “disastrous outcomes” resulted from these procedures. This included protein deficiency-induced liver disease, “which often progressed to liver failure and death.” This inauspicious start is remembered as “one of the dark blots in the history of surgery,” as I discuss in my video The Mortality Rate of Bariatric Weight-Loss Surgery.

    Today, death rates after bariatric surgery are considered “very low,” occurring on average in perhaps 1 in 300 to impacting 1 in 500 patients. The most common procedure is stomach stapling, also known as sleeve gastrectomy, in which most of the stomach is permanently removed. Only a narrow tube of the stomach is left so as to restrict how much food people can eat at any one time. It’s ironic that many patients choose bariatric surgery convinced that, “for them, ‘diets do not work,’” when, in reality, that’s all the surgery may be—an enforced diet. Bariatric surgery can be thought of as a form of internal jaw wiring.

    Gastric bypass, known as Roux-en-Y gastric bypass, is the second most common bariatric surgery. It combines restriction—stapling the stomach into a pouch smaller than a golf ball—with malabsorption by rearranging one’s anatomy to bypass the first part of the small intestine. It appears to be more effective than just cutting out most of the stomach, resulting in a loss of about 63% of excess weight compared to 53% with a gastric sleeve. But gastric bypass carries a greater risk of serious complications. Many are surprised to learn that new “surgical procedures…do not require premarket testing and approval by the Food and Drug Administration (FDA)” and are largely exempt from rigorous regulatory scrutiny.

    Doctor’s Note

    I didn’t know there wasn’t some kind of approval process for new surgical procedures!

    This is the first video in a four-part series on bariatric surgery. Coming up are:

    My book How Not to Diet is focused exclusively on sustainable weight loss. Check it out from your local public library or pick it up from wherever you get your books. (All proceeds from my books are donated to charity.)

     

    Michael Greger M.D. FACLM

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  • 12/23: CBS Evening News


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    At least 2 killed in Pennsylvania nursing home explosion; California flooding threat grows as wildfire survivors face Christmas evacuation.

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  • FDA approves weight loss drug in daily pill form


    FDA approves weight loss drug in daily pill form – CBS News









































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    Regulators at the U.S. Food and Drug Administration gave the green light to a pill version of the blockbuster weight-loss drug Wegovy, the first daily oral medication approved to treat obesity. Dr. Jon LaPook has more.

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  • Metal Shards Spark Nationwide Recall of Ready-to-Eat Holiday Kielbasa

    By Deanna Neff HealthDay ReporterTUESDAY, Dec. 23, 2025 (HealthDay News) — Olympia Provisions has recalled about 1,930 pounds of ready-to-eat holiday sausage.

    The recalled meat is wrapped and vacuum-sealed in 16-ounce clear pouches and labeled “OLYMPIA PROVISIONS UNCURED HOLIDAY KIELBASA.”

    The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced the Class I recall on Dec. 19 due to possible metal or other fragments in the meat. 

    Consuming the recalled kielbasa may pose serious health risks to consumers.

    The ready-to-eat sausages were manufactured on Oct. 14, 2025, and carry a “BEST IF USED BY” date of 02/19/26 printed on the side of the label.

    Packages have the establishment number — “EST. 39928” — inside the USDA mark of inspection.

    The contamination came to light through after a consumer reached out to the Portland, Ore., company, which then notified FSIS. To date, there have been no confirmed reports of medical emergencies or injuries.

    The recalled meat was distributed to retail shops in California, Oregon and Washington. 

    However, because the company sells its artisanal products through its website, the sausages were also shipped to online customers nationwide. This makes it crucial for anyone who purchased holiday meat through the internet to see whether it’s part of the recall.

    Safety inspectors are particularly worried about the product’s long shelf life. Because the kielbasa is fully cooked and vacuum-sealed, it can be stored for months. 

    Federal officials expressed concern that many consumers might have the product sitting in their refrigerators or freezers, unaware of the potential hazard.

    If you find one of these packages in your home, discard the sausage immediately or return it to the place of purchase for a full refund.

    Health officials urge anyone who believes they may have suffered an injury from consuming the meat to contact a health care provider.

    Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-674-6854 or send a question via email to MPHotline@usda.gov. 

    SOURCE: U.S. Department of Agriculture Food Safety and Inspection Service, recall announcement, Dec. 19, 2025

    Copyright © 2025 HealthDay. All rights reserved.

    HealthDay

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  • Is Aflatoxin a Concern? | NutritionFacts.org

    Is “toxic mold syndrome” a real thing? What do we do about toxic mold contamination of food?

    In recent years, mold has been blamed for all sorts of “vague and subjective” symptoms, but we have little scientific evidence that mold should be implicated. However, this “concept of toxic mold syndrome has permeated the public consciousness,” perpetuated by disreputable predatory practices of those making money testing homes for mold spores or testing people’s urine or blood. But all these tests are said to “further propagate misinformation and inflict unnecessary and often exorbitant costs on patients desperate for a clinical diagnosis, right or wrong, for their constellation of maladies…The continued belief in this myth is perpetuated by those charlatans who believe that measles vaccines cause autism, that homeopathy works, that fluoride in the water should be removed….”

    Mold toxin contamination of food, however, has emerged as a legitimate issue of serious concern, and mycotoxins are perhaps even more important than other contaminants that might make their way into the food supply. Hundreds of different types have been identified, but only one has been classified as a known human carcinogen, and that’s aflatoxin. The ochratoxin I’ve previously discussed is a possible human carcinogen, but we know aflatoxin causes cancer in human beings. In fact, aflatoxins are amongst the most powerful known carcinogens.

    It has been estimated that about a fifth of all liver cancer cases may be attributable to aflatoxins. “Since liver cancer is the third-leading cause of cancer deaths worldwide, and mortality rapidly follows diagnosis, the contribution of aflatoxins to this deadly cancer is significant.” And once aflatoxin makes it into the food, there is almost nothing we can do to remove it. Cooking, for example, doesn’t help. Indeed, as shown below and at 1:50 in my video Should We Be Concerned About Aflatoxin?, once it makes it into crops or into the meat, dairy, and eggs from animals consuming those crops, it’s too late. So, we have to prevent contamination in the first place, which is what we’ve been doing for decades in the United States. Because of government regulations, “companies in developed countries…are ‘always sampling’ for aflatoxin,” resulting in nearly $1 billion in losses every year. That may get even worse if climate change exacerbates aflatoxin contamination in the Midwest Corn Belt.

    So, on a consumer level, it is more of a public health problem in the less industrialized world, such as in African countries, where conditions are ripe and farmers can’t afford to throw away $1 billion in contaminated crops. Aflatoxin remains a public health threat in Africa, Southeast Asia, and rural China, affecting more than half of humanity. This explains why the prevalence of liver cancer in those areas may be 30 times higher, yet it is not a major problem in the United States or Europe.

    Only about 1% of Americans have detectable levels of aflatoxins in their bloodstream. Why not 0%? The U.S. Food and Drug Administration works to ensure that levels of exposure to these toxins are kept as low as practical, not as low as possible. In California, for instance, there has been an increase in “unacceptable aflatoxin levels” in pistachios, almonds, and figs. Unacceptable in Europe, that is, so it affects our ability to export, but not necessarily unacceptable for U.S. consumers, as we allow twice as much aflatoxin contamination.

    Figs are unique since they’re “allowed to fully ripen and semidry on the tree.” This makes them “particularly susceptible to aflatoxin production.” It would be interesting to know about the fig-consuming habits of the 1% of Americans who were positive for the toxin. If figs were to blame, I’d encourage people to diversify their dried fruit consumption, but nuts are so good for us that we really want to keep them in our diets. The cardiovascular health benefits we get from nuts outweigh their carcinogenic effects; nut consumption prevents thousands of strokes and heart attacks for every one case of liver cancer. “Thus, the population health benefits provided by increased nut consumption clearly outweigh the risks associated with increased aflatoxin B1 exposure.”

    So, we’re left with aflatoxin being mostly a problem in the developing world, and, because of that, it “remains a largely and rather shamefully ignored global health issue….” Where attention has been paid, it has been largely driven by the need to meet stringent import regulations on mycotoxin contamination in the richer nations of the world, rather than to protect the billions of people exposed on a daily basis.

    Doctor’s Note

    This is the last video in a four-part series on mold toxins. If you missed the others, check the related posts below. 

    Michael Greger M.D. FACLM

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  • The U.S. Might Finally Approve a Sunscreen Ingredient the World’s Been Using for Decades

    Sunscreens in the United States might soon be able to include a new ingredient.

    On Thursday, the U.S. Food and Drug Administration announced that it is proposing to permit bemotrizinol as an active ingredient in sunscreens. Information reviewed by the agency indicates that bemotrizinol protects against ultraviolet A and B rays, very little of it is absorbed by the body through the skin, and it rarely irritates the skin. If this motion goes through, it would be another active sunscreen ingredient broadly considered safe and effective by the FDA for adults and children over the age of six months.

    Already approved in other countries

    “The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” FDA Commissioner Marty Makary said in an FDA statement.

    Over-the-counter (OTC) monograph drugs like sunscreen can be sold without an approved drug application if they fulfill certain criteria, including rules dictated by their monograph. A monograph is a set of conditions (like active ingredients and doses) for a therapeutic category under which an OTC drug is “generally recognized as safe and effective.” OTC monograph drug categories include sunscreens, antacids, allergy medications, laxatives, and so on.

    “Bemotrizinol has been approved in Europe, Australia, Japan and other countries for more than two decades, and it has a steadfast track record for safety and tolerability,” Sairekha Ravichandran, a dermatologist at the Moffitt Cancer Center, said in a statement published by the center after the FDA’s announcement. “One drawback of some chemical sunscreens we have now is that they can become unstable and break down when exposed to sunlight,” she added. “But not bemotrizinol. This is a very stable sun filter that may even help to stabilize other unstable filters when added to a sunscreen formulation.”

    Concentrations of up to 6%

    According to the agency, DSM Nutritional Products LLC—a company that manufactures products for the pharmaceutical and cosmetic industries, among others—filed a request for the FDA to add bemotrizinol concentrations of 6% or less as a new active ingredient in the OTC monograph for sunscreens.

    “The reforms to the monograph drug system contained in the CARES Act have greatly streamlined the monograph drug regulatory process,” Karen Murry, Acting Director of the Office of Nonprescription Drugs, said in the FDA statement. “We look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past.”

    Margherita Bassi

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  • Botulism outbreak sickens more than 50 babies and expands to all ByHeart products

    Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.No deaths have been reported in the outbreak, which was announced Nov. 8.Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. Another 12 cases were identified with the expanded definition, including two that occurred in the original timeline and 10 that occurred from December 2023 through July 2025.ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”“That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking ByHeart. Being included in the investigation of the outbreak “feels like a win for all of us,” she said Wednesday.“I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized,” she said.In a statement late Wednesday, ByHeart officials said the company is cooperating with federal officials “to understand the full scope of related cases.”“The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination,” the statement said.Lab tests detected contaminationThe FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.“We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote on its website last month.Those results and discussions with the FDA led CDC officials to expand the outbreak, according to Dr. Jennifer Cope, a CDC scientist leading the investigation.“It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” Cope said. “They couldn’t isolate it to specific lots from a certain time period.”Inspection documents showed that ByHeart had a history of problems with contamination.In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, documents show.Infant botulism is rareInfant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.“The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

    Federal health officials on Wednesday expanded an outbreak of infant botulism tied to recalled ByHeart baby formula to include all illnesses reported since the company began production in March 2022.

    The U.S. Food and Drug Administration said investigators “cannot rule out the possibility that contamination might have affected all ByHeart formula products” ever made.

    The outbreak now includes at least 51 infants in 19 states. The new case definition includes “any infant with botulism who was exposed to ByHeart formula at any time since the product’s release,” according to the U.S. Centers for Disease Control and Prevention. The most recent illness was reported on Dec. 1.

    No deaths have been reported in the outbreak, which was announced Nov. 8.

    Previously, health officials had said the outbreak included 39 suspected or confirmed cases of infant botulism reported in 18 states since August. That’s when officials at California’s Infant Botulism Treatment and Prevention Program reported a rise in treatment of infants who had consumed ByHeart formula. Another 12 cases were identified with the expanded definition, including two that occurred in the original timeline and 10 that occurred from December 2023 through July 2025.

    ByHeart, a New York-based manufacturer of organic infant formula founded in 2016, recalled all its products sold in the U.S. on Nov. 11. The company, which accounts for about 1% of the U.S. infant formula market, had been selling about 200,000 cans of the product each month.

    News that ByHeart products could have been contaminated for years was distressing to Andi Galindo, whose 5-week-old daughter, Rowan, was hospitalized in December 2023 with infant botulism after drinking the formula. Galindo, 36, of Redondo Beach, California, said she insisted on using ByHeart formula to supplement a low supply of breast milk because it was recommended by a lactation consultant as “very natural, very gentle, very good for the babies.”

    “That’s a hard one,” Galindo said. “If there is proof that there were issues with their manufacturing and their plant all the way back from the beginning, that is a problem and they really need to be held accountable.”

    Amy Mazziotti, 43, of Burbank, California, said her then-5-month-old son, Hank, fell ill and was treated for botulism in March, weeks after he began drinking ByHeart. Being included in the investigation of the outbreak “feels like a win for all of us,” she said Wednesday.

    “I’ve known in my gut from the beginning that ByHeart was the reason Hank got sick, and to see that these cases are now part of the investigation brings me to tears — a mix of relief, gratitude and hope that the truth is finally being recognized,” she said.

    In a statement late Wednesday, ByHeart officials said the company is cooperating with federal officials “to understand the full scope of related cases.”

    “The new cases reported by CDC and FDA will help inform ByHeart’s investigation as we continue to seek the root cause of the contamination,” the statement said.

    Lab tests detected contamination

    The FDA sent inspectors last month to ByHeart plants in Allerton, Iowa, and Portland, Oregon, where the formula is produced and packaged. The agency has released no results from those inspections.

    The company previously reported that tests by an independent laboratory showed that 36 samples from three different lots contained the type of bacteria that can cause infant botulism.

    “We cannot rule out the risk that all ByHeart formula across all product lots may have been contaminated,” the company wrote on its website last month.

    Those results and discussions with the FDA led CDC officials to expand the outbreak, according to Dr. Jennifer Cope, a CDC scientist leading the investigation.

    “It looks like the contamination appeared to persist across all production runs, different lots, different raw material lots,” Cope said. “They couldn’t isolate it to specific lots from a certain time period.”

    Inspection documents showed that ByHeart had a history of problems with contamination.

    In 2022, the year ByHeart started making formula, the company recalled five batches of infant formula after a sample at a packaging plant tested positive for a different germ, cronobacter sakazakii. In 2023, the FDA sent a warning letter to the company detailing “areas that still require corrective actions.”

    A ByHeart plant in Reading, Pennsylvania, was shut down in 2023 just before FDA inspectors found problems with mold, water leaks and insects, documents show.

    Infant botulism is rare

    Infant botulism is a rare disease that affects fewer than 200 babies in the U.S. each year. It’s caused when infants ingest botulism bacteria that produce spores that germinate in the intestines, creating a toxin that affects the nervous system. Babies are vulnerable until about age 1 because their gut microbiomes are not mature enough to fight the toxin.

    Baby formula has previously been linked to sporadic cases of illness, but no known outbreaks of infant botulism tied to powdered formula have previously been confirmed, according to research studies.

    Symptoms can take up to 30 days to develop and can include constipation, poor feeding, loss of head control, drooping eyelids and a flat facial expression. Babies may feel “floppy” and can have problems swallowing or breathing.

    The sole treatment for infant botulism is known as BabyBIG, an IV medication made from the pooled blood plasma of adults immunized against botulism. California’s infant botulism program developed the product and is the sole source worldwide.

    The antibodies provided by BabyBIG are likely most effective for about a month, although they may continue circulating in the child’s system for several months, said Dr. Sharon Nachman, an expert in pediatric infectious disease at Stony Brook Children’s Hospital.

    “The risk to the infant is ongoing and the family should not be using this formula after it was recalled,” Nachman said in an email.

    Families of several babies treated for botulism after drinking ByHeart formula have sued the company. Lawsuits filed in federal courts allege that the formula they fed their children was defective and ByHeart was negligent in selling it. They seek financial payment for medical bills, emotional distress and other harm.

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  • US Medicare Potentially Adding Coverage For CBD

    Discover what US Medicare potentially adding coverage for CBD means for pain relief, wellness, costs, and patient care access.

    In good news, US Medicare potentially adding coverage for CBD.  The federal agency  is quietly moving toward a potential shift which could make cannabidiol (CBD) — the non-intoxicating compound extracted from hemp — more accessible to older Americans. Recent regulatory proposals and reporting indicate the Centers for Medicare & Medicaid Services (CMS) is considering ways for some Medicare programs, particularly Medicare Advantage, to reimburse certain hemp-derived products who meet federal and state rules. If finalized, the change would be a major step for seniors who already show high interest in CBD as an alternative for pain, sleep and anxiety.

    RELATED: Can Microdosing Marijuana Help You

    CBD’s popularity has exploded in the past decade. Shelves in pharmacies and grocery stores are stocked with tinctures, capsules, creams and gummies marketed to relieve everything from chronic pain to insomnia. Advocates argue broader coverage would lower out-of-pocket costs for seniors and integrate CBD into managed care pathways; critics caution federal law and uneven evidence mean wide insurance coverage would be premature. Reporting on this evolving policy debate shows regulators are trying to thread the needle — permitting coverage for a limited set of compliant hemp products while avoiding conflict with federal drug law.

    Photo by Olena Ruban/Getty Images

    What does the medical evidence say? The clearest, FDA-backed use of CBD today is for rare seizure disorders: Epidiolex, a prescription CBD product, is approved to treat Lennox-Gastaut syndrome, Dravet syndrome and seizures associated with tuberous sclerosis complex. Outside those indications, research is promising but mixed. Systematic reviews and clinical summaries indicate cannabinoids can help with chemotherapy-related nausea, some chronic pain syndromes and spasticity from multiple sclerosis, while CBD specifically has shown benefit as an adjunct for certain refractory epilepsies. However, many other claims — for anxiety, arthritis pain, sleep, and neurodegenerative disease — rely on smaller studies, observational data or preclinical work and need larger randomized trials.

    Medical authorities urge cautious optimism. The National Institutes of Health / NLM clinical reviews and summaries map the most robust evidence (epilepsy) and identify risks such as liver enzyme elevations and drug interactions require monitoring. The Mayo Clinic likewise notes while CBD is under investigation for many conditions, most over-the-counter CBD products lack FDA approval and strong evidence, and only one prescription CBD product is currently FDA-approved. Those organizations remain important resources for clinicians and patients weighing potential benefits and harms.

    RELATED: What About A Cannabis Cocktail/ Holiday Party

    What would Medicare coverage mean in practice? If CMS finalizes a rule allowing certain hemp-derived CBD products into benefits, coverage would likely be narrow: prescription formulations with proven indications or tightly specified, compliant hemp products produced under strict quality standards. Policymakers must address product quality, labeling, dosing, and safety surveillance before broad reimbursement. Until then, seniors interested in CBD should consult their clinicians about potential benefits, interactions with other medications, and whether an FDA-approved prescription product is appropriate.

    As regulators consider coverage, the debate will hinge on two forces: growing consumer demand from older Americans and the medical community’s call for better evidence and safeguards. The coming months could bring concrete policy steps from CMS; for now the conversation spotlights a larger question — how to responsibly integrate a widely used but unevenly regulated product into mainstream healthcare.

    Amy Hansen

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  • Looking to winterize your skin? DC dermatologist on how lotions ‘will not cut it’ this time of year – WTOP News

    A D.C. dermatologist has tips on how to help your skin combat the cold, dry air of winter and avoid flare-ups of conditions like eczema.

    WTOP’s Alan Etter on how to winterize your skin in dry weather.

    The cold, dry air of winter can make your skin drier than usual and make skin conditions like eczema harder to keep under control.

    But there are strategies to help winterize your skin and combat the weather changes.

    Dr. Adam Friedman, professor and chair of dermatology at George Washington University School Medicine and Health Sciences, said there are certain things you can be doing to keep your skin hydrated.

    “Your moisturizer needs a winter upgrade,” Friedman said. “Lotions will not cut it this time of year. I recommend creams and ointments to actually trap and hold moisture in the skin, giving the skin a time to repair and actually stay calm.”

    So what should you be looking for on the bottles and tubes?

    “Products that say ‘for eczema,’ as this is an FDA regulated term requiring a barrier protectant called colloidal oatmeal, which has decades of supporting data,” he said.

    And if your skin is really thick and flakey, he said to look for exfoliating products.

    “Keratolytics like urea, mandelic acid … ammonium lactate, these can safely exfoliate that thick skin and help pull water in,” he said.

    He said the simpler the better, when it comes to what is in the products. You want to limit how often you’re cleansing and avoid lengthy showers.

    “We want mild cleansers, because bathing, how one bathes, can play a very big role in how dry one’s skin is during the wintertime,” he said. “We want to keep showers short, not scalding hot, lukewarm. The most important thing is using a mild cleanser, and honestly, not to the whole body.”

    He said not every body part needs to be cleaned everyday. So what should you be doing?

    “The only areas that need soap every day are the underarms, face and groin,” Friedman said. “We can skip a day here and there, because soap is very drying. But then even more importantly is applying that cream or ointment based moisturizer to damp skin, usually within 30 seconds after getting out of the shower.”

    And when it comes to which brands to buy?

    “If a claim sounds too good to be true, it probably is,” he said. “My advice is, go for the bigger name brands that have the resources and take the time to actually evaluate their products with clinical studies.”

    WTOP’s Mike Murillo contributed to this report. 

    Get breaking news and daily headlines delivered to your email inbox by signing up here.

    © 2025 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

    Valerie Bonk

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  • FDA warns consumers about 19 cookware products that could leach lead into your food. Here’s the list.

    The Food and Drug Administration is warning consumers about 19 types of cookware that may contain lead, increasing the risk that the toxic metal could wind up in people’s food. 

    Consumers should check whether they have the items in their homes, and throw them away if they do, the FDA said in an alert posted on its website. 

    “Do not donate or refurbish this cookware,” the agency noted.  

    The suspect cookware, all manufactured outside the U.S. and mostly in India, is made from aluminum, aluminum alloys and brass that have been tested by the FDA and state agencies, with the results showing that they can leach lead into food.

    The FDA’s warning expands on its August alert about the cookware, with the agency adding nine products to its list of items to discard due to the risk of lead exposure. 

    Lead poisoning can lead to symptoms including abdominal pain, nausea, vomiting, appetite loss, memory loss, and pain or tingling in your hands or feet, among other issues, according to the Centers for Disease Control and Prevention. Children are especially sensitive to lead, which can damage their brains and nervous systems, slowing their growth and development, the agency says.

    Women of childbearing age and new mothers who are breastfeeding their infants are also at risk for lead poisoning, the FDA notes.

    Below are the cookware products the FDA says should be discarded, along with the manufacturer or distributor when that is specified. The items were sold by a handful of retailers in states including California, Illinois, Maryland, New Jersey and New York, as well as Washington, D.C. The FDA didn’t specify if the products were sold more widely, but noted that other items could be added to its alert.

    • Sonex aluminum pot (Manufacturer: Sonex Cookware)
    • IKM aluminum saucepan, size 2 with a 9″ wooden handle (Manufacturer: JSM Foods)
    • IKM 4-quarter pital brass pot (Manufacturer: JSM Foods)
    • Brass tope (Manufacturer: Kraftwares)
    • Aluminum kadai size 5 (Distributor: Lotus Mom)
    • Silver Horse aluminum caldero 28
    • Silver Horse aluminum degda 24
    • Silver Horse aluminum degda 20
    • Silver Horse kadai 26
    • Silver Horse aluminum milk pan 4
    • Chef Milk pan, 24 centimeters (Distributor: Shata Traders)
    • Aluminum hammered kadai, size 7 (Distributor: Indian Cookware & Appliance 
    • Brass pot (sold at Santos Agency)
    • Dolphin brand aluminum saucepan
    • 2-quart aluminum saucepan (Distributor: Win Chong Trading Corp.)
    • 3-quart aluminum saucepan (Distributor: Win Chong Trading Corp.)
    • Royal Kitchen cookware, milk pan size 3 (Distributor: New Reliance Traders)
    • Tiger White kadai 
    • JK Vallabhdas aluminum kadai (Grain Market)

    A kadai is a type of wide pan used in South Asian cooking, while a degda is a type of pot often used to cook rice. A tope is another type of pot used in South Asian cooking.

    The FDA urged retailers and distributors to contact the agency with any questions about the safety and regulatory status of any products they sell that are used to prepare food. Contact the FDA at premarkt@fda.hhs.gov.

    Edited by

    Alain Sherter

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  • Boar’s Head Cheese Recall Over Potential Listeria Contamination – KXL

    WASHINGTON, DC – Boar’s Head cheese products are being recalled over potential Listeria contamination. According to the FDA, a Boar’s Head supplier issued the recall and it’s being categorized as a Class One, which means exposure could result in serious health consequences or death.

    The recalled items included Boar’s Head Grated Pecorino Romano Cheese, FS Grated Romano Cheese, Pre-cut Pecorino Romano, EverRoast Chicken Caesar Salad, and EverRoast Chicken Caesar Wraps sold at Kroger stores in Kentucky and Indiana.

    According to the recall alert, the affected products are past their shelf life and “should already be out of distribution,” however, consumers are advised to discard any remaining products that may be in their possession.

    More about:

    Tim Lantz

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  • Dessert recall map shows new warning issued in 33 states

    Prime Food Processing LLC is voluntarily recalling over 2,000 cases of two dessert buns due to the packaging not declaring milk, affecting nearly three dozen states.

    Newsweek reached out to the company via phone on Friday night after hours and left a message.

    Why It Matters

    Numerous public health alerts and recalls have been issued this year due to potential damage, foodborne illness, contamination and undeclared food allergens.

    Millions of Americans experience food sensitivities or allergies every year. According to the U.S. Food and Drug Administration (FDA), the nine “major” food allergens in the United States are eggs, milk, fish, wheat, soybeans, crustacean shellfish, sesame, tree nuts and peanuts.

    “People who have an allergy or severe sensitivity to milk risk a serious or life-threatening allergic reaction if they consume these products,” the alert warns in part.

    What To Know

    According to the alert, the voluntary recall includes 2,243 cases of the dessert buns. The products were distributed to Asian grocery stores from April 2, 2025, to November 14, 2025.

    Prime Food brand Lava Bun with Salted Egg Yolk with UPC number 97903705873- 24 oz. Item #PD4188 is impacted by the recall, with a lot code range of 25092-25318 and an expiration range of 07/26-03/27, the alert notes.

    Prime Food brand Lava Bun with Green Tea Flavor is also included in the recall, with UPC number #97803705883- 24 oz. Item #PD4198. The product has a lot code range of 25092-25318 and an expiration range of 07/26-03/27, according to the alert.

    “The milk in these products is derived from unsalted butter listed in the ingredient statement,” the alert says in part.

    There have been no allergic reactions or illnesses reported as of Thursday, the alert notes. The impacted 33 states are as follows: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.

    Below is a map of the impacted states:

    What People Are Saying

    The alert, in part: “The issue was identified during an internal product review. The recall was initiated after it was discovered that packaging did not declare milk in the allergen statement. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company’s label review process.”

    What Happens Next

    Customers who have purchased the recalled dessert buns are urged to return the uneaten product and packaging for a full refund, the alert says.

    People with additional questions may contact the company via phone at 718-963-2323 from 9 a.m. to 5 p.m. ET weekdays.

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  • Patient guide to menopause HRT, must-knows after FDA change

    What does it mean when a warning label is removed from a medication after two decades?

    On Nov. 10, the U.S. Food and Drug Administration said it will ask companies to remove most “black box” safety warnings — used on medications to warn patients of serious health risks —  from hormone drugs commonly used to treat menopause symptoms. The change comes after years of advocacy from gynecologists, patients and professional medical organizations. 

    The FDA began requiring the warnings in 2003 after results from a large study raised concerns the medications could increase the risk of breast cancer, stroke and heart attack. Patients became hesitant to take the medications, and prescriptions decreased.

    But the science wasn’t so clear cut. The study that drove the change included mostly women older than 60, and hormone formulations and delivery methods different from what’s often used today. More recent scientific research has shown the medications to be much safer than previously believed, especially for women under 60. Some types of hormone therapy slightly increase a woman’s risk for certain health conditions, but the increased risk is small. 

    We spoke with four OB/GYNs who specialize in menopause management to find out what you need to know before your next doctor’s appointment. 

    What are the types of menopause hormone therapies? 

    Menopause hormone therapy, sometimes called hormone replacement therapy or HRT, refers to medications prescribed to treat menopause symptoms, including hot flashes, night sweats, mood swings and vaginal dryness. They work by replenishing hormones, such as estrogen and progesterone, that naturally diminish during the transition to menopause. 

    The medications take several forms. 

    Local estrogen therapy comes in creams, rings and tablets. These treatments are called “local” because their impact is limited to the area where they are applied, such as the vagina. These therapies address symptoms including vaginal dryness, itching, urinary tract infections and the sudden urge to urinate.

    With local therapies, the hormones are absorbed into the bloodstream only in trace amounts, making them a low-risk option. However, it also means they can’t treat broader symptoms, such as hot flashes or mood swings.

    Systemic hormone therapy, on the other hand, is designed to circulate the hormones throughout the bloodstream. It offers whole-body benefits but also carries more risk as a result. These therapies are administered orally or absorbed through the skin via patches, sprays or gels.  

    Systemic therapies include estrogen-only therapy, progesterone-only therapy or a combination of estrogen and progesterone. Women who have had their uterus removed only need to take estrogen. Women who still have their uterus must also take progesterone, often in combination with estrogen, to  protect against endometrial cancer. The FDA said black-box warnings for endometrial cancer will remain on estrogen-only systemic medications. 

    Different versions of estrogen and progesterone carry different risks and benefits. 

    “The treatments are highly individualized,” Dr. Marcy Nagpal, an OB/GYN at the Medical University of South Carolina, said in an email to PolitiFact. Talking with your doctor is the best way to know which therapy might be right for you. 

    Which patients are the best candidates for these meds? 

    Women with menopausal symptoms who are under 60, or women who had their last menstrual period within the last 10 years, doctors told us.

    But others can be candidates, too. 

    “At this time, it’s reasonable for anyone who feels that they are experiencing symptoms related to menopause to consider evaluation and treatment options,” Nagpal said. 

    If you don’t have symptoms, you do not need to take menopausal hormone therapy, said Dr. Jennifer Howell, a Duke University OB/GYN. It’s “not generally recommended for health promotion.” 

    Some people might be less suited for systemic therapies. Among them: Women who have or had breast cancer; who suffered a heart attack or stroke; who have had blood clots in their legs, lungs or brain; or who have active liver or gallbladder disease. Alternative medications and non-hormonal options to manage the menopause symptoms also are available, doctors said. 

    What are the benefits? 

    Doctors we talked to overwhelmingly pointed to symptom relief. 

    “Hot flashes and night sweats stop, sleep improves, mood is stabilized, joint pain often improves, and vaginal dryness and pain with vaginal penetration resolves,” said Dr. Karen Adams, OB/GYN and director of the menopause program at Stanford Medicine. She said recurrent urinary tract infections and frequent urination can stop.

    Dr. Nanette Santoro, an OB/GYN and professor at the University of Colorado, said, “Depending on just how annoying and disruptive those symptoms are, (the medications) can be a godsend.”

    While taken, systemic therapy can also prevent the rapid loss of bone density that typically accompanies menopause. 

    “Women can lose up to 20% of bone mass in the first five years after their final period,” said Adams. Stronger bones can reduce the risk of fracture and osteoporosis.

    But contrary to recent claims, data on whether hormone therapy can prevent heart attacks or dementia are not conclusive, Howell and Santoro said. 

    During the FDA announcement about the removal of black box warnings, assertions made about significantly improved cardiovascular health and lower Alzheimer’s risk are not supported by evidence, Adams said. “We absolutely do not have that data.”

    Likewise, the statement that these menopause therapies are life-extending “goes very far beyond the data and is in exactly no clinical guidelines,” Santoro said. 

    What are the risks of menopause hormone therapy? 

    With few exceptions, most symptomatic women can use local low-dose estrogen without risk, Howell said. 

    “The local forms should never have had this labeling at all,” Adams said. “The black box was placed on all estrogen products without regard to whether they were local or systemic, and a correction of that was long overdue.” 

    Systemic hormone therapies carry more risk and can be navigated with a more in-depth conversation with a doctor.

    Research shows that women who take a combination of estrogen and progesterone have an increased risk of breast cancer, but it’s “very small,” Howell said, and mainly pertains to prolonged use among older women.

    “This risk increases slowly and incrementally over time,” Santoro said, and applies to those who take hormones for longer periods, usually more than four to five years. 

    The risk profile also depends on the type of hormones a patient takes. Newer formulas appear to be more neutral for breast cancer risk than the formulas used in the 2002 study that led to the warnings, Adams said. And some estrogen-only therapies have been found to reduce breast cancer risk. 

    With some hormones, the risk varies depending on how they are taken. For example, some oral medications increase the risk for developing blood clots, but when the same medication is absorbed through the skin, it doesn’t appear to have that risk. 

    “Sorting out the risks and benefits for hormone therapy is a task for a patient and her doctor,” Santoro said, to determine the best type of hormones, how long to take them, and how to manage any risks. 

    Will this change impact insurance coverage?

    Doctors said it’s unlikely. 

    Most generic hormone therapy treatments are covered by insurance, Howell said, but specialized formulations that can be more convenient, safe or less messy can be challenging to get covered.  

    Tips for discussing HRT with your doctor

    If you are approaching menopause, or already in the throes of it, here are some pointers about discussing hormone therapy with your doctor. 

    First, make sure you and your doctor are compatible. 

    “This is a topic that can require a deep well of knowledge,” Nagpal said. “It’s reasonable to ask your doctor if they are comfortable with menopause medicine and, if not, to recommend someone who is.” 

    The Menopause Society, a nonprofit for healthcare professionals focused on improving menopause care, offers a search function to find certified providers in your area who have passed a test about menopausal management. 

    When scheduling, consider making an appointment specifically to address treatment options, rather than trying to combine the discussion with other concerns, Nagpal said. 

    On the day of your appointment, Santoro recommended bringing a list of your symptoms, ordered by which you would most like addressed. 

    “It’s not always possible to take care of everything with hormones alone, and knowing the bothersomeness is very helpful to me as the doctor, so I make my best recommendation,” she said. 

    Knowing your own health history — current medications, past health events, how long since your last period — and your family health history can also help.

    Nagpal advises keeping an open mind. 

    “Therapies that are appropriate for one person may not be indicated or appropriate for someone else,” she said. Getting the right dose and regimen might take some trial and error, doctors said. So don’t be alarmed if it takes a few visits and changes to get the most appropriate treatment. 
     

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  • New FDA-approved eye drop aims to help adults with age-related vision issues

    There is a new FDA-approved eye drop on the market called Vizz. This once-daily, prescription eye drop is said to help combat presbyopia, otherwise known as age-related blurry vision.

    Drugmaker LENZ Therapeutics touts that with just one drop in each eye, a person’s vision will improve for up to 10 hours, so they won’t have to wear reading glasses.

    Dr. Robert Johnson Jr. has been running Johnson Family Eyecare in Latrobe, Pennsylvania, for 46 years, and he explains that these eye drops basically act like a focus on a camera lens.

    “Vizz and the drug that has come before it, Vuity, have both worked on the same structural function; they cause your iris, or the colored part of your eye, to get smaller and smaller,” Dr. Johnson explained. “As your pupil gets smaller, it becomes apparent that it is like looking through a pinhole, and your depth of focus therefore increases.”

    Vizz is priced at $79 a month for 25 doses and $198 for three months, 75 doses, but prices may vary at different pharmacies. There are some side effects, including eye redness, headaches, and dimmed vision.

    Dr. Johnson cautions that while these new eye drops may help some, they are not a cure-all for presbyopia, but rather, they are just another good tool in the fight against age-related blurry vision.

    “It will work much better for the younger, 40, 50, 55-year-old patients than it will for the 60, 65, 70-year-old patients,” Dr. Johnson said. “Because they have less of a need to focus. By the time you get to be my age, your natural ability to focus is all gone. Therefore, the pupil would have to be made obsessively smaller and smaller. And if that pupil becomes too small, we begin to lose the amount of light that gets into the eye, and now you are going to have a 70-year-old who can read, but who can’t drive when the sun goes down.”

    Dr. Johnson advises those interested to consult their eye care professional to determine if these eye drops may be right for you.

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  • At Least 15 Babies Contract Infant Botulism Tied To Baby Formula – KXL

    Acquired Through MGN Online on 08/09/2024.

    NEW YORK, NY – America’s infant botulism outbreak is growing with multiple states affected, including New York and New Jersey, despite a nationwide recall of a certain baby formula.

    The FDA warned parents on Saturday that 13 babies in ten states had gotten sick and needed to be hospitalized after drinking ByHeart Whole Nutrition Infant Formula. But now the number has grown to 15 babies in 12 states.  The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Pennsylvania, Rhode Island, Texas, Oregon and Washington.

    All the infants are being treated with BabyBIG, a special IV medicine designed to treat botulism.

    The illness can cause serious complications, including trouble breathing and respiratory arrest. ByHeart, which is based in New York City, first issued a voluntary recall of two lots of formula which it’s now expanded to all.

    More about:

    Tim Lantz

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  • FDA warns websites selling fake or unapproved forms of Botox, similar drugs

    U.S. health regulators sent warning letters Wednesday to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable drugs commonly used to smooth wrinkles.

    The Food and Drug Administration said it was taking action after receiving reports of injuries in connection with the products, including what it said were symptoms of botulism.

    Botox is a diluted, purified form of botulinum, one of the most toxic substances in the world. The ingredient works by temporarily blocking nerve signals and causing muscles to relax. While most famously approved for cosmetic use, Botox is also approved in the U.S. for a number of medical conditions including muscle spasms, eye disorders and migraines.

    The FDA warning letters mostly went to cosmetics websites. In each case, the FDA said the companies were offering unofficial or mislabeled versions of Botox-like drugs that haven’t been approved by the agency. In addition to the original drug, introduced by Allergan in 1989, the FDA has approved several competing versions.

    FDA-approved Botox drugs carry the agency’s most serious warning, a boxed label alerting doctors and patients that the medications can cause serious or life-threatening side effects.

    In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening muscles needed for breathing and swallowing. Signs of botulism include difficulty swallowing or breathing, slurred speech and muscle weakness. Those symptoms can occur several hours after an injection.

    In a press release Wednesday, the FDA said patients should only receive the drugs from health professionals who are licensed and trained to administer them. Patients experiencing signs of botulism should “seek immediate medical care,” the agency noted. 

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  • FDA’s top drug regulator resigns after federal officials probe ‘serious concerns’

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

    WASHINGTON —

    The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

    Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

    “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

    The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.

    The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

    Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.

    Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

    Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

    Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

    Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

    The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

    In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.

    According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

    Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

    Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

    The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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  • FDA’s top drug regulator quits as agency officials probe actions

    Washington — The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.

    Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.

    “Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.

    The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements” during his time at the FDA.

    The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.

    Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and Tidmarsh was involved in his ouster from those leadership positions, according to the lawsuit.

    Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.

    Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.

    Upheaval at FDA  

    Tidmarsh’s ouster is the latest in a string of leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.

    Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.

    The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.

    In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.

    According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.

    Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.

    Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.

    The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.

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