FDA Approves Moderna's RSV Vaccine for Younger Adults
Moderna may sell the shot for adults under 60 who are at increased risk from respiratory syncytial virus, or RSV. The Food and Drug Administration approved it last year for adults 60 and older, giving the company a second product after its Covid vaccine.
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UPI
an hour ago
- UPI
FDA closes investigation into deadly listeria outbreak
The Food and Drug Administration has closed an investigation into a listeria outbreak. It was responsible one death and at least 10 people being sickened. File Photo (2020) Jim Lo Scalzo/EPA July 24 (UPI) -- The Food and Drug Administration has closed an investigation into a listeria outbreak that killed one person and sickened 10 in several western states, health officials announced Thursday. People were sickened by the outbreak after consuming products produced by California-based Fresh & Ready Foods, officials announced Thursday. The recall applied to Ready-to-Eat products sold in Arizona, California, Nevada and Washington. Illnesses have been reported in California and Nevada. Dozens of items have been recalled, ranging from sandwiches and protein snacks to pasta dishes and croissants. "FDA is working with Fresh & Ready Foods on corrective and preventive actions," the FDA said in a statement. The recalled products were distributed between April 18th and April 28th in vending machines and breakrooms in corporate offices, medical buildings and healthcare facilities, the FDA said. The products had "Use By" dates between April 22nd and May19th. The FDA said it made the discovery during environmental testing at a production facility that turned up listeria on a piece of equipment. "Fresh & Ready Foods has taken immediate corrective actions including removing equipment to address this issue to ensure ongoing food safety and compliance with FDA guidelines," the statement continued.
CNN
an hour ago
- CNN
100 days into the job, FDA Commissioner talks to CNN about staff changes, agency process— and Coke's switch to sugar
The US Food and Drug Administration is plowing ahead with sweeping plans to crack down on ultra processed foods and reshape the way new drugs and devices are reviewed and approved, the agency's commissioner, Marty Makary, told CNN in an interview this week. Makary sat down with CNN at the FDA's White Oak, Maryland campus, roughly 100 days into his tenure as the head of the agency that oversees vast portions of the US's food and health system: drugs, medical devices, tobacco and a portion of the food supply that accounts for roughly a fifth of the US economy. In the large, sunny room overlooking the courtyard at the center of the FDA's sprawling grounds, Makary put forth talking points he has often repeated on his podcast, 'FDA Direct'— a new feature for a commissioner. In a wide-ranging interview, he addressed everything from the agency's staffing changes to his thoughts on Coca-Cola's switch to real sugar. Makary, a gastrointestinal surgeon, took over the FDA just as broad layoffs and a slew of departures of experienced senior staff hit the agency amid changes orchestrated by DOGE, a White House efficiency group that attempted to reform the federal government through dramatic cuts. Makary was sworn in on the same day that the cuts took place, April 1. The FDA has since reinstated 'hundreds' of those terminated employees, Makary told CNN on Monday, and the waters have calmed since the layoffs. 'I want the public to know something very clear,' Makary said. 'The FDA is strong, and it will continue to be strong. The trains are running on time,' he said. 'We're going to meet all our targets this year,' he said, referring to the number of drugs and devices the FDA aims to evaluate by January. Such an achievement, if met, would be a relief for the US pharmaceutical industry, which has been watching cautiously as the agency overhauls its regulatory process, promising speedy new pathways for approvals. There has been skepticism. Earlier this year, hundreds of biotech executives had publicly lamented that FDA's leadership on science would be 'irretrievably lost' because of the April staffing losses. While scientists reviewing new drugs and devices were spared from cuts, administrative staff who aid their work were not. Since Makary assumed his post, the FDA also rolled out Elsa, a new artificial intelligence chatbot billed as a tool to help staff speed up clinical reviews and scientific evaluations. But Elsa has made up nonexistent studies and gotten facts wrong, according to six current and former FDA officials who spoke to CNN. Asked about the potential risks of AI-aided review, Makary said it is a work in progress. 'We never want to miss something that could be dangerous,' he said. 'It is a balancing act, and we've got to continue to try to do it.' The FDA is also a critical part of Health Secretary Robert F. Kennedy Jr.'s vision to 'Make America Healthy Again' through food policy reforms. This week, the US Department of Health and Human Services, which oversees the FDA, took a first major step toward regulating ultra processed foods by asking industry and scientific experts for feedback on how to define them. A major tenet of Kennedy's MAHA agenda is to remove artificial ingredients from foods, overhaul prescription drug use and tackle environmental toxins, all of which he believes are driving chronic illness among American children. Speaking to CNN, Makary laid out a framework for the FDA's broader food policy plans, including dramatic changes to the federal dietary guidelines, a compass for doctors, schools and families on the foods to eat and avoid. They are 'cleaning house' on the guidelines, Makary said. 'We're going to go bold on this because for too long, people have been confused, they've been misled.' 'We have a public trust epidemic in health care because in part people were lied to about what's healthy and what's not healthy,' he said — an assertion that would be highly disputed by experts who advise on the guidelines every five years. Moreover, the dietary guidelines are not entirely up to Makary and his agency. They'll have to hammer out the final recommendations by December with the US Department of Agriculture, and there has already been friction. Makary is also determined to see an end to what he called 'the 70-year war on natural saturated fat'— a substance, he says, that has 'never been found in any clinical trial to be directly associated with heart disease.' That claim is disputable. While Makary did not elaborate on which types of natural saturated fat have been demonized, as he put it, nutrition experts have said there are still significant and well-established harms to heart health from fats in red and processed meats. In dairy, different saturated fats are thought to have varied levels of risk and benefit. Makary's comments come as major food companies and fast-food chains scramble to position themselves as MAHA allies, promising to remove artificial ingredients and food dyes, and switch out seed oils for Kennedy's favored frying ingredient, beef tallow. Coca-Cola announced last week that it would start offering products with cane sugar rather than high-fructose corn syrup, news that was heralded by President Donald Trump. Experts say that is a marginal change; both are ultimately bad for your health. Asked about Coke's sugar announcement, Makary said, 'There are incremental benefits to the different types of sugar out there' but that 'I think it's a good switch.' There is more to come. The commissioner also said that FDA is 'doing an inventory' of more than 11,000 chemicals that are banned in Europe and other countries, but 'common' in the US food supply. Before coming to the FDA, Makary, a surgeon at Johns Hopkins University, was probably best known for a series of books on flaws in the health care system. He supported lockdowns and masking in the early days of the Covid-19 pandemic, but later became a prominent critic of vaccine requirements and booster shots. He argued in a February 2021 Wall Street Journal op-ed that the US would reach herd immunity by that April; instead, new waves of Covid strains hit the population. Those views did not exactly alienate Makary from the medical establishment or Washington's political world. Three Democratic senators voted to confirm him, making him the only one of Trump's health nominees to win Democratic votes in this administration. 'The day before my Senate confirmation hearing, I was in the operating room. So this is an entirely different domain for me,' Makary said. Sandee LaMotte contributed to this report.
Yahoo
an hour ago
- Yahoo
Thousands of K‑Cups Recalled Due to Potential Health Risks—Here's What Keurig Users Should Look For
If you like dark roast blends, you'll want to check this out. If you use a Keurig, you'll want to check out this recall. The FDA announced a voluntary recall of New Mexico Pinon Coffee, Dark Blend, due to an issue with the seal on the coffee K-Cup lids. Some of the coffee pod lids were not properly sealed, which could allow the food-safe dye on the label to run during the brewing process and potentially contaminate your coffee. The impacted products were sold nationwide and include 10-count packages of New Mexico Pinon Coffee, Dark Pinon Single Serve Keurig Cups with a product number: F03308 and UPC code: 812361033081. They have a lot code of 251749, and a "best buy" date of 05/08/2026. Related: The Top 6 Causes of Food Recalls—and the States Most Often Impacted The recall was deemed a "Class III" FDA recall, which means that it's unlikely to cause a serious adverse health issue—and so far, no one has reported a health issue related to the recall. The FDA still recommends throwing out the impacted K-Cups or returning them to the retailer for a refund. If you have any questions or concerns, you can contact New Mexico Pinon Coffee's customer service line at 505-298-1964, according to a press release. Read the original article on Real Simple Solve the daily Crossword
