Latest news with #U.S.FoodandDrugAdministration
Miami Herald
an hour ago
- Health
- Miami Herald
Cookie Recall Update As FDA Sets Highest Risk level
The U.S. Food and Drug Administration (FDA) has elevated the risk level of a recent cookie recall to Class I—the highest and most serious category—amid concerns over undeclared allergens. New Grains Gluten Free Bakery announced a product recall that was publicized by the FDA earlier in May. The company found that some of its baked goods, including four types of cookie, may contain eggs, soy, or milk, despite consumers not being advised of this. Newsweek has contacted New Grains Gluten Free Bakery for comment via online form. According to the FDA, millions of people in the U.S. have food allergies or food sensitivities. Food sensitivities can range from mild reactions to potentially life-threatening symptoms. The FDA recognizes nine major food allergens: milk, eggs, sesame, fish, tree nuts, crustacean shellfish, peanuts, wheat and soybeans. The inclusion of these ingredients in a product without proper disclosure poses a serious risk of allergic reactions, which can range from mild discomfort to life-threatening anaphylaxis. The affected products, which include gluten-free varieties of Chocolate Chip, Frosted Sugar, Coconut Macaroon, and Brownie Chocolate Chip cookies, were found to contain undeclared allergens such as egg, milk, and soy. These allergens were not properly identified on the packaging due to print quality issues that rendered ingredient lists and allergen warnings either unreadable or missing. Compounding the problem, the lot codes and date codes printed on the cookie packaging were also unreadable or absent, making it difficult for consumers and retailers to identify and isolate affected batches. The FDA's Class I designation applies to recalls where there is a reasonable chance a product could cause serious health consequences or death. The cookies were sold in clear plastic bags with net weights of four ounces, containing six or eight cookies per package, depending on the variety, and were distributed in Utah. The bakery's website says its mission is to "create and deliver high-quality, healthy, and delicious gluten-free products to our customers, and make every eating experience satisfying, exceeding their expectations." Product recalls are issued by manufacturers if there are concerns that a food may be harmful in some way; such as when testing reveals that products are infected with potentially harmful bacteria, or amid fears that they could be contaminated with a foreign object from the manufacturing process. No illnesses have been reported to date. Earlier this month, New Grains Gluten Free Bakery announced that it was recalling several of its products, including breads, bagels and croutons, because they may contain undeclared eggs, soy, and milk. Consumers who have purchased the affected products are urged not to consume them and to return them to the place of purchase for a full refund. Consumers with questions may contact New Grains Gluten Free Bakery at 801-980-5751 between 10 a.m. and 3 p.m. MST, Monday through Friday. Related Articles Salmonella Recall: List of Products ImpactedAlbertsons Recall in 11 States and DC as Salmonella Warning IssuedAldi Salmon Recalled Over Life-Threatening Soy Allergy RiskFDA Issues Warning About Popular Allergy Medications 2025 NEWSWEEK DIGITAL LLC.
The Sun
10 hours ago
- Health
- The Sun
US FDA approves Moderna's next-gen Covid vaccine for adults 65 or older
THE U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors, Moderna said in a statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is increasing regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine, branded mNEXSPIKE, can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule.
The Sun
10 hours ago
- Health
- The Sun
FDA approves Moderna's new Covid shot for seniors, at-risk
THE U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements. The vaccine has also been approved for people aged 12 to 64 with at least one or more underlying risk factors, Moderna said in a statement. The Department of Health and Human Services, under the leadership of long-time vaccine skeptic Robert F. Kennedy Jr., is increasing regulatory scrutiny on vaccines. The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness. The Moderna vaccine, branded mNEXSPIKE, can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives. The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy's announcement days earlier that the agency would remove the shots from its immunization schedule.
Time of India
14 hours ago
- Health
- Time of India
US FDA approves Moderna's next-gen COVID vaccine for adults 65 or older
The U.S. Food and Drug Administration has approved Moderna 's next-generation COVID-19 vaccine for all individuals aged 65 and above, the company said on Saturday , the first endorsement since the regulator tightened requirements. The vaccine has also been approved for individuals aged 12 to 64 with at least one or more underlying risk factors, Moderna said in a statement.
NBC News
15 hours ago
- Health
- NBC News
Salmonella outbreak in cucumbers expands to 18 states, 45 sickened
A salmonella outbreak traced to a Florida-based cucumber producer has expanded to include 45 people reporting illness in 18 states, the U.S. Food and Drug Administration said Friday. Target stores joined a growing list of retailers that sold recalled cucumbers or ready-to-eat products featuring the fruit, and it's warning that purchasers should throw them away. The retailer issued a list of recalled products, including a Greek-style chicken salad from Boar's Head and several types of sushi restaurant staples, such as maki rolls with tempura and California rolls, all sold under the Mai brand. Last week, grocery store chain Walmart was added to the list of retailers urging customers to put the possibly tainted products in the trash, according to the U.S. Food and Drug Administration; its Marketside cucumber slices are a part of the recall. Patients connected to the outbreak have turned up in Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Michigan, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia, the FDA said on Friday. Of 45 people who have reported illness connected to the outbreak, 16 have been hospitalized, the agency said. No deaths have been reported. While investigators' focus has been on the strain salmonella montevideo, multiple other strains were detected in samples taken from a Pennsylvania distribution center belonging to Florida-based Bedner Growers, believed to be a source, the FDA said in its Friday statement. The FDA said that those different strains so far appear to be unrelated to the spring outbreak, but that it is investigating further alongside scientists from the U.S. Centers for Disease Control and Prevention. "CDC is working to determine if additional human illnesses match these additional strains," the FDA said. "Further analysis of the sample is pending." All the illnesses so far have been connected to cucumbers produced by Bedner and distributed by Fresh Start Produce Sales, the agency said. The cucumbers and products that contained them were sold from April 29 to May 19, the FDA said. The first retailers noted for selling the potentially tainted cucumbers were three Bedner's Farm Fresh Market locations in Florida, but the list of public-facing sellers has continued to increase. Other distributors as well as eateries were told they may have also purchased the possibly tainted cucumbers, labeled for wholesale as 'supers,' 'selects,' or 'plains," the FDA said. FDA inspectors unearthed tainted cucumbers during an inspection last month of Bedner Growers' facilities, it said. The review was a follow-up to a Salmonella Africana outbreak linked to the producer last year, according to the agency. Bedner's did not immediately respond to a request for comment late Friday. A spokesperson for Fresh Start Produce Sales said last week that the company "is committed to protecting public health and helping Bedner Growers with its recall." Salmonella is a bacterium that can thrive amid animals and their fecal matter and contaminate nearby produce, which can reach the dinner table if unwashed, according to the FDA and CDC. Older people, children under 5, and those with compromised immune systems are particularly susceptible to the salmonella's worst symptoms and even death. Patients sickened by it can develop stomach cramps, diarrhea, nausea and the urge to vomit anywhere from six hours to six days after infection, the CDC says. Salmonella is 'a leading cause of foodborne illness, hospitalizations, and deaths in the United States and worldwide," the CDC states.
