Cookie Recall Update As FDA Sets Highest Risk level
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources.
Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content.
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.
Why It Matters
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.
What To Know
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.
Stock image of Christmas cookies in a tin.
Stock image of Christmas cookies in a tin.
Silas Stein/picture-alliance/dpa/AP
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.
What Happens Next
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.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
5 hours ago
- Yahoo
Perspective Therapeutics Commences Recruitment for [212Pb]VMT-α-NET in the Third Dose Escalation Cohort of its Ongoing Phase 1/2a Clinical Trial
[212Pb]VMT-α-NET Phase 1/2a study is advancing into Cohort 3 with a fixed administered dose that is up to 20% higher (6 mCi) than the dose administered to patients in Cohort 2 Dosimetry sub-study analysis presented at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) 2025 Annual Meeting to advance utility of dosimetry in clinical development when considered with clinical data On track to submit further clinical updates to scientific congresses in 2H 2025, including longer safety follow-up on all patients who have received at least one treatment of [212Pb]VMT-α-NET and anti-tumor activities in patients dosed to date who have had the opportunity to receive at least one scan after their full treatment SEATTLE, June 21, 2025 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. ("Perspective" or the "Company") (NYSE AMERICAN: CATX), a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body, today announced that alignment was reached with the U.S. Food and Drug Administration (FDA) to open the third dosing cohort (Cohort 3) of its ongoing Phase 1/2a clinical trial for [212Pb]VMT-α-NET in patients with unresectable or metastatic somatostatin receptor 2 (SSTR2)-positive neuroendocrine tumors (NETs) who have not received prior radiopharmaceutical therapies (RPT). "We are excited to start exploring a higher dose level of VMT-α-NET after successfully completing an interaction with the FDA that was agreed prior to commencement of this trial," commented Markus Puhlmann, Chief Medical Officer of Perspective. "We are encouraged by the overall clinical profile observed at the second dose level of VMT-α-NET—including evidence of anti-tumor activity and primarily low-grade adverse events—and we believe it is important to assess whether a higher dose could further improve the therapeutic profile. Meanwhile, we remain committed to engaging with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of our proprietary RPTs." Patients in Cohort 3 will receive up to four fixed administered doses of [212Pb]VMT-α-NET at 6 mCi every eight weeks if they weigh more than 60kg (133lb), or 100μCi/kg of body weight if they weigh less than or equal to 60kg. Observations of dose limiting toxicities (DLTs) in up to eight patients within 42 days of the first treatment cycle will be used to assess whether this cohort of patients have received maximum tolerated dose (MTD) or maximum feasible dose (MFD). Once a safety monitoring committee (SMC) has reviewed the data from these initial patients, it may recommend exploring alternative dosing and/or recruit more patients into Cohort 3. Perspective is notifying sites that Cohort 3 is now open for recruitment. Patients currently being evaluated for entry into the study will enroll into Cohort 3 if they qualify. Pending feedback from sites on operationalizing enrollment into Cohort 3, an update on pace of recruitment will be provided in due course. About [212Pb]VMT-α-NETPerspective designed [212Pb]VMT-α-NET to target and deliver 212Pb to tumor sites expressing SSTR2. The Company is conducting a multi-center, open-label, dose-escalation, dose-expansion study ( identifier NCT05636618) of [212Pb]VMT-α-NET in patients with unresectable or metastatic SSTR2-positive neuroendocrine tumors who have not received a prior RPT. Interim update with a data cut-off date of April 30, 2025 were reported in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in May 2025. Cohort 2 was reopened in August 2024. During 2H 2025, some of the 33 additional patients enrolled after the cohort reopened and through April 30, 2025 will have had the opportunity for at least 32 weeks of follow-up after their initial doses, sufficient time to receive at least one scan after their full treatment (up to four doses every eight weeks), if they receive all four doses of treatment per protocol. About Perspective Therapeutics, Therapeutics, Inc. is a radiopharmaceutical company pioneering advanced treatments for cancers throughout the body. The Company has proprietary technology that utilizes the alpha-emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties. The Company is also developing complementary imaging diagnostics that incorporate the same targeting moieties, which provides the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity. The Company's melanoma (VMT01), neuroendocrine tumor (VMT-α-NET), and solid tumor (PSV359) programs are in Phase 1/2a imaging and therapy trials in the U.S. The Company is growing its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations. For more information, please visit the Company's website at Safe Harbor StatementThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include statements concerning, among other things, the Company's ability to pioneer advanced treatments for cancers throughout the body; the Company's belief that it is on track to submit further clinical updates to scientific congresses in 2H 2025 and the planned content of such updates; the Company's ability to explore a higher dose level of VMT-α-NET; the Company's commitment to engage with the FDA to evaluate the clinical utility of dosimetry estimates and analyses in the development of its proprietary RPTs; the Company's expectation that patients currently being evaluated for entry into its VMT-α-NET study will enroll into Cohort 3 if they qualify; the ability of the Company's proprietary technology utilizing the alpha emitting isotope 212Pb to deliver powerful radiation specifically to cancer cells via specialized targeting moieties; the Company's prediction that the use of complementary imaging diagnostics that incorporate the same targeting moieties provides the opportunity to personalize treatment and optimize patient outcomes; the Company's belief that its "theranostic" approach enables the ability to see a specific tumor and then treat it to potentially improve efficacy and minimize toxicity; the Company's ability to grow its regional network of drug product finishing facilities, enabled by its proprietary 212Pb generator, to deliver patient-ready products for clinical trials and commercial operations; and other statements that are not historical fact. These forward-looking statements involve risks and uncertainties that could cause the Company's actual results to differ materially from the results described in or implied by the forward-looking statements. Certain factors that may cause the Company's actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC"), in the Company's other filings with the SEC, and in the Company's future reports to be filed with the SEC and available at Forward-looking statements contained in this news release are made as of this date. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. Media and Investor Relations Contacts: Perspective Therapeutics IR:Annie J. Cheng, CFAir@ Russo Partners, LLCNic JohnsonPerspectiveIR@
Newsweek
5 hours ago
- Newsweek
The Key to Better Sleep Is in Your Gut, Says Gastroenterologist
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. Around 25 million U.S. adults suffer from insomnia. At the same time, more than 3.9 million Americans are taking probiotics, usually for gut health, according to the American Gastroenterological Association (AGA). And gut health could be the key to better sleep. A study published in the journal Engineering examined a specific probiotic strain called Lactobacillus helveticus CCFM1320. This probiotic produces a compound known as SAM (S-adenosylmethionine), which helps regulate the body's internal clock and supports the production of melatonin, a hormone that promotes sleep. The researchers found that this probiotic could significantly improve sleep quality. The Gut as a Second Brain Neuroscientist Dr. Chelsie Rohrscheib, the head of sleep at Wesper, a national home sleep disorder diagnostics company, told Newsweek: "The gut essentially acts as a secondary nervous system and creates and releases many crucial neurotransmitters, such as serotonin, which also help to regulate nervous system activity. "This allows for two-way communication between the gut and the brain, called the gut-brain axis. Healthy gut microbes are essential to keeping the gut healthy and functioning, and there is ample evidence that gut microbiota dysregulation can negatively impact the activity of the gut-brain axis. Because the brain is highly sensitive, this can lead to poor sleep quality." Stock image of a woman taking pills from her nightstand before bed. Stock image of a woman taking pills from her nightstand before bed. Liudmila Chernetska/iStock / Getty Images Plus Is CCFM1320 a Game-Changing Strain? To test the effectiveness of CCFM1320 in humans, scientists from Jiangnan University conducted a four-week study with 60 volunteers who experienced sleep difficulties. Participants were divided into two groups: one received the probiotic, while the other took a placebo. Results showed that those who consumed the probiotic had better sleep scores, lower levels of the stress hormone cortisol, and a healthier balance of gut bacteria. Additionally, the probiotic boosted the expression of genes involved in producing and utilizing SAM, a key factor in sleep and overall health. Strain-Specific Benefits Dr. Michel Bass, a board-certified gastroenterologist and the Founding Medical Director at Oshi Health in Philadelphia, Pennsylvania, emphasized the importance of strain specificity: "Not all probiotics are created equal. This study identified CCFM1320 as uniquely beneficial for sleep quality. This isn't a generic 'take-any-probiotic' situation—it's about strain-level specificity," Bass told Newsweek. "That's where a lot of public messaging needs to evolve. Just like different medications target different conditions, different strains do different things. And this one appears to enhance melatonin synthesis via SAM methylation—a novel pathway." Probiotic Supplements vs. Fermented Foods Stock image of an assortment of fresh vegetables and meats. Stock image of an assortment of fresh vegetables and meats. esilzengin/iStock / Getty Images Plus While fermented foods like yogurt, kimchi, and kefir are beneficial for general gut health, Bass explained that they may not provide targeted probiotic strains at therapeutic levels. "If someone wants to improve things like sleep quality or reduce stress hormones like cortisol, a strong, well-researched supplement—especially one with proven strains like CCFM1320—is usually more effective," he said. "That said, eating fermented foods is still a great daily habit and can complement targeted probiotic supplements." Jason Eastty, owner of Healthspan Longevity in Westborough, Massachusetts, and a nutrition specialist, added that overall good nutrition can combat poor sleep. "Having a nutrient deficiency—like low iron, magnesium, or vitamin D—can throw off your gut microbial balance, leading to poor sleep. Clinical trials have shown that correcting these deficiencies helps microbial diversity and improves sleep efficiency," Eastty said. He also emphasized that a whole-foods diet rich in fiber—from fruits, vegetables, legumes, nuts, seeds, and whole grains—is essential to feeding the "good" bacteria in your gut.
Newsweek
8 hours ago
- Newsweek
Baby Pulls Out Breathing Tube, Next Few Crucial Seconds Caught on Camera
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Newsweek AI is in beta. Translations may contain inaccuracies—please refer to the original content. The heartstopping moment a mom and dad rushed to their baby's aid after she removed the tube that helps her breathe has been caught on camera. Dannii Sterling and Gary Burgess from Ashford, Kent, in the U.K., demonstrated an incredible level of care and composure as they tended to their daughter Billie. "Billie had decannulated herself, which means she pulled her tracheostomy tube out," Sterling told Newsweek. "We don't actually know how long she would be okay without it, so it's a case of getting a new one ASAP." Tracheostomy tubes are used to create an opening in the windpipe to assist with breathing. Writing alongside a video chronicling the drama, which was posted to Instagram under the handle billiesbreathingbattle, Sterling said her daughter has become "extremely inquisitive" about the tube, leading to "frightening" moments like these. "She doesn't understand that she shouldn't disconnect her vent ALL. DAY. LONG. Or that she shouldn't pull on her tracheostomy with both hands and yank it out of her neck," she said. Gary and Dannii coming to Billie's aid after she removed her tracheostomy tube. Gary and Dannii coming to Billie's aid after she removed her tracheostomy tube. Instagram/BilliesBreathingBattle Sterling knows there is every chance this will happen again, and it will take time for Billie to understand the importance of the tube. But after everything they have been through together as a family, to have their daughter happy and at home makes it all worthwhile. Billie was born on November 12, 2023, at 27 days, 4 weeks gestation via emergency caesarean in challenging circumstances for both mother and child. "I was unfortunately suffering from severe preeclampsia and was extremely unwell; this was the only option to save both mine and Billie's lives," Sterling said. Sterling would have to wait to properly meet her daughter. Weighing just 1lb 11oz, Billie was taken to a Neonatal Intensive Care Unit (NICU) immediately after she was born. "Billie's lungs were so underdeveloped that she has severe chronic lung disease, which has caused an accumulation of issues and complications for Billie," Sterling said. "There have been numerous occasions where we have very nearly lost her, and she is extremely lucky to still be alive." When Billie was just a month old, she was transferred by emergency ambulance to a London hospital to undergo lifesaving bowel surgery. "I was warned Billie may not make it to London alive," Sterling said. But Billie did make it to London and through the surgery she so desperately needed. In her short life, Billie has undergone nine different surgeries and procedures. These include a procedure for a stoma opening and reversal on her bowel for necrotizing enterocolitis (NEC), heart surgery for patent ductus arteriosus (PDA), bronchoscopies and tracheostomy procedures on her airway. She's also had a Percutaneous endoscopic gastrostomy (PEG) feed fitted to her abdomen as well as central and peripheral lines to allow intravenous access when administering medications. The first six months of Billie's life were spent intubated and sedated. Due to her premature birth, brain scans showed Billie is also at risk of suffering from Cerebral Palsy as she develops. Billie lives with chronic lung disease and severe bronchomalacia, meaning her airway is not fully formed and is "floppy" rather than stiff. "Billie has frequently stopped breathing as her airway collapses and her heart rate drops so low that she requires CPR," Sterling said. "Billie had the majority of her life not being able to go 7 days without having an infection, including pneumonia and sepsis." Despite the challenges faced in the early part of her life, Billie has found a way to blossom into the happiest little girl. Best of all, after 456 days in hospital, in February 2025, Billie finally came home. "She is growing and becoming stronger day by day, and myself and Gary can finally enjoy her little personality and character," Sterling said. "She's a good girl really but is always being mischievous. She loves being with her family and just generally watching everyone be silly." Gary and Dannii out with Billie, who is going from strength to strength. Gary and Dannii out with Billie, who is going from strength to strength. Instagram/BilliesBreathingBattle Though Sterling acknowledges leaving the house with Billie can be a challenge, with all of the things they need to maintain her care, making it feel like they are "packing for a mini holiday," they have been out on trips together. Billie is usually just happy at home, though, enjoying her favorite show, Miss Rachel. "We have to be super careful with her and germs, which can be stressful sometimes but we do as much as possible with her to try and make life as normal as possible," Sterling said. Being prepared for moments like the one captured on the video is an example of the new normal they face as a family. Sterling and Burgess are more than up to the challenge, though. "We had lots of training before the hospital allowed us to be discharged," she said. "They teach you all about emergency situations and how to react, but I think you look calm on the outside but are freaking out on the inside." With time, they hope Billie begins to understand why she shouldn't touch the tube. Until then, both mom and dad know they will have to have "eyes in the back of [their] heads." A brighter future is on the horizon, one where Billie starts school and no longer needs the tracheostomy. That begins with ventilator breaks, with a view to building up to the point where she is off the machine all day. Sterling knows they are on a "journey" with their daughter, but if the video she shared online shows anything, it's that Billie is in the best possible hands.
