logo
Biscuit Recall Update as FDA Issues Risk Warning

Biscuit Recall Update as FDA Issues Risk Warning

Newsweek2 days ago
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.
A recall of various biscuit products due to a labeling error has received a risk warning by the Food and Drug Administration (FDA).
Shang Hao Jia Inc. in California issued a voluntary recall for select lots of three varieties of soda biscuits on July 21 as the labels did not declare all the allergen ingredients: whole milk powder and wheat. The FDA later issued a Class III risk classification for the recall on August 11.
Newsweek contacted Shang Hao Jia Inc. for comment by phone outside regular working hours.
A stock image of biscuits.
A stock image of biscuits.
Press Association/AP
Why It Matters
A Class III risk classification represents a situation "in which use of, or exposure to, a violative product is not likely to cause adverse health consequences."
Milk and wheat are two of the nine major food allergens as defined in U.S. law. The others are eggs, fish, crustacean shellfish, tree nuts, peanuts, soybeans and sesame.
Allergic reactions vary in severity from mild symptoms, such as hives and lip swelling, to life-threatening complications, such as anaphylaxis, that may include fatal respiratory problems.
What To Know
These are the affected products:
Soda Biscuit Rye Flavor—4,800 units, with the UPC 6 970425 865055
Soda Biscuit Sea Salt Fresh Milk Flavor—4,800 units, with the UPC 6 970425 865031
Soda Biscuit Quinoa Chia Seed Flavor—4,800 units, with the UPC 6 970425 865048
The products were distributed to six wholesale supermarkets in California. They were manufactured by Zhejiang Dingdian Industry Co. Ltd.
As of August 11, no illnesses had been reported in connection with the consumption of the recalled products.
What People Are Saying
The Mayo Clinic said on its website: "Milk allergy is an atypical immune system response to milk and products containing milk. It's one of the most common food allergies in children. Cow's milk is the usual cause of milk allergy, but milk from sheep, goats, buffalo and other mammals also can cause a reaction.
"An allergic reaction usually occurs soon after you or your child consumes milk. Signs and symptoms of milk allergy range from mild to severe and can include wheezing, vomiting, hives and digestive problems. Milk allergy can also cause anaphylaxis—a severe, life-threatening reaction."
The Food and Drug Administration said on its website: "People with food allergies should read labels and avoid the foods they are allergic to. The law requires that food labels identify the food source of all major food allergens used to make the food."
Dr. Sebastian Lighvani, the director of New York Allergy & Asthma PLLC, previously told Newsweek: "Every three minutes in the United States, someone ends up in an emergency room because of an allergic reaction after accidental ingestion of food. So even when we try hard, these reactions are happening. And if you look at the incidence of anaphylaxis, it has skyrocketed in the last five, 10, 20 years. And in the U.S., there's like a 300 to 400 percent increase in the rates of anaphylaxis to foods."
What Happens Next
The recall is listed as ongoing, according to the FDA.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update
BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update

Yahoo

timean hour ago

  • Yahoo

BrainStorm Cell Therapeutics Announces Second Quarter 2025 Financial Results and Provides Corporate Update

Conference call and webcast scheduled for 8:30 a.m. Eastern Time Today, Thursday, August 14, 2025 NEW YORK, Aug. 14, 2025 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. "BrainStorm remains focused on executing our clinical development plan for NurOwn®. We reached an important milestone in Q2 with FDA clearance to initiate our Phase 3b trial, designed to generate confirmatory data to support a potential BLA submission," said Chaim Lebovits, President and CEO. "We are also advancing key operational activities, including discussions with clinical sites as well as ongoing engagement with our selected CDMO partners to ensure readiness for clinical drug supply. We are encouraged by the ongoing interest and support from clinicians and the ALS community, and we remain confident that, if approved, NurOwn has the potential to make a meaningful difference for patients and their families." Mr. Lebovits continued, "We support the FDA's consideration of the Citizen Petition, which may provide a fresh opportunity for an objective evaluation of the scientific evidence. We continue to stand behind the integrity and rigor of our data and will continue to engage with clinicians and the ALS community." Recent Highlights NurOwn (MSC-NTF) for ALS FDA has cleared the company to initiate the Phase 3b clinical trial of NurOwn® The Phase 3b trial, known as ENDURANCE, is expected to enroll approximately 200 participants at leading academic medical centers and will consist of a 24-week randomized, double-blind, placebo-controlled phase, followed by a 24-week open-label extension in which all participants will receive NurOwn. The primary endpoint is the change from baseline to week 24 in the ALS Functional Rating Scale-Revised (ALSFRS-R). Successful completion of the double blind portion of the study (Part A) is expected to generate the clinical data needed to support a new BLA submission. Details of the trial, including a list of anticipated participating clinical sites, are available on ID NCT06973629. A Citizens Petition submitted to the FDA by ALS Community requesting a new review of the NurOwn data The company acknowledges that the FDA's consideration of the petition provides a new opportunity to reaffirm NurOwn's potential as a therapy for ALS. BrainStorm was not involved in drafting or submitting this petition or its contents. New survival data from NurOwn Expanded Access Program show that 100% of participants (10/10) in the EAP survived more than 5 years from the onset of ALS symptoms, compared to published estimates indicating that approximately 10% of individuals with ALS would survive beyond 5 years. The single death in the cohort occurred following elective euthanasia. The median survival observed in the EAP cohort was 6.8 years (range: 6 to 7 years) from symptom onset. Although the EAP cohort included participants earlier in their disease course, these results are encouraging and support further study. Manufacturing Partnership with Minaris BrainStorm has signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO) specializing in cell and gene therapies, to manufacture NurOwn for the upcoming Phase 3b clinical trial. NurOwn® data selected as Breakthrough Science for Presentation at ISCT 2025 Meeting The new pharmacogenomic data were delivered in an oral presentation at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, in New Orleans. The data highlight the impact of the UNC13A genotype on clinical outcomes for ALS patients treated with NurOwn. The presentation was featured in the ISCT public announcement regarding the meeting, which indicated that the data were "carefully reviewed and selected by the ISCT 2025 Planning Faculty, to explore the latest breakthroughs in the clinical translation of Mesenchymal Stem/Stromal Cells and how they will shape the future of cell therapies." Financial Results for the Second quarter Ended June 30, 2025 Cash, cash equivalents, and restricted cash were approximately $1.03 million as of June 30, 2025. Research and development expenditures, net, for the quarter ended June 30, 2025 were $1.1 million, compared to $0.9 million for the quarter ended June 30, 2024. General and administrative expenses for the quarter ended June 30, 2025 were approximately $1.4 million, compared to approximately $2.1 million for the quarter ended June 30, 2024. Net loss for the quarter ended June 30, 2025, was approximately $2.9 million, as compared to a net loss of approximately $2.5.4 million for the quarter ended June 30, 2024. Net loss per share for the three months ended June 30, 2025, and 2024 was $0.34 and $0.60, respectively. Conference Call and Webcast Participant Numbers: Toll Free 877-545-0320 International 973-528-0002 Participant Access Code 601260 Webcast The replay of the conference call can be accessed by dialing the numbers below and will be available until August 28. Replay Numbers: Toll Free 877-481-4010 International 919-882-2331 Reply Passcode 52831 About NurOwn® The NurOwn® technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. About BrainStorm Cell Therapeutics Inc. BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI) is a leading developer of autologous adult stem cell therapies for debilitating neurodegenerative diseases. The company's proprietary NurOwn® platform uses autologous mesenchymal stem cells (MSCs) to produce neurotrophic factor-secreting cells (MSC-NTF cells), designed to deliver targeted biological signals that modulate neuroinflammation and promote neuroprotection. NurOwn® is BrainStorm's lead investigational therapy for amyotrophic lateral sclerosis (ALS) and has received Orphan Drug designation from both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A Phase 3 trial in ALS (NCT03280056) has been completed, and a second Phase 3b trial is set to launch under a Special Protocol Assessment (SPA) agreement with the FDA. The NurOwn clinical program has generated valuable insights into ALS disease biology, including pharmacogenomic response associated with the UNC13A genotype, biomarker data collected at seven longitudinal time points, and a comprehensive analysis of the "Floor Effect" — a critical challenge in measuring clinical outcomes in advanced ALS. BrainStorm has published its findings in multiple peer-reviewed journals. In addition to ALS, BrainStorm has completed a Phase 2 open-label multicenter trial (NCT03799718) of MSC-NTF cells in progressive multiple sclerosis (MS), supported by a grant from the National MS Society. BrainStorm is also advancing a proprietary, allogeneic exosome-based platform designed to deliver therapeutic proteins and nucleic acids. The company recently received a Notice of Allowance from the U.S. Patent and Trademark Office for a foundational patent covering its exosome technology, further strengthening BrainStorm's growing IP portfolio in this emerging area of regenerative medicine. To learn more, visit Notice Regarding Forward-Looking Statements This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties, including statements regarding meetings with the U.S. Food and Drug Administration (FDA), Special Protocol Assessment (SPA), the clinical development of NurOwn as a therapy for the treatment of ALS, the future availability of NurOwn to patients, and the future success of BrainStorm. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will" "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on BrainStorm's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. These potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. CONTACTS Investors:Michael WoodPhone: +1 646-597-6983mwood@ Media: Uri Yablonka, Chief Business OfficerPhone: +1 917-284-2911uri@ CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS U.S. dollars in thousands (Except share data) June 30,December 31, 20252024 UnauditedAudited U.S. $ in thousands ASSETSCurrent Assets: Cash and cash equivalents$ 824$ 187 Other accounts receivable 106 63 Prepaid expenses and other current assets 585 135 Total current assets$ 1,515$ 385Long-Term Assets: Prepaid expenses and other long-term assets $ 24$ 22 Restricted Cash 201 184 Operating lease right of use asset (Note 3) 495 807 Property and Equipment, Net 331 434 Total Long-Term Assets$ 1,051$ 1,447Total assets$ 2,566$ 1,832LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)Current Liabilities: Accounts payables$ 5,997$ 6,080 Accrued expenses 367 619 Short-term loans (Note 7) 101 300 Operating lease liability (Note 3) 381 549 Employees related liability 1,682 1,430 Total current liabilities$ 8,528$ 8,978Long-Term Liabilities: Operating lease liability (Note 3) 95 171 Warrants liability (Note 4) - 447 Total long-term liabilities$ 95$ 618Total liabilities$ 8,623$ 9,596Stockholders' Deficit: Stock capital: (Note 5) 16 14 Common Stock of $0.00005 par value - Authorized: 250,000,000 shares at June 30, 2025 and at December 31, 2024 respectively; Issued and outstanding: 10,120,109 and 6,141,762 shares at June 30, 2025 and December 31, 2024 respectively Additional paid-in-capital 226,446 218,974 Treasury stocks (116) (116) Accumulated deficit (232,403) (226,636) Total stockholders' deficit$ (6,057)$ (7,764)Total liabilities and stockholders' deficit$ 2,566$ 1,832 BRAINSTORM CELL THERAPEUTICS INC. AND SUBSIDIARIES INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED) U.S. dollars in thousands (Except share data) Six months ended Three months ended June 30, June 30, 2025202420252024 UnauditedUnaudited Operating expenses:Research anddevelopment, net$ 2,424$ 1,883$ 1,120$ 922 General and administrative 3,238 3,573 1,453 2,060Operating loss (5,662) (5,456) (2,573) (2,982)Financial income (expense), net (284) 43 (330) 30Gain (loss) on change in fair value of Warrants liability (Note 4) 179 529 - (411)Net loss$ (5,767)$ (5,942)$ (2,903)$ (2,541)Basic and diluted net lossper share from continuing operations$ (0.77)$ (1.35)$ (0.34)$ (0.60)Weighted average numberof shares outstanding usedin computing basic and diluted net loss per share 7,487,495 4,531,801 8,620,400 4,747,699 Logo - View original content to download multimedia: SOURCE BrainStorm Cell Therapeutics Inc.

Whoop there it is: FDA wants to regulate wearable firm's blood pressure tool
Whoop there it is: FDA wants to regulate wearable firm's blood pressure tool

Boston Globe

time2 hours ago

  • Boston Globe

Whoop there it is: FDA wants to regulate wearable firm's blood pressure tool

Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up But in a response sent Aug. 4, Whoop rejected the FDA's assessment, saying the software didn't meet the definition of a medical device and the company would continue to offer the feature to users. The company, which shared the letter with The Boston Globe, also argued the move went against the goals of the Trump administration. Advertisement 'Seeking to regulate the feature as a medical device also runs counter to the stated policy of the Secretary of the Department of Health and Human Services, Robert F. Kennedy Jr., of 'clearing away regulatory barriers so innovation can thrive,'' Whoop said in the letter. Advertisement Whoop's refusal to comply with the FDA's request is uncommon, legal experts said. The FDA, which oversees the safety of medical devices and pharmaceuticals, is usually the ultimate decider of what comes under its jurisdiction and which devices can be sold to help people manage or treat health conditions. Chris Robertson, a Boston University law professor who teaches FDA law, said any communication from the FDA to a company is typically enough to make the company get in line with federal standards. 'You're playing with fire here,' Robertson said. 'That means that Whoop is taking a real calculated gamble.' Wearable technology sits in a grey area when it comes to regulation. The wearables market, estimated by one market intelligence group to be worth $84 billion in 2024, is rapidly expanding, and companies are racing to add new features that give users unique health measurements. Related : Smart wristbands, watches and rings that assess heart rates don't have to get cleared as medical devices. But Whoop competitors, such as Apple and Fitbit, have sought FDA approval for certain software tools in recent years. The crux of Whoop's argument rests on the 21st Century Cures Act, a 2016 law that exempts wellness software features from the definition of a medical device, so long as those features aren't related to the diagnosis, prevention, or treatment of a disease. Blood Pressure Insights, Whoop said, is only intended to be used as a way to gauge a person's performance, quality of sleep, and stress levels . The FDA, however, has rejected Whoop's characterization of the blood pressure tool. In its letter, the agency said the product qualifies as a medical device because its measurements are 'inherently associated with the diagnosis of a disease or condition,' such as hypertension, or high blood pressure. Advertisement Whoop has registered one of its products with the FDA, securing medical device approval for its Heart Screener tool. That tool measures the heart's electrical activity to alert users to potentially abnormal heart rates and atrial fibrillation, a common type of abnormal heart rhythm. The FDA said it doesn't comment on 'ongoing investigations, compliance matters or enforcement activities except with the company involved.' Related : The confrontation is reminiscent of the clash more than a decade ago between the FDA and the personal genomics platform 23andMe, said health law expert Frances Miller, who also teaches at Boston University. The FDA and 23andMe went back and forth on whether the company's health test — which the company claimed could tell customers their risk of conditions like gallstones, heart disease, or arthritis — constituted a medical device. In 2013, the FDA sent a warning letter to 23andMe much like the one it sent Whoop, and 23andMe ultimately capitulated. But the landscape looks different today, Miller said. The FDA has experienced significant cuts under President Trump, and federal agencies as a whole have lost power. In addition, Kennedy has publicly stated his vision that 'every American is wearing a wearable within four years.' Whether Whoop will win its fight against regulation is unclear, Miller said. 'I could have given you a very confident answer a year and a half ago,' Miller said. 'Not now. They're pushing the envelope.' Marin Wolf can be reached at

FDA eyes warning label for antidepressants during pregnancy
FDA eyes warning label for antidepressants during pregnancy

The Hill

time2 hours ago

  • The Hill

FDA eyes warning label for antidepressants during pregnancy

The Food and Drug Administration (FDA) is considering placing a black-box warning on antidepressant use in pregnancy, alarming some doctors who worry that a reignited debate about the drugs' safety will discourage pregnant people from seeking treatment. FDA Commissioner Marty Makary recently hosted a panel discussion about the use of antidepressants during pregnancy, specifically serotonin reuptake inhibitors (SSRIs), with participants challenging the scientific consensus. While the drugs may pose some risk during pregnancy, the risks associated with not treating mood disorders like depression, to both pregnant people and developing fetuses, are much higher, according to physicians and medical experts. The American College of Obstetricians and Gynecologists (ACOG) released a statement calling the discussion 'alarmingly unbalanced,' warning that it is dangerous to minimize the effects of mental health conditions during pregnancy and postpartum. 'Unfortunately, the many outlandish and unfounded claims made by the panelists regarding SSRIs will only serve to incite fear and cause patients to come to false conclusions that could prevent them from getting the treatment they need,' the statement reads. Many panelists suggested pregnant people should be better warned about the harms the drugs pose to a developing fetus and discussed changing current labeling on antidepressants. Makary said in his opening remarks the drugs could influence the development of organs like the brain and heart in utero. He added that SSRIs have been 'implicated in different studies to be involved in postpartum hemorrhage, pulmonary hypertensions and cognitive downstream effects in the baby.' One of the panelists, Anick Bérard, a professor of epidemiology at the University of Montreal, claimed that the use of the SSRIs paroxetine and fluoxetine greatly increased the risk of adverse health events like miscarriage or low birth weight. For example, Bérard stated that SSRI use during pregnancy increased the absolute risk of miscarriage from about 6 percent to 10 percent. 'This needs to be well talked about when treating pregnant women who are depressed, anxious or using antidepressants,' she said. Physicians and physician groups have since criticized the discussion, calling it 'one-sided' given that only one of the 10 panelists spoke positively about SSRIs and how they can be used as an effective tool to treat depression and anxiety during pregnancy. Tiffany Moore Simas, an OB-GYN at UMass Memorial Health, said the unbalanced nature of the discussion will worsen stigma around antidepressant use during pregnancy and that a 'black box' label is not necessary on the drugs. 'Many perinatal individuals choose not to do pharmacotherapy for fear of fetal harm and for the stigma associated with psychiatric medication,' she said. 'That panel added to this fear of harm.' A spokesperson for the Department of Health and Human Services, which oversees the FDA, would not comment on any future policy decisions regarding antidepressants. The spokesperson did say that suggesting the expert panel was 'one-sided' or politically driven is 'insulting' to its participants. 'Commissioner Makary has an interest in ensuring policies reflect the latest gold standard science and protect public health,' the spokesperson said. 'To suggest that his engagement on women's health signals a desire to manipulate outcomes is politically motivated and undermines the serious work being done to improve care for millions of women.' Many people struggle with their mental health during pregnancy, with research showing that up to 20 percent of women experience depression during a pregnancy, and about 20 percent suffer from anxiety. About 8 percent of these women take an SSRI to treat the conditions. Those conditions carry health risks if left untreated, like preeclampsia, preterm birth, low birth weight, and suicide — one of the leading causes of maternal mortality in the United States. Some research suggests that 5 to 14 percent of pregnant or postpartum people experience suicidal ideation and that suicide could account for 20 percent of postpartum deaths. 'There is a real, biologic reason why pregnant and postpartum persons are susceptible to these conditions, and we need to treat them as needed,' said Moore Simas. 'There are consequences to not doing that.' Recommending that a patient start or stay on an SSRI during pregnancy is not a decision that physicians take lightly, doctors told The Hill, and providers typically will try to limit the number of potentially harmful exposures to a fetus. As a result, the first line of treatment for mild depression and sometimes moderate depression is therapy. But moderate and severe depression are important to treat, and there is 'reassuring' evidence that treating those conditions with SSRIs does not expose pregnant people to increased risks of birth defects, according to Nicole Leistikow, a psychiatry professor at the University of Maryland who specializes in treating women. There is a roughly 3 to 5 percent chance of birth defects occurring in any given pregnancy, according to data from the Centers for Disease Control and Prevention, and numerous large studies conducted over the last 30 years show that SSRIs do not increase this risk. FDA panelists noted that there have not been randomized trials to assess the safety of SSRIs, which some physician groups, like ACOG, agree should be conducted and prioritized. But physicians who spoke with The Hill noted that the studies panelists referenced were not well designed, with some having inappropriate control groups. They added that well-designed studies on antidepressant use in pregnancy will compare outcomes between appropriate groups, like women with depression taking antidepressants and women with depression not taking antidepressants.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store