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FDA Raises Concerns About Probiotic Products Sold for Use in Hospitalized Preterm Infants

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Warning Letters Issued to Two Companies for Illegally Selling Probiotic Products to Treat Diseases in Preterm Infants

As part of the U.S. Food and Drug Administration’s commitment to protecting public health, the agency is advising the public, including healthcare providers, of the possible risks that products containing live bacteria or yeast, which are commonly called probiotics, pose to preterm infants in hospital settings. The agency recently sent a letter to healthcare providers warning them about this topic and has issued two warning letters to companies for illegally selling their products for use in treating or preventing certain diseases in preterm infants.

Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements. The FDA is concerned as these products can be dangerous for preterm infants and are being illegally sold to treat or prevent diseases in preterm infants in hospital settings, such as to reduce the risk of necrotizing enterocolitis. Preterm infants who are administered a probiotic product are at risk of invasive, potentially fatal disease, or infection, caused by the bacteria or yeast contained in the probiotics.

The FDA is aware that certain probiotic products used in hospital settings to prevent necrotizing enterocolitis have contributed to invasive disease, including one infant death in 2023, and have been associated with more than two dozen other reported adverse events in the United States since 2018. The agency is also concerned about and is investigating reports that these products may have contributed to additional adverse events, including death, and is working to obtain the proper evidence and medical records, where possible. Any death or adverse event in an infant following the use of a probiotic product is very concerning, and the FDA is actively working with healthcare providers to better understand the link between the probiotic products used and the adverse events in preterm infants reported by these institutions. 

Importantly, the FDA has not approved any probiotic product for use as a drug or biological product in infants of any age. Unapproved, unlicensed probiotics that are used to treat or prevent a disease or condition in preterm infants have not undergone the agency’s thorough premarket evaluation for safety and effectiveness. Further, they have not been evaluated for compliance with the agency’s rigorous manufacturing and testing standards for drugs and biological products, including testing for other organisms. For these products to be lawfully marketed as drugs and biological products, the FDA requires approval of a Biologics License Application to ensure they have been appropriately evaluated. In the absence of an approved product, healthcare providers who administer products containing live bacteria or yeast to treat, mitigate, cure or prevent a disease or condition are required to submit an Investigational New Drug application to the agency to ensure the investigational use of an unapproved product is conducted with the appropriate safeguards.

“Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “With today’s message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency’s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses.”

The agency is committed to ensuring that any violations and safety issues presented by these products are addressed by their manufacturers. The agency issued a warning letter to Abbott Laboratories on Oct. 24, 2023, for its product, Similac Probiotic Tri-Blend, which contains B. infantis (Bb-02), S. thermophilus (TH-4) and B. lactis (BB-12). Of note, this product is not an infant formula and is not related to the previous issues the agency has noted with powdered infant formula manufactured by Abbott Nutrition. Abbott has agreed to discontinue sales of its Similac Probiotic Tri-Blend product and is working with the FDA to take additional corrective actions. 

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The warning letter notes the company sells the probiotic product for use in hospital settings for preterm infants. Based on the intended uses on the company’s websites and Abbott’s marketing materials, the product is an unapproved new drug and an unlicensed biological product being sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act. Additionally, the product is an adulterated dietary supplement under the FD&C Act because, when intended for consumption by preterm infants, the Bb-02 and TH-4 ingredients have not met the applicable safety requirements. 

The agency also recently issued a warning letter to Infinant Health, Inc (formerly Evolve BioSystems Inc.) regarding its probiotic product, Evivo with MCT Oil, an unapproved and unlicensed product sold for use in treating or preventing disease in preterm infants, in violation of the FD&C Act and the Public Health Service Act. The product was intended to be added to food for preterm infants and as such was also found to be an adulterated food under the FD&C Act. This product has since been voluntarily recalled and is no longer available in the U.S.

“Protecting public health, especially of the most vulnerable populations such as preterm infants, is one of the highest priorities for the FDA,” said Jim Jones, the FDA’s Deputy Commissioner for Human Foods. “We are encouraging all involved in the care of preterm infants, including parents, caregivers and healthcare providers, to be aware of the possible risks associated with the administration of probiotic products to preterm infants in hospital settings. The FDA continues to investigate these incidents and is committed to using our available resources and authorities to identify and address potentially unsafe products in the market.”

The FDA understands there are conflicting data in the literature on the safety and effectiveness of probiotics for the prevention of necrotizing enterocolitis, and that the study of the use of probiotics has been complicated by several factors, including the use of different probiotics in different trials. Because of the potential for harm posed by these products in highly vulnerable individuals, such as preterm infants, the agency urges the industry, clinical and research funding communities to focus on high quality clinical trials with products meeting quality criteria to provide definitive evidence to inform the use of these products by healthcare providers and, where appropriate, to support applications for drugs and biological products for use in infants of any age. 

The agency continues to carefully review and investigate adverse event reports for probiotics. To inform the agency’s surveillance efforts, and to better understand these issues to help protect public health, the FDA encourages healthcare providers and caregivers to report adverse events following use of probiotics to the manufacturer, the FDA’s MedWatch program and CFSAN’s Adverse Event Reporting System. Caregivers may also speak with their healthcare provider regarding concerns or questions with these products.

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Popular Nasal Decongestant Falls Short: FDA Advisers Question Efficacy

FDA questions effectiveness of popular nasal decongestant phenylephrine, raising concerns about congestion relief.

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In a surprising turn of events, government experts have cast doubt on the effectiveness of the leading decongestant found in popular over-the-counter medications like Sudafed and Dayquil. A recent review conducted by the Food and Drug Administration (FDA) found that the main drug ingredient, phenylephrine, offers no significant relief from nasal congestion. This revelation raises concerns among millions of Americans who rely on these medications for congestion relief.

Phenylephrine became the primary ingredient in over-the-counter decongestants after pseudoephedrine, an older ingredient, was moved behind pharmacy counters due to its potential for illegal drug processing. However, the FDA’s outside advisers unanimously voted against the efficacy of phenylephrine, prompting a reevaluation of its effectiveness. Despite phenylephrine-based versions dominating the market, accounting for four-fifths of the $2.2 billion oral decongestant market, the FDA’s conclusions suggest a need to reconsider their availability.

The FDA review identified significant flaws in the original studies that supported phenylephrine’s approval. These studies, conducted in the 1960s and 1970s, were deemed inadequate by modern standards. Furthermore, three recent, well-conducted studies by reputable pharmaceutical companies found no discernible difference between phenylephrine medications and placebos in relieving congestion. This raises concerns about the effectiveness of phenylephrine, which has relied on outdated research.

The FDA’s advisory panel’s unanimous vote against phenylephrine’s effectiveness could lead to regulatory action requiring drugmakers like Johnson & Johnson and Bayer to withdraw their phenylephrine-based oral decongestants from store shelves. This move may force consumers to opt for behind-the-counter pseudoephedrine products or phenylephrine-based nasal sprays and drops. However, it would necessitate extensive education efforts by the FDA, pharmacists, and drugstores to inform consumers about alternative options for treating congestion.

The Consumer Healthcare Products Association, representing nonprescription drugmakers, argued that the recent studies have limitations and advocated for continued “easy access” to phenylephrine. However, the FDA review highlighted the shortcomings of the original studies and the lack of modern scientific evidence supporting phenylephrine’s efficacy. Balancing public health concerns and consumer access will be a crucial challenge for regulators moving forward.

The FDA’s recent review has cast doubt on the effectiveness of phenylephrine, the key ingredient in popular nasal decongestants. This finding prompts a reevaluation of treatment options for nasal congestion and calls for further research to provide effective relief for individuals in need.

Check out the article from the Associated Press: https://apnews.com/article/sudafed-decongestants-phenylephrine-pseudoephedrine-fda-0f140bafae9a500c5fba05fe764ecb66

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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Important Recall Alert – Listeria Contamination in Meal Kits

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mouthwatering tacos in macro shot photography. Listeria
Photo by Jeswin Thomas on Pexels.com

In recent news, Reser’s Fine Foods has issued a recall on several of its popular meal kits due to potential contamination with Listeria monocytogenes, a harmful bacteria known to cause food poisoning. This recall was prompted by the inclusion of chicken from their ingredient supplier, BrucePac, which has also been recalled due to contamination concerns.

What Products Are Affected?

The affected meal kits include a variety of delicious options that many consumers may have purchased. These products consist of:

  • Taco Meal Kits
  • Enchilada Meal Kits
  • Quesadilla Meal Kits
  • Stir Fry Meal Kits
  • Salad Meal Kits

All of these products have been classified under a Class II recall by the U.S. Food and Drug Administration (FDA), indicating that while exposure may lead to temporary or medically reversible health consequences, the probability of serious adverse health effects is remote.

Understanding Listeria

Listeria monocytogenes is a bacterium that can lead to listeriosis, a serious infection typically caused by eating contaminated food. Symptoms can include fever, muscle aches, and gastrointestinal issues. Pregnant women, newborns, older adults, and individuals with weakened immune systems are particularly vulnerable to severe outcomes from listeriosis.

What Should Consumers Do?

If you have purchased any of the affected meal kits, it is crucial to check the packaging for any recall notices. Consumers should discard any recalled products or return them to the place of purchase for a refund. It is also advisable to stay informed by checking official announcements from the FDA and Reser’s Fine Foods regarding the recall.

Stay Informed

For the latest updates and more detailed information about this recall, visit the following resources:

Stay vigilant and prioritize your health by being aware of food recalls and potential safety issues. Your safety is paramount, so always make sure to stay informed about the food products you consume.

Related link:

https://www.newsweek.com/taco-meal-kit-recall-30-states-fda-1978552

At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

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Is There an E. Coli Outbreak at McDonald’s? What You Need to Know

McDonald’s faces an E. coli outbreak linked to Quarter Pounders, with 75 cases reported. The company is investigating potential onion contamination and prioritizing customer safety.

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E. coli outbreak


In the fast-paced world of fast food, health and safety are paramount. Recently, McDonald’s has been at the center of an alarming E. coli outbreak linked to their popular Quarter Pounders. With at least 75 reported cases across 13 states, including serious hospitalization and even a death, many consumers are understandably concerned. Let’s break down the situation, what officials are saying, and how McDonald’s is responding to the crisis.

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🚨 E. coli outbreak linked to McDonald’s Quarter Pounders! Stay safe & report any symptoms. Food safety is a top priority. 🍔 FoodSafety #ecolioutbreak2024 https://stmdailynews.com ♬ original sound – STMDailyNews – STMDailyNews

The Details of the Outbreak

Reports have confirmed that this E. coli outbreak is associated with Quarter Pounders sold across various McDonald’s locations. As of now, Colorado and Montana have recorded the highest number of illnesses, causing health officials to raise the alarm. The symptoms of E. coli infection can be severe and include stomach cramps, diarrhea, and vomiting, which can lead to life-threatening complications, especially in vulnerable populations.

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Possible Cause: Onions?

Amidst this distressing news, McDonald’s has identified a potential link to onions used in their Quarter Pounder recipe. While investigations are ongoing, the company is taking proactive measures by gradually reintroducing the Quarter Pounder to their menu without the traditional onions. This decision reflects their commitment to ensuring customer safety while addressing supply issues that may have arisen from the outbreak.

McDonald’s Response

In light of the ongoing investigation, McDonald’s has expressed its dedication to maintaining high food safety standards. They have collaborated closely with health officials, including the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), to trace the source of the contamination and prevent further incidents.

As they navigate this situation, the fast-food giant is emphasizing transparency with their customers. They have urged people to stay informed through official communication channels and monitor updates about the progress of the outbreak and safety measures being undertaken.

Consumer Safety: What Can You Do?

As the situation unfolds, it is essential for consumers to remain vigilant about their food choices:

  1. Stay Updated: Follow news reports and health advisories to keep track of the latest developments regarding this outbreak and any additional safety alerts.
  2. Practice Good Hygiene: Always wash your hands before eating, and keep an eye on cleanliness when dining out.
  3. Consider Menu Options: If you’re concerned about the outbreak, consider ordering items that do not contain ingredients linked to health risks or opt for menu items that have been specifically noted as safe.
  4. Know the Symptoms: Familiarize yourself with the signs of E. coli infection, and if you or someone you know experiences severe symptoms following a visit to McDonald’s, seek medical attention immediately.

The recent E. coli outbreak tied to McDonald’s Quarter Pounders has undoubtedly raised concerns among consumers, but the company is actively working to address the situation and safeguard the health of its patrons. While it’s human nature to worry about food safety, especially with such a concerning issue at hand, it’s also important to empower ourselves with knowledge and the right precautions.

As McDonald’s rolls out their menu changes, we hope that they can swiftly resolve this situation, ensuring that everyone can enjoy their meals with renewed confidence. Let’s all take a moment to prioritize food safety in our daily dining habits, and keep the conversation going around this crucial topic. Always stay informed, stay safe, and enjoy your meals wisely!

Read the release from McDonald’s corporate news site https://corporate.mcdonalds.com/corpmcd/our-stories/article/always-putting-food-safety-first.html

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At our core, we at STM Daily News, strive to keep you informed and inspired with the freshest content on all things food and beverage. From mouthwatering recipes to intriguing articles, we’re here to satisfy your appetite for culinary knowledge.

Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

https://stmdailynews.com/food-and-drink/

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