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.
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.
- Dear Healthcare Provider Letter: Warning Regarding Use of Probiotics in Preterm Infants
- Warning Letter: Abbott Laboratories
- Warning Letter: Infinant Health, Inc formerly Evolve Biosystems Inc.
FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors
Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.
“The FDA continues to address unmet medical need and advance the development of safe and effective therapies for the millions of Americans whose lives are affected by rare tumors,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “Desmoid tumors are rare tumors that can lead to severe pain and disability. Today’s approval will offer the first approved treatment option for patients beyond surgery and radiation.”
The effectiveness of Ogsiveo was evaluated in an international, multicenter, randomized, double-blind, placebo-controlled trial in 142 adult patients with progressing desmoid tumors not amenable to surgery. Patients were randomized to receive 150 milligrams (mg) of Ogsiveo or placebo orally, twice daily, until disease progression or unacceptable toxicity. The main efficacy outcome measure was progression-free survival (the length of time after the start of treatment for which a person is alive and their cancer does not grow or spread). Objective response rate (a measure of tumor shrinkage) was an additional efficacy outcome measure.
The pivotal clinical trial demonstrated that Ogsiveo provided clinically meaningful and statistically significant improvement in progression-free survival compared to placebo. Additionally, the objective response rate was also statistically different between the two arms with a response rate of 41% in the Ogsiveo arm and 8% in the placebo arm. The progression-free survival results were also supported by an assessment of patient-reported pain favoring the Ogsiveo arm.
The most common side effects seen in at least 15% of the patients in the trial were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea.
Ogsiveo was granted Priority Review under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition compared to available therapies. Ogsiveo also received FDA Fast Track and Breakthrough Therapy designations for the indication noted above, as well as Orphan-Drug designation for treatment of desmoid tumor (aggressive fibromatosis). Orphan-drug designation provides incentives to assist and encourage drug development for rare diseases.
The FDA granted the approval of Ogsiveo to SpringWorks Therapeutics Inc.
Salmonella Outbreak: Cantaloupe Recall Investigation
Salmonella outbreak: Cantaloupes recalled. Ongoing investigation. Stay informed for updates on the recall.
In recent weeks, an outbreak of Salmonella linked to cantaloupes has raised concerns across the United States and parts of Canada. The outbreak, which began in early November 2023, has resulted in numerous cases of illness reported from various states. Health authorities, including the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), are diligently investigating this outbreak to identify the source of contamination and prevent further illnesses. This blog post aims to provide an overview of the outbreak investigation, affected products and stores, symptoms of Salmonella infection, and recommendations for consumers and businesses.
On November 22, 2023, Crown Jewels Produce, Sofia Produce, and CF Dallas initiated a recall of fresh cantaloupes and related products due to potential Salmonella contamination. As of November 24, CDC reported a total of 99 cases from 32 states, with the latest onset date being November 10, 2023. The investigation is still ongoing, as authorities are working to determine if additional products are linked to the illnesses. The FDA will provide updates on this situation as more information becomes available.
Affected Products and Stores:
The following brands of whole fresh cantaloupes have been recalled:
- Cantaloupes labeled “Malichita” or “Rudy,” with the numbers “4050” and “Product of Mexico/produit du Mexique.”
- These cantaloupes were sold in retail stores located in Arizona, California, Maryland, New Jersey, Tennessee, Illinois, Indiana, Kentucky, Michigan, Ohio, Oklahoma, Wisconsin, Texas, Florida, and Canada. It is important to note that this list may not include all states, as the cantaloupes could have reached consumers through further retail distribution.
Recalled cut cantaloupe and products made from the recalled whole cantaloupes include:
- ALDI’s cantaloupe, cut cantaloupe, and pineapple spears in clamshell packaging with Best-by dates between October 27 and October 31.
- Vinyard’s cantaloupe chunks and cubes, fruit mixes, melon medleys, and fruit cups containing cantaloupe. Most of these products have a “Vinyard” label, and some have a red label with “Fresh” sold between October 30 and November 10 in Oklahoma stores.
- Freshness Guaranteed seasonal blend, melon trio, melon mix, fruit blend, fruit bowl, seasonal fruit tray, fruit mix, and cantaloupe chunks. RaceTrac fruit medley sold in clear square or round plastic containers at select retail stores in Indiana, Michigan, Ohio, Kentucky, North Carolina, Tennessee, Virginia, Illinois, Texas, and Louisiana.
Symptoms of Salmonella Infection:
Salmonella infection typically manifests within 12 to 72 hours after consuming contaminated food and typically lasts for four to seven days. Common symptoms include diarrhea, fever, and abdominal cramps. It is important to note that severe infections are more likely to occur in children younger than five, the elderly, and individuals with weakened immune systems.
Status and Recommendations:
The investigation into the cantaloupe-related Salmonella outbreak is still ongoing. Authorities will continue to provide updates as new information becomes available. In the meantime, the following recommendations are crucial:
- Consumers, restaurants, retailers, and wholesalers should refrain from consuming, selling, or serving recalled cantaloupes or products containing cantaloupe.
- Those who have frozen cantaloupes for later use should check their freezers and discard any recalled fresh or cut cantaloupes.
- If you are unsure whether your cantaloupe is part of the recall, it is best to err on the side of caution and dispose of it.
- Retailers and wholesalers who received recalled whole melons should identify the boxes labeled “Malachita/Z Farms” or “Malichita” or “Rudy” from Crown Jewels Produce and Sofia Produce (TruFresh) and remove them from their inventory.
- It is crucial to follow FDA’s safe handling and cleaning advice, ensuring that any surfaces and containers that may have come in contact with the recalled products are thoroughly cleaned and sanitized to prevent cross-contamination.
- If you suspect you may be experiencing symptoms of a Salmonella infection after consuming recalled cantaloupes, it is essential to seek medical attention promptly.
The outbreak investigation of Salmonella linked to cantaloupes is a matter of concern, and authorities are actively working to protect public health. By staying informed, following the recommendations, and taking necessary precautions, we can collectively mitigate the risks associated with this outbreak. Stay tuned for updates and adhere to the guidance provided by health authorities to ensure the safety of yourself and your loved ones.
FDA Expands Cinnamon Applesauce Recall: Lead Contamination Concerns
FDA expands recall of cinnamon applesauce pouches due to lead contamination. Illnesses potentially linked to recalled product reported. Investigation ongoing.
In a recent development, the Food and Drug Administration (FDA) has issued an updated advisory regarding the investigation of elevated lead levels in cinnamon applesauce pouches. This update includes an expanded recall from WanaBana LLC, now encompassing Weis and Schnucks-brand cinnamon applesauce pouches. The move comes in response to growing concerns over potential health risks associated with lead contamination in these products.
Emerging Health Concerns:
As of November 13, 2023, the FDA has received 22 reports of illnesses that may be connected to the recalled cinnamon applesauce pouches. In light of this, the FDA is diligently assessing incoming adverse reports of related illnesses. Their investigation is ongoing, with a primary focus on identifying the source of lead contamination and determining whether additional products are also linked to these reported illnesses.
The FDA’s Commitment:
To ensure public safety, the FDA will continue to update this advisory as new information becomes available. This demonstrates their dedication to protecting consumers and their commitment to swift action when potential health risks are identified.
The expanded recall of cinnamon applesauce pouches serves as a stark reminder of the importance of rigorous product safety measures. It is crucial for consumers to stay informed and heed the FDA’s recommendations regarding recalled products. By working together, government agencies, manufacturers, and consumers can help maintain the highest standards of food safety, ultimately safeguarding the well-being of individuals and families across the nation. https://www.fda.gov/food/alerts-advisories-safety-information/fda-advises-parents-and-caregivers-not-buy-or-feed-wanabana-apple-cinnamon-fruit-puree-pouches?utm_medium=email&utm_source=govdelivery
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