May 29, 2022

FDA Updates Activities on Infant Formula Supply Challenges

The FDA has updated its activities on infant formula supply challenges. The agency is trying to increase the supply and availability of infant formula since the Abbott Nutrition plant in Sturgis, Michigan closed because the FDA found Cronobacter contamination in the environment. The agency warned parents not to use certain powdered infant formula products from that facility on February 17, 2022. A recall was issued by Abbott the same day. Cronobacter is a bacteria that can cause serious illness and death in infants, particularly premature babies and those with other medical conditions. A consent decree of permanent injunction was filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. Abbott has agreed to take corrective actions following the FDA … [Read more...]

FDA Issues Final Guidance For Seeds Used For Sprouting

The FDA is issuing final guidance for seeds used for sprouting. The guidance outlines FDA's concerns over food poisoning outbreaks associated with th consumption of raw and lightly cooked sprouts. The guidance gives firms recommended steps to prevent adulteration throughout the production chain. Between 1996 and 2020, the were 52 reported foodborne illness outbreaks associated with contaminated sprouts. As a result, at least 2700 Americans were sickened. Contamination can occur at any point in the supply chain, but the seeds themselves are the most likely source of contamination in many of these outbreaks. In 2019 and 2020, an E. coli O103 outbreak linked to raw sprouts at Jimmy John's restaurants sickened at least 22 people in Iowa. Another Jimmy Jon's outbreak, this time caused … [Read more...]

Abbott Enters Consent Decree With FDA To Reopen Infant Formula Plant

Abbott enters consent decree with the FDA to reopen their Sturgis, Michigan powdered infant formula plant that was closed after Cronobacter was discovered in the environment. The FDA inspection was prompted by reports of infant illnesses and deaths. The United States filed the decree on behalf of the FDA. It would require Abbott Nutrition to take "specific measures designed to increase safety and ensure compliance wi the Federal Food, Drug and Cosmetic Act" and the FDAs Good Manufacturing Practice requirements. Attorney General Merrick B. Garland said in a statement, "The actions we are announcing today will help to safely increase the supply of baby formula for families. The Justice Department will vigorously enforce the laws ensuring the safety of our food and other essential … [Read more...]

USDA Offers Tips to Keep Infants Safe While Formula Shortages Exist

The USDA offers tips to keep infants safe while powdered infant formula shortages are ongoing. The shortage is caused by pandemic supply chain issues and the closure of Abbott Nutrition's Sturgis, Michigan plant for environmental Cronobacter contamination. The contamination was discovered during an FDA inspection after reports of infant illnesses. Many parents depend on formula in the first year of a baby's life. Some mothers cannot breastfeed, and some infants require supplemental nutrition or specialty formulas because of medical issues. To keep infants safe, the USDA says parents should not make homemade infant formula. There are serious safety and health concerns related to homemade formula because they can be deficient in nutrients that babies need for health and growth. … [Read more...]

USDA Addresses Powdered Infant Formula Shortage

The USDA has announced that it is addressing the powdered infant formula shortage and is asking states to take advantage of flexibility in the WIC (Women Infants and Children) program. The shortage was caused by pandemic-related supply chain issues and by the closure of Abbott Nutrition's Sturgis, Michigan plant, where Cronobacter was found in environmental samples after complains of infant illnesses. Agriculture Secretary Tom Vilsack said in a statement, "We’re acutely aware that the ongoing recall has left many parents and caregivers concerned about access to formula and how they will feed their babies. Our team is committed to the health and safety of all Americans and is calling on states to act immediately to offer maximum flexibility, information, and support to WIC … [Read more...]

FDA Warning About Accidental Ingestion of Food Products With THC

The FDA is warning consumers about the accidental ingestion by children of food products containing THC (tetrahydrocannabinol). Some copycat products containing THC are made to look like children's cereals and candy, such as Cap'n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix. Accidental ingestion of these products can cause serious adverse events in children and adults. These products appeal to kids and can be mistaken for popular foods. The FDA is aware of multiple media reports describing children and adults who ate these products and experiencing adverse events. From January 2021 through April 24, 2022, the FDA received more than 100 adverse event reports related to those who consumed these products. Some … [Read more...]

Minnesota Offers Powdered Infant Formula Substitution Choices

The Minnesota Department of Health is offering powdered infant formula substitutions for WIC parents since the recall of Abbott Nutrition's products has limited choices. Those Abbott Nutrition products, which include various types of Similac, EleCare, and Alimentum formulas, were recalled in February 2022 after the FDA received reports of infants being sickened with Cronobacter infections. WIC, or Women, Infants and Children, is a special supplemental nutrition program that provides federal grants to states to help low-income pregnant, breastfeeding, and non-breastfeeding postpartum women and infants and children up to the age of five. WIC is located in hospitals, county health departments, clinics, and schools. Since the massive recall, parents have reported having difficulty … [Read more...]

With Warmer Weather Here, Keep Food Safety in Mind

With warmer weather here at last, it's important to keep food safety in mind with these tips from the Michigan Department of Agriculture and Rural Development. Picnics and barbecues mean that you are eating and preparing food in weather more conducive to the growth of potentially harmful bacteria. You should always take precautions when preparing, holding, and serving foods, but those precautions are especially important when the ambient air temperature is high. Tina Slawinski, MDARD's Food and Dairy Division Director, said in a statement, "Food which hasn’t been cooked or stored properly can cause mild foodborne illness, but it can also lead to serious illness or even death. Whether you’re packing a picnic for a sporting event or outdoor recreation, or planning a backyard barbecue, … [Read more...]

FDA Responds to Apparent Shortages of Powdered Infant Formula

The FDA is responding to apparent shortages of powdered infant formula after the issues of Cronobacter contamination at Abbott Nutrition's facility that made Similac and other brands. The update states that before these products were voluntarily recalled because of reports of infant illnesses, there were supply chain issues associated with the COVID-19 pandemic. While Cronobacter was found in environmental samples at the Abbott facility, those samples did not match the isolates from two of the infant patients. And the patient isolates did not match each other. FDA Commissioner Robert M. Califf, M.D. said in a statement, "We recognize that many consumers have been unable to access infant formula and critical medical foods they are accustomed to using and are frustrated by their … [Read more...]

FDA Warns Companies Allegedly Selling Adulterated Dietary Supplements

The FDA has sent warning letters to companies that are allegedly selling adulterated dietary supplements. The supplements contain new dietary ingredients for which the FDA has not received the required premarket NDI notifications. Others contain unsafe food additives. And others are drugs that have not been approved, because they are intended for use in the care, mitigation treatment, or prevention of disease. Edit: The FDA has removed Glanbia from this list "On May 9, 2022, the FDA issued a Constituent Update (below) stating that Glanbia Performance Nutrition (Manufacturing), Inc. (Glanbia), along with 10 other companies, was illegally selling adulterated dietary supplements. However, the FDA has since determined that Glanbia was incorrectly identified and does not sell the … [Read more...]

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