Sammy's Milk is warning parents about the age range for their Goat Milk Toddler Formula. It should not be used as an infant formula. The company was asked by the FDA to provide a warning against the use of that formula as an infant formula becasue the FDA is concerned that the product may not meet all FDA requirements for infant formula. It may not provide sufficient nutrition for infants. The FDA had a meeting with company officials this week when the government found that representation on the Sammy's Milk website and social media platforms could be interpreted to indicate that the formula is safe for infants. Sammy's Milk wants to emphasize that its product is specifically formulated for children between the ages of 12 and 36 months. The packaging indicates this. The product … [Read more...]
LittleOak Infant Formula Products Not Approved For Sale in Canada
LittleOak Infant Formula products are not approved for sale in Canada, according to the Canadian Food Inspection Agency (CFIA). These products are made with natural goat milk. Last week, the FDA warned American parents against using these products because the company did not submit premarket notification to the government about the products safety and nutritional adequacy. The company has not submitted the required pre-market submission to Canadian officials either, so these products have not been evaluated to make sure they meet Canadian food safety and nutritional standards and regulations. The infant formula products also do not meet Canadian labelling and composition requirements. The CFIA is conducting a food safety investigation. That may trigger the recall of more … [Read more...]
FDA Warns About LittleOak Natural Goat Milk Infant Formula
The FDA is warning parents about LittleOak Natural Goat Milk Infant Formula because the company did not submit the required premarket notification to the FDA to demonstrate the safety and nutritional adequacy of the product. The FDA must review key information about the product ingredients, nutritional information, and manufacturing information before infant formula can be sold in the United States. In addition, preparation instructions on the product do not align with measurements that are used on other approved infant formula bottles. If powdered infant formula is not diluted correctly, the infant can suffer physical problems. Diluting it too much may slow or delay growth, and not diluting it enough can cause dehydration, electrolyte imbalance, and kidney issues. The FDA did not … [Read more...]
Parent’s Choice and Tippy Toes Sensitivity Infant Formulas Recalled
Parent's Choice Sensitivity Premium Infant Formula and Tippy Toes Sensitivity Premium Infant Formula are being recalled because these items were inadvertently released after being rejected. No specific reason for the rejection was given. The recall initiation date was June 16, 2023, but the classification date was not until September 6, 2023. Because this recall notice was posted on the FDA's Enforcement Report page instead of the regular recall page, there is no mention of whether or not any illnesses have been reported to the company to date in connection with the consumption of these infant formulas. The recalling firm is PBM Nutritionals, LLC of Georgia, Vermont. The product was shipped to these states: Illinois, Alabama, Iowa, Georgia, Mississippi, Indiana, Arkansas, … [Read more...]
Three Infant Food Manufacturers Get Warning Letters From FDA
Three infant food manufacturers received warning letters from the FDA after inspections were conducted at their facilities. The letters were for violations of the Federal Food, Drug and Cosmetic Act and FDA infant formula regulations. The letters were issued to ByHeart Inc., Mead Johnson Nutrition (Beckett), and Perrigo Wisconsin LLC. The letters "reflect findings from FDA inspections of these facilities over the last several months." At each inspection, the FDA issued inspectional observations and exercised oversight of each firm as they initiated recalls, in December 2022, February 2023, and March 2023. The recalls were for infant formulas potentially contaminated with Cronobacter sakazakii, a pathogen that can cause serious illness and death in vulnerable infants. The letters … [Read more...]
Cronobacter Added to Notifiable Pathogens Reported to CDC
The Council of State and Territorial Epidemiologists (CSTE) is recommending that cronobacter be added to the list of notifiable pathogens reported to the Centers for Disease Control and Prevention (CDC). This is notable, since this pathogen, which can be deadly to infants, has not been tracked and is not reportable except in two states: Minnesota and Michigan. Because it is not tracked, we do not know how many infants are sickened by this pathogen. It's unfortunate that states will not be required to notify the CDC about these infections, but will only be asked to, although states usually do comply with this type of request. The position statement establishes standardized criteria for case definition and case counting that will be used for public health surveillance purposes. This … [Read more...]
Recalled Gerber Good Start Formula Sold After Recall Issued
Recalled Gerber Good Start SoothePro Infant Formula was sold after the recall was first issued on March 27, 2023, so the company is alerting the public. The infant formula was recalled for possible Cronobacter sakazakii contamination. The recalling firm is Perrigo Company. The formula was manufactured at the company's Gateway Eau Claire, Wisconsin manufacturing facility from January 2, 2023 to January 18, 2023. Cronobacter sakazakii is problematic in baby foods, and there have ben several recalls for infant formula for this type of contamination in the past few years. AWG is a cooperative food wholesaler distributing to independently owned supermarkets. This recalled product was distributed from its Nashville Division only to independent retailers located in Alabama, Georgia, … [Read more...]
FDA Strategy to Increase Resilience of Infant Formula Market
The FDA has released a national strategy to increase the resilience of the infant formula market in the United States. Last year, cronobacter illnesses among some infants led to the inspection of Abbott Nutrition's Sturgis, Michigan plant where problems were found, including multiple swabs indicating cronobacter contamination. Many recalls were issued and the plant was closed, which threw the infant formula supply in the United States into chaos. While there was not a match between the contamination in the Abbott plant and the sick infants, the situation highlighted how brittle the supply of powdered infant formula is in this country. In 2022, the Food and Drug Omnibus Reform Act directed the FDA to develop this strategy to help keep the market for this product stable. FDA … [Read more...]
ProSobee Infant Formula Recalled For Possible Cronobacter
ProSobee Infant Formula that is Simply Plant-Based is being recalled for possible Cronobacter contamination. The recall notice says that the product has been tested and confirmed negative for contaminants, but the recall is being issued out of an abundance of caution because there is a possibility of cross-contamination with Cronobacter sakazakii. There have been no adverse reactions or illnesses received to date. The recalling firm is Reckitt. The recalled product is Enfamil ProSobee brand. The recalled product is Enfamil ProSobee Simply Plant-Based Infant Formula that is packaged in 12.9 ounce containers. Two batches are included in this recall, totaling about 145,000 cans. The product was manufactured between August 2022 and September 2022. The infant formula was distributed … [Read more...]
ByHeart Infant Formula Powder Recalled For Possible Cronobacter
ByHeart Infant formula powder has been recalled for possible Cronobacter contamination. None of the distributed ByHeart products have tested positive for the pathogen. No illnesses or consumer complaints have been received to date. And this recall is not related to ByHeart's manufacturing facility that is located in Reading, Pennsylvania. The facility is running. Out of an abundance of caution, the company is recaling five batches of ByHeart Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12 Months for potential cross-contamination with Cronobacter sakazakii. The formula is packaged in 24 ounce containers. The formula was distributed directly to consumers in the United States. You can identify the formula by the number that is stamped on the bottom of the can. … [Read more...]
