June 7, 2025

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...]

FDA Completes Second Pre-Market Consultation for Cultured Food

The FDA has completed its second pre-market consultation for human food made using animal cell culture technology. The information was submitted to the FDA from GOOD Meat, Inc. The firm is using animal cell culture technology to take living cells from chickens and grows the cells in a controlled environment to make cultured animal cell food. This consultation is not an approval process. It means that after the government has evaluated the data and information that was shared by the firm, the FDA has no further questions at this time about the firm's safety conclusion. GOOD Meat says that its products are meat made from cells of animals instead of slaughter. During this consultation, the FDA evaluated the company's production process and the cultured cell material that was made in … [Read more...]

Salmonella Hartford Outbreak Case Count Grows to 47 Sick

The Salmonella Hartford outbreak that is listed on the FDA's CORE Outbreak Investigation Table has grown from 31 to 47 cases since the last update was issued on March 8, 2023. There are three other active outbreak investigations on that table. The Salmonella Hartford outbreak has not been linked to any specific food. Traceback has been initiated, but no on-site inspection has taken place, there is no recall, and no sample collection and analysis has started. We do not know where the patients live, their age range, or illness onset dates. And we do not know if anyone has been hospitalized. The other outbreak investigations are unchanged. The hepatitis A outbreak in a not yet identified food, which has sickened at least five people, is unchanged. In that investigation, traceback … [Read more...]

FDA Calls For Enhanced Safety Steps in Powdered Infant Formula

The FDA is calling for enhanced safety steps in powdered infant formula in the wake of the cronobacter crisis in that industry in 2022. Back then, Abbott Nutrition had to close their plant in Sturgis, Michigan that manufactured that formula after cronobacter contamination was found. The whole issue started when four infants were sickened and two died in 2021 and 2022. Those infants were fed powdered infant formula made by Abbott Nutrition. Although cronobacter was found in the Abbott facility, the FDA did not find a connection between the illnesses and the facility. In addition, the FDA found insanitary conditions at that facility. The Abbott facility closed for months after the contamination was found, causing a severe shortage in the infant formula products they made. The FDA … [Read more...]

FDA Adds Salmonella Hartford Outbreak to CORE Investigation

The FDA has added a new Salmonella Hartford outbreak to its CORE Outbreak Investigation Table. It joins three other outbreak investigations that are still active as of March 8, 2023. The Salmonella Hartford outbreak has sickened at least 31 people so far. No food has been identified yet. There is no information about illness onset dates, if anyone has been hospitalized, or the patient age range. So far, traceback has been initiated in this outbreak investigation. The hepatitis A outbreak investigation has been updated. There are now just five illnesses in that outbreak. That number was reduced from nine cases, after the Centers for Disease Control and Prevention (CDC) excluded some suspect cases from the overall count. Sample collection and analysis, along with traceback, has … [Read more...]

FDA Advises Labeling of Plant-Based Milk Alternatives

The FDA is advising companies about labeling of plant-based milk alternatives, since they have different nutrient compositions than cow's milk. These recommendations will make it clear to consumers about these differences so they can make informed decisions. Plant-based products are made from hazelnuts, walnuts, coconuts, cashews, almonds, sesame seed, flax seed, hemp seed, rice, oats, and legumes, including soy. The FDA recommends that these products are labeled with "milk" in their names, such as "almond milk." They would also like to see a voluntary nutrient statement that shows consumers how the product compares with cow's ilk. If the product does not include the word "milk" as part of it name, but instead uses a word like "drink" and doesn't make any claims comparing the … [Read more...]

FDA on Wild Harvest Oysters Salmonella Outbreak in FL GA AL

FDA is weighing in on the wild harvest oysters Salmonella outbreak that has sickened at least eight people in Florida, Georgia, and Alabama.  Any retailers and restaurants that have received wild harvest oysters from harvest area FL-3012 in Cedar Key, Florida, harvested between December 16, 2022 and February 24, 2023 should be discarded. Consumers who bought those oysters at retail in those three states should also discard them. The FDA says it's possible that other states may have received the oysters. So if you purchased raw oysters, check the packaging to see if they were harvested in that area. A Salmonella outbreak linked to those oysters has been detected by the state health departments in Florida, Georgia, and Alabama. Eight cases are linked to this outbreak. We do not … [Read more...]

Enoki Mushrooms From China Subject to Import Alert For Listeria

Enoki mushrooms from China are now subject to an FDA Import Alert after several recalls have been issued for that product for possible Listeria monocytogenes contamination, and a Listeria monocytogenes outbreak. In July of 2022, the FDA issued an import alert for this type of mushrooms that were imported from Korea because of many recalls for possible Listeria, and Listeria monocytogenes outbreaks. The import Alert #25-21 has been expanded to include enoki mushrooms from China to detention without physical examination. From October 2020 through February 2023, state public health authorities sampled enoki mushrooms from various retail locations. Multiple states found Lsieria monocytogenes, which triggered 18 recalls of enoki mushrooms since 2021. Eight of those recalls were for … [Read more...]

FDA Releases Guidance Document For Food Delivery Services

The FDA has released a guidance document for food delivery services that is designed to ensure that food ordered online or over the phone is safe to eat. The parameters cover proper packaging, temperature control, verification practices, receiving and storage, and controls for physical contamination and allergen control. The FDA coordinated with the USDA and the CDC to produce this document. The New Era of Smarter Food Safety blueprint identified the safety of foods ordered online and delivered directly to consumers as a priority. Since the pandemic there has been a huge increase of food ordered from retailers. The food includes produce and meal-kit subscription services, food from ghost kitchens, grocery stores, and third-party delivery services. The "last mile" of delivery is … [Read more...]

FDA Announces Action Levels For Lead in Processed Baby Food

The FDA is announcing action levels and draft guidance for lead in processed baby food. This, the FDA says, would result in "significant reductions in exposures to lead from food while ensuring availablility of nutritious foods. This plan is part of Closer to Zero, part of the governments' plant to reduce exposure to the heavy metals lead, arsenic, cadmium, and mercury in foods consumed by young children and babies. FDA Commissioner Robert M. Califf, M.D. said in a statement, "For more than 30 years, the FDA has been working to reduce exposure to lead, and other environmental contaminants, from foods. This work has resulted in a dramatic decline in lead exposure from foods since the mid-1980s.The proposed action levels announced today, along with our continued work with our state … [Read more...]

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