June 22, 2022

New Listeria Monocytogenes Outbreak on FDA CORE Table

A new Listeria monocytogenes outbreak has been posted on the FDA's CORE Outbreak Investigation Table. At least 12 people are sick in this new outbreak. No food has been identified yet as the cause of these illnesses. We do not know the ages of the patients, illness onset dates, or whether or not anyone has been hospitalized. In addition, no traceback has been initiated, there has been no on-site inspection, no sample collection, and no sample analysis. There are six other active investigations on the table besides the new Listeria monocytogenes outbreak. Two have been solved, and one, the Cronobacter illnesses in four infants who consumed powdered infant formula, has been transferred to an IMG investigation. The Salmonella Senftenberg outbreak linked to recalled Jif peanut butter … [Read more...]

DeLauro Concerned About Abbott Nutrition Facility Reopening

Congresswoman Rose DeLauro (D-CT) is concerned about the Abbott Nutrition facility reopening after Cronobacter contamination was found in the plant. In a press release, she states, "Following credible reports that Abbott Nutrition had falsified records, cut corners, and instituted substandard safety practices, the Sturgis, Michigan, facility reopened to begin manufacturing infant formula once again. Given that there is no transparency on the reopening process to the public, irresponsible is the only word that comes to mind." In testimony to Congress in late May 2022, FDA Commissioner Robert Califf said that inspectors had found "shocking" conditions in the plant and that it had "egregiously unsanitary" conditions. Califf added that an investigation could not conclude that those … [Read more...]

FDA Starts Dietary Supplement Education Initiative

The FDA has started a Dietary Supplement Education Initiative to help consumers understand the risks and benefits of these products. The program, called Supplement Your Knowledge, offers fact sheets and educational material. More than half of Americans take dietary supplements. These products  are regulated by the FDA as food, not as drugs. The FDA does not approve these products before they are sold to consumers. The companies that make them are responsible for making sure they meet safety standards and do not violate the law. The FDA monitors adverse events reporting and can take action after complaints or injuries have been registered. There have been many recalls of dietary supplements for the inclusion of unapproved drugs that can cause serious health problems. In 2017, … [Read more...]

FDA Importing Specialized Medical Infant Formula to Increase Supply

The FDA is importing specialized medical infant formula to increase thee U.S. supply after the Abbott Nutrition plant in Sturgis, Michigan was closed when Cronobacter contamination was found. Cronobacter can cause serious and fatal infections in infants, especially those that are premature. The FDA says that millions of bottles of these formulas will be imported. FDA Commissioner Robert M. Califf, M.D. said in a statement, "We have made tremendous progress, including notable steps in just the past week, which will allow us to immediately begin bringing specialty and infant formula products into the U.S. as quickly as possible. We continue to work closely with our U.S. government partners and domestic and international manufacturers to identify additional formula product that will be … [Read more...]

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 Closes Listeria and Norovirus Outbreak Investigations

The FDA closes Listeria and norovirus outbreak investigations on its CORE Outbreak Investigation Table, while the alleged cereal outbreak case count increased. There are now only three active food poisoning outbreak investigations being conducted by the FDA. The Listeria monocytogenes outbreak that closed has sickened at least 20 people. A vehicle was not identified, even though traceback was initiated, an on-site inspection was initiated, and samples were collected and analyzed. The outbreak status is still listed as "ongoing" because the most recent illness onset date was April 20, 2022. It can take up to 70 days for the symptoms of listeriosis to manifest. The CDC will continue to monitor for more illnesses. This investigation will be reopened if more new illnesses are reported … [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...]

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...]

FDA CORE Outbreak Investigation Table Updated Again

The FDA CORE Outbreak Investigation Table has been updated again with more information about the incidents the agency is investigating. Three of the investigations have changed. The reports of adverse reactions possibly related to dry cereal have increased to 555 from 529 in the last update issued on May 4, 2022. On the website iwaspoisoned, there are more than 7,000 reports of illness since late 2021. An on-site inspection has been initiated, and samples have been collected and analysis on a product has begun. One of the two active Listeria monocytogenes outbreaks has also been updated; the number of illnesses has increased to 20 cases from 19. That investigation was launched on February 9, 2022; no source has been identified. For the investigation of "Cronobacter illnesses … [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...]

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