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...]
Two New Outbreaks on FDA CORE Investigation Table
There are two new outbreaks on the FDA CORE Outbreak Investigation Table. One is a Salmonella Newport outbreak, and the other is a Cryptosporidium outbreak. Four other outbreaks remain on the table. The new Salmonella Newport outbreak in a not yet identified food has sickened at least eight people. In that investigation, traceback has been initiated, but there is no recall, no onsite inspection, and no sample collection or analysis. The new Cryptosporidium outbreak in a not yet identified food has sickened at least 11 people. In that outbreak, traceback has been initiated. We don't know the states where ill people live, their age range, or if anyone has been hospitalized. The other outbreaks remain unchanged. In the Listeria monocytogenes outbreak linked to Soft Serve on the … [Read more...]
Toxic Yellow Oleander in Weight Loss Products Prompts FDA Warning
Toxic yellow oleander in some weight loss products has prompted an FDA warning. The FDA and the Maryland Department of Health have found that some products labeled Nuez de la India, potentially marketed as "botanical food," India Nuts for Weight Loss," "slimming seeds," India seeds for weight loss," or "diet seeds," appear to be yellow oleander, which is highly toxic. Yellow oleander is poisonous and native to Mexico and Central America. Eating this plant or its seeds can cause severe and even fatal health effects. The plant can affect the gastrointestinal tract, your heart, and cause neurological problems. Symptoms of yellow oleander poisoning include nausea, vomiting, dizziness, diarrhea, abdominal pan, cardiac changes, dysrhythmia (abnormality in heart rhythm), and more. One … [Read more...]
FDA Completes Final Actions on Partially Hydrogenated Oils
The FDA has completed final administrative actions on the use of partially hydrogenated oils (PHOs), also known as trans fats, in the food supply. This final rule reflects the agency's reasoning in removing this product. In 2015, the FDA stated that these oils are harmful to human health, and that removing them from the food supply could prevent thousands of heart attacks every year. Oils are hydrogenated to make them sold at room temperature. PHOs were used to make many foods because they were a cheap source of solid fats. Trans fats raise the level of LDL proteins in the blood, they can weaken cell membrane structures, contribute to insulin resistance, and are associated with certain types of cancer. In the final rule, the FDA states that PHOs are no longer included in an … [Read more...]
FDA CORE Table Updated With More Cases and Listeria Outbreak
The FDA CORE Table updated with more cases in one of the cyclospora outbreaks and the Salmonella outbreak. And a new Listeria monocytogenes outbreak has been added. The E. coli O157:H7 outbreak has ended unsolved. There are seven active outbreak investigations on the table. For the E. coli O157:H7 outbreak investigation that ended, twelve people were sickened. Traceback was initiated, but officials could not identify a food that was the cause of those illnesses. One of the three cyclospora outbreaks on the table has had a case count increase of eight more illnesses, from 47 sick to 55. Traceback has been initiated, and sample collection and analysis has started. The other two cyclospora outbreaks are unchanged. For the outbreak of Salmonella Paratyphi B var. L(+) tartrate+, … [Read more...]
FDA Denies Petition on Phthalates in Food Packaging Again
The FDA denied a petition on phthalates in food packaging that requested that the agency reconsider its denial of a citizen petition issued by Earth Justice on May 19, 2022. The original denial was for a petition that Earth Justice filed showing that phthalates, a petrochemical used in food packaging, including packaging used for meat, milk, and spices, is harmful to human health. There is a ban on phthalate use in children's toys. Earth Justice claims that evidence shows phthalates interfere with the human body's hormone regulated processes, and can cause birth defects, infertility, miscarriage, breast cancer, diabetes, and asthma. At the time of the original denial, Earth Justice attorney Katherine O'Brien said in a statement, "FDA’s decision recklessly green-lights ongoing … [Read more...]
FDA Report on Food Poisoning Risk Factors in Restaurants
The FDA has released its report on food poisoning risk factors in fast food and food service restaurants. The report covers the years from 2017 t0 2018. Risk factors that can contribute to outbreaks of foodborne illness include inadequate cooking, poor personal hygiene, and using food from unsafe sources. This study is part of a ten-year study that spans the years 2013 to 2024. The restaurants used in the study were located across the country and were randomly selected by the FDA Retail Food Specialists. The key objectives of the study were to identify the occurrence of risk factors, the prevalence of food safety management systems, the prevalence of certified food protection managers, and prevalence of employee health policies. That last risk factor is important because the CDC … [Read more...]
FDA Releases Report on Testing Ready to Eat Dips and Spreads
The FDA has released their report on testing ready to eat dips and spreads for possible Salmonella and Listeria monocytogenes contamination. This sampling assignment started in March 2021 and was completed in January 2022. Refrigerated dips and spreads include hummus, tahini, pimento cheese, and yogurt-based products. There have been multiple recalls for tahini and hummus for bacterial contamination in the past few years. From 2017 through 2022, for instance, there were five recalls of hummus and six recalls of multi-commodity dips that were contaminated with Salmonella or Listeria. In 2019, a Salmonella Concord outbreak linked to tahini sickened at least six people in three states, and also in 2019, a Salmonella outbreak at Moby Dick House of Kabob in Maryland was potentially … [Read more...]
FDA Issues Final Guidance for Inorganic Arsenic in Apple Juice
The FDA has issued final guidance for the levels of inorganic arsenic in apple juice to the action level of 10 parts per billion. This guidance is for industry to help protect public health, but it does not establish legally enforceable responsibilities. Inorganic arsenic is the most harmful form of this toxic heavy metal. Arsenic occurs in the environment, both naturally and as a result of arsenic-containing pesticides that were used on food crops. Pollution from coal-fired power plants, mining, and fracking also deposit the heavy metal in soils and in water. Acute symptoms of arsenic poisoning include vomiting, diarrhea, and abdominal pain, followed by numbness and tingling of the extremities. Long term complications of arsenic poisoning include cancer, liver disease, diabetes, … [Read more...]
Salmonella Sun Sprouts Warning Letter Sent After Outbreak
A Salmonella Sun Sprouts warning letter was sent to that company by the FDA after an outbreak, which happened from December 2022 to January 2023, linked to those raw sprouts sickened at least 63 people in eight states. The case count by state was: Arizona (1), Iowa (6), Kansas (6), Missouri (9), Nebraska (26), New Hampshire (1), Oklahoma (1), and South Dakota (13). Ten people were hospitalized. The FDA inspected the sprouting operation of Rhodes Legacy Inc. doing business as Sun Sprouts, because of the outbreak. FDA's traceback investigation identified the brand's alfalfa sprouts as a likely source of illnesses in that outbreak. The inspection revealed "serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption … [Read more...]
