March 28, 2024

FDA’s Annual Warning About Consuming Raw Flour

It's time for the FDA's annual warning about consuming raw flour, since the holiday season is a traditional time for a lot of baking. There have been many outbreaks linked to raw flour and products made with raw flour, such the Salmonella outbreak linked to recalled Gold Medal flour earlier this year, and the E coli outbreak linked to cake mix two years ago. Because it is dry, flour seems so innocuous. But pathogens such as Salmonella and E. coli can easily survive in low water foods. And flour is a raw agricultural product made from raw grains, which means that it can be contaminated with pathogens in the field, during harvest or transport, or during processing. The only thing that makes flour safe to eat is heat. Do not eat any uncooked cookie dough or batter. And do not make … [Read more...]

FDA Warns Against Neptune’s Fix Because of Serious Health Risks

The FDA is warning consumers not to buy or use Neptune's Fix, a product that is marketed for pain relief, to improve brain function, and treat anxiety, depression, and opioid use disorder. The government has received reports of serious complications after the use of this product, including seizures and loss of consciousness. The product contains tianeptine, which is a substance that is not approved by the FDA for any medical use. Tianeptine is considered an alternate to fentanyl and oxycodone. While some companies in this country are planning to seek FDA approval for this drug, that has not happened. According to Consumer Reports, tianeptine-related calls to poison controls centers have "skyrocketed" since 2015. At least four people in the United States have died after using the … [Read more...]

Two New Outbreaks on FDA’s CORE Outbreak Investigation Table

There are two new outbreaks on the FDA's CORE Outbreak Investigation Table, joining three other outbreaks. Only two of the five outbreaks have been solved so far. The first new outbreak is a Listeria monocytogenes outbreak that has sickened at least 11 people. No food has been identified in relation to these illnesses. We do not know the patient age range, where the patients live, illness onset dates, or if anyone has been hospitalized. Samples have been collected and analysis has started in this investigation. The second new outbreak is an E. coli O103 outbreak that has sickened at least 12 people. Again, we do not know the patient age range, if anyone has been hospitalized, where patients live, or when people got sick. No food has been linked to this outbreak. Traceback has … [Read more...]

FDA Plans to Ban Brominated Vegetable Oil in Food

The FDA plans to ban the use of brominated vegetable oil (BVO) in food, after studies conducted with the National Institutes of Health found the product is potentially dangerous for human consumption. Brominated vegetable oil is a mixture of brominated triglycerides that are made by combining bromine with unsaturated vegetable oils. BVO is authorized for use in small amounts to keep citrus flavoring from separating and floating to the top of some beverages. The FDA took BVO off the Generally Recognized as Safe (GRAS) list in 1970 and began overseeing its use under food additive regulations. Many beverage makers have reformulated their products to replace BVO. Now, few beverages available in the United States contain BVO. Scientists found that the thyroid is a target organ of … [Read more...]

FDA Issues Updated Compliance For Infant Formula

The FDA has issued updated compliance for infant formula after the disastrous shutdown of Abbott Nutrition for cronobacter contamination in 2022 that caused severe shortages. The press release states that, "This effort is part of the FDA's ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry." The FDA released its internal evaluation of the response in 2022. It recommended that the agency review and update its compliance program to make sure it reflected the latest science on Cronobacter, and offered consistency and clarify for manufacturers on inspection and compliance activities. The FDA has published its updated compliance program, which it says builds on the lessons learned over the last several years. Salmonella and … [Read more...]

California Bans Red 3, Brominated Vegetable Oil, Other Additives

California bans Red 3, brominated vegetable oil, potassium bromate, and propylparaben from being added to food because of possible adverse health effects. The governor signed the legislation on October 7, 2023. Industry has until 2027 to comply with this new law. The synthetic dye, Red 3, is made from petroleum. The law, Assembly Bill 418, makes California the first state in the country to ban the use of these additives in packaged foods. The FDA says they are safe to consume. Center for Science in the Public Interest (CSPI) states that the FDA learned Red 3 was a carcinogen in the 1980s and declared it as a carcinogen in 1990. This 2012 article from The National Library of Medicine states that Red 3 causes cancer in animals. The FDA has eliminated the use of this food dye from … [Read more...]

Cantaloupe Salmonella Outbreak Solved, But No Brands Named

The cantaloupe Salmonella outbreak has been solved, but no brand names or farms were named, according to the FDA. There are only two active outbreak investigations on the FDA CORE Outbreak Investigation Table at this time. Eleven of the seventeen outbreaks the FDA has investigated during 2023 have been unsolved, with no brand name, restaurant, or processor named. The Salmonella Newport outbreak linked to cantaloupe as well as watermelons sickened at least 11 people. The FDA conducted traceback, inspected a facility, collected samples, and analyzed those samples, but could not identify a brand name or farm. The CDC found that patients ate cantaloupe and/or watermelon before getting sick. Most of these patients lived in the Midwest. Investigators were not able to determine a … [Read more...]

Oceanitan Baby Food Manufacturer Receives FDA Warning Letter

Oceanitan baby food manufacturer received an FDA warning letter after a consumer complaint was filed about an infant contracting a botulism infection. An inspection found that these ready to eat baby food products that are packaged in reduced oxygen packaging are adulterated because they were "prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health." That facility is located at 2937 East Pico Boulevard in Los Angeles, California. The FDA inspectors also found that there were significant violations of the labeling regulations for foods, which means the baby foods were misbranded, and the owner in charge did not comply with preventive controls provisions of the Current Good Manufacturing Practice, … [Read more...]

More FDA Outbreak Investigations Closed With No Answers

There are more FDA Outbreak Investigations closed with no answers, in the just updated FDA CORE Outbreak Investigation Table. So far nine outbreaks this year have ended unsolved. For the Cryptosporidium outbreak that sickened at least 11 people, the outbreak is over and the investigation has ended. The only action the FDA took in this outbreak was to conduct traceback. For the two Cyclospora outbreaks, the outbreaks are over and the investigations have closed with no answers. One of the outbreaks sickened at least 72 people, and the other sickened at least 140 people. The FDA conducted traceback and collected samples for analysis, but could not find the source of the parasite. There is a new Salmonella Thompson outbreak on the table. The product responsible for these illnesses … [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...]

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