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...]
FDA Posts Minor Updates on CORE Outbreak Investigation Table
The FDA has posted minor updates on the CORE Outbreak Investigation Table. There are six outbreaks on the table, and only two have been solved. Last week, the FDA added the recall of Ice Cream House ice cream products in relation to the Listeria monocytogenes outbreak that has sickened at least two people. All of Ice Cream House's frozen desserts are included in this recall. That outbreak investigation has not been updated since September 1, 2023. For the outbreak of Salmonella Newport, which has sickened at least eight people, the FDA has conducted an on-site inspection, has collected samples, and the samples are being analyzed. Traceback had already begun. In the Cryptosporidium outbreak in a not yet identified food, traceback has been initiated. At least 11 people are sick … [Read more...]
Gluten-Free on a Product Label Means Something For Celiacs
Gluten-Free on a product label really means something for celiacs. The FDA regulates the claim of "gluten free" and sets standards and definitions for the food industry to use. About 3 million Americans have celiac disease, which an auto-immune digestive disorder. People with this disease must avoid gluten or they can suffer from serious health consequences, including malnourishment. Gluten, a protein found in wheat, rye, triticale, and barley, gives bread its structure. Foods that include gluten include breads, cakes, cereals, pastas, and others including beer. In celiacs, gluten molecules attack villi in the small intestines. Those villi promote nutrient absorption. When they are damaged by gluten, nutrients can't be properly absorbed. Celiac disease is heredity, and it can … [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...]
