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The harmful levels of lead in apple cinnamon fruit puree pouches prompted the FDA to work with Austrofood to quickly voluntarily recall the impacted product. Austrofood is the manufacturer of the recalled pouches and manufactured the pouches at the company’s Ecuadorian facility. The FDA’s leading hypothesis is that the contamination of the cinnamon was an act of economically motivated adulteration. The FDA has initiated additional efforts to prevent future lead-related incidents, including looking closely at cinnamon and other spices in our food supply, especially those in foods that babies and young children often consume. On Aug. 9, the FDA issued a warning letter to Austroffod. The FDA also focused on implementing a strategic, long-term iterative approach to reducing childhood dietary exposure to lead, arsenic, cadmium, and mercury. The FDA is asking Congress for the authority to establish binding contamination limits in foods. The FDA also seeks authority to require the industry to test final products for contaminants and maintain records that the FDA could remotely access and review. Additionally, the FDA is seeking to expand the agency’s mandatory recall authority to mandate recalls for more contaminated foods or ingredients. The FDA has also placed Negasmart, the distributor of the cinnamon used in the contaminated applesauce products, on multiple import alerts. The FDA is dedicated to enhancing the safety of cinnamon, ground spices, and other products sold in the US, reducing dietary exposure to heavy metals, and working with federal and state partners to reduce contaminant levels in food products, particularly those consumed by babies and young children. @ https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-austrofood-and-continues-robust-activities-ensure-safety-cinnamon-products?utm_medium=email&utm_source=govdelivery

The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia. While originally reported as two separate outbreaks, the CDC and FDA combined these two outbreak investigations since they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick. Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, and Thomas Produce Company, of Boca Raton, Florida, are likely sources of illnesses in this outbreak; however, these growers do not account for all the illnesses in this outbreak. Based on traceback information collected, Thomas Produce Company supplied cucumbers to multiple points of service where ill people reported eating cucumbers. As part of the investigation, the FDA conducted an onsite inspection at Thomas Produce Company and collected samples. Salmonella Braenderup was detected in samples of canal water used by Thomas Produce Company. WGS analysis determined that the water used by Thomas Produce Company contained Salmonella, which matches a strain of Salmonella Braenderup that is causing some of the illnesses in this outbreak. Additional types of Salmonella were detected in both soil and water samples collected at Bedner Growers, Inc. and Thomas Produce Company. Multiple other strains of Salmonella, unrelated to this outbreak investigation, found at Bedner Growers, Inc. matched clinical isolates from illnesses in the National Center for Biotechnology Information’s (NCBI) database. Bedner Growers, Inc.’s and Thomas Produce Company’s cucumber growing and harvesting season is over. There is no product from these farms on the market, and there is likely no ongoing risk to the public.@ https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-salmonella-cucumbers-june-2024?utm_medium=email&utm_source=govdelivery

The FDA and state and local partners have collected multiple samples of Diamond Shruumz-brand products for testing and analysis. Sample analysis is ongoing; however, as of August 8, 2024, test results are available for 19 Diamond Shruumz-brand Chocolate Bars. The Diamond Shruumz-brand Cones and Gummies samples have also been collected, and testing and analysis are ongoing. To date, the FDA has tested 19 samples of Chocolate Bars and one raw ingredient that was reportedly used in the manufacturing of some Diamond Shruumz-brand products. Six (6) of the 19 Chocolate Bars and the raw ingredient contained muscimol. Muscimol does not appear in all products and cannot explain all the symptoms reported by ill patients who consumed the Diamond Shruumz-brand Chocolate Bars. In addition to muscimol, FDA analyses of Diamond Shruumz-brand Chocolate Bar samples identified the presence of the following compounds: Acetylpsilocin (also known as 4-acetoxy-N, N-dimethyltryptamine, 4-acetoxy-DMT, O-acetylpsilocin or psilacetin) was found in nine (9) Chocolate Bar samples; Psilocin, a Schedule I-controlled substance, was found in four (4) Chocolate Bar samples; Pregabalin, a prescription drug, was found in three (3) Chocolate Bar samples; and Desmethoxyyangonin, dihydrokavain, and kavain (kavalactones found in the kava plant), were all present together in 15 Chocolate Bar samples. As of August 9, 2024, a total of 130 illnesses have been reported from 29 states; 53 have been hospitalized, and there are two potentially associated deaths. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-illnesses-diamond-shruumz-brand-chocolate-bars-cones-gummies-june-2024?utm_medium=email&utm_source=govdelivery

CORE update of August 14, 2024: the CORE list of outbreaks and adverse events includes seven activities. The outbreak of Cyclospora cayetanensis illnesses (ref #1245) linked to an unidentified product increased the case count from 2 to 21. The outbreak of Salmonella Newport (ref #1248) linked to an unidentified product the case count has increased from 2 to 3. FDA has initiated traceback. The outbreaks of Cyclospora cayetanensis (ref #1237 and ref #1239), these outbreaks are being combined into the Cyclospora cayetanensis outbreak (ref #1237) based on traceback information from the FDA’s investigation and epidemiology provided by the CDC. For the outbreak of Cyclospora cayetanensis (ref #1237), the case count has been adjusted from 26 to 44; this includes 16 cases from the combined Cyclospora cayetanensis (ref #1239) outbreak plus additional illnesses. The outbreak of Salmonella Typhimurium (ref #1234) linked to an unidentified product, the case count has increased from 88 to 89. The investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory has been updated to include additional illnesses ( total illnesses 130, 53 hospitalizations, and two potential deaths), and laboratory results of product samples. The outbreak of Salmonella Africana and Salmonella Braenderup illnesses (ref #1227), the FDA has updated the advisory to include additional investigational findings. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks?utm_medium=email&utm_source=govdelivery