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The FDA published more than 200 decision letters, known as Complete Response Letters (CRLs), on July 10, 2025. The CRLs were issued in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024, marking a significant step in the Agency’s broader initiatives to modernize and increase transparency. By making the CRLs available, the public now has significantly greater insight into the FDA’s decision-making and the most common deficiencies cited that sponsors must address before their application is approved. The FDA issues CRLs for various reasons, most related to safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues. Marty Makary, M.D., M.P.H., said that “For far too long, drug developers have been playing a guessing game when navigating the FDA; today, the FDA is bringing meaningful treatments to patients faster.” The CRLs were redacted for trade secrets and confidential commercial information. The Agency is in the process of publishing additional CRLs from its archives and continually exploring ways to provide the public with greater transparency into its decision-making process. @ https://www.fda.gov/news-events/press-announcements/fda-embraces-radical-transparency-publishing-complete-response-letters?utm_medium=email&utm_source=govdelivery

The FDA reported that Natureen International Inc. (Walnut, CA) recalled 244 bags of Wei-Chuan Dried Black Fungus Slice (2.5 oz/bag), because it has the potential to be contaminated with Salmonella. 

The recalled Wei-Chuan Dried Black Fungus was distributed in Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio, and Wisconsin through direct delivery to retail stores and supermarkets from the Wei-Chuan Chicago Branch. The product comes in a 2.5-ounce / bag, clear plastic package marked with (lot # XJ17) at the bottom of the front package side and also with an expiration date of (EXP:20260417). No illnesses have been reported to date in connection with this problem. The California Department of Public Health notified the FDA that the product was contaminated with Salmonella. Production of the product has been suspended while the FDA and the company continue their investigation into the source of the problem. @ https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/natureen-international-inc-recalls-wei-chuan-dried-black-fungus-slice-25oz-because-possible-health?utm_medium=email&utm_source=govdelivery

The CORE update list of outbreaks and adverse events includes eight postings. A new outbreak of Salmonella Anatum (ref #1312) linked to an unidentified product has been added to the table. The outbreak of Salmonella Enteritidis (ref #1301) linked to an unidentified product, the outbreak has ended. @ https://www.fda.gov/food/outbreaks-foodborne-illness/investigations-foodborne-illness-outbreaks?utm_medium=email&utm_source=govdelivery

The UK Health Security Agency published a report on STEC data from 2023. The main points of the 2023 annual report are: (i) Overall, 2,018 cultured-confirmed cases of STEC were reported in England during 2023, a decrease of 2.2% compared to 2022. (ii) A total of 533 culture-confirmed cases of STEC O157 were reported in England in 2023 compared to 762 in 2022, a decrease of 30%. A total of 2,260 cases of STEC non-O157 were reported, representing a 14% increase compared to 2022 and a 125.6% increase compared to 2019. The most commonly isolated serogroup was STEC O26. Children aged 1 to 4 years had the highest annual incidence of STEC O157 infections. (iii) Around a third of confirmed STEC O157 cases and one third of STEC non-O157 cases in England were hospitalized. One death was reported among STEC O157 cases, and 2 deaths among STEC non-O157 cases. (iv) 2.1% of STEC O157 cases and 1.7% of STEC non-O157 reported developing HUS. 10% of confirmed STEC O26 cases developed HUS. (v) Seven outbreaks of STEC involving 228 cases, 145 of whom were residents in England, were investigated in 2023. One outbreak involved STEC O157, 3 involved STEC O145, 2 involved STEC O26, and 1 involved STEC O183. A suspected or confirmed vehicle was identified for all 7 outbreaks and included beef, salad leaves, cucumber, dried fruits, and dairy products.