This was just posted on the FDA website a few moments ago:
The FDA announced today that its Import Divisions may detain without physical examination, importations of enoki mushrooms from the ROK. This country-wide import alert, IA #25-21, “Detention Without Physical Examination of Enoki Mushrooms from Korea (the Republic of) due to Listeria monocytogenes,” was issued to protect public health and help prevent the importation of enoki mushrooms that could be linked to human infections. The FDA issues import alerts to help prevent potentially violative products from being distributed in the United States.
In fiscal year 2021, FDA testing revealed that 43% of enoki mushrooms sampled from the ROK were contaminated with Listeria monocytogenes (L. monocytogenes). L. monocytogenes is a human pathogen that can be found in moist environments, soil, water, decaying vegetation and animals, and can survive and even grow under refrigeration and other food preservation measures.
The sampling was conducted following an FDA investigation into a multistate outbreak spanning from 2016-2020. This outbreak linked multiple cases of human infections of L. monocytogenes to enoki mushrooms from the ROK. The outbreak accounted for a total of 36 U.S. cases reported across 17 states, 12 cases in Canada, and six cases in Australia. The 36 U.S. cases yielded 31 hospitalizations and four deaths.
From March 2020 through May 2022, state public health authorities conducted sampling of enoki mushrooms from U.S. retail locations. L. monocytogenes was detected in multiple state samples, which led to 21 recalls of enoki mushrooms in the United States. Nine of the recalls were linked to enoki mushrooms grown in the ROK and were confirmed by labeling, traceback, or whole genome sequencing (WGS).
After the 2020 outbreak, the FDA began implementing an Imported Specialty Mushroom Prevention Strategy, with a focus on enoki mushrooms, to protect public health and prevent future L. monocytogenes outbreaks in specialty imported mushrooms. The FDA’s prevention strategies are affirmative, deliberate approaches undertaken by the agency to limit or prevent the recurrence of a root cause that led to an outbreak or adverse incident.
AN EARLIER OUTBREAK
An outbreak of Listeriosis was investigated by the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), and state partners.[1] This outbreak has been linked to enoki mushrooms supplied by Green Co. LTD, from the Republic of Korea. Enoki mushrooms were supplied by H&C Food Inc., Guan’s Mushroom Co., and Sun Hong Foods, Inc. A total of 36 cases have been linked to this outbreak from 17 different states (AZ, CA, FL, HI, IN, KY, MD, MA, MI, MO, NJ, NY, NC, RI, TN, VA, and WA) as of June 9, 2020. This outbreak was given the CDC outbreak code 1710MLGX6-3WGS.
Reported cases ranged from less than 1 year to 96 years in age (median 67). Fifty-eight percent of ill people were female. Of 33 ill people with information available, 31 hospitalizations were reported. Four deaths were reported from California (2), Hawaii, and New Jersey. Six cases were pregnancy-associated, with two resulting in fetal loss. Of cases with information available, 17 were reported as Asian in race.
Listeria specimens from ill people were collected between November 23, 2016, to December 13, 2019. Whole-genome sequencing (WGS) showed that bacteria isolated from ill people were closely related genetically, implying that people in this outbreak likely shared a common source of infection. Isolates had a PFGA Ascl/Apal pattern combination GX6A16.0051, GX6A12.0538\GX6A12.0001. Cases were also identified in Canada (n=6 between October 5, 2017, and February 19, 2019) and Australia (n=6), and positive samples from enoki mushrooms were identified in France in 2017.
In interviews, 12 out of 22 (55%) cases reported eating mushrooms, including enoki, portobello, white, button, cremini, wood ear, maitake, and oyster mushrooms. The FDA and state officials collected enoki mushrooms for testing. The Michigan Department of Agriculture and Rural Development collected enoki mushrooms from a grocery store where a case reported shopping and identified the outbreak strain in two samples. These mushrooms were labeled as “Product of Korea” and were distributed by Sun Hong Foods, Inc. On March 9, 2020, Sun Hong Foods, Inc. recalled enoki mushrooms. These products were distributed to CA, TX, OR, WA, IL, and FL. They were carried at J&L Supermarket, Jusgo Supermarket, ZTao Market, New Sang Supermarket, and Galleria Market.
The California Department of Public Health collected enoki mushrooms from grocery stores and identified the outbreak strain in one sample. These mushrooms were labeled as “Product of Korea” and were distributed by Guan’s Mushroom Co. On March 23, 2020, Guan’s Mushroom Co. recalled enoki mushrooms. These products were distributed from CA, NY, and PA in retail stores through produce distributors or wholesalers.
The FDA collected samples of enoki mushrooms for testing at import from Green Co. LTD of the Republic of Korea. On April 6, 2020, two samples were shown to have tested positive for the outbreak strain of Listeria monocytogenes. As a result, on April 7, 2020, the FDA placed Green Co. LTD on Import Alert, and subsequently H&C Foods Inc. recalled enoki mushrooms supplied by Green Co. LTD. The mushrooms were distributed to NY, MD, and VA areas through Great Wall Supermarket between February 15, 2020, and March 5, 2020.
On March 18, 2020, the Korean Ministry of Food and Drug Safety published its investigation findings and steps it will take to prevent future illnesses. It found Listeria monocytogenes in enoki mushrooms produced by two firms in the Republic of Korea. As of June 9, 2020, this outbreak was deemed over.
CAUSATION
The causal link between Cara Garza’s, and subsequently Charlie Mae Garza’s, infection with Listeria monocytogenes and consumption of enoki mushrooms from Gyu Kaku is clear. On January 25, 2018, Cara consumed enoki mushrooms in a dish of assorted veggies, rice, and garlic beef noodles at Gyu-Kaku located in Windward Mall in Kaneohe, Hawaii. This location received enoki mushrooms from D. Otani Produce Inc., which received mushrooms from Guan’s Mushroom Co. (Forest Mushroom Food Inc.). Guan mushrooms were recalled due to contamination with Listeria monocytogenes. At the time of this meal, Cara was 34 weeks pregnant with her daughter, Charlie Mae. Charlie Mae was prematurely born on January 27, 2018, resulting from the complications of Cara Garza’s Listeriosis.
Cara began to experience fever, headache, and ultimately pre-term labor on January 27. These symptoms are consistent with Listeria monocytogenes infections in pregnant women. Cara went into pre-term labor that evening. She sought medical attention at Kapiolani Medical Center for her symptoms and labor, and on January 27, 2018, Charlie Mae was prematurely born. A blood specimen from Charlie Mae’s placenta cord was collected on January 27, and it tested positive for Listeria monocytogenes at Kapiolani Medical Center. This specimen was further sequenced at the State of Hawaii Biological Response Laboratory, where it matched other recent samples that were linked to the enoki mushroom outbreak (Specimen ID: N18-040, allele code: LMO1.0 – 51.2.1.23.1.1). Charlie Mae was diagnosed with neonatal sepsis and Listeriosis on January 30, 2018.
Given that Charlie Mae was diagnosed with a Listeria monocytogenes infection at birth, her mother’s recent history of symptoms consistent with a Listeria monocytogenes infection and her recent exposure to a source associated with a Listeria outbreak, and Charlie Maes cord blood specimen, which tested positive for a strain of Listeria monocytogenes that matched other cases in the multistate Listeria outbreak linked to enoki mushrooms (CDC ID: 1710MLGX6-3), Charlie Mae Garza was considered a case in the Listeria monocytogenes outbreak linked to enoki mushrooms and other varieties of mushrooms. It is therefore most likely that Charlie Mae got her Listeria monocytogenes infection from her mother, Cara, who fell ill from consuming enoki mushrooms at Gyo Kaku.