March 1, 2023
The FDA is expanding Import Alert (IA) #25-21 "Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes," to subject enoki mushrooms from China to detention without physical examination (DWPE) to further protect public health. Previously, this IA only included enoki mushrooms from the Republic of Korea. From October 2020 through February 2023, state public health authorities conducted sampling of enoki mushrooms from retail locations. Multiple state samples detected L. monocytogenes, which led to 18 recalls of enoki mushrooms in the U.S. since 2021. Eight of the recalls were linked to enoki mushrooms grown in the Republic of Korea, and 10 from China, confirmed via labeling, traceback, or whole genome sequencing (WGS). During this time, FDA sampled and analyzed 127 shipments of enoki mushrooms imported from China and found 18 to be violative. This represents a violation rate of over 14%. This effort identified 15 firms with violative product out of at least 37 declared firms that had exported enoki mushrooms from China to the U.S. Additionally, a recent FDA multi-state outbreak investigation linked three cases of listeriosis to enoki mushrooms labeled as a product of China.
Given the latest data and information, the FDA is expanding the country-wide import alert to subject enoki mushrooms from China to DWPE to help prevent the importation of enoki mushrooms that appear to contain human pathogens that may be injurious to public health. The FDA issues Import Alerts to help prevent potentially violative products from being distributed in the United States.
Original Constituent Update
FDA Issues Country-Wide Import Alert for Enoki Mushrooms from the Republic of Korea
July 20, 2022
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.