Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                CFSAN Constituent Updates

CFSAN Constituent Updates Home
          Food
          News & Events from CFSAN
          CFSAN Constituent Updates
          FDA Expands Country-Wide Import Alert for Enoki Mushrooms to ChinaCFSAN Constituent Updates FDA Expands Country-Wide Import Alert for Enoki Mushrooms to China
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintWhat's New

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.

                                                                                  Content current as of:
      03/01/2023
              
              
Regulated Product(s)
		 Food & BeveragesCFSAN Constituent Updates
 Subscribe to CFSAN Constituent Updates
                        Get email updates delivered to your inbox.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop