(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
In the past, shipments of canned and dried morel mushrooms have been detained due to the presence of Gyromitra esculenta. This mushroom species is known to produce monomethylhydrazine (MMH), a substance which causes severe gastrointestinal disturbance and, in some cases, death.
In addition to Gyromitra esculenta, CFSAN has identified another species, Verpa bohemica, which can also cause toxic effects in some
All requests for addition to DWPE will be evaluated by the Division of Import Operations (DIO) and the Center for Food Safety and Applied Nutrition (CFSAN), Office of Compliance, Division of Enforcement.
Release of Articles Subject to Detention Without Physical Examination under This Import Alert:
In order to secure release of an individual shipment subject to detention without physical examination under this alert, the owner, consignee, and/or another responsible party to the shipment should provide evidence which demonstrates that the product does not bear or contain monomethylhydrazine (MMH) or Verpa bohemica. Such evidence may be in the form of a private laboratory analysis.
Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration, per the notice of detention. If a private laboratory is used, further information regarding private laboratory analyses is found in FDA's ORA Lab Manual, volume III, section 7. Following receipt and review of analytical results, the FDA may, at its discretion, collect and analyze audit samples before rendering a final decision on the admissibility of the article.
Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):
In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so the agency will have confidence that future entries will be in compliance with the Federal Food Drug and Cosmetic Act (i.e., the Act). For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9-8, "Detention without Physical Examination (DWPE)."
If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this import alert, all relevant information supporting the request should be forwarded to the following address:
Food and Drug Administration
Division of Import Operations
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857
Or, be sent via email to: Importalerts2@fda.hhs.gov
Questions or issues involving import operations should be addressed to the ORA/Division of Import Operations at (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov
Questions or issues involving science policy, analysis, preparation, or analytical methodology, should be addressed to ORA/Office of Regulatory Science at email@example.com
Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to CFSAN/Division of Enforcement's Food Adulteration Assessment Branch at CFSANEnforcement@fda.hhs.gov
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to
bear or contain a poisonous or deleterious substance which may render the article injurious to health.
Contains: [Adulteration, Section 402(a)(1)]
OASIS charge code – POISONOUS ***
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)