Import Alert 25-02

(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 # 25-02
Published Date: 05/23/2022
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Morel Mushrooms Due to Adulteration"

Reason for Alert:

NOTE: The revision to this import alert dated 05/23/2022 updates the title of the alert, guidance section, charge section, and PAF/PAC sections. Changes are bracketed by asterisks (***).

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
individuals.

Guidance:

***Divisions may detain without physical examination, the identified products from the firms listed on the Red List.

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 oraorsprivatelabimportalerts@fda.hhs.gov

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

                                                                                                                                                                        ***

Product Description:

All morel and false morel mushrooms (fresh, canned and dried)

Charge:

*** Presence of Gyromitrin and similar hydrazine derivatives.

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)


FRANCE


Plantin SAS
Date Published : 09/16/2009
Route De Nyons , Puymeras, Vaucluse FRANCE
25 P - C 06 Mushroom, Morel, Whole (Button) (Fungi), Raw, Fresh, Refrigerated
Date Published: 03/12/2020

25 P - E 06 Mushroom, Morel, Whole (Button) (Fungi), Commercially Sterile
Date Published: 09/16/2009

25 P - H 06 Mushroom, Morel, Whole (Button) (Fungi), Ntrl/Artfcl Dried
Date Published: 09/16/2009