IA #25-02 - 9/19/96, REVISION OF IMPORT ALERT #25-02, "**DETENTION
WITHOUT PHYSICAL EXAMINATION** OF MOREL MUSHROOMS DUE TO
ADULTERATION AND SUBSTITUTION", ATTACHMENT A - 9/19/96
NOTE: This import alert is being revised to update
the format and to create an attachment.
TYPE OF ALERT : Detention Without Physical Examination and
Increased Surveillance
(NOTE: This import alert contains guidance to
FDA field personnel only. It does not
establish any requirements, or create any
rights or obligations on FDA or on regulated
entities.)
PRODUCT : ** All morel and false morel mushrooms
(fresh, canned and dried)
May be labeled as:
- morels, or morille mushroom (Morchella
esculenta)
- black morels (Morchella conica)
- pointed morels (Morchella angusticeps)
- false morels or round morels gyromitres
(Gyromitra esculenta)**
PRODUCT CODE : ** 25 P[] A 06
25 P[] E 06
25 P[] H 06 **
PROBLEM : ** Adulteration due to toxic substances:
- Gyromitra esculenta: Gyromitrin toxin-
causes monomethylhydrazine poisoning;
- Verpa bohemica: Unidentified toxin similar
to gyromitrin - produces gastrointestinal and
neurological effects in some individuals;**
and - Substitution with toxic mushrooms (as
identified above)
PAC FOR
COLLECTION : ** 07F800 **
PAF : FDQ
COUNTRY : ** France (FR, 350)**
MANUFACTURER/
SHIPPER : See Attachment
MANUFACTURER/
SHIPPER'S ID# : See Attachment
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
mushroom toxins, a poisonous and deleterious
substance which may render it injurious to
health [Adulteration, Section 402(a)(1)]; and
it appears to bear or contain species of
mushroom other than morels but its labeling
fails to reveal the presence of a species of
mushroom other than morels ** [Misbranding,
Section 403(a)(1)]."
RECOMMENDING
OFFICE : ** ATL-DO (HFR-SE150), BLT-DO (HFR-MA270) and
DIOP (HFC-170) **
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
individuals. **
GUIDANCE : ** Districts may detain without physical
sampling and analysis, any shipments of
fresh, dried, or canned morel mushrooms from
those manufacturers and/or shippers listed on
the attachment to this alert.
Increased surveillance of fresh, dried, and
canned morel mushrooms from other firms and
countries appears to be warranted.
Questions regarding products or sampling
should be directed to John Gecan at (202)
205-4513.
Samples should be sent to CFSAN, Division of
Microanalytical Evaluations, HFS-315, ATTN:
John S. Gecan/Stanley M. Cichowicz for
specific identification.
Mark packages: "DO NOT SEND TO SAMPLE
ROOM."**
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Morel, Mushrooms, Gyromitra esculenta, Verpa
bohemica
PREPARED BY : Ivette Aguirre-Flores and Alwin Collins, DIOP
(HFC-170) (301) 443-6553.
DATE LOADED
INTO FIARS : September 19, 1996
Attachment A - 9/19/96
Detain without physical sampling and analysis, all shipments of
fresh, dried, or canned morel mushrooms from the firms listed on
this attachment.
FRANCE
FIRM
Plantin S.A.
84110 Vaison La Romaine
Puymeras, France
MID #FRPLA4110LAR
FEI #1000230157
ETS. G. Borde
B.P. 4
43170 Saugues, France
MID #FRETSBOR4431PAR
FEI #1000192787