Import Alert 25-02
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(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: 03/18/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Morel Mushrooms Due to Adulteration and Substitution"
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. **
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 Red List below.
Increased surveillance of fresh, dried, and canned morel mushrooms from other firms and countries appears to be warranted.
Increased surveillance of fresh, dried, and canned morel mushrooms from other firms and countries appears to be warranted.
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 mushroom toxins, a poisonous and deleterious substance which may render it injurious to health [Adulteration, Section 402(a)(1)]."
OASIS charge code - POISONOUS
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)]."
OASIS charge code - FALSE
** "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)]."
OASIS charge code - POISONOUS
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)]."
OASIS charge code - FALSE
FRANCE
Plantin SAS
Date Published : 09/16/2009
Route de Nyons/R.C. Carpentras 69 B 21 , Puymeras , St Romain En Viennois, FRANCE
25 P - A 06 Mushroom, Morel, Whole (Button) (Fungi)
Date Published: 09/16/2009
25 P - E 06 Mushroom, Morel, Whole (Button) (Fungi)
Date Published: 09/16/2009
25 P - H 06 Mushroom, Morel, Whole (Button) (Fungi)
Date Published: 09/16/2009
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