IA #20-06, 1/3/05, IMPORT ALERT #20-06,"DETENTION WITHOUT PHYSICAL EXAMINATION
OF APPLE JUICE AND APPLE JUICE PRODUCTS DUE TO PATULIN" ATTACHMENT A 9/7/07
TYPE OF ALERT: Detention Without Physical Examination
(NOTE: This import alert represents the Agency's current guidance to FDA
field personnel regarding the manufacturer(s) and/or product(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.)
PRODUCT: Apple juice; apple juice food products
PRODUCT CODE: Various, (See Attachment)
PROBLEM: Mycotoxins (Patulin)
PAF: MYC
OASIS CHARGE
CODE: Patulin
PAC: 07001
COUNTRY: See Attachment A
MANUFACTURER/
GROWER: See Attachment A
CHARGE: "The article is subject to refusal of admission pursuant to
Section 801(a) (3) of the Act, in that it appears to contain
Patulin, a poisonous and deleterious substance which may
render it injurious to health [Adulteration, Section 402(a)
(1)]."
RECOMMENDING
OFFICE: NYK-DO (HFR-NE152) and the Imports Branch, Division of
Enforcement, Office of Compliance, CFSAN (HFS-606)
REASON FOR
ALERT: Patulin is a toxic substance produced by molds that may grow
on apples. In the past, Patulin has been found to occur at
high levels in some apple juice products offered for sale in
or imported into the United States. As set out in
Compliance Policy Guide 510.150 "Apple Juice, Apple Juice
Concentrates and Apple Juice Products-Adulteration with
Patulin", the action level for Patulin is 50 ppb or above,
as determined in single strength apple juice reconstituted;
or single strength apple juice (if the food is an apple
juice concentrate); or the single strength apple juice
component of the food (if the food contains apple juice as
an ingredient).
GUIDANCE: Districts may detain, without physical examination, apple
juice and apple juice products for the presence of Patulin
for the firm(s) listed on Attachment A.
When Districts encounter shipments of apple juice and/or
apple juice products which are violative for Patulin, a
recommendation for detention without physical examination
and background information, including analytical worksheets,
should be forwarded to DIOP, HFC-171. DIOP will coordinate
with CFSAN for concurrence.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
827-7605.
For guidance on removal from detention without physical
examination, refer to the Regulatory Procedures Manual,
Chapter 9, "Automatic Detention".
Questions may be directed to Patricia Stephenson, CFSAN,
HFS-606, at 301-436-2060.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: Apple Juice, Apple Juice Products, Patulin, Mycotoxins
PREPARED BY: Patricia Stephenson, CFSAN, 301-436-2060
Linda Wisniowski, DIOP, 301-443-6553
DATE LOADED
INTO FIARS: January 3, 2005
Attachment A - There are no firms or products on DWPE at this time
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