Import Alert 20-06
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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 # 20-06
Published Date: 01/24/2012
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Apple Juice Products Due to Patulin"
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).
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 the red list for this alert.
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 301 796-6600.
For guidance on removal from detention without physical examination, refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination."
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 301 796-6600.
For guidance on removal from detention without physical examination, refer to the Regulatory Procedures Manual, Chapter 9, "Detention Without Physical Examination."
Product Description:
Apple juice;
apple juice food products
apple juice food products
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)]"
OASIS charge code - PATULIN
OASIS charge code - PATULIN
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(20 S - - 01) Apple, Core Fruit Juices or Concentrates
Problems:
PATULIN;
MEXICO
Huertas de la Empacadora S de PR de RL
Date Published : 01/24/2012
Arroyo Las Canoas s/n , Mpio de Guerrero , Guerrero, MX-CHH MEXICO
20 S - - 01 Apple, Core Fruit Juices or Concentrates
Date Published: 01/24/2012
Desc:Apple Juice from Concentrate
Problems:
PATULIN;
20 S - - 02 Crab Apple, Core Fruit Juices or Concentrates
Date Published: 01/24/2012
Desc:Apple Juice from Concentrate
Problems:
PATULIN;
20 S - - 99 Core Fruit Juices or Concentrates, N.E.C.
Date Published: 01/24/2012
Desc:Apple Juice from Concentrate
Problems:
PATULIN;
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