Import Alert 26-04
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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 # 26-04
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Detention Without Physical Examination of Expressed Mustard Oil"
Reason for Alert:
Expressed mustard oil is not permitted for use as a vegetable oil. It may contain 20 to 40% erucic acid, which has been shown to cause nutritional deficiencies and cardiac lesions in test animals. Expressed mustard oil is reportedly used by some cultures as a cooking oil. NYK-DO has documented entries of this product for cooking or other general use.
It is important to note that there is another product referred to as mustard oil that is GRAS (Generally Recognized As Safe) and does have an approved food use. This oil is essential oil of mustard or volatile mustard oil and is a flavoring produced by steam distillation of black mustard flour or mustard cake. Although commonly referred to as mustard oil, this product has very little triglyceride component, and therefore, probably very little viscosity. This essential oil has an approved use as a flavoring per CFR 182.20.
It is important to note that there is another product referred to as mustard oil that is GRAS (Generally Recognized As Safe) and does have an approved food use. This oil is essential oil of mustard or volatile mustard oil and is a flavoring produced by steam distillation of black mustard flour or mustard cake. Although commonly referred to as mustard oil, this product has very little triglyceride component, and therefore, probably very little viscosity. This essential oil has an approved use as a flavoring per CFR 182.20.
Guidance:
Districts may detain without physical examination all entries of expressed mustard oil. Districts may need to establish which type of oil is offered for entry to determine applicability of this import alert.
This alert applies only to the viscous fatty oil expressed from mustard seed, which does not contain the flavoring components found in the essential oil. The correct product code for the essential oil of mustard used as a flavoring is 28O[][]01.
This alert applies only to the viscous fatty oil expressed from mustard seed, which does not contain the flavoring components found in the essential oil. The correct product code for the essential oil of mustard used as a flavoring is 28O[][]01.
Product Description:
Expressed Mustard Oil,
Crude vegetable oil (mustard)
Refined vegetable oil, single ingredient (mustard)
Crude vegetable oil (mustard)
Refined vegetable oil, single ingredient (mustard)
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear a food additive, which is unsafe within the meaning of section 409 [adulteration, Section 402(a)(2)(c)]."
OASIS charge code - UNSAFE ADD
OASIS charge code - UNSAFE ADD
Countries
MULTIPLE COUNTRIES (PODS ONLY)
(26 A - - 12) Mustard Oil, Crude, See 28O for mustard oil as a flavoring
Notes:Crude vegetable oil (mustard)
(26 C - - 12) Rapeseed/Canola Oil, Refined, Single Ingredient
Notes:refined vegetable oil; single ingredient (mustard)
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