Import Alert 29-01

(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 # 29-01
Published Date: 03/21/2018
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Mandarin Orange Float Drink for Lead"

Reason for Alert:

Canned Mandarin Orange Float drink from Korea (Ligo brand, Mandarin Orange Float) contained elevated levels of lead (49-64 ppb). The source of this lead appeared to be the tin liner which has undergone severe corrosion. Considering that the "use by date" is in 2001, the product could be expected to be far more degraded at the end of the shelf life. FDA's analysis indicates the lead exposure from this product (8 oz.) could result in an intake in excess of the Provisional Total Tolerable Intake of Lead for children.

Guidance:

Districts may detain without physical examination (DWPE) all shipments of Mandarin Orange Float drink in cans from firms in the attachment for this alert.

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.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:

Mandarin Orange Float Drink

Charge:

“The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. [Adulteration, Section 402(a)(1)]” Contains:

(OASIS CHARGE: POISONOUS)

Countries

KOREA, REPUBLIC OF (SOUTH)

  • (20 K - - 06) Orange, Citrus Fruit Juices or Concentrates
    Desc: Mandarin Orange
    Problems:LEAD;

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


KOREA, REPUBLIC OF (SOUTH)


Nam Aujan & Bros
Date Published : 09/18/2009
Suite 328-702, Orun-Dongsongpa-Ku , Seoul, KOREA, REPUBLIC OF (SOUTH)
20 K - - 06 Orange, Citrus Fruit Juices or Concentrates
Date Published: 09/18/2009

Desc: Mandarin Orange Float Drink
Problems: LEAD;