Import Alert 99-31

"Detention Without Physical Examination of Food Products Due to the Presence of Melamine and/or Melamine Analogs"

In September 2008, FDA became aware of thousands of infant illnesses in China associated with the consumption of infant formula suspected of containing melamine. As recently as October 1, 2008, reports indicated there have been over 53,000 illnesses, nearly 13,000 hospitalizations, 100 seriously ill cases and at least four infant deaths in China.

As a result, the U.S. and other countries have been sampling and testing infant formula, milk-derived ingredients, and finished food products containing milk. Information received from a number of sources, and from a number of different countries, indicates a wide range and variety of products, such as candies, desserts, and beverages, have been found to be contaminated with melamine.

To date, FDA testing has found melamine contamination in multiple products imported from China. FDA is continuing its testing of a variety of products for melamine and its analogs.

Melamine is a compound used primarily in commercial and industrial applications. There is no approved melamine use in direct addition to human or animal food in the U.S.

Districts may detain without physical examination the identified products offered for importation from the manufacturers and/or shippers identified in the attachmnet for this import alert.

Appropriate screening criteria have been set.

***In order to secure release of an individual shipment detained pursuant to this Import Alert, the importer should provide results of a third-party laboratory analysis, of a representative sample of the lot, which verifies the product does not contain melamine or cyanuric acid. Third-party laboratories may use any method that is found acceptable to FDA and which meets the method performance of the LC-MS/MS methods available at http://www.fda.gov/AnimalVeterinary/ScienceResearch/ToolsResources/ucm135002.htm***

*** For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600. ***

In order to remove a firm from detention without physical examination, information should be provided to FDA to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation, so that the agency will have confidence that future entries will be in compliance.

Requests for removal from DWPE should be directed to FDA's Division of Import Operations and Policy at:

Food and Drug Administration
Division of Import Operations and Policy
12420 Parklawn Drive
Elem 3109
Rockville, MD 20857

Various (see attachmnet)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409 [Adulteration, section 402(a)(2)(C)(i)]."

OASIS charge code - MELAMINE

and/or

"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 it injurious to health [Adulteration, section 402(a)(1)]."

OASIS charge code - POISONOUS


and/or

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food [Adulteration, 402(a)(3)]."

OASIS charge code - UNFIT4FOOD