Import Alert 72-05

"Detention Without Physical Examination of Pet And Laboratory Animal Food Due To The Presence Of Melamine And/Or Melamine Analogs (Trazines)"

In March 2007, FDA began investigating pet deaths in the United States associated with the consumption of pet food. FDA found melamine and melamine analogs *** (cyanuric acid, ammelide, and ammeline) *** in the pet food, and traced this contamination to products labeled as "wheat gluten" and "rice protein concentrate" imported from China.

*** In response to these findings, *** FDA issued Import Alert #99-29 "Detention without Physical Examination of All Vegetable Protein Products from China for Animal or Human Food Use Due to the Presence of Melamine and/or Melamine Analogs". In addition, FDA issued field-sampling assignments for various imported human and animal food products containing plant proteins. To date, FDA collected and analyzed 222 samples of a variety of human, bird and fish food as well as pet treats. Of these 222 samples, analysis revealed multiple pet food samples were contaminated with melamine and/or melamine analogs. However, FDA's evaluation of all sample results determined the levels of melamine and/or melamine analogue contamination presented a health risk in only four of the pet food samples.

Melamine, a compound used primarily in commercial and industrial applications and its related compounds have not been approved in the United States for use as an ingredient in animal or human food.

Districts may detain without physical examination the identified products offered for importation from the manufacturers and/or shippers listed on the attachment to this import alert.

If district resources permit, sample collection is warranted of pet food including, but not limited to, pet treats, bird food or fish food from Chinese and Taiwanese firms not identified on the attachment to this alert for melamine and/or melamine analogs analysis.

Sample collection for melamine and/or melamine analogs analysis is also warranted of other pet treats, bird food or fish food products not subject to detention without physical examination originating from the firms listed on the attachment to this import alert.

*** When entries are analyzed by either FDA or private laboratories and the combined total concentration of melamine and melamine analogs are equal to or greater than 2.5 ppm, the analytical worksheets should be forwarded to Judy Baron, Center for Veterinary Medicine (CVM, HFV-232), 240-276-9771, for Center evaluation. ***

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 *** that the combined total concentration of melamine or melamine analogs in the product is less than 2.5 ppm. *** 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/Food/ScienceResearch/LaboratoryMethods/DrugChemicalResiduesMethodology/ucm071637.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 enable the agency to assess whether the firm has resolved the conditions that gave rise to the appearance of a violation, so that the agency will have confidence that future entries will be in compliance.

Questions concerning removal from detention without physical examination, such as the types of supporting documentation to provide, should be addressed to the Division of Import Operations and Policy (DIOP) (301) 796-0356 It is recommended that DIOP be contacted prior to submission of a request for removal from detention without physical examination.

FDA *** field *** offices should forward requests for removal from DWPE to DIOP, HFC-170. Removals from detention without physical examination require CVM concurrence.

Cat Food/Treats
Dog Food/Treats
Pet Food/Treats
Fish Food/Treats
Bird Food/Treats

"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