Melamine Update: FDA Issues Sweeping Import Alert and Requests Comment on its Interim Safety/Risk AssessmentNovember 14, 2008
On November 12, 2008, FDA issued an Import Alert on all food containing milk products from China. The Import Alert was issued because of concerns over melamine contamination of China’s milk products, including Chinese infant formula, which has been linked to 53,000 illnesses and at least four infant deaths. To request removal from the new Import Alert, firms will need to provide (1) evidence of five consecutive non-violative shipments (demonstrated through independent laboratory analyses and subsequent FDA release); (2) documentation from a third-party, in whom FDA has sufficient confidence, demonstrating that controls are in place such that products will not be contaminated with melamine and melamine analogues; and (3) documentation that the firm is in compliance with all Chinese government requirements for exporting the product to the United States.
Notably, the new Import Alert references appropriate standards for third party laboratories to test for melamine and cyanuric acid in foods. In 2007, FDA issued an Import Alert on bulk vegetable proteins from China before it had established acceptable testing standards for melamine. For several weeks thereafter, compliant products were subjected to unnecessary import delays. Without appropriate testing standards in place, importers were left with no means of providing adequate information to FDA to secure the product’s release from Customs. It appears that this scenario will not repeat itself. However, a different, equally unpleasant scenario appears to be unfolding. Although the Import Alert is for food containing milk products, foods that do not contain milk products but are imported using a product code listed in the Import Alert also are likely to be detained (e.g., cereal preparations, snack foods, and candy specialties).
On November 13, 2008, FDA published a Federal Register notice requesting comment on its October 3, 2008 “Interim Safety and Risk Assessment of Melamine and its Analogues in Foods for Humans.” The agency’s interim assessment concludes that, “based on currently available data and information, there is too much uncertainty for FDA to establish a level of melamine and its analogues in infant formula that does not raise public health concerns.” For other foods, the assessment concludes that levels of melamine below 2.5 ppm do not raise public health concerns. The Federal Register notice states that the assessment “was developed rapidly due to the extremely time-sensitive need to understand the nature of the potential risk.” In addition to seeking public comment, the agency will seek peer review of the assessment.
FDA’s initial conclusion that the presence of melamine in food (other than infant formula) at levels below 2.5 ppm does not raise public health concerns will be of no comfort to importers. Under the new Import Alert, the amount of melamine permitted in foods is zero.