Memoradum: Important FDA Letter to Food/Feed Manufacturers

Public Health Service

Food and Drug Administration

May 7, 2007

Dear Food Manufacturers:

The U.S. Food and Drug Administration (FDA) is taking this opportunity to remind food manufacturers of their legal responsibility to ensure that all ingredients used in their products are safe for human consumption. In view of the recent recalls of various pet foods due to the presence of wheat gluten and rice protein concentrate contaminated with melamine, and information revealing that some of this contaminated pet food may have been mixed with feed for pigs and poultry meant for human consumption, manufacturers are encouraged to make sure they have procedures in place that ensure the safety of the ingredients in their products, as well as the safety of the packaging and processing supplies they use. Manufacturers should also verify that their suppliers have such procedures in place. Advice on how to ensure that food ingredients and food products are safe for human consumption can be found at

FDA issued a protein ingredient surveillance assignment on May 1, 2007. As part of this assignment, FDA, in conjunction with state regulatory authorities, will be performing inspections of various food and feed facilities and collecting and testing for the presence of melamine a variety of protein ingredients, and finished products containing such ingredients, commonly found in the U.S. food and feed supplies. FDA has initiated this assignment to help ensure the safety of the U.S. food and feed supplies. The assignment will supplement melamine testing already conducted by FDA. The protein concentrates being tested include wheat gluten, corn gluten, corn meal, soy protein, and rice protein concentrate. Over the next few weeks, the assignment may expand in size and scope to include additional types of protein concentrates and finished products.

During inspections of manufacturing facilities conducted as part of this assignment, FDA will reiterate to the food and feed industry the importance of assuring the safety and security of their ingredients and products by knowing their manufacturing and packaging operators, ingredient suppliers, contract manufacturers and sources for all incoming materials. FDA will collect samples primarily during inspections of domestic food manufacturers or, in the case of imports, at the point of entry. The samples will be analyzed at a variety of laboratories that are part of the Food Emergency Response Network (FERN).

Manufacturers are responsible for taking their own measures to ensure the safety of their products. Manufacturers should not wait for possible FDA testing of their materials as manufacturers bear the responsibility of ensuring only safe products are put on the market. For those companies interested in performing their own tests for melamine, the methodology used by the FERN laboratories can be found at


Robert E. Bracket, Ph.D.
Center for Food Safety and Applied Nutrition

Stephen F. Sundlof, D.V.M., Ph.D.
Center for Veterinary Medicine

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