The Food and Drug Administration is issuing a proposed rule covering the use of private sampling services and laboratories in connection with imported food. Once finalized, the rule will strengthen the safety and wholesomeness of the U.S. food supply by helping to assure the integrity and scientific validity of data and results submitted to FDA.
The new regulations would require samples to be properly identified, collected and maintained; mandate that private laboratories use validated or recognized analytical methods; and direct private laboratories to submit the results directly to FDA. The proposal also would require importers to provide notice to FDA about the use of a sampling service or a private laboratory to sample and test food that is subject to an FDA enforcement action.
"This is yet another of the many steps initiated by our agency to protect Americans from food that appears to be adulterated or misbranded," said Dr. Lester M. Crawford, the Acting FDA Commissioner. "When it is finalized, this regulation will add an important building block to the FDA regulatory wall that helps to keep suspect food from harming our consumers."
Imports of food are rapidly rising and last year reached more than 6 million shipments. FDA estimates that importers hire more than 100 private laboratories to generate analytical data in support of claims that imported food products comply with U.S. laws. After questions were raised in mid-1990s about the coordination between these firms and FDA, the agency conducted several meetings with stakeholders that resulted in suggestions that the FDA take the following actions: