Citing its link to a 20-state Salmonella outbreak and its history of food safety violations, US Food and Drug Administration (FDA) has ordered peanut butter maker Sunland Inc. to suspend operations. The agency suspended the company’s food facility registration, which prohibits it from doing business, today.
It was the FDA’s first use of its registration suspension authority as outlined by the Food Safety Modernization Act. Under the provision, the agency has the authority to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious illness or death. Documents recently released by the FDA, show that Sunland products tested positive for Salmonella 11 times between June 2009 and September 2012.
In a letter to Sunland president Jimmie Shearer, the FDA listed the areas in the plant where Salmonella was found in the plant and the occasions that it was discovered in the finished nut products. The agency also repeated an allegation that Sunland has publicly denied: that the company knowingly shipped contaminated product.
“Your facility distributed at least a portion of eight (8) lots of peanut and almond butter consisting of multiple brands manufactured between March 01, 2010 and September 2012, after composite testing of those lots revealed the presence of Salmonella. Specifically, when composite testing of a lot was positive for Salmonella, individual containers of product from the positive tested lots were re-tested and portions, or all, of these lots were distributed based on the re-test (non-composite) testing. The initial Salmonella positive composite test results were disregarded. At least one of the batches from a lot with initial positive composite test results, manufactured on July 14, 2012, that was ultimately distributed, contained a Pulsed Field Gel Electrophoresis (PFGE) pattern that was indistinguishable from the clinical isolates for the outbreak strain Salmonella Bredeney.Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers,” the letter stated.
Sunland can now request an informal hearing on certain issues related to the order. If the company requests the hearing and the FDA determines that the suspension remains necessary, the agency will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and implement solutions. The FDA will only reinstate Sunland’s registration when the company has demonstrated is ability to produce safe products.
