Peanut butter and related products linked to a deadly Salmonella outbreak have resulted in the shutdown of a major U.S. company.
On Monday, the U.S. Food and Drug Administration took the unusual action of suspending New Mexico-based Sunland Inc.’s food facility registration and the agency prohibited the company from distributing food.
Sunland is a producer of nuts, and nut and seed spreads linked to the outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, according to the FDA.
“Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce,” according to an FDA news release issued Monday.
The outbreak and “Sunland’s history of violations” led the FDA to make the decision to suspend the company’s registration, the news release stated.
The action was the FDA’s first use of its registration suspension authority under the Food Safety Modernization Act.
“This new authority enables the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met,” the release stated.
“A review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012. Between March 2010 and September 2012, at least a portion of eight product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers,” according to the FDA release.
Sunland President and CEO Jimmie Shearer disputes the FDA’s assertions.
“At no time in its 24-year history has Sunland, Inc. released for distribution any products that it knew to be potentially contaminated with harmful microorganisms. The company has followed internal testing protocols that it believed resulted in the isolation and destruction of any product that did not pass the test designed to detect the presence of any contaminants,” Shearer stated on Nov. 15 in a news release. “In every instance where test results indicated the presence of a contaminant, the implicated product was destroyed and not released for distribution.”
Shearer stated that in light of the FDA investigation, the company will not publicly discuss the matter.
According to the FDA, during its inspection of the Sunland plant in September and October 2012, the agency found the presence of Salmonella in 28 environmental samples (from surfaces in production or manufacturing areas) and in 13 nut butter product samples and one product sample of raw peanuts. Four of the peanut butter product samples showed the presence of the outbreak strain of Salmonella Bredeney.
Moving forward, the FDA contends Monday’s action offers Sunland, Inc. the opportunity to request an informal hearing on certain issues related to the order.
“If, after providing this opportunity, the FDA determines that the suspension remains necessary, the FDA will require Sunland, Inc. to submit a corrective action plan to address the immediate problems and to implement a sustainable solution to those problems in a sound scientific manner. The FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products,” according to the release.