The U.S. Food and Drug Administration (FDA) has suspended the food facility registration of Sunland Inc., a food producer linked to Salmonella-tainted peanut butter that has sickened at least 41 people this year. 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.
The fact that peanut butter made by the company has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration.
This 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.
A review of Sunland Inc.’s product testing records indicated 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.
Additionally, during its inspection of the plant in September and October 2012, the FDA 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.
The suspension order 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.
FDA letter to Sunland