The Agency’s action marks the first use of its registration suspension authority, under the Food Safety Modernization Act (FSMA). 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.
Sunland’s peanut butter has been linked to a Salmonella Bredeney outbreak that has sickened 41 people in 20 states. FDA added that the company’s history of violations also played into its decision to suspend the company’s registration.
The FDA identified products from June 2009 to August 2012 that tested positive for salmonella through the firms’ internal testing system but were cleared for partial distribution.
An FDA report alleged: “Since 2009, your firm has distributed lots of peanut butter and nut butters that were positive for Salmonella… products since 2009 that have been manufactured by your firm, have tested positive for Salmonella by your firm's internal testing program, and were at least partially distributed by your firm.”
FDA added that, during an inspection of the plant in September and October 2012, the presence of Salmonella was detected 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.
Sunland has 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 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.
FDA will reinstate Sunland, Inc.’s registration only when FDA determines that the company has implemented procedures to produce safe products.