The Food and Drug Administration (FDA) has suspended operations at nut and seed spread manufacturer Sunland Inc.’s New Mexico plant after investigators reportedly discovered Salmonella-tainted peanut butter linked to an outbreak that has allegedly sickened 41 people in 20 states this year. According to FDA, “the fact that peanut butter made by the company has been linked to an outbreak … coupled with Sunland’s history of violations led [the agency] to make the decision to suspend the company’s registration.”
According to news sources, this marked FDA’s first use of its registration suspension authority under the 2011 Food Safety Modernization Act, which gives the agency the authority to take such 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.
In a November 26, 2012, letter to Sunland’s president, FDA Commissioner Margaret Hamburg said that evidence the agency collected in response to the outbreak demonstrated that “[n]ut butter and nut products manufactured, processed, packed, and held by your facility are contaminated with salmonella, or are at risk for contamination with salmonella, based on the conditions in your facility. Your facility’s testing records over the past 3 years include multiple positive salmonella results throughout your facility and in finished product. Due to this contamination and/or risk for contamination, FDA has determined that these products have a reasonable probability of causing serious adverse health consequences or death to humans.”
Further FDA review of Sunland’s product testing records showed that “11 product lots of nut butter revealed the presence of salmonella between June 2009 and September 2012. 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.” During September and October 2012 plant inspections, FDA also found 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.
The suspension order offers the company an opportunity to request an informal hearing on certain issues related to the order. If, after providing this opportunity, FDA determines that the suspension remains necessary, it 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. The FDA will reinstate the company’s registration only when the agency determines that the company has implemented procedures to produce safe products. See Agri-Pulse, November 26, 2012.