FDA Suspends Sunland Inc.'s Food Facility Registration
On November 26, 2012, the FDA suspended Sunland Inc.'s facility registration. This was the FDA's first use of its registration suspension authority, under the Food Safety Modernization Act (FSMA). FDA has the authority to suspend a registration where there is a reasonable probability that the food will cause serious adverse health consequences or death to humans or animals and the facility (1) created, caused, or was otherwise responsible for such reasonable probability; or (2) knew of, or had reason to know of, such reasonable probability, and packed, received, or held such food. See Section 415(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Suspension of a facility's registration means that the facility is prohibited from: (1) introducing food into interstate or intrastate commerce; (2) importing or exporting food into the U.S. from the facility; and (3) offering to import or export food into the U.S. from the facility. In effect, the agency has obtained injunctive relief without the need to further follow the legal process or the potentially time consuming activities involved in obtaining an injunction.
FDA suspended Sunland's registration because it made peanut butter linked to an outbreak of Salmonella Bredeney and because there has been a history of violations associated with the plant. Sunland's product testing records showed product lots of nut butter containing Salmonella and at least a portion of these product lots were distributed to consumers. Additionally, during its inspection of the plant in September and October 2012, the FDA found Salmonella in 28 environmental samples and in 13 nut butter product samples and one product sample of raw peanuts. During its investigation FDA also observed serious violations of Current Good Manufacturing Practice regulation.
Sunland has an opportunity to request an informal hearing on certain issues related to the suspension order or to appeal the suspension order. See Section 415(b)(2) of the FD&C Act. 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. The FDA says it will reinstate Sunland's registration only when they determine that the company has implemented procedures to produce safe products.
The current situation presents unique enough facts and circumstances so that we cannot be certain how frequently FDA will use this new authority. We believe that it will still be quite rare, but only time will tell.