The Food and Drug Administration (FDA) has flexed some of its regulatory muscle under the Food Safety Modernization Act (FSMA) in suspending Sunland Inc.’s (“Sunland”) food facility registration, effectively halting that entity’s operations. FDA has linked Sunland to a salmonella outbreak occurring in 20 states. The agency decided that public health risk, coupled with a two-year history of violations from Sunland, warranted the first facility registration suspension under the authority of FSMA.
In September 2012, FDA and the Centers for Disease Control and Prevention (CDC) traced back a multistate salmonella outbreak to “Trader Joe’s™ brand Valencia Creamy Salted Peanut Butter Made with Sea Salt.” Sunland is a producer of nuts and nut and seed spreads and the sole manufacturer of the contaminated product in question. FDA’s review of Sunland’s records suggested that it released some impacted product that its own testing had identified as containing salmonella. Given the public health concern, FDA decided to suspend Sunland’s registration under the agency’s FSMA authority.
FDA was granted authority to require registration over food facilities by Section 305 of the Bioterrorism Act and Section 102 of the FSMA. Collectively, these Acts amended Section 415 of the Food Drug and Cosmetic Act (FDCA) to mandate registration of any food facility that is “engaged in manufacturing, processing, packing, or holding food” for any general food category as defined in 21 C.F.R. § 170.3 (includes peanut butter) or any category published by FDA guidance. Most importantly, the FSMA specifically granted FDA authority to suspend registration for any facility that “has a reasonable probability of causing serious adverse health consequences.”
The suspension authority in particular is a powerful enforcement tool. Under Section 301(dd) of the FDCA, failure to comply with the registration requirements is a prohibited act. This is also restated in 21 C.F.R. § 1.241, which states that failure to register a food facility, or timely update an existing registration, is a prohibited act under the FDCA. According to FDA’s Compliance Policy Guide (CPG), lack of registration is a “readily corrected” violation and, as such, the CPG advises the use of Untitled Letters as a first agency response. A review of recent Warning Letters has revealed numerous instances where FDA has cited a food facility for violation of the registration requirement. The consequences of a suspension, however, are much more serious. Under the FSMA, a food facility’s registration suspension prohibits the firm from introducing food into interstate or intrastate commerce, thus effectively shutting down its operations.
Prior to the enactment of the FSMA, FDA’s enforcement authority over food products was more limited. This is evidenced by the 2009 Peanut Corporation salmonella outbreak that infected 677 people in 45 states. FDA could not readily shut down the facility or mandate a recall of products that were suspected to be contaminated and had to rely on Peanut Corporation’s voluntary recalls to remove the salmonella-impacted products. The recall eventually included over two years of processed peanut butter products. Peanut Corporation filed for bankruptcy during the recalls, hampering FDA’s efforts to remove the contaminated products from the market. In the aftermath of the 2009 outbreak, FDA provided testimony to Congress requesting new authority over food products—specifically, the ability to require preventative controls, improved access to records and increased food registration authority. These requests were largely granted under FMSA.
In the case of Sunland, FDA’s suspension of the firm’s facility registration makes any further shipment into interstate commerce a prohibited act under Section 301(d) of the FDCA. FDA’s suspension order affords Sunland an opportunity for an informal hearing regarding issues related to the suspension. The suspension order will remain in effect until FDA’s concerns have been addressed and will most likely require submission of a corrective and preventive action plan, as well as evidence that the firm is capable of producing safe products.
FDA’s suspension authority is a powerful tool, and it is likely that the agency will begin to rely on this new authority in light of its expanding responsibilities under FSMA, and given agency resource constraints, could use its suspension authority in lieu of injunctions. As the Sunland enforcement action unfolds, food manufacturers should watch closely and take the opportunity to ensure that their own operations are in compliance with good manufacturing practices. Similarly, customers throughout the food supply chain should have appropriate supplier management programs to ensure that manufacturers and other entities in the supply chain are qualified and audited for compliance with FDA requirements.