On November 26th, 2012 the U.S. Food and Drug Administration (FDA) suspended the food facility registration of Sunland, Inc., a New Mexico producer of peanut butter and peanut products due to a “reasonable belief” that their products had sickened some consumers with a strain of Salmonella. This marks the first time that FDA has leveraged this new enforcement authority given to it under the 2011 Food Safety Modernization Act (FSMA). Under the FSMA, FDA can suspend the registration of a food facility due to the reasonable probability of adverse health consequences. It’s a significant enforcement step for FDA to take and one that should cause Industry to sit up and take note.
Long Awaited Enforcement Powers
Before the enactment of the Food Safety Modernization Act, FDA did not have the power to suspend a facility’s registration. Rather, FDA had to undertake a more lengthy process to effect substantial enforcement action against a food manufacturer or facility. Now, under FSMA, FDA can, by order, immediately suspend a food facility registration as well as initiate a mandatory recall of foods with a suspected food safety issue. In the past, FDA actions were limited to a specific food product. Now FDA can stop all foods produced by a facility dead in their tracks. Section 102 of the Food Safety Modernization Act, Registration of Food Facilities, contains the language that grants FDA this power.
If the Secretary determines that food manufactured, processed, packed, received, or held by a facility registered under this section has a reasonable probability of causing serious adverse health consequences or death to humans or animals, the Secretary may by order suspend the registration of a facility –
Through this suspension power, FDA can reach any facility that created, caused, or was otherwise responsible for such reasonable probability, that knew of, or had reason to know of the issue or that packed, received, or held such food. Therefore, this Sunland Salmonella issue could expand to other food facilities.
Risk, Technology and Consequences
Americans remember all too clearly the deaths, illnesses and convoluted enforcement challenges associated with the Peanut Corporation of America scandal in 2008 and 2009. FDA is under constant pressure to enforce precisely and quickly and attention has been on the Agency all the more now that FSMA is in implementation status. Most of the FSMA provisions have been on hold at FDA or the Office of Management and Budget for 18 months. Suspending Sunland’s registration was a way for FDA to flex its regulatory muscle and show it’s still relevant.
High-risk food is at the heart of FSMA, and not just from an enforcement perspective. In the spring of 2012 FDA, in conjunction with the Institute of Food Technologies, launched a tracking and tracing pilot project that focused on high-risk foods, peanut butter being one of them. Although FDA has yet to identify high-risk foods under FSMA, the IFT project and FDA’s criteria for high-risk foods both identified peanut butter and peanut products as “foods of interest” from a safety standpoint. The results of the IFT study have not yet been released but were due in the summer of 2012. High-risk foods will also be a priority for FDA’s newest flagship food regulatory programs including Hazard Analysis and Risk-Based Preventive Controls (HARPC), the Foreign Supplier Verification Program (FSVP) and the Voluntary Qualified Importer Program (VQIP).
What’s next for Sunland? Following a suspension FDA is required to give opportunity for an informal hearing. However, with the slim margins and deadlines that many in the food manufacturing sector face, a suspension, no matter what the final outcome, could put the company out of business. It is possible that Sunland can recover but it must address FDA’s concerns and implement a corrective action plan in time (not to mention a hefty PR campaign). What companies need to learn here is that by the time things get to the point of facility registration suspension it is too late already.
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