In a FSMA First, FDA Suspends a Food Facility’s Registration

By Ricardo Carvajal & John R. Fleder –

On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella.  Until the order is vacated and the registration is reinstated, Sunland may not introduce food from the facility into interstate or intrastate commerce.  This marks the first time that FDA has exercised this authority, which was conferred on the agency by the Food Safety Modernization Act (“FSMA”), enacted on January 4, 2011.

If FDA determines that food manufactured, processed, packed, received, or held by a registered facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, FDA can suspend the registration of the facility that (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.  The authority to suspend a registration cannot be delegated by the Commissioner.

FDA determined that Sunland’s products have a reasonable probability of causing serious adverse health consequences or death to humans, and that the facility created, caused, or was otherwise responsible for the probability.  FDA relied in part on multiple test results purportedly showing that the products manufactured, processed, packed, and held by the facility “are contaminated with Salmonella, or are at risk for contamination with Salmonella, based on the conditions in [the] facility.”  FDA cited both its own product and environmental test results, and those provided to FDA by the facility.  FDA also questioned the facility’s decision to release certain products into commerce:

Your facility distributed at least a portion of eight (8) lots of peanut and almond butter… after composite testing of those lots revealed the presence of Salmonella. Specifically, when composite testing of a lot was positive for Salmonella, individual containers of product from the positive tested lots were re-tested and portions, or all, of these lots were distributed based on the re-test (non-composite) testing. The initial Salmonella positive composite test results were disregarded. At least one of the batches from a lot with initial positive composite test results… that was ultimately distributed, contained a Pulsed Field Gel Electrophoresis (PFGE) pattern that was indistinguishable from the clinical isolates for the outbreak strain Salmonella Bredeney. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that the two isolates are the same strain of Salmonella Bredeney.

Sunland has the opportunity to request an informal hearing on reinstatement of its registration.  The request must be submitted within 3 business days after issuance of the order unless Sunland wants a hearing within 2 business days, in which case the request must be submitted within 1 business day.  The request “must present specific facts showing that there is a genuine and substantial issue of fact that warrants a hearing.”  The order states that “[a] hearing will not be granted on issues of policy or law.”  If the request is granted, the hearing will be conducted under the procedures specified in 21 CFR Part 16.

On its website, Sunland issued a statement suggesting that FDA’s decision caught Sunland by surprise.  In a previously issued statement, Sunland denied having released products “that it knew to be potentially contaminated with harmful microorganisms.”

This suspension action specifically, and more generally the FDA’s FSMA suspension authority, raise an interesting question.  If FDA believes that a food company is involved in a situation the agency believes presents “a reasonable probability of serious adverse health consequences” etc., when will the agency use the suspension authority provided in  FSMA and when will it alternatively seek its more traditional remedy of pursuing judicial relief in the form of a seizure action or an injunction case?  When will it impose an administrative detention?  We are unaware of any FDA guidelines that answer these questions.  Although the suspension authority presents the bureaucratic obstacle of requiring the explicit approval of the FDA Commissioner, it also provides FDA with a swift remedy that does not, in and of itself, require involvement from either the Justice Department or a court.  With that said, a suspended company should have the legal right to challenge a suspension order in court, by seeking a temporary retraining order to block the order  from remaining in effect.  We expect many companies to request the expedited hearing provided by FSMA.  Indeed, we expect many companies to pursue both remedies in cases where a company does not believe that the suspension order is legally or factually justified.

Seizure actions and injunction cases initiated by FDA and DOJ often proceed on a litigation calendar that does include expedited procedures.  There is no doubt that suspension orders issued by FDA will lead to expedited litigation when a company challenges an order.  Hopefully, this fact alone will dictate caution by FDA, as it will need to be prepared to defend its order in the administrative hearing provided in 21 CFR Part 16 and also in emergency court proceedings in a suit filed by the suspended entity.