FDA Exhibits Increased Authority under Food Safety and Modernization Act
In early September of 2012, the U.S. Food and Drug Administration (“FDA“) and Centers for Disease Control and Prevention (“CDC“) announced an investigation into a multi-state outbreak of Salmonella Bredeney infections linked to peanut butter manufactured by Sunland, Inc. The outbreak sickened 42 people in 20 states according to the CDC. As part of the investigation in late September, the FDA and CDC briefed Sunland on the status of the investigation and the company volunteered to recall approximately 100 products, which included peanut butter and other products made with nuts and seeds. A list of those products can be found in Sunlands recall announcement.
During the investigation, the FDA discovered multiple sanitation violations at the Sunland manufacturing facility. FDA testing revealed the presence of Salmonella in raw peanuts from the peanut processing facility. The FDA also found that Sunland had knowingly released contaminated products onto the market between 2009 and 2012. A copy of the FDAs inspection report can be found here.
In response to the outbreak, the FDA suspended the food facility registration of Sunland on November 26, 2012. Registration with the FDA is required for any facility that manufactures, processes, packs, or holds food for consumption in the United States. 21 CFR 1.225. If a facilitys registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce. The suspension, however, is only temporary, and does not prevent Sunland from continuing to manufacture foods while the registration is suspended.
Significantly, this was the FDAs first use of its registration suspension authority pursuant to the Food Safety Modernization Act (“FSMA”). 21 U.S.C. § 350d(b). As we have previously reported, the FSMA contains various sweeping provisions that expand the FDAs power to regulate food facilities. The new authority enables the Agency to suspend registration when food manufactured, processed, packed, received, or held by a facility (1) has a reasonable probability of causing serious adverse health consequences or death to humans or animals; or (2) the facility knew of, or had reason to know of, such reasonable probability, and packed, received or held such food.
On December 20, 2012, the U.S. Department of Justice (“DOJ“) filed a complaint against Sunland and its president, Jimmie D. Shearer, in the U.S. District Court in the District of New Mexico seeking a permanent injunction. The suit was filed on behalf of the federal government by US Attorney for the District of New Mexico Kenneth Gonzales. The DOJ press release can be found here.
According to FDAs press release, on December 21, 2012, U. S. District Court Judge William P. Johnson signed a consent decree imposing requirements on Sunland to keep potentially harmful products from entering the marketplace. The consent decree requires that Sunland retain an independent sanitation expert to develop a sanitation control program that the company must then implement in compliance with current good manufacturing practice (“cGMP”) regulations. According to the consent decree, the FDA has determined that adequate grounds no longer exist to continue the suspension and will reinstate Sunlands food facility registration. However, the company cannot process or distribute food from its peanut butter plant until it has complied with the consent decrees requirements to the Agencys satisfaction and obtained written authorization from the FDA.
This case highlights the FDAs increased authority under the FSMA to take enforcement actions against non-compliant food facilities. Fuerst Ittleman David & Joseph will continue to monitor the FDAs measures under the FSMA. For more information regarding the FSMA, FDA enforcement measures, or other compliance issues, please contact us at email@example.com or (305) 350-5690.