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FDA Isssues First Suspension of Registration under FSMA

Posted in Food Safety, Food Safety Modernization Act, Uncategorized

The FDA has issued its first Mandatory Suspension of Registration under the Food Safety and Modernization Act FSMA.  (see FDA Order ( http://www.fda.gov/Food/FoodSafety/CORENetwork/ucm320413.htm?source=govdelivery ) The order was issued to Sunland Inc for contamination in their peanut facility.  This facility has been linked to a number of recent salmonella discoveries in food being sold in stores.  If a facility’s registration is suspended, that facility is prohibited from introducing food into interstate or intrastate commerce.

According to the FDA Sunland raw and roasted peanuts sold to retail customers are distributed mostly under the company’s own label and were distributed primarily to produce houses and nationally large supermarket, grocery and retail chains and on the internet. Peanut butter and other nut and seed spreads made by Sunland Inc. are distributed nationally under several brand names via supermarket chains and on the internet.

A list of all products being recalled by Sunland Inc. can be found in their recall notice: http://www.fda.gov/Safety/Recalls/ucm323824.htm.

This was the FDA’s first use of its registration suspension authority, under the Food Safety Modernization Act. FSMA section 102(b) which allows the agency to take this action when food manufactured, processed, packed, received, or held by a facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and other conditions are met.

The FDA’s review of Sunland Inc.’s product testing records showed that 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012.  Between March 2010 and September 2012, at least a portion of 8 product lots of nut butter that Sunland Inc.’s own testing program identified as containing Salmonella was distributed by the company to consumers.  There were a number of  factors noted including the lack of record keeping, numerous positive samples found with  contamination in the plant, and improper handling practices that were identified that appear to be the contributing factors to the suspension.  FSMA has a express procedural outline that would need to be followed by a suspended entity.