FDA Suspends Sunland Inc.'s Food Facility Registration
This is the first use of the suspension authority allowed by the Food Safety Modernization Act, the agency announced Nov. 26.
In a letter dated Nov. 26, FDA Denver District Director LaTonya M. Mitchell informed Jimmie Shearer, president of Portales, N.M.-based Sunland Inc., that his company's food facility registration was suspended effectively immediately upon his receipt of the letter. An extensive recall of products made at Sunland's Peanut Butter Plant is under way because they are suspected of being contaminated with Salmonella, and this is FDA’s first use of the suspension authority allowed by the Food Safety Modernization Act.
"FDA has determined that food manufactured, processed, packed, received, or held by your facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and that your facility created, caused, or was otherwise responsible for such reasonable probability," Mitchell wrote. "FDA is issuing this Order under section 415(b)(1) of the FD&C Act, and the Order is effective immediately upon your receipt. While this Order is in effect, pursuant to section 415(b)(4) of the [Federal Food, Drug, and Cosmetic Act], no person can import or export food into the United States from your facility, offer to import or export food into the United States from your facility, or otherwise introduce food from your facility into interstate or intrastate commerce in the United States."
Sunland, Inc. can request an informal hearing; FDA said it will reinstate the registration only if it determines the company has implemented procedures to produce safe products. The agency's announcement said the fact that peanut butter made by Sunland "has been linked to an outbreak of Salmonella Bredeney that has sickened 41 people in 20 states, coupled with Sunland’s history of violations led FDA to make the decision to suspend the company’s registration."
It said a review of Sunland’s product testing records showed 11 product lots of nut butter showed the presence of Salmonella between June 2009 and September 2012, and between March 2010 and September 2012, at least a portion of eight product lots of nut butter that Sunland's own testing program identified as containing Salmonella was distributed by the company to consumers, according to FDA, which said Salmonella was confirmed in 28 surface samples taken during its inspection of the plant in September and October 2012.