FDA reinstates Sunland’s food facility registration

The US Food and Drug Administration (FDA) has reinstated the food facility registration of Sunland, a manufacturer and distributor of peanut products linked to a nationwide outbreak of Salmonella Bredeney that sickened 42 people in 20 states in 2012.

The move comes after a federal judge of the District of New Mexico signed a consent decree imposing certain requirements on the company to prevent potentially harmful products from entering the market.

In line with the consent decree, the FDA has authorised Sunland to restart processing and distribution of raw peanuts from its peanut mill plant in Portales, New Mexico.

However, the US-based firm cannot resume processing or distribution of ready-to-eat food until it completes additional corrective activities and receives written authorisation from the FDA.

The consent decree requires the company to retain an independent sanitation expert to develop a sanitation control programme. The company must also comply with cGMP regulations.

In addition, the plant must undergo environmental monitoring and testing to ensure the absence of disease-causing organisms in the facility or in its products, and must have comprehensive inspections conducted by an independent sanitation expert.

The consent order permits Sunland to receive, hold and distribute raw, unshelled peanuts from its storage buildings as raw peanuts are bound for processing plants that implement a procedure to eliminate Salmonella and other pathogenic bacteria.

Sunland, which operates a facility in New Mexico, issued a recall of its products in September 2012 after they were linked to a Salmonella outbreak.

The products were sold under various brands names to Trader Joe’s, Target, Whole Foods, Safeway, and other large grocery chains.

On 26 November 2012, the FDA announced the suspension of Sunland’s food facility registration as the company had not provided enough assurance that existing problems would be corrected.

The suspension marked the agency’s first use of its authority to prohibit a food facility from introducing product into the interstate or intrastate marketplace, an authority provided to it under the FDA Food Safety Modernization Act of 2011.