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Sunland: FDA Didn't Warn Of Peanut Butter Recall-Related Suspension

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SUNLAND
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The Food and Drug Administration suspended Sunland Inc.'s registration as a food facility on Monday, two months after issuing a recall on 240 products containing Sunland's organic peanut butter, which has sickened at least 41 people with salmonella. The move surprised many observers because it was the FDA's first use of a new power granted by the Food Safety Modernization Act of 2011. But it was even more shocking to the people who work at the Portales, N.M.-based company, because they say they weren't given any advance notice that the suspension was coming.

Indeed, the FDA hadn't contacted Sunland for weeks before Monday, according to Sunland spokeswoman Katalin Coburn,

Coburn told The Huffington Post that the company on Nov. 9 submitted its official response to the FDA's inspection findings, which had been issued on Oct. 29. She said the company's officers felt confident that it outlined a solid plan for preventing future contamination. For that reason, they expected the FDA to address the response -- either positively or negatively -- before taking any further punitive measures. They even sent the FDA a letter last week informing the agency that they planned to start shelling this season's peanut harvest within a matter of days.

The FDA's next missive was the letter informing Sunland that its license had been suspended.

"FDA officials had plenty of opportunities to tell us what was wrong with our response," Coburn said. "But we heard nothing. Instead on Monday, they notified Sunland at the same time they told the media. The communication has been one-sided for weeks, and we feel very disappointed about that."

The FDA letter announcing the suspension of Sunland's license declares that the company's response "omits significant details regarding planned physical repairs and corrective actions, and the adequacy or effectiveness of these corrective actions cannot be determined based on the information provided in the response."

Devin Koontz, a spokesman at the FDA office in Denver, which is overseeing the Sunland case, added that the agency was not obligated to address Sunland's response before taking action.

"We reviewed the proposed responses to our inspection, both here in the Denver office and in Washington," Koontz said. "We felt that those proposed actions did not provide enough assurance that they were going to prevent further contaminated food from leaving its facility."

Michael Doyle, director of the University of Georgia's Center for Food Safety, visited the Sunland plant several weeks ago to help develop its response to the FDA inspection report. He concurred that there were serious problems with the company's food safety plan, but said that this was "not atypical" of factories its size.

"My sense is that the FDA is interested in making sure that small- and middle-sized companies are bringing their food safety standards to a higher level," Doyle said. "They want to send a message, and that's good. The industry needs to know what are acceptable practices."

Sunland had stopped producing peanut butter when the recall began, so the immediate impact of its license suspension is limited. The company will not be permitted to sell any peanut butter, or even produce any peanut butter for later sale, until its registration is renewed. For that to happen, Sunland will have to submit a detailed corrective action plan to the FDA, implement that plan, and then hope the FDA verifies that implementation with another inspection, this time on Sunland's dime.

Coburn said that Sunland's officers have not spoken with the FDA since being informed of the suspension, but they have begun the work of overhauling the plant to bring it up to code. The company also committed to stop selling peanuts roasted in the shell after being told that production process could lead to contamination. Coburn said the work could be done by January 2013.

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