Specter of Oyster Bacteria Brings Suit Against FDA

(CN) — The Food and Drug Administration must implement stricter standards to protect consumers from tainted raw oysters, a nonprofit claims in a federal action.

"If past experience holds true, this year an estimated thirty Americans will become seriously ill, and half of those people will die, from consuming raw shellfish contaminated with a bacteria called Vibrio vulnificus," the complaint filed Wednesday in Washington begins.

The Center for Science in the Public Interest calls V. vulnificus "the leading cause of deaths linked to seafood consumption in the United States."

While otherwise healthy people react to this bacteria with normal food-poisoning symptoms, V. vulnificus is more dangerous for those with diabetes, cancer, liver disease or other pre-existing health conditions.

Half of those who contract septicemia from V. vulnificus die, and those who survive may require amputation or skin debridement, according to the complaint.

The Center for Science in the Public Interest says it filed a citizen petition in 2012, asking the U.S. Food and Drug Administration to require seafood companies to ensure V. vulnificus is at a nondetectable level in oysters and other shellfish meant to be eaten raw.

For four years, the FDA has neither granted nor denied the center's petition. Its stated policy since 1993 has only been that at-risk individuals should not consume raw shellfish.

The center hopes the court will move the FDA's hand.

"The considerable danger to public health caused by V. vulnificus counsels in favor of expeditious action on CSPI's petition," the complaint states. "The pace of defendant's decisional process has lagged unreasonably in light of the nature and extent of the public health interests at stake and the defendant's obligation to determine every two years the most significant foodborne contaminants and to adopt appropriate standards based on that determination."

The Center is represented by Julie Murray, an attorney with Public Citizen Litigation Group.

"The FDA's failure to adopt a safety standard to control these deadly bacteria is unconscionable," Murray said in a statement. "The technology to eliminate or reduce V. vulnificus while preserving the texture and flavor of raw oysters is readily available. What's missing is the FDA's resolve to do something meaningful about this public health hazard."

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