The FDA’s failure to act to protect the public from deadly bacteria in shellfish not only means the agency is in violation of the Food Safety Modernization Act, but it means at least 15 people will likely die unnecessarily every year, according to a lawsuit filed in federal court.
“The U.S. Food and Drug Administration (FDA) should stop dragging its feet and act on a four-year-old petition urging the agency to regulate deadly bacteria in shellfish harvested in Gulf Coast waters and sold for raw consumption,” wrote the legal team for the Center for Science in the Public Interest (CSPI) in a lawsuit filed in late May in U.S. District Court for the District of Columbia.
“Without this safety standard, in the next year, an estimated 30 people will become seriously ill, and 15 of them will die, after consuming raw shellfish that contain the bacteria, called Vibrio vulnificus (V. vulnificus),” the complaint states, citing statistics from the FDA and Centers for Disease Control and Prevention.
FDA policies prohibit agency staff from commenting on pending litigation. The government has until July 25 to file a response to CSPI’s complaint. The FDA updated its warning to consumers in June 2015 regarding consumption of raw oysters and other shellfish because of V. vulnificus.