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F.D.A. Leaves Tainted Foods on Shelves Too Long, Report Finds F.D.A. Leaves Tainted Foods on Shelves Too Long, Report Finds
(8 days later)
The Food and Drug Administration is not moving quickly enough to ensure that contaminated food is removed from store shelves, despite being given the necessary authority, federal investigators have concluded.The Food and Drug Administration is not moving quickly enough to ensure that contaminated food is removed from store shelves, despite being given the necessary authority, federal investigators have concluded.
The inspector general of the Department of Health and Human Services examined 30 of 1,557 food recalls between 2012 and 2015. The investigators found that the F.D.A. did not always evaluate food-borne hazards in a timely manner or ensure that companies initiated recalls promptly, leaving consumers at risk.The inspector general of the Department of Health and Human Services examined 30 of 1,557 food recalls between 2012 and 2015. The investigators found that the F.D.A. did not always evaluate food-borne hazards in a timely manner or ensure that companies initiated recalls promptly, leaving consumers at risk.
Food companies took an average of 57 days to recall items after the F.D.A. was apprised of the potential hazards. One recall did not begin for 303 days, the investigators said.Food companies took an average of 57 days to recall items after the F.D.A. was apprised of the potential hazards. One recall did not begin for 303 days, the investigators said.
“Each and every day is important, because every day the product remains on the shelf, consumers are potentially at risk for serious illness or death,’’ said George Nedder, an assistant regional inspector general at Health and Human Services and lead author of the new report.“Each and every day is important, because every day the product remains on the shelf, consumers are potentially at risk for serious illness or death,’’ said George Nedder, an assistant regional inspector general at Health and Human Services and lead author of the new report.
The F.D.A. has jurisdiction over most of the food supply in the United States, including virtually all processed food. (The Department of Agriculture oversees meat and poultry, and handles recalls of those products.)The F.D.A. has jurisdiction over most of the food supply in the United States, including virtually all processed food. (The Department of Agriculture oversees meat and poultry, and handles recalls of those products.)
About 48 million Americans get sick from food-borne diseases each year, according to the agency. Of those, 128,000 are hospitalized and 3,000 die.About 48 million Americans get sick from food-borne diseases each year, according to the agency. Of those, 128,000 are hospitalized and 3,000 die.
Food recalls are announced frequently, but the vast majority are voluntary. Sometimes a company comes forward to report contamination, adulteration or mislabeling to the F.D.A. Sometimes the agency approaches a manufacturer after learning of a hazard from a state agency or other source.Food recalls are announced frequently, but the vast majority are voluntary. Sometimes a company comes forward to report contamination, adulteration or mislabeling to the F.D.A. Sometimes the agency approaches a manufacturer after learning of a hazard from a state agency or other source.
In the past few months, the F.D.A. has announced recalls of contaminated apple slices (with listeria), biscotti (undeclared nuts) and adobo sauce (salmonella), among other problems.In the past few months, the F.D.A. has announced recalls of contaminated apple slices (with listeria), biscotti (undeclared nuts) and adobo sauce (salmonella), among other problems.
The report noted numerous failings, among them “deficiencies in F.D.A.’s oversight of recall initiation, monitoring of recalls,” and in collecting and tracking recall data. Investigators also found that the F.D.A. did always not evaluate health hazards in a timely manner.The report noted numerous failings, among them “deficiencies in F.D.A.’s oversight of recall initiation, monitoring of recalls,” and in collecting and tracking recall data. Investigators also found that the F.D.A. did always not evaluate health hazards in a timely manner.
Many of the problems detailed in the report were the subject of an unusual “early alert memorandum” from the inspector general’s office in June 2016, which warned that “consumers remained at risk of illness or death for several weeks after F.D.A. was aware of a potentially hazardous food in the supply chain.’’Many of the problems detailed in the report were the subject of an unusual “early alert memorandum” from the inspector general’s office in June 2016, which warned that “consumers remained at risk of illness or death for several weeks after F.D.A. was aware of a potentially hazardous food in the supply chain.’’
The new report noted that it took the agency 165 days to start a recall of nut butters that may have been tainted with salmonella; 151 days to recall hazelnuts that also suspected of salmonella contamination; 82 days to recall frozen spinach suspected of high levels of cadmium; and 27 days to start a recall of cooked duck eggs carrying the bacteria that cause botulism.The new report noted that it took the agency 165 days to start a recall of nut butters that may have been tainted with salmonella; 151 days to recall hazelnuts that also suspected of salmonella contamination; 82 days to recall frozen spinach suspected of high levels of cadmium; and 27 days to start a recall of cooked duck eggs carrying the bacteria that cause botulism.
“The latest O.I.G. report confirms what we have known for years,” said Representative Rosa L. DeLauro, Democrat of Connecticut. “The F.D.A.’s response to food recalls is both slow and inadequate.”“The latest O.I.G. report confirms what we have known for years,” said Representative Rosa L. DeLauro, Democrat of Connecticut. “The F.D.A.’s response to food recalls is both slow and inadequate.”
F.D.A. Commissioner Scott Gottlieb said that the agency had taken to heart the inspector general’s earlier warning and had already started to address recall enforcement problems that have persisted for years.F.D.A. Commissioner Scott Gottlieb said that the agency had taken to heart the inspector general’s earlier warning and had already started to address recall enforcement problems that have persisted for years.
Dr. Gottlieb said that most food recalls occur within four days of a problem being reported, an assertion that Mr. Nedder disputed.Dr. Gottlieb said that most food recalls occur within four days of a problem being reported, an assertion that Mr. Nedder disputed.
“Our ability to affect a recall in a timely fashion is a core consumer protection function of the F.D.A.,” Dr. Gottlieb said in an interview. “If we’re not executing that well, then we’re not fulfilling our mandate.”“Our ability to affect a recall in a timely fashion is a core consumer protection function of the F.D.A.,” Dr. Gottlieb said in an interview. “If we’re not executing that well, then we’re not fulfilling our mandate.”
Among the improvements the agency has made, he added, are establishing a team of senior staffers who review complex cases and try to expedite action.Among the improvements the agency has made, he added, are establishing a team of senior staffers who review complex cases and try to expedite action.
Food-borne diseases continue to represent a substantial public health threat, although the incidence of the most common infections has held steady for many years. Campylobacter infections, for example, were lower in 2016, compared with the period from 2013 to 2015, according to the Centers for Disease Control and Prevention.Food-borne diseases continue to represent a substantial public health threat, although the incidence of the most common infections has held steady for many years. Campylobacter infections, for example, were lower in 2016, compared with the period from 2013 to 2015, according to the Centers for Disease Control and Prevention.
But infections with Shiga toxin-producing E. coli, Yersinia and Cryptosporidium (a parasite) increased during that time.But infections with Shiga toxin-producing E. coli, Yersinia and Cryptosporidium (a parasite) increased during that time.
The Food Safety Modernization Act, which President Obama signed into law in 2011, was intended to give the F.D.A. more power to police food companies. The law gave the agency the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so.The Food Safety Modernization Act, which President Obama signed into law in 2011, was intended to give the F.D.A. more power to police food companies. The law gave the agency the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so.
The F.D.A. has used this recall authority twice, according to the inspector general’s report.The F.D.A. has used this recall authority twice, according to the inspector general’s report.
Dr. Sidney Wolfe, senior adviser at Public Citizen, an advocacy group he founded, said six years after the law was signed, the F.D.A. should have made more progress.Dr. Sidney Wolfe, senior adviser at Public Citizen, an advocacy group he founded, said six years after the law was signed, the F.D.A. should have made more progress.
“The kinds of things that the inspector general has found are things that might be excusable in the first couple of years,” said Dr. Wolfe. “But not seven years into it.”“The kinds of things that the inspector general has found are things that might be excusable in the first couple of years,” said Dr. Wolfe. “But not seven years into it.”
Agency officials acknowledged that challenges remain. “We work cooperatively with industry in the overwhelming number of cases,” said Douglas Stearns, director of F.D.A.’s office of enforcement and import operations. Agency officials acknowledged that challenges remain. “We work cooperatively with industry in the overwhelming number of cases,” said Douglas Stearn, director of F.D.A.’s office of enforcement and import operations.
“At the same time, we are very dependent on what a firm tells us. Sometimes we do not get all the information we need, and sometimes the information provided is not accurate.”“At the same time, we are very dependent on what a firm tells us. Sometimes we do not get all the information we need, and sometimes the information provided is not accurate.”