The U.S. 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 foodborne 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.
“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.)
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.
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.’’
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.
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.
FDA will also release guidance in the first half of 2018 on what information it can release about where recalled food and diet supplements were sold. A coalition of safety advocates urged Gottlieb in August to release the names of the stores that sell recalled food items, which FDA has claimed is confidential business information. The Agriculture Department releases it, as do other agencies including the Consumer Product Safety Commission.
FDA Commissioner Scott Gottlieb, MD said in a statement (edited below) that, “One of our most important jobs at the U.S. Food and Drug Administration is ensuring the safety of the U.S. food supply. When we learn about a food in the marketplace that may be unsafe, we must act quickly to keep people from getting sick or being harmed. If foodborne illness has already occurred, we also must act quickly to keep more people from becoming ill. The re-issued, final version of the report by the Office of the Inspector General (OIG), which examined our food recall practices over the time period from Oct. 1, 2012 to May 4, 2015, raised some significant concerns for me. While the FDA has addressed many of the findings after the draft version was first released in 2016, we still have more work to do. I take these obligations very seriously. Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe foods, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission. …
“Among other steps, the agency will issue guidance on recall communications in the first half of 2018. As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product. If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.”
Going public: Early disclosure of food risks for the benefit of public health
NEHA, Volume 79.7, Pages 8-14
Benjamin Chapman, Maria Sol Erdozaim, Douglas Powell
Often during an outbreak of foodborne illness, there are health officials who have data indicating that there is a risk prior to notifying the public. During the lag period between the first public health signal and some release of public information, there are decision makers who are weighing evidence with the impacts of going public. Multiple agencies and analysts have lamented that there is not a common playbook or decision tree for how public health agencies determine what information to release and when. Regularly, health authorities suggest that how and when public information is released is evaluated on a case-by-case basis without sharing the steps and criteria used to make decisions. Information provision on its own is not enough. Risk communication, to be effective and grounded in behavior theory, should provide control measure options for risk management decisions. There is no indication in the literature that consumers benefit from paternalistic protection decisions to guard against information overload. A review of the risk communication literature related to outbreaks, as well as case studies of actual incidents, are explored and a blueprint for health authorities to follow is provided.