Going public: FDA leaves tainted foods on shelves too long, report finds

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.

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.

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.

Dr. Gottlieb said that most food recalls occur within four days of a problem being reported, an assertion that Mr. Nedder disputed.

“Delay is deeply concerning to me as well,” Gottlieb, a physician, said in an interview. “I think it’s working a lot better now.”

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.”

Here’s some suggestions:

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.

Going public: Why FDA doesn’t share retail outlet information (but should) edition

Earlier this month Doug and I had a paper published in the Journal of Environmental Health about the need for public health folks (especially at the local and state levels) who are dealing with an outbreak to have a plan on when to go public. The plan should include what info the release; how they release it; and, what triggers release.

There are a bunch of great folks in these agencies who are often understaffed, overworked and dealing with political pressures – but often don’t look to the risk communication world for tips on this stuff.

Caitlin Dewey at the Washington Post wrote about why FDA doesn’t practice sharing outlets/retailers where recalled products are sold, even those linked to illnesses.

The FDA does not specify, however, which stores, centers or schools — because that would violate its interpretation of an obscure trade secret rule.

This interpretation differs from that of other agencies in the federal food safety system, an overlapping and often illogical network of regulatory fiefdoms. The system, which is responsible for keeping food free of bacteria and other pathogens, frequently has to weigh the very real interests of private food companies against potential risks to the public. In the case of releasing retailer lists during major outbreaks, the FDA has historically sided with business, ruling that such lists constitute “confidential commercial information” and thus should not be available for public consumption.

Critics say that the agency’s unwillingness to share this information poses a clear danger to public health, particularly in cases like the current E. coli outbreak, where parents may not know if their child consumed the recalled product. According to the Centers for Disease Control and Prevention, 14 of the 16 people who have fallen ill were children.

It could also prove relevant in incidents like last year’s multistate hepatitis A outbreak, which was traced to frozen strawberries imported from Egypt and sold at several Tropical Smoothie Cafes. The FDA did not specifically reveal which locations, however — a measure that some experts say would have gotten the news to ill consumers faster. That’s important in the case of an illness like hepatitis A, which can be treated with a vaccine for a limited period after exposure.

Doug and I argue that public health agencies (like FDA) should be in the business of sharing the info they have, the info they don’t have and all the uncertainties. This includes distribution data. There are lots of ways that folks get food safety and recall information. Sometimes it’s directly from their retailer of choice; or maybe it comes from a local media source. Or someone shared something on Facebook.

Bill Hallman and colleagues at Rutgers conducted a survey of consumers and their self-reported behaviors following 2008’s Salmonella saintpaul in tomatoes, er, peppers outbreak and found that lots of people (81%) say they they share recall info when they see it. 38% believe that the food they purchase is less likely to be recalled than their neighbors. And less than 60% report checking their fridges and pantries for the food.

Releasing retailer/distribution information might increase the chance individuals will say to themselves ‘I’ve bought some soynut butter recently, and I got it at that grocery store’ and they go check.

But I could just be optimistic.

A food safety Facebook friend posted a couple of days ago about a Listeria monocytogenes-linked recall. It was so important to him that he posted the info twice once on Feb 17 and again March 11, ‘I want to again stress that you should check any production codes immediately and if you have any of these products, either throw them away or return them to your grocery store. I just checked my cheese stash and had the pepperjack slices that are included.’

But, like Hallman and colleagues found, while he shared the info, he wasn’t motivated to actually go to his fridge to look for it the first time he posted. Maybe the distribution information would have triggered a behavioral response.

Tweeting about Food Safety

Do you remember how you first heard about the latest round of Salmonella in the peanut butter?  Was it on the evening news, in the paper, or did you hear about it through Facebook or Twitter?  If you’re in the under 30 crowd you might fit into the latter category.  Social networking sites, like Facebook, Twitter and MySpace are increasingly being utilized for up-to-the-minute recall information.

During the recent Salmonella outbreak, the United States Department of Health and Human Services – specifically the Food and Drug Administration and Centers for Disease Control and Prevention – engaged in a heavy social media push to inform citizens about the health risks and product recalls.  As a result, the CDC Social Media Center was created as a central hub for harnessing the power of social networking to spread recall information.

Twitter is one of the sites currently used in the assortment of links.   Twitter allows users to “follow” one another’s “tweets” about what they do during the day.  The website is on the rise among medical professionals and there are accounts for all ranges of industry available.  Why not food safety?

Federal health agencies have been experimenting with new Internet tools, dubbed Web 2.0, that make it easier to deliver information directly to the public. The "Health 2.0" movement got a big boost with the arrival of President Barack Obama, who is pushing federal agencies to use the tools to make the federal government more transparent and participatory.

Current news about FDA recalls can be found @FDArecalls and public health updates from the CDC can be found @CDCemergency. The only snag is you have to sign up in order to receive tweets from the FDA, but hey, its free.  After all, you’re no one if you’re not on Twitter.


Salmonella recalls grow; Obama orders review of FDA operations

As the number of recalled products topped 800, U.S. President Barack Obama said this morning he is ordering a “complete review” of the Food and Drug Administration after it failed to detect shipments of salmonella-contaminated peanut products.

In an interview taped Sunday and aired this morning on the television gabfest, Today, Obama said the agency’s failure to recognize and intercept the products was only the latest of numerous “instances over the last several years” in which “the FDA has not been able to catch some of these things as quickly as I expect them to catch.”

“At bare minimum, we should be able to count on our government keeping our kids safe when they eat peanut butter.”

USA Today today reported that the recall, one of the largest ever, started with bulk peanut butter, spread to crackers and cookies and has engulfed products as diverse as kettle corn, pad Thai and trail mix, with over 800 recalls and many more expected this week.

Robert Brackett, senior vice president of the Grocery Manufacturers Association, said anecdotal evidence indicates that sales of all peanut-related products, even unaffected peanut butters, are slipping, adding,

"All it takes is a little company, and it has a huge ripple effect.”

The GMA says Peanut Corporation of America supplied less than 1% of peanut products sold in the U.S. Still, the FDA says the company has more than 300 customers, many of whom used PCA’s products as an ingredient.

Brackett fears consumers will tire of checking recall lists and begin shunning anything with peanuts. Past food scares have shown that to be true.

When asked by CBC Radio in Sudbury, Ontario this morning, “what’s a consumer to do,” I said,

“Avoid the stuff for now. It may not be fair, but the recall list is growing so fast, it’s prudent. And now folks have an idea what people with peanut allergies have to go through.”

Most recalled meat is never recovered

Yesterday, Bill Marler listed the top 20 E. coli-in-beef outbreaks and recalls in the U.S. for 2007.

Apparently, most of that meat is either eaten, or never recovered.

That’s what Julie Schmit and Barbara Hansen concluded in USA Today today, after a review of recall data from the U.S. Department of Agriculture.

For 73 meat recalls this year and last, recovery rates per recall averaged 44%, but for five recalls that followed reports of consumer illness, recovery rates per recall averaged just 20%.

Kenneth Petersen, USDA assistant administrator, said that recalls spawned by reports of illness have low recovery rates because weeks or months can pass between when a product is produced, someone gets sick and illness is linked with food; recalls resulting from the USDA’s product testing tend to result in higher recovery rates.

There have been 54 meat recalls this year, up from 34 last year. For the most recent recalls, recovery rates are not yet available.

To get more consumers to check homes for recalled meats, the USDA next year plans to publicize names of retailers selling meat that was later recalled.

The story explains that on Sept. 29, Topps Meat recalled 21.7 million pounds of frozen hamburger because of potential contamination with the deadly E. coli O157:H7 bacteria. The recall, the second-biggest ever for ground beef, was well publicized. Still, New Jersey officials found 141 boxes of recalled burgers in 12 state stores about a month after the recall. Some retailers said they didn’t know about the recall, says New Jersey consumer affairs spokesman Jeff Lamm.

Recall fatigue is becoming a serious issue. In July, USA Today reported that retailers have been slow to pull Castleberry’s products that may be infected with botulism.

As I said in July, public communications about recalls need to be much more than a press release — they must be rapid, reliable, repeated and relevant, and that the produce outbreaks of 2006 marked significant changes in how stories were being told using Internet-based networking like YouTube, wikipedia, and blogs.