Michelle Ewing of The Statesman reports the deaths of 10 children may be linked to homeopathic tablets that claim to relieve babies’ teething pain, according to the Food and Drug Administration.
FDA is looking into the deaths and 400 “adverse events” reported to the agency.
“The relationship of these deaths to the homeopathic teething products has not yet been determined and is currently under review,” the FDA said in a statement, according to CNN.
The news comes less than two weeks after the FDA warned parents against using the products amid reports of infants and children having seizures, difficulty breathing, lethargy and other health issues after taking the tablets.
On Tuesday, Hyland’s announced it will no longer distribute its teething products in the U.S.
Thirty-six people infected with the outbreak strains of Salmonella Reading or Salmonella Abony were reported from nine states.
Seven ill people were hospitalized. No deaths were reported.
Epidemiologic and traceback evidence indicated that alfalfa sprouts supplied by Sprouts Extraordinaire of Denver, Colorado were the likely source of this outbreak.
On August 5, 2016, Sprouts Extraordinaire recalled alfalfa sprout products from the market due to possible Salmonella contamination.
This outbreak appears to be over. However, sprouts are known to cause foodborne illness and outbreaks
Public health investigators used the PulseNet system to identify illnesses that may have been part of this outbreak. PulseNet, coordinated by CDC, is the national subtyping network of public health and food regulatory agency laboratories. PulseNet performs DNA fingerprinting on Salmonella bacteria isolated from ill people by using techniques called pulsed-field gel electrophoresis (PFGE) and whole genome sequencing (WGS). CDC PulseNet manages a national database of these DNA fingerprints to identify possible outbreaks.
Thirty-six people infected with the outbreak strains were reported from nine states. Of those ill people, 30 were infected with Salmonella Reading, 1 was infected with Salmonella Abony, and 5 were infected with both. A list of the states and the number of cases in each can be found on the Case Count Map page.
Illnesses started on dates ranging from May 21, 2016 to September 10, 2016. Ill people range in age from less than 1 year to 72, with a median age of 30. Fifty-six percent of ill people were female. Seven ill people reported being hospitalized, and no deaths were reported.
This outbreak appears to be over. However, sprouts are known to cause foodborne illness and outbreaks.
Epidemiologic and traceback evidence indicated that alfalfa sprouts supplied by Sprouts Extraordinaire of Denver, Colorado were the likely source of this outbreak.
In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Of the 31 ill people who were interviewed, 18 (58%) reported eating or possibly eating alfalfa sprouts in the week before illness started. This proportion is significantly higher than results from a 2006 survey of healthy people, in which 3% reported eating raw alfalfa sprouts on a sandwich in the week before they were interviewed. Ill people in the current outbreak reported eating raw sprouts on sandwiches from several restaurants.
Federal, state, and local health and regulatory officials performed a traceback investigation from five restaurants where ill people reported eating alfalfa sprouts. This investigation indicated that Sprouts Extraordinaire supplied alfalfa sprouts to all five of these locations.
On August 5, 2016, Sprouts Extraordinaire recalled its alfalfa sprout products from the market due to possible Salmonella contamination. These products were sold in boxes labeled “5-lb Living Alfalfa.” Read the Advice to Restaurants, Retailers and Consumers.
This outbreak appears to be over. However, sprouts are known to cause foodborne illness and outbreaks. More information about steps to reduce your risk of getting sick from eating sprouts is available on the Advice to Restaurants, Retailers and Consumers page.
The U.S. Centers for Disease Control worked with public health and regulatory officials in many states and the U.S. Food and Drug Administration (FDA) to investigate a multistate outbreak of Shiga toxin-producing Escherichia coli (STEC) infections.
Illnesses started on dates ranging from December 21, 2015 to September 5, 2016. Ill people range in age from 1 year to 95, with a median age of 18. Seventy-six percent of ill people were female. Seventeen ill people were hospitalized. One person developed hemolytic uremic syndrome, a type of kidney failure, and no deaths were reported.
Epidemiologic, laboratory, and traceback evidence indicated that flour produced at a General Mills facility in Kansas City, Missouri was the likely source of this outbreak.
In interviews, ill people answered questions about the foods they ate and other exposures in the week before they became ill. Twenty-eight (76%) of 37 people reported that they or someone in their household used flour in the week before they became ill. Nineteen (50%) of 38 people reported eating or tasting raw homemade dough or batter. Twenty-one (57%) of 37 people reported using Gold Medal brand flour. Three ill people, all children, reported eating or playing with raw dough at restaurants.
In an epidemiologic investigation, investigators compared the responses of ill people in this outbreak to those of people of similar age and gender reported to state health departments with other gastrointestinal illnesses. Results from this investigation indicated an association between getting sick with STEC and someone in the household using Gold Medal brand flour.
Federal, state, and local regulatory officials performed traceback investigations using package information collected from ill people’s homes and records collected from restaurants where ill people were exposed to raw dough. These initial investigations indicated that the flour used by ill people or used in the restaurants was produced during the same week in November 2015 at the General Mills facility in Kansas City, Missouri, where Gold Medal brand flour is produced.
On May 31, 2016, General Mills recalled several sizes and varieties of Gold Medal Flour, Gold Medal Wondra Flour, and Signature Kitchens Flour due to possible E. coli contamination. The recalled flours were produced in the Kansas City facility and sold nationwide.
In June 2016, laboratory testing by FDA isolated STEC O121 in open samples of General Mills flour collected from the homes of ill people in Arizona, Colorado, and Oklahoma. WGS showed that the STEC O121 isolates from the flour samples were closely related genetically to the STEC O121 isolates from ill people. The flour collected in Oklahoma was not included in the initial General Mills recall. The other flour samples that were tested came from lots of flour included in the initial recall announced by General Mills. In July 2016, laboratory testing by General Mills and FDA isolated STEC O26 from a sample of General Mills flour. WGS showed that the STEC O26 isolated from the flour sample was closely related genetically to isolates from an ill person in the PulseNet database. The flour tested was not included in the earlier General Mills recalls. As a result of these findings, General Mills expanded its recall on July 1, 2016 and again on July 25, 2016 to include more production dates.
Although the outbreak investigation is over, illnesses are expected to continue for some time. The recalled flour and flour products have long shelf lives and may still be in people’s homes. Consumers who don’t know about the recalls could continue to eat the products and get sick. A list of the recalled products and how to identify them is available on the Advice to Consumers page.
This outbreak is a reminder that is it not safe to taste or eat raw dough or batter, whether made from recalled flour or any other flour. Flour or other ingredients used to make raw dough or batter can be contaminated with STEC and other germs that can make people sick.
That conclusion — which flies in the face of conventional wisdom that eggs from backyard poultry and small local enterprises are safer to eat than “commercially produced” eggs — was drawn from a first-of-its kind, six-month study done last year in Pennsylvania. Researchers collected and tested more than 6,000 eggs from more than 200 selling points across the state.
Salmonella enteritidis is a leading foodborne pathogen in the United States, with many outbreaks in humans traced back to shell eggs. The FDA requires shell-egg producers from farms with more than 3,000 chickens be in compliance with the FDA Final Egg Rule, which is aimed at restricting the growth of pathogens. However, small flocks with fewer than 3,000 layer chickens currently are exempted. Eggs from these producers often are marketed via direct retail to restaurants, health-food stores and farmers markets, or sold at on-farm roadside stands.
From April to September 2015, the researchers purchased two to four dozen eggs from each of 240 randomly selected farmers markets or roadside stands representing small layer flocks in 67 counties of Pennsylvania. Internal contents of the eggs and egg shells were cultured separately for Salmonella using standard protocols. Salmonella recovered were classified by serotype, and any Salmonella enteritidis isolates present were further characterized to evaluate their relatedness to isolates of the bacteria that have caused foodborne illness outbreaks.
Test results revealed that of the 240 selling points included in the study, eggs from five — 2 percent — were positive for Salmonella enteritidis. Eggs sold at one of the positive selling points contained the bacteria in egg shells; the eggs from the other four selling points had Salmonella enteritidis in internal contents.
That is a higher prevalence of the pathogen than that found in studies of eggs from large flocks, noted lead researcher Subhashinie Kariyawasam, microbiology section head at Penn State’s Animal Diagnostic Laboratory. Those eggs, from flocks of more than 3,000 birds, are subject to federal regulations aimed at reducing Salmonella enteritidis contamination.
These regulations require measures such as placement of Salmonella-“clean” chicks, intensive rodent control, cleaning and disinfecting between flocks, environmental monitoring of pullet and layer houses, continuous testing of eggs from any Salmonella-positive houses, and diverting eggs from Salmonella-positive houses for pasteurization.
Kariyawasam — who presented the research findings to the American Veterinary Medical Association and the American Association of Avian Pathologists at their August meeting in San Antonio, Texas — said the study clearly demonstrated that Salmonella enteritidis is present in the eggs produced by small flocks.
“The research highlights the potential risk posed by the consumption of eggs produced by backyard and small layer flocks. And, analysis of the Salmonella enteritidis present in the eggs from small flocks shows they are the same types commonly reported to the Centers for Disease Control and Prevention from human foodborne outbreaks,” she said. “These findings emphasize the importance of small-producer education on Salmonella enteritidis control measures and perhaps implementation of egg quality-assurance practices to prevent contamination of eggs produced by backyard and other small layer flocks.”
Eggs from small flocks make a negligible contribution to the table egg industry in the United States, Kariyawasam noted. But the growing demand for backyard eggs and eggs from nonfarm environments — with small egg-producing flocks managed in cage-free systems and pasture situations — suggests these production systems deserve some scrutiny.
“We were curious about Salmonella contamination of eggs produced by these flocks because the prevalence of this pathogen in smaller flocks was not known. Now we know that the prevalence of Salmonella enteritidis in eggs produced by small flocks is higher than in eggs produced by larger flocks.”
Allen writes that Donald Trump often suggests that dogs can be fired. But who could have guessed that he would come out against safe food for all those unemployed canines?
In an official fact sheet that was pulled offline on Thursday afternoon—but not before The Hill reported its key points—the Trump campaign railed against the “FDA food police,” complaining that the agency “dictate[s] how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food.”
Dr. Douglas Powell, a former Kansas State University food safety professor who now publishes the popular Barfblog, says the FDA’s role is key.
“Just like we regulate the nutritional content of vitamins that we add to breakfast cereal or bread, dogs also need proper nutrition,” he told The Daily Beast. “We should use science to improve the lives of not only humans but our four-legged companions.”
Paring back dog food regulations wasn’t even the most outrageous suggestion in the now-deleted fact sheet. As The Hill reported, the “FDA food police” was listed as one of many “specific regulations to be eliminated” in Trump’s economic plan. The fact sheet depicted “farm and food production hygiene,”food temperature regulations, and “inspection overkill” as cumbersome and costly safety measures that must be reviewed and potentially “scrapped.”
The Trump campaign did not immediately respond to request for comment on the “FDA Food Police” but, according to Dr. Powell, the use of the term is “patently ridiculous.”
“Regulations and the ‘food police’ are there to set minimal standards,” said Powell. “The best companies will go above and beyond those minimal standards.”
So tinkering with what are already basic preventative measures against foodborne illness, Powell says, is simply a bad idea. The FDA has already investigated ten foodborne illness outbreaks so far this year and, according to CDC estimates, every year 48 million Americans get sick from their food and 3,000 of them die. The annual figure for foodborne illness-related hospitalizations is a whopping 128,000.
Powell predicts that if Trump were to pare back FDA regulations, most providers would still be motivated to produce safe food under threat of litigation but “you would see more people trying to cut corners.”
“Every time we have an outbreak, once you delve into the details, what you find is that it wasn’t some act of God,” Powell explained. “It was a series of small mistakes, largely driven by economics, that add up and lead to catastrophe down the road. And people die.”
In fact, Trump’s own restaurants have benefited from “inspection overkill.” In 2012, as the Associated Press reported, the steakhouse in the Trump International Hotel in Las Vegas received 51 violations “including month-old caviar and expired yogurt.” The hotel reportedly “made [adjustments] immediately” and reopened shortly thereafter.
And during an ungraded inspection of the Trump Cafe and Grill October 2015, the New York City health department found 45 violations. By the time the graded inspection came around two months later, the restaurant had reduced the number of violations to 12. Now, it serves delicious taco bowls.
Of course, as Powell explains, it is not usually the FDA itself that goes around looking for aging yogurt in Trump restaurants but rather local food inspectors who largely adhere to the FDA food code.
“[FDA food police] is a term that doesn’t mean anything but it resonates with, I guess, the people who would vote for Trump,” Powell speculated. “He’s just doing it as an anti-regulation thing. It’s not really about food safety. It’s just an easy target.”
This isn’t the first time that the FDA has been the “easy target” of an anti-regulation message. In the early 1990s, in what the New York Times editorial board would later call “an industry-financed scare campaign,” advertisements helped convince Americans to restrict the FDA’s ability to regulate vitamin and supplement labelling. The result was the 1994 Dietary Supplement Health and Education Act (DSHEA), which set up a separate set of standards for dietary supplements than for other food.
One particularly memorable 1993 TV commercial in that “scare campaign,” as Powell recalls, featured Mel Gibson’s house being raided for vitamins by a SWAT team meant to represent the FDA.
“If you don’t want to lose your vitamins, make the FDA stop,” Gibson implores at the end of the ad.
But the Trump campaign may already be rethinking its own anti-FDA stance. As The Hill reported early Thursday evening, the anti-regulation fact sheet has already been replaced with one that doesn’t specifically target the FDA. Humans and dogs everywhere can rest a little easier tonight.
I am the director of the FDA’s Gulf Coast Seafood Laboratory (GCSL) on Dauphin Island, Alabama, where we detect chemical and biological hazards and work to reduce the likelihood of illness associated with seafood. In early August, the agency invited U.S. Rep. Robert Aderholt to tour the facility and see our work first-hand. Rep. Aderholt represents Alabama’s Fourth Congressional District and chairs the House Appropriation Committee’s Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies.
At the GCSL, we use the latest technology to detect and identify things that can potentially contaminate seafood. There are drug and chemical residues that may be present from the use of antibiotics and other chemicals in aquaculture production. There are also petrochemicals from off-shore drilling.
There are marine biotoxins that occur naturally, such as harmful algal toxins that go up the marine food chain and eventually get into fish. There are bacteria that occur naturally in marine waters, such as vibrios, that can cause serious, even deadly, illnesses. And there are viruses, such as the norovirus, in marine water that are ingested by shellfish.
We routinely test a wide array of samples from public and private sources, and work closely with FDA’s compliance and enforcement teams in and out of the country so that action can be taken when appropriate.
Our scientists are often brought in when a natural or man-made disaster threatens to contaminate fish or an outbreak is tied to seafood. We’re involved right now in the response to an outbreak of hepatitis A in Hawaii tied to imported scallops, providing microbiological support to identify the virus that has sickened more than 200 people.
When the Deepwater Horizon oil rig exploded in 2010, spilling an estimated 4.9 million barrels of oil into the Gulf of Mexico, we staffed sampling locations. A year after that spill, we allayed the concerns of fishermen participating in the Alabama Deep Sea Fishing Rodeo tournament, billed as the largest fishing tournament in the world. FDA’s Office of Regulatory Affairs set up a mobile laboratory in our parking lot and together we tested samples that fishermen brought in, working round-the-clock for two weeks. We were able to assure the fishermen that there was no oil or dispersants in their fish.
In 2005, we were heavily involved in the response to Hurricane Katrina, in which there were concerns that chemicals would be swept into the Gulf and then into the fish. We deployed staff to sample crabs, shrimp and other seafood and send them by courier back to our labs. Ultimately, we found some elevated levels of bacterial contamination, but that dissipated relatively quickly during the time in which the area was closed to fishing.
We are also invited by other countries to assist in emergency response. For example, six years ago we traveled to Chile after an earthquake there and used our technology to detect norovirus in the drinking water.
When Haiti was hit with a cholera outbreak in 2010, we responded in collaboration with the Centers for Disease Control and Prevention. Our tests found cholera in seafood collected from Port au Prince. These findings were used to tighten recommendations on the movement of ballast water in and out of ships to minimize transmission of the outbreak.
We work with the seafood industry to find practical solutions to common problems. For example, we’re working with oyster fisherman to identify strategies to control bacterial (vibrio) growth. And we’ve advised barracuda fishermen to avoid certain parts of the Caribbean where the fish are vulnerable to biotoxins.
As I showed Rep. Aderholt around our labs, it was a good opportunity to reflect on the important work we do here and the impact we have. Whether it’s in the United States or overseas, we want to be known as a group of scientists that helps people everywhere enjoy seafood safely.
So next time you see an advert claiming the product removes 99.9 per cent of bacteria, talk to a microbiologist who will say that’s a 3-log reduction, we look for 5-7 log reductions.
Maggie Fox of NBC News reports the U.S. Food and Drug Administration says antibacterial soaps do little or nothing to make soap work any better and said the industry has failed to prove they’re safe. Companies will have a year to take the ingredients out of the products, the FDA said. They include triclosan and triclocarban. Soap manufacturers will have an extra year to negotiate over other, less commonly used ingredients such as benzalkonium chloride.
“Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections,” the FDA said in a statement. “Some manufacturers have already started removing these ingredients from their products.” Triclosan used in 93 percent of liquid products labeled “antibacterial” or “antimicrobial” – at least 2,000 different products, according to the FDA. “Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water”.
In 2013 FDA gave soap makers a year to show that adding antibacterial chemicals did anything at all to help them kill germs. It made the rule final Friday.
Mike Hornick of The Packer writes that health officials will begin routinely asking listeria outbreak victims if they consumed leafy greens, according to the Centers for Disease Control and Prevention.
It was the first reported listeria outbreak in the U.S. associated with leafy greens, and the eighth with fresh produce. All occurred since 2008, according to an Aug. 26 report by the CDC.
“It is unclear whether the appearance of these outbreaks might be attributed to improved outbreak detection, changes in consumer behavior, or changes in production and distribution,” the report says. “Fresh produce processors are advised to review food safety plans and consider incorporating measures to avoid the growth and persistence of listeria.”
In the Ohio centered outbreak, the older questionnaire failed to identify a common source for seven infections reported by Nov. 30.
Then in December and January, eight new or previously interviewed patients or their representatives took part in open-ended interviews or provided shopper card records.
That revealed the connection. All reported consuming leafy greens in the month before the onset of illness.
Among these, seven reported romaine and six reported spinach, higher than national food consumption estimates of 47% and 24%, respectively. Six patients recalled consuming packaged salad, according to the report.
Dole Fresh Vegetables denied responsibility in two foodborne illness lawsuits that followed the outbreak.
One of my daughters got married on the weekend. I have two grandsons. The Tragically Hip may never play live again (it’s a Canadian thing, but 1-in-3 Canadians watched the concert Saturday night from Kingston).
At the time, I applauded Jeni’s CEO John Lowe for the proactive steps they announced after finding Listeria in their ice cream, but also wondered why they weren’t looking before?
Lowe also said, “Finally, let me reiterate: we will not make or serve ice cream again until we can ensure it is 100% safe. Until we know more about reopening, we are going to continue to keep our heads down and to work hard to get this issue resolved. But know this: you’ll be hearing from us soon.”
Sounds like some cookie-cutter MBA approach to crisis.
“Two of 75 samples were found to have listeria by the FDA’s lab. Those two samples came from:
* The floor adjacent to the prep room, nine feet from a prep table where the base for Intelligentsia Black Cat Espresso was being processed and packaged.
* The floor of the wash room by a drain, two feet from a sink used to wash, rinse and sanitize equipment parts, utensils and containers used in production.”
Jeni’s said it took immediate corrective actions and prevented any spread to food contact surfaces or areas around food contact surfaces. It also noted that it has taken more than 2,000 environmental swabs in the past year and listeria has never been detected on food contact surfaces or around food contact surfaces and that its “test-and-hold” procedures, which have been in place for a year, have not turned up a single positive test for listeria.