WTKR reports that the U.S. Food and Drug Administration has issued a warning to the maker of Purell hand sanitizer to stop making unproven claims that the product can help eliminate diseases like Ebola, MRSA and the flu.
According to CNN, the FDA’s director of compliance sent a “warning letter” to Gojo, Purell’s parent company, to stop making unproven claims for marketing purposes that could position the hand sanitizer as a pharmaceutical drug.
The letter from the FDA reportedly notes that Purell says on its website and on social media that the sanitizer “kills more than 99.99% of the most common germs that may cause illness in a healthcare setting, including MRSA & VRE.” Purell and Gojo also note that “Purell Advanced Gel, Foam, and Ultra-Nourishing Foam Hand Sanitizer products demonstrated effectiveness against a drug resistant clinical strain of Candida auris in lab testing.
Finally, the FDA chastized Purell for claiming on the Q&A section on its website that the product can be “effective against viruses such as the Ebola virus, norovirus and influenza.” The FDA says it is not aware of any hand sanitizers that have been tested against Ebola.
Chris Koger of The Packer writes the U.S. Food and Drug Administration will be collecting romaine samples in California and Arizona for a year to test for salmonella and E. coli following several foodborne outbreaks linked to the lettuce.
The new program begins this month, according to the FDA, citing two E. coli outbreaks in 2018 linked to romaine, and another one in October that was suspected to be from the leafy green. In its notice on the surveillance program, the FDA also cited a 2012 Salmonella Newport outbreak from romaine.
“Consistent with the FDA’s mission to protect consumers, if one of the target pathogens is detected as a result of this assignment, the agency will perform whole genome sequencing of the microorganism’s DNA to determine its virulence and whether it is genetically related to isolates causing human illness,” according to the notice.
All samples will be tested before processing to allow the FDA to quickly find the point of origin, which has been problematic in recent outbreaks as public and federal health agencies traced lettuce through the supply chain. In part, traceability hurdles have led to the FDA’s New Era of Smarter Food Safety program, which tasks the industry with enhancing traceability methods and technology.
Trimmed and washed lettuce will be tested, but not fresh-cut lettuce, and no lettuce at the farm-level will be involved in the surveillance program.
Samples will be targeted at facilities and farms identified in the outbreaks starting in 2017, including wholesalers, foodservice distribution centers, and commercial cooling and cold storage facilities, according to the FDA notice.
I love Mondays in Australia because it’s Sunday in the U.S., football and hockey are on TV for background, the kid is at school when not in France, and I write (Sorenne painting in France).
Fourteen years ago, me and Chapman went on a road trip to Prince George (where Ben thought he would be eaten by bears) to Seattle, then to Manhattan, Kansas, where in the first week I met a girl, got a job, and then spinach happened.
Leafy greens are still covered in shit.
I am drowning in nostalgia, but things haven’t changed, and, as John Prine wrote, all the news just repeats itself.
Same with relationships.
Former U.S. Food and Drug Administration food safety chief, David Acheson, writes that on October 31, 2019, FDA announced a romaine lettuce E. coli O157:H7 outbreak for which the active investigation had ended and the outbreak appeared to be over. As such FDA stated there was no “current or ongoing risk to the public” and no avoidance of the produce was recommended.
Since that announcement, however, I have seen a number of articles condemning FDA and CDC. Why? Because the traceback investigation of the outbreak began in mid-September when CDC notified FDA of an illness cluster that had sickened 23 people across 12 states. So why the delay in announcing it to the public?
Despite the critical (and rather self-serving; always self-serving) stance on the “inexcusable” delay taken by a prominent foodborne illness attorney and his Food Safety “News” publication – which blasted a headline FDA “hid” the outbreak – my stance, having been an FDA official myself involved in outbreak investigations, is that the delay was practical and sensible.
Why? As FDA states right in its announcement:
When romaine lettuce was identified as the likely source, the available data indicated that the outbreak was not ongoing and romaine lettuce eaten by sick people was past its shelf life and no longer available for sale.
Even once romaine was identified as the likely cause, no common source or point of contamination was identified that could be used to further protect the public.
During the traceback investigation, the outbreak strain was not detected in any of the samples collected from farms, and there were no new cases.
Thus, neither FDA nor CDC identified any actionable information for consumers.
So, if it is not in consumers’ best interest to publicize an issue that no longer exists, why should they be driven away from a healthy food alternative? Why should unfounded unease be generated that will damage the industry, providing no benefit for consumers but ultimately impacting their pockets? There is just no upside to making an allegation without information. We’ve seen the impact on consumers and the industry when an announcement of a suspected food turns out to be incorrect; specifically “don’t eat the tomatoes” when it turned out to be jalapeno and serrano peppers. Having learned from such incidents, FDA’s approach is: If we don’t have a message that will help protect the public, then there is no message to be imparted.
So, rather than condemn FDA and CDC, I would commend them for getting the balance correct. And, perhaps, instead of any condemning, we should be working together to get the answers faster, to get outbreak data through better, faster, more efficient and coordinated traceability. Our entire system is too slow – a topic we have discussed many times in these newsletters.
The public and the scientific community need to be informed to prevent additional people from barfing.
I also rarely eat lettuce of any sort because it is overrated and the hygiene controls are not adequate.
Greek salad without lettuce is my fave.
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.
The U.S. Food and Drug Administration says that unscrupulous sellers have sold “miracle” bleach elixirs for decades, claiming that they can cure everything from cancer to HIV/AIDS, hepatitis, flu, hair loss, and more. Some have promoted it to parents as a way to cure autism in children.
The health claims are false, not to mention abhorrent. When users prepare the solution as instructed, it turns into the potent bleaching agent chlorine dioxide, which is an industrial cleaner. It’s toxic to drink and can cause severe diarrhea, vomiting, life-threatening low blood pressure, acute liver failure, and damage to the digestive tract and kidneys.
Stocknews Brief reports that poison control centers across the country have seen 16,500 cases involving chlorine dioxide since 2014. At least 50 of those cases were deemed life-threatening. Eight people died.
FDA says that the products have been hard to scrub out because of claims on social media, where the drinks are promoted along with false health information.
In an ongoing effort to understand sources of foodborne illness in the United States, the Interagency Food Safety Analytics Collaboration (IFSAC) collects and analyzes outbreak data to produce an annual report with estimates of foods responsible for foodborne illnesses caused by pathogens. The report estimates the degree to which four pathogens – Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter – and specific foods and food categories are responsible for foodborne illnesses.
The Centers for Disease Control and Prevention (CDC) estimates that, together, these four pathogens cause 1.9 million foodborne illnesses in the United States each year. The newest report (PDF), entitled “Foodborne illness source attribution estimates for 2017 for Salmonella, Escherichia coli O157, Listeria monocytogenes, and Campylobacter using multi-year outbreak surveillance data, United States,” can be found on the IFSAC website.
The updated estimates, combined with other data, may help shape agency priorities and inform the creation of targeted interventions that can help to reduce foodborne illnesses caused by these pathogens. As more data become available and methods evolve, attribution estimates may improve. These estimates are intended to inform and engage stakeholders and to improve federal agencies’ abilities to assess whether prevention measures are working.
Foodborne illness source attribution estimates for 2017 for salmonella, Escherichia coli O157, listeria monocytogenes, and campylobacter using multi-year outbreak surveillance data, United States, Sept.2019
Tom Karst of The Packer writes that teasing the details of a new era of smarter food safety, Food and Drug Administration deputy commissioner for food policy and response Frank Yiannas spoke Sept. 18 at the United Fresh Washington Conference.
Before coming to FDA last December, Yiannas was vice president of food safety at Walmart from 2008 to 2018.
And Disney in Orlando before that.
Yiannas said the FDA’s work on produce safety has been front and central to his work since he joined the agency.
He praised the industry for its contribution to food safety and said the public-private partnership on food safety efforts must strengthen even more in what he called a new era of smarter food safety that is set to begin in 2020.
“I was asked by the Commissioner to continue to lead our efforts on modernization,” Yiannas said. “We’ve come a long way since 2011, but there’s still work to be done.”
Tech-enabled traceability and tech-enabled outbreak response will be one area of focus for the new era of smarter food safety, Yiannas said.
While produce has an impressive safety record overall, he said there are weak points in the supply chain.
“What I have learned over the years, and especially from my vantage point with the world’s largest company, is that I do believe the food system’s Achilles heel is traceability and transparency,” he said.
He noted that in both the spinach-related foodborne illness outbreak in 2006 and the romaine-related outbreak in 2018, traceability was an issue.
“It seems eerily similar almost a decade later,” he said. “And we still are having to do these overly broad consumer advisories.”
Distributed ledger or blockchain technology can be part of the solution, he said, but that isn’t the focus.
“It is not about the technology— it is about solving some of our many public health challenges,” he said.
Helping efforts to create a culture of food safety among growers, food marketers, and consumers is another element of the new era plan, he said.
“What I’ve learned over the years, is that it’s impossible to make progress without changing and influencing behavior,” he said, noting the importance of “digital prompts” to encourage right behavior.
In the spring of 2018, an E. coli O157 outbreak linked to romaine lettuce grown in the Yuma, Arizona area resulted in 210 reported illnesses from 36 states, 96 hospitalizations, 27 cases of hemolytic uremic syndrome (HUS) and five deaths.
The U.S. Food and Drug Administration has launched a new initiative with support from the Arizona Department of Agriculture, and in conjunction with the University of Arizona Cooperative Extension, the Wellton-Mohawk Irrigation and Drainage District (WMIDD), and members of the Yuma area leafy greens industry to better understand the ecology of human pathogens in the environment in the Yuma agricultural region. This initiative will be a multi-year study which will focus on how these pathogens survive, move and possibly contaminate produce prior to harvest.
While the FDA, the Arizona Department of Agriculture and other state partners conducted an environmental assessment from June through August 2018 that narrowed the scope of the outbreak, the specific origin, the environmental distribution and the potential reservoirs of the outbreak strain remain unknown.
Between 2009 and 2017, FDA and partners at CDC identified 28 foodborne STEC outbreaks with known or suspected links to leafy greens. Like a lot of fresh produce, leafy greens are often eaten raw without a kill-step, such as cooking, that could eliminate pathogens that may be present.
Sounds like Yuma growers could use a Box of Rain. Or maybe more knowledge of the microbial ripple effect. May death be groovy for you, long-time Grateful Dead collaborator and lyricist Robert Hunter, who passed on Tuesday, aged 78.
Norman Sharpless and Frank Yiannas of the U.S. Food and Drug Administration write that fresh papayas are most often eaten raw, without cooking or processing to eliminate microbial hazards; and therefore, the way they are grown, harvested, packed, held, processed and distributed is crucial to minimizing the risk of contamination with human pathogens.
Since 2011, American consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. And, just this June we started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.
This trend has to stop. The pattern of recurrent outbreaks we have observed since 2011, including the 2019 illnesses, have involved Salmonella infections traced back to, or are suspected of being associated with, papaya grown in Mexico. The recurring nature of these outbreaks is a clear indication that more must be done within all sectors of the papaya industry to protect its customers and to meet its legal obligations. This includes growers, importers and even retailers that can and must do more.
This is why today we have issued a letter calling on all sectors of the papaya industry to take actions to prevent these outbreaks in the future. We are urging growers, packers, shippers and retailers in the papaya industry to review their operations and make all necessary changes to strengthen public health safeguards.
Our letter calls on the papaya industry to assess the factors that make their crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that contamination must be implemented.
We are strongly encouraging the papaya industry to examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards. All sectors of the industry should adopt tools and practices needed to enhance traceability since papayas are a perishable commodity, to more rapidly facilitate the tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.
And finally, they should fund and actively engage in food safety research to identify the potential sources and routes of contamination by microbial pathogens and develop data-driven and risk-based preventive controls.
In response to this most recent Salmonella Uganda outbreak, the FDA deployed an inspection team to the packing house and farm that was linked to the contaminated papayas via traceback and epidemiological evidence. The findings of those visits will be made public when their investigation is complete. We have also increased sampling and screening of papayas at the border. In addition, the FDA is actively collaborating with our counterparts in the Mexican government regarding this current outbreak through the agency’s Latin America Office to determine ways to further our collaborative prevention efforts.
The U.S. Federal Food, Drug, and Cosmetic Act prohibits food producers from introducing, or delivering for introduction, into interstate commerce adulterated foods (meaning foods that are potentially harmful to consumers). Additionally, there are new requirements under the FDA Food Safety Modernization Act (FSMA). The Produce Safety Rule under FSMA sets science- and risk-based minimum standards for domestic and foreign farms for the safe growing, harvesting, packing and holding of covered produce, which includes papayas. Another FSMA rule, the Foreign Supplier Verification Program (FSVP) makes importers responsible for verifying that the foods they bring into the U.S., including papayas, have been produced in a manner that meets applicable U.S. safety standards.
The U.S. Centers for Disease Control (CDC), public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) are investigating a multistate outbreak of Cyclospora infections linked to fresh basil from Siga Logistics de RL de CV of Morelos, Mexico.
CDC is advising that consumers do not eat or serve any fresh basil from Siga Logistics de RL de CV of Morelos, Mexico. This investigation is ongoing and the advice will be updated when more information is available.
Consumers who have fresh basil from Siga Logistics de RL de CV of Morelos, Mexico, in their homes should not eat it. Throw the basil away, even if some has been eaten and no one has gotten sick.
Do not eat salads or other dishes that include fresh basil from Siga Logistics de RL de CV of Morelos, Mexico. This includes dishes garnished or prepared with fresh basil from Siga Logistics de RL de CV of Morelos, Mexico, such as salads or fresh pesto.
If you aren’t sure the fresh basil you bought is from Siga Logistics de RL de CV of Morelos, Mexico, you can ask the place of purchase. When in doubt, don’t eat the fresh basil. Throw it out.
Wash and sanitize places where fresh basil was stored: countertops and refrigerator drawers or shelves.
The FDA strongly advises importers, suppliers, and distributors, as well as restaurants, retailers, and other food service providers to not sell, serve or distribute fresh basil imported from Siga Logistics de RL de CV located in Morelos, Mexico. If you are uncertain of the source, do not sell, serve or distribute the fresh imported basil.
Two hundred and five people with laboratory-confirmed Cyclosporainfections and who reported eating fresh basil have been reported from 11 states; exposures occurred at restaurants in 5 states (Florida, Minnesota, New York, Ohio, and Wisconsin).
Illnesses started on dates ranging from June 10, 2019 to July 18, 2019.
Five people have been hospitalized. No deaths attributed to Cyclospora have been reported in this outbreak.
Epidemiologic evidence and early product distribution information indicate that fresh basil from Siga Logistics de RL de CV of Morelos, Mexico is a likely source of this outbreak.
2019 Outbreak of Cyclospora infections linked to fresh basil from Mexico
One of daughter Sorenne’s chores is to feed our two cats every night, with their special anti-neurotic food.
And every night I say, wash your hands.
Same with Ted the Wonder Dog and treats.
With the recent announcements of the Food and Drug Administration (FDA) and theCenters for Disease Control and Prevention (CDC) investigating contaminated Pig Ear Treats connecting to Salmonella, Pet Supplies Plus is advising consumers it is recalling bulk pig ear product supplied to all locations by several different vendors due to the potential of Salmonella contamination. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the products or any surfaces exposed to these products.
Testing by the Michigan Department of Agriculture and Rural Development revealed that aging bulk pig ear product in one of our stores tested positive for Salmonella. We have pulled bulk pig ear product from the shelves at all of our stores and have stopped shipping bulk pig ears from our Distribution Center. We are working with the FDA as they continue their investigation as to what caused the reported Salmonella related illnesses.