For E. coli HUS Defense, Don’t Include These Gels
Hand hygiene is crucial to minimizing the risk of E. coli O157:H7 infection and other foodborne disease, but some store-bought hand sanitizers are giving consumers a false sense of security that the products can ward off E. coli, which carries with it the life-threatening risk of hemolytic uremic syndrome, or HUS.
Our HUS lawyers took note this week when the Food and Drug Adminstration warned four companies that they must stop claiming that over-the-counter hand sanitizers and antiseptic gels will prevent dangerous bacterial infections. The statements are unproven, FDA said, and the letters mean the companies have 15 days to correct the claims or have the products seized.
One company claims that its hand sanitizing lotion prevents infection from E. coli and the H1N1 flu virus, while another claims its “patented formulation of essential plant oils” kills Salmonella. These claims are unproven and illegal, the FDA said.
“FDA has not approved any products claiming to prevent infection from MRSA, E. coli, Salmonella, or H1N1 flu, which a consumer can just walk into a store and buy,” said Deborah Autor, compliance director at FDA’s Center for Drug Evaluation and Research.
The FDA warnings concern the following products:
- Staphaseptic First Aid Antiseptic/Pain Relieving Gel, by Tec Laboratories.
- Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant, by JD Nelson and Associates.
- Dr. Tichenor’s Antiseptic Gel, by Dr. G.H. Tichenor Antiseptic Co.
- Clean Well All-Natural Hand Sanitizer, Clean Well All-Natural Hand Sanitizing Wipes, and Clean Well All-Natural Antibacterial Foaming Hand Soap, by Oh So Clean Inc., also known as CleanWell Company.
Food Safety Budget Greatly Expanded at FDA
Food safety and nutrition spending would increase by $324 million at the Food and Drug Administration in the next fiscal year under the proposed budget of the Obama administration. FDA’s “Transforming Food Safety and Nutrition” initiative is the biggest of four “critical initiatives and increases” in the budget proposal.
FDA said in a press release that the food safety and nutrition upgrade goes with a $4.3 billion overall request that reflects a 33 percent increase from the fiscal 2010 enacted budget. The agency said it will establish a prevention-focused food safety system and leverage the valuable work of FDA’s state and local food safety partners. “The result will be a stronger, more reliable food safety system to protect American consumers,” the FDA press release said.
The increase will help FDA begin to implement the landmark Food Safety Modernization Act signed by the president last month. Already the agency has taken steps to sharpen its role in detecting outbreaks of E. coli and other foodborne illness.
Prevention is Key to Fighting Non-O157 STECs
The under secretary for food safety at USDA stressed the need for preventative programs and policies to stop the spread of non-O157 types of shiga-toxin E. coli (STEC). Dr. Elisabeth Hagen didn’t get specific in her address to a food safety conference in Washington, D.C., held by the Pew Charitable Trusts and Center for Science in the Public Interest, but she was resolute in saying prevention of these pathogens is attainable.
“We can prevent it. It should not be a fact of life that people will get sick from or die from the food they eat. American consumers should not expect, nor accept that,” Dr. Hagen told the conference.
She said USDA has been more focused on stopping E. coli O157:H7, the primary type of shiga toxin-producing E. coli. The agency’s most aggressive act to prevent E. coli O157:H7 was to ban it from ground beef after a 1993 hamburger outbreak resulted in four child deaths and sickened 400 other people. It is therefore considered an adulterant in ground beef and testing is required by manufacturers and by USDA inspectors on a sample basis.
Since then there has been a growing realization that non-O157 STECs are just as powerful and hazardous to human health. The six most prevalent non-O157 STECs are O26, O103, O111, O121, O45, and O145. According to CDC, these pathogens cause an estimated 36,700 illnesses, 1,100 hospitalizations and 30 deaths in the U.S. each year. And currently, they’re not explicitly addressed by policies at USDA, the government regulator of meat and other foods.
“In order to be a truly prevention-based food safety system, we need to stay one step ahead of these threats,” Dr. Hagen said. ” We should not wait for a public health emergency to force our hand to address the range of E. coli threats in ground beef that exist in 2011.”
“We can’t wait for a historic outbreak, from these and other foodborne pathogens, before we take steps to improve our protection of public health. We’re striving to be a prevention-based system.”
She told the conference that prevention isn’t just one person or group’s responsibility; it’s a shared one. It’s shared among producers, government and the food service industry at large. Also, there are steps that consumers can take to supplement these systematic efforts to prevent foodborne illness and USDA already has programs in place for consumer food safety awareness. Click here for a copy of the undersecretary’s remarks on non-O157 STECs and antibiotic-resistant pathogens.
Keeping Lettuce Cold to Slow E. coli O157:H7
Maintaining fresh-cut iceberg and romaine lettuce at 41 degrees or lower is critical for reducing the food safety risks of E. coli O157:H7, USDA researchers have found.
A recent study by USDA’s Agricultural Research Service showed that E coli O157:H7 grows at a rapid, temperature-dependent rate before the lettuce deteriorates. That means the visual quality of bagged, fresh-cut lettuce is a poor indicator of the products’ food safety status.
Given the lack of visual cues, proper refrigeration is important to limit the growth of disease-causing microorganisms.
Results indicate that storage at 41 degrees, or 5 degrees Celsius, allowed the survival of E. coli O157:H7 on the packaged lettuce, but limited its growth.
All of the bagged products in the experiment were intentionally misted with E. coli bacteria in the lab and the bags were resealed. When they were stored at 54 degrees, or 12 degrees Celsius, the relative warmth led to a large increase in E. coli O157:H7 population on lettuce salads held for three days.
From 1990 to 2005, there were more than 700 foodborne illness outbreaks in the United States caused by contaminated produce. Many of those were lettuce E. coli outbreaks. The most recent major outbreak of E. coli in lettuce occurred earlier this year, sickening more than 20 people in six states.
Food safety law firm Pritzker Olsen has been retained by an E. coli HUS victim in connection with that particular E. coli O145 outbreak. The illnesses are associated with contaminated lettuce recalled by Freshway Foods of Sidney, Ohio.
The client, a student at Daemen College in Amherst, New York, contracted an E. coli infection in April that developed into hemolytic uremic syndrome (HUS), a life-threatening illness that can cause kidney failure, central nervous system damage, heart problems, pancreatitis, and other serious medical conditions. The student’s illness resulted in three separate hospitalizations
If you or a loved one have been sickened by E. coli or other human pathogen in leafy green vegetables, contact an attorney at Pritzker Olsen for a free case consultation. By phone, your free inquiry can be taken at 1-888-377-8900 (Toll Free) or you may contact us online with the form on side of this web page.
Our firm is one of the few in the country practicing extensively in the area of food borne illness litigation and we have recovered tens of millions of dollars for victims of food poisoning. Pritzker Olsen is dedicated to education and prevention of E. coli and other harmful bacteria found in our food. Our founder and president, Fred Pritzker, is a sought-after food safety expert who has long advocated strong food safety laws and more inspections of our food.
Beef E. coli Study Aims at Cutting E. coli in Cattle
Welcomed research on production practices that possibly could reduce the E. coli O157:H7 pathogen load in cattle raised on small-scale cow/calf operations is being funded at Southern University by a $1 million grant from the federal government.
Dr. Divya Jaroni, a food microbiologist at Southern University Ag Center, will head the study in collaboration with scientists at Louisiana State University and Texas Tech University.
The team will study the prevalence of E. coli under different herd, farm and environment conditions across several farms. Guidelines for on-farm Best Management Practices will be developed and the effectiveness of these practices in reducing E. coli O157:H7 on small-scale cow/calf operations will be validated.
The grant money comes from the USDA through its National Institute of Food and Agriculture – Agricultural and Food Research Initiative (AFRI) program.
E. coli O157:H7 in ground beef and other beef products is a major food safety concern and one approach to reduce the threat of contamination in the slaughter process is to develop farming and ranching practices that reduce the load of the pathogen inside the animals before they are butchered.
These bacteria grow harmlessly inside the hind guts of cows and are expelled in feces. When the organisms contaminate cuts of meat at the packing plant, they become a danger to humans because they emit a powerful toxin once inside a person’s intestines. These Shiga toxins attack red blood cells in a process that often leads to clotting and kidney failure. Once in the bloodstream they can cause heart damage, central nervous system disorders, coma, paralysis and brain injury.
In 5 to 15 percent of cases, E. coli infections develop into life-threatening hemolytic uremic syndrome (HUS) or a related condition known as thrombotic thrombocytopenic purpura (TTP.) Children under 5 years old are most susceptible to getting HUS.
Mandatory Restaurant Grade Posting
A few weeks ago I was invited to speak to a group of Illinois sanitation inspectors whose job it is to inspect and grade restaurants. My presentation was about how lawyers prove food safety cases. During the talk I asked the sixty or so attendees what they thought about mandatory restaurant grade posting. Surprisingly, at least to me, most were against it. Their comments are summarized as follows:
- Inspections are just “snapshots in time;” what happens on just one day may or may not be indicative of restaurant cleanliness throughout the course of a year
- With so much riding on a sanitation score, the relationship between inspector and restaurant will become contentious and lead to much more administrative action
- Posting restaurant scores is punitive; it’s better to encourage (one inspector from a small town said their practice is to publicize good scores)
- Many low risk violations may lower a score even though there is no real threat to the public.
My reaction to the inspector’s comments is that those concerns can be address in a uniform and fair grading system. And the system can be fine-tuned over time. Overall, the public’s right to know trumps any perceived unfairness to restaurants. Transparency is rarely a bad thing.
