The CDCand the FDAreported that their information indicated that chopped romaine lettuce grown in Yuma Arizona is probably the cause of the contamination with E. coli O157: H7. A common grower had not yet been identified.As of April 12, 2018, 35 people from 11 states (Connecticut 2; Idaho 8; Illinois 1 Michigan 1; Missouri 1; New Jersey 7; New York 2; Ohio 2; Pennsylvania 9; Virginia 1; and Washington 1) were infected with the outbreak strain of E. coli O157:H7. Twenty-two ill people have been hospitalized, including three people who developed hemolytic uremic syndrome.
Epidemiologic data collected to date indicates that chopped romaine lettuce was the probable source of this outbreak. Twenty-six (93%) of 28 ill people that were interviewed reported consuming romaine lettuce in the week before their illness started. This percentage is significantly higher than results from common healthy people in which 46% reported eating romaine lettuce in the week before they were interviewed. Most of the interviewed people reported eating a salad at a restaurant, and romaine lettuce was the only common ingredient identified among the salads eaten. The restaurants reported using bagged, chopped romaine lettuce to make salads. At this time, ill people are not reporting eating whole heads or hearts of romaine.Investigations are being conducted to find the source of the chopper romaine lettuce involved in the outbreak. A common grower or brand has not yet been identified. However, the data indicates that the chopped romaine lettuce was from the Yuma, Arizona growing region. The Yuma region supplies romaine to the U.S. during November-March each year.The current outbreak is not related to a recent multistate outbreak of E. coli O157:H7 infections linked to leafy greens reported in January this year. People in the previous outbreak were infected with a different DNA fingerprint of E. coli O157:H7 bacteria.
The CDC, the FDA, several states, and U.S. Department of Agriculture’s Food Safety and Inspection Service are investigating a multistate outbreak of Shiga toxin-producing E. coli O157:H7 infections.The investigation started by the New Jersey Department of Health, working together with the CDC and FDA. In New Jersey, ill people included in the outbreak had test results showing the presence of E. coli bacteria. Laboratory testing is ongoing to link their illnesses to the outbreak using DNA fingerprinting.In this outbreak, there are currently 17 cases in 7 states: Connecticut (2), Idaho (4), Missouri (1), New Jersey (6), Ohio (1), Pennsylvania (2), and Washington (1). The 17 illnesses occurred until March 31, 2018. Six of those infected have been hospitalized, one of the hospitalized patients developed hemolytic uremic syndrome. Illnesses started on March 22, 2018, and data include cases that were diagnosed until March 31, 2018. The states associated with the outbreak are not clustered together, making a common source more difficult to find.The investigation of the E. coli outbreak is still ongoing. To date, no specific food item, grocery store, or restaurant chain has been identified as the source of infections. People that became ill are being interviewed by State and local public health officials, to determine what they eat and what they could have been exposed to in the weeks before getting ill.PulseNet (the national sub-typing network) is being used to identify illnesses that might be part of this outbreak. E. coli bacteria isolated from ill people it tested using Pulse-Field-Gel (PFGE) and Whole Genome Sequencing (WGS). The DNA fingerprints obtained by PulseNet are used to identify possible outbreaks, and WGS gives a more detailed DNA fingerprint of the organisms. Some people may not be included in CDC’s case count because no bacterial isolates are available for the DNA fingerprinting needed to link them to the outbreak.
The Lawsuits are coming
Marler Clarkfrom the Food Safety Law firm reports that his firm was retained by three patients affected in the multi-state E. coli outbreak. The clients reside in Idaho, New Jersey, and Pennsylvania. One client was hospitalized for three weeks after developing hemolytic uremic syndrome. Since the source of the outbreak is unknown, it is not clear who will be the target of the lawsuit.
Posted by ruth on Apr 5, 2018 in All, Blog Post, Food Safety | Comments Off on Salmonella in Kratom causes FDA to Orders Mandatory Recall
Triangle Pharmanaturals mandatory Recall
The U.S. Food and Drug Administration (FDA) announceda mandatory recall for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, (Las Vegas-based company) after several products were found to contain salmonella.The products involved in the recall include Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.Triangle Pharmanaturals manufacture, process, pack and/or hold additional brands of food products containing powdered kratom, including powder and encapsulated powder forms.The forced recall follows Triangle Pharmanaturals, refusal to cooperate and voluntarily pull its products after they tested positive for Salmonella, the FDA said.The agency statement said “This is the third time the FDA has started the process of using its mandatory recall authority, but the first time” it’s issued such an order due to a company rejected the voluntary recall request.“Our first approach is to encourage voluntary compliance, but when we have a company like this one, which refuses to cooperate, is violating the law and is endangering consumers, we will pursue all avenues of enforcement under our authority,” FDA Commissioner Scott Gottlieb said.
“This action is based on the imminent health risk posed by the contamination of this product with salmonella, and the refusal of this company to voluntarily act to protect its customers and issue a recall, despite our repeated requests and actions,” said Dr. Gottlieb, M.D. “We continue to have serious concerns about the safety of any kratom-containing product and we are pursuing these concerns separately. But the action today is based on the risks posed by the contamination of this particular product with a potentially dangerous pathogen.”The mandatory recall is the FDA’s first since it was given the authority to issue such an order for food products in 2011. Under the FDA Food Safety Modernization Act, the FDA has the authority to order the recall of food products when it determines that there is a reasonable probability that the article is adulterated and that its use could cause serious adverse health consequences or death to humans or animals. Under the federal law, Dietary supplements are considered foods, not drugs.Two samples of kratom products manufactured by Triangle Pharmanaturals, and collected by the Oregon Public Health Division, tested positive for salmonella, as did four additional samples of various types of kratom product associated with the firm collected by the FDA.
What is Kratom?
Mitragyna speciosa, commonly known as kratom, is a plant that grows in Thailand, Malaysia, Indonesia and Papua New Guinea. The leaves of Kratom are used as an herbal drug by people of Southeast Asia. Kratom leaves in low doses are used as a stimulant and at high doses as a sedative, recreational drug, pain killer, medicine for diarrhea, and treatment for opiate addiction.The leaves can be chewed, dried and smoked, or powdered and consumed as a tea or in supplements. The product is promoted in the US as a way to treat muscle pain, diarrhea, and opiate withdrawal. Although it’s legal in the US, it’s illegal in some Southeast Asian countries.The FDA would like people to avoid kratom or its psychoactive compounds, mitragynine, and 7-hydroxymitragynine, because there is substantial evidence that kratom affects the same opioid brain receptors as morphine and appears to have properties that expose people who consume it.
NutriZone recall Kratom
The FDA announcedthat NutriZone, LLC of Houston, Texas is recalling four different dietary supplements containing kratom due to contamination with Salmonella. The products were sold in Pennsylvania, Oklahoma, Washington, Missouri, Florida, Mississippi, California, and Texas.The potential for contamination was noted after routine sampling and testing by the FDA revealed the presence of Salmonella. No illnesses have been reported to date in connection with this problem.
A multi-state outbreak of Salmonellosis linked to kratom
FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom. On March 22, 2018, PDX Aromatics of Portland, Oregon, issued their second expanded recallin due to additional positive Salmonella samples associated with PDX Aromatics’ products. On March 23, 2018, Tamarack Inc.voluntarily recalled Eclipse kratom-containing powder products. These recalls are in addition to NutriZone, LLC of Houston and Triangle Pharmanaturals.According to the Centers for Disease Control and Prevention (CDC), since late last month, 87 cases, in 35 states linked to kratom products have resulted in 27 hospitalizations. Epidemiological and laboratory data indicates the Kratom is the likely source of this outbreak. CDC reported a total of 87 people infected with outbreak strains of Salmonella I 4,,12:b:- (50), Salmonella Javiana (5), Salmonella Okatie (16), or Salmonella Thompson (16). Of 69 people with available information, 27 (39%) have been hospitalized. No deaths have been reported. Recent data showed additional strains including Salmonella Okatie, Salmonella Javiana, and SalmonellaThompson.
Of the 55 people interviewed, forty (73%) reported consuming kratom in pills, powder, or tea. Most people remembered consuming the powder form of kratom. The information collected about the purchasing location of kratom by the ill people, a single common brand or supplier of kratom has not been linked to the outbreak.Most people infected recover without treatment, though the FDA said an unusually high number of people linked to the outbreak involving kratom were hospitalized.Tests showed 26 different kratom products, from multiple manufacturers, were contaminated.
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