The FDA and CDC continue to investigate a multistate outbreak of E. coli O157:H7 associated with unpasteurized raw milk cheese from RAW FARM LLC, formerly known as Organic Pasteur.
As this investigation continues, the Food and Drug Administration and the Centers for Disease Control and Prevention continue to recommend that RAW FARM brand raw cheddar cheese manufactured by RAW FARM, LLC of Fresno, California, not be eaten, sold, or served. . It is against federal law to sell unpasteurized milk across state lines, but that prohibition does not apply to cheese.
State and local public health officials interviewed infected individuals about the foods they ate in the week before becoming ill. According to the FDA’s Feb. 28 outbreak update, seven of the nine patients interviewed so far reported eating RAW FARM brand raw cheddar cheese, which led to the outbreak. continues to show that this is likely to be the cause.
As of February 28, 11 confirmed cases have been reported from five states: California (4), Colorado (3), New Jersey (1), Texas (1), and Utah (2). There is.
Whole-genome sequence analysis of E. coli isolated from sick people indicates that those involved in this outbreak likely share a common source of infection. Five patients were admitted. Both have developed hemolytic uremic syndrome (HUS), a serious condition that can lead to kidney failure. No deaths were reported.
Health officials in Colorado, California, and Utah collected a variety of RAW FARM brand products for testing, including raw milk, butter, cheddar cheese, and kefir. So far, no E. coli has been detected in product samples. Although E. coli was not detected in product samples, epidemiological evidence indicates that RAW FARM brand raw cheddar cheese manufactured by RAW FARM LLC is the likely source of this outbreak. Additional testing is underway.
In response to this investigation, on February 16, RAW FARM LLC initiated a recall of many RAW FARM brand raw cheddar cheeses that are currently within their expiration dates. On February 26, the company withdrew the recall, even though epidemiological evidence showed the cheese was the likely cause of the outbreak.
Previous outbreaks and recalls related to unpasteurized dairy products sold by RAW FARM (formerly known as Organic Pasteur) include:
RAW FARM LLC recall and spread of infection
May 2023 Campylobacter raw milk recall
August 2023 Salmonella Cheese Recall
October 2023 Salmonella raw milk outbreak
San Diego County – 12 diseases
Orange County—7 Diseases
Recall of organic pasture dairy company and spread of infection:
September 2006 Raw milk E. coli outbreak: 6 people sick/2 people HUS
September 2007 Fresh Cream Listeria Recall
December 2007 Raw milk Campylobacter outbreak: 8 people
September 2008 Campylobacter recall in fresh cream
November 2011 Raw milk E. coli outbreak: 5 sick/3 HUS
May 2012 Campylobacter raw milk/cream outbreak: 10 people sick, cases reported from January to April
October 2015 Campylobacter raw milk recall
January 2016 E.coli raw milk outbreak: 9 people sick/2 people HUS
Organic Pasteur Lawsuit
This summer, U.S. District Judge Jennifer L. Thurston in Eastern California signed a consent decree agreed to by the United States and Organic Pastures’ attorneys and owner Mark McAfee.
The Eastern District Court will continue to have jurisdiction over civil matters involving concerns regarding Organic Pasture’s new legal name, RAW FARM LLC, which it has had for 15 years.
In March 2023, the U.S. Department of Justice filed civil contempt charges against RAW FARM, Mark McAfee, and Aaron McAfee. An evidentiary hearing on this matter was scheduled for August 9, 2023, but was canceled by the consent order.
This means that the court’s jurisdiction continues over the dairy operation and its owners and that the April 2010 order remains in effect for all directors, officers, agents, representatives, attorneys and other parties. means that
After 60 months, the RAW FARM defendants can petition the Food and Drug Administration (FDA) for “relief from this statute.” In the meantime, they must “adhere to FDA decisions.”
Under the agreement, the FDA will have the authority to inspect without prior notice. This Decree specifies specific auditing and labeling requirements that must be complied with. This includes hiring an independent “labeling expert.”
The Department of Justice reopened the 2008 case in March 2023 and announced that Organic Pastures, now known as RAW FARM LLC, was granted a 2010 April 2010 lawsuit restricting the distribution of unapproved drugs, misbranded foods, raw milk and raw milk in interstate commerce. The lawsuit alleges that it is in violation of a permanent injunction. Dairy products for human consumption.
Organic Pastures’ production and sale of raw milk in California, where it is legal, was not affected by the April 2010 order. The dairy business is estimated to have 60,000 raw milk retail customers in the Golden State.
In reopening the case, the Justice Department said raw cheese that claims it can cure, alleviate, treat or prevent human diseases, including heart disease, osteoporosis and viral infections, violates an April 2010 order. Ta.
The court previously agreed with the Department of Justice that RAW FARM and the McAfee Parties violated a permanent injunction issued on April 20, 2010. Before any new testimony was given, the defendant consented to a consent decree.
The government also disputes RAW FARM’s claim that its raw milk labeled as “pet food” is safe for human consumption.
“Organic Pastures and its representatives, Mark and Aaron McAfee, have engaged in a pattern of distributing their products in interstate commerce while making unproven claims about the ‘wonders’ of raw milk and related products. ” the Justice Department’s petition states.
In the March 2023 petition, the government wanted to hold RAW FARM/Organic Pastures and McAfee in contempt for contempt.
While the 2008 civil case was pending, Organic Pastures faced similar charges in a criminal case involving similar conduct 15 years earlier. The criminal case was settled in a plea agreement on December 22, 2008, and approved by Judge Sandra M. Snyder on January 9, 2009.
Under the plea agreement, Organic Pastures, Inc. pleaded guilty to two misdemeanor counts of introducing and delivering counterfeit branded foods into interstate commerce. McAfee entered into a deferred prosecution agreement and agreed to submit two information charging him and Organic Pastures with similar violations.
In these agreements, Defendants acknowledged that: (1) on two separate occasions, “with Defendant Organic Pastures’ knowledge and consent, one of Defendant Organic Pastures’ agents or employees; More than people [a] Defendant Organic Pastures, Inc. “knowingly labeled such food and/or dietary supplements as ‘pet food’ to be sent into interstate commerce for human consumption.” (2) Organic Pastures’ raw milk and raw milk products are “foods and/or dietary supplements and are not introduced into interstate commerce. or was misbranded in that it was labeled or otherwise labeled in a false and misleading manner when delivered for installation.”
In an April 2010 order, Organic Pastures and McAfee admitted that they violated federal food safety laws by introducing and/or distributing raw milk into interstate commerce in 2007. The company also admitted to violating the FDA’s “unapproved herbal medicine” regulations. They opposed the order, saying it contradicted California’s regulations for the raw milk industry.
Editor Dan Flynn contributed to this article.
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