The FDA and CDC continue investigating a multistate outbreak of E. coli O157:H7 linked to unpasteurized, raw milk cheese from RAW FARM LLC, formerly known as Organic Pasteurs.
As this investigation continues, the Food and Drug Administration and the Centers for Disease Control and Prevention continue to recommend that people not eat, sell, or serve RAW FARM-brand Raw Cheddar cheese made by RAW FARM, LLC, of Fresno, CA. 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 have interviewed outbreak patients about the foods they ate the week before they became sick. Seven of the nine patients interviewed so far reported eating RAW FARM-brand Raw Cheddar cheese, which continues to show the cheese is the likely source of this outbreak, according to a Feb. 28 outbreak update from the FDA.
As of Feb. 28, 11 confirmed patients have been reported from five states: California with 4, Colorado with 3, New Jersey with 1, Texas with 1, and Utah with 2.
Whole genome sequencing analysis of E. coli isolates from ill people shows that people in this outbreak likely share a common source of infection. Five patients have been hospitalized. Two have developed hemolytic uremic syndrome (HUS), a severe condition that can lead to kidney failure. No deaths have been reported.
Health officials in Colorado, California, and Utah have collected various RAW FARM-brand products for testing, including Raw Milk, Butter, Cheddar cheese, and Kefir. So far, no product samples have detected E. coli. While E. coli has not been found in product samples, epidemiologic evidence shows that RAW FARM-brand Raw Cheddar cheese made by RAW FARM LLC is the likely source of this outbreak. Additional testing is ongoing.
In response to this investigation, on Feb. 16, RAW FARM LLC initiated a recall of lots of RAW FARM-brand Raw Cheddar cheese currently within shelf life. On Feb. 26, the company withdrew its recall even though epidemiologic evidence shows 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 Pasteurs, include:
RAW FARM LLC recalls and outbreaks
May 2023 Campylobacter Raw Milk Recall
August 2023 Salmonella Cheese Recall
October 2023 Salmonella Raw Milk Outbreak
San Diego County—12 illnesses
Orange County—7 illnesses
Organic Pastures Dairy Company recalls and outbreaks:
September 2006 Raw Milk E.coli Outbreak: 6 ill/2 HUS
September 2007 Raw Cream Listeria Recall
December 2007 Raw Milk Campylobacter Outbreak: 8 ill
September 2008 Raw Cream Campylobacter Recall
November 2011 Raw Milk E.coli Outbreak: 5 ill/3 HUS
May 2012 Campylobacter Raw Milk/Cream Outbreak: 10 ill, reported illnesses from Jan. thru April
October 2015 Campylobacter Raw Milk Recall
January 2016 E.coli Raw Milk Outbreak: 9 ill/2 HUS
Court action related to Organic Pasteurs
This past summer, U.S. District Judge Jennifer L. Thurston for Eastern California signed a Consent Decree agreed upon by attorneys for the United States and Organic Pastures and owner Mark McAfee.
It continues a 15-year-old jurisdiction of the Eastern District Court over a civil matter involving the concern over RAW FARM LLC, Organic Pasture’s new legal name.
In March 2023, the U.S. Department of Justice raised possible civil contempt allegations against RAW FARM, Mark McAfee, and Arron McAfee. An evidentiary hearing on that issue was set for Aug. 9, 2023, but was canceled by the Consent Decree.
That means the court’s jurisdiction continues over the dairy operation and its owners, and an April 2010 Order remains in effect for all the directors, officers, agents, representatives, attorneys, and others involved.
The RAW FARM defendants, after 60 months, can petition the Food and Drug Administration (FDA) for “relief from this Decree.” In the meantime, they must “abide by the decisions of the FDA.”
Under the agreement, the FDA gets the power to inspect without prior notice. The Decree spells out specific requirements for audits and labeling that must be followed. It includes hiring an independent “labeling expert.”
The Department of Justice reopened a 2008 litigation last in March 2023, claiming Organic Pastures, known now as RAW FARM LLC, was violating an April 2010 Permanent Injunction, which imposed restrictions from distributing in interstate commerce unapproved drugs, misbranded food and raw milk and raw milk products for human consumption.
The production and sale of raw milk by Organic Pastures within California, where it is legal, was not impacted by the April 2010 order. It’s estimated that the dairy operation has 60,000 retail customers of raw milk in the Golden State.
In re-opening the case, DOJ said a raw cheese claiming it can cure, mitigate, treat, or prevent human disease, including heart disease, osteoporosis, and viral infections, violates the April 2010 order.
The Court previously agreed with the DOJ that RAW FARM and the McAfee parties violated the Permanent Injunction Order issued on April 20, 2010. Before any new testimony was taken, the Defendants agreed to the Consent Decree.
The government also takes issue with RAW FARM’s claim that its raw milk, labeled as “pet food,” is safe for human consumption.
“Organic Pastures and its principals, Mark and Aaron McAfee, have thus continued their pattern of distributing their products in interstate commerce with unproven claims about the ‘wonders’ of raw milk and its associated products,” said the DOJ petition.
In that March 2023 petition, the government wanted to hold RAW FARM/Organic Pastures and McAfee in contempt with contempt sanctions.
While the 2008 civil case was pending, Organic Pastures, 15 years ago, also faced similar charges in a criminal action involving similar conduct. The criminal matter concluded in settlement by plea agreement on Dec. 22, 2008, and was approved by Magistrate Judge Sandra M. Snyder on Jan. 9, 2009.
Under the plea agreement, Organic Pastures pleaded guilty to two counts of misdemeanor introduction and delivery for introduction into interstate commerce of misbranded food. McAfee entered into a deferred prosecution agreement whereby he agreed to the filing of a two-count information charging him and Organic Pastures with the same violations.
In these agreements, both defendants admitted that: (1) on two separate occasions, “one or more of defendant Organic Pastures’ agents or employees, with the knowledge and consent of Organic Pastures, caused [a] box of raw milk and dairy products, labeled as or otherwise represented to be ‘pet food,’ to be sent by defendant Organic Pastures” into interstate commerce, “knowing that the intended use of such foods and/or dietary supplements was for human consumption;” and (2) Organic Pastures’ raw milk and raw milk products “were foods and/or dietary supplements, and were misbranded when so introduced into or delivered for introduction into interstate commerce, in that they were falsely and misleadingly labeled as, or otherwise represented.
In the April 2010 order, Organic Pastures and McAfee acknowledged violating federal food safety law by introducing and/or distributing raw milk into interstate commerce in 2007. They also conceded that they violated the “unapproved raw drugs” provision of the FDA. They did oppose the order as inconsistent with the State of California’s regulation of the raw milk industry.
Editor Dan Flynn contributed to this article.
(To sign up for a free subscription to Food Safety News,click here)
