---
title: "After a Fourth E. coli Outbreak Linked to Raw Milk Cheese, Marler Clark will Petition FDA to Require a Warning Label and to Finish the Review of Its 60-Day Aging Rule That the Agency Promised in 2013"
date: 2026-09-26T01:35:00-07:00
author: Bill Marler
canonical_url: "https://marlerclark.com/news_events/after-a-fourth-e-coli-outbreak-linked-to-raw-milk-cheese-marler-clark-will-petition-fda-to-require-a-warning-label-and-to-finish-the-review-of-its-60-day-aging-rule-that-the-agency-promised-in-2013"
section: News
---
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# After a Fourth E. coli Outbreak Linked to Raw Milk Cheese, Marler Clark will Petition FDA to Require a Warning Label and to Finish the Review of Its 60-Day Aging Rule That the Agency Promised in 2013

 

 

 BAINBRIDGE ISLAND, Wash. — Food safety attorney William D. Marler is advocating a citizen petition asking the U.S. Food and Drug Administration to require a warning statement on cheese made from unpasteurized milk, and to complete the reevaluation of its 60-day aging rule that the agency announced in 2013 and never finished.

The petition follows the [September 25 announcement](https://www.cdc.gov/ecoli/outbreaks/raw-milk-cheese-09-26/index.html) by the Centers for Disease Control and Prevention and [FDA](https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o26h11-raw-milk-cheese-september-2026) of a multistate outbreak of Shiga toxin-producing *E. coli* O26:H11 linked to Graziers grass-fed raw milk cheese made by Sierra Nevada Cheese Company of Willows, California. Thirteen people in nine states are sick, eight have been hospitalized, and three have developed hemolytic uremic syndrome (HUS), the kidney failure that follows some *E. coli* infections. The median age of the sick is five, and more than half are children age five or younger. FDA contacted the company on September 24, and the company recalled all four Graziers raw milk varieties the same day: medium cheddar, sharp cheddar, jalapeño jack and Monterey jack, sold nationwide in stores and online and in five-pound loaves to food service customers and wholesalers. The cheese has a long shelf life, and CDC says the true number of sick people is likely much higher.

“This is the fourth outbreak in thirty-one months linked to raw milk cheese that met FDA’s 60-day rule,” Marler said. “Forty-three people sick, seventeen in the hospital, at least six with kidney failure, and this time most of the sick are five years old or younger. FDA has required a warning on unpasteurized juice since 1998, after a child died in the 1996 Odwalla outbreak. The same sentence belongs on unpasteurized cheese.”

**The rule, and what FDA already knows about it**

Unpasteurized milk cannot be shipped across state lines in a bottle. It can be shipped as cheese, under standards of identity written in the 1940s that allow raw milk if the cheese is aged at least 60 days, on the theory that acid, salt and time would kill what pasteurization was not there to kill. FDA’s own science says otherwise:

- A [joint FDA and Health Canada risk assessment](https://www.fda.gov/food/risk-and-safety-assessments-food/joint-fda-health-canada-quantitative-assessment-risk-listeriosis-soft-ripened-cheese-consumption) found the risk of listeriosis from a serving of soft-ripened cheese made from raw milk to be 50 to 160 times greater than from the same cheese made from pasteurized milk, and found that 60 days of aging can increase that risk for soft-ripened cheese rather than reduce it.
- In [February 2013](https://www.federalregister.gov/documents/2013/02/11/2013-02960/draft-joint-food-and-drug-administrationhealth-canada-quantitative-assessment-of-the-risk-of) FDA said it would use that assessment to reevaluate the 60-day requirement. Thirteen years later, no proposed rule, no completed reevaluation and no explanation has been published.
- FDA [tested 1,606 aged raw milk cheeses](https://www.fda.gov/food/hfp-constituent-updates/fda-shares-completed-survey-and-data-ongoing-sampling-program) from 2014 to 2016 because, in its own words, evidence indicated that 60 days of aging may not eliminate or adequately reduce disease-causing bacteria. It found *Salmonella*, *Listeria monocytogenes* and Shiga toxin-producing *E. coli*, and generic *E. coli*, the indicator of insanitary processing, in 5.4 percent of samples. Then it stopped large-scale sampling.

**Four outbreaks, all in cheese that complied with the rule**

- [February 2024](https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-e-coli-o157h7-raw-cheddar-cheese-february-2024) — Raw Farm (Fresno, Calif.), raw cheddar, *E. coli* O157:H7: 11 sick in five states, 5 hospitalized, 2 with HUS.
- [October 2025](https://doh.wa.gov/you-and-your-family/illness-and-disease-z/foodborne-illness/outbreaks/2025-outbreak-shiga-toxin-producing-e-coli-stec-infections-linked-twin-sisters-creamery-aged-raw) — Twin Sisters Creamery (Ferndale, Wash.), aged raw milk cheese, *E. coli* O103 and O26: 10 sick in Washington and Oregon, 1 hospitalized. The Washington State Department of Health noted that the cheese “is aged at least 60 days, as required by law.”
- [March 2026](https://www.cdc.gov/ecoli/outbreaks/rawcheese-03-26/index.html) — Raw Farm, raw cheddar and raw milk, *E. coli* O157:H7: 9 sick in three states, 3 hospitalized, 1 with HUS, more than half of them children under five.
- [September 2026](https://www.cdc.gov/ecoli/outbreaks/raw-milk-cheese-09-26/investigation.html) — Sierra Nevada Graziers, *E. coli* O26:H11: 13 sick in nine states, 8 hospitalized, 3 with HUS, more than half of them age five or younger.

**What the petition will ask**

The petition, filed under 21 CFR 10.30, asks FDA to amend [21 CFR 101.17](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-101/subpart-A/section-101.17), the regulation that has carried the unpasteurized juice warning since 1998 and the shell egg safe handling statement since 2000, to require this statement on any cheese made from milk that has not been pasteurized or treated by an equivalent process:

**WARNING: This product is made from unpasteurized (raw) milk and may contain harmful bacteria that can cause serious illness in children, older adults, pregnant women, and persons with weakened immune systems.**

The warning would travel with the cheese: onto imports, onto online product pages and, by sign or placard, onto the deli counter, where five-pound loaves are cut and re-wrapped with no manufacturer’s label at all. The petition also asks FDA to publish, within one year, either a proposed rule on the 60-day requirement or a written explanation of why it will not, and to publish the raw milk cheese sampling results it already collects.

“This petition does not ask FDA to ban raw milk cheese or to tell adults what to eat,” Marler said. “It asks for one sentence on the package, in the place a parent will see it. [CDC’s advice](https://www.cdc.gov/food-safety/foods/raw-milk.html) in this outbreak is to choose pasteurized dairy, especially for children under five. FDA and CDC already say that on their websites. They should say it on the label.”

**What consumers should do**

Check refrigerators and freezers for Graziers medium cheddar, sharp cheddar, jalapeño jack or Monterey jack and throw it away or return it. Symptoms of *E. coli* infection usually begin three to four days after exposure: severe stomach cramps, diarrhea that is often bloody, and vomiting. In young children, urinating less often, unusual tiredness and a loss of color in the cheeks are [signs of HUS](https://www.cdc.gov/ecoli/signs-symptoms/hus.html) and call for emergency care.

**About Marler Clark**

Marler Clark, The Food Safety Law Firm, has represented victims of foodborne illness since the 1993 Jack in the Box *E. coli* outbreak, including children who developed hemolytic uremic syndrome after consuming unpasteurized dairy products. Bill Marler, the firm’s managing partner, publishes Marler Blog, founded Food Safety News in 2009, teaches food safety at the Harvard T.H. Chan School of Public Health, and is the subject of the book and Emmy Award–winning Netflix documentary *Poisoned*. www.marlerclark.com

\###

  

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