Public Comment Sought on Draft FDA Petition to Require a Warning Label on Raw Milk Cheese - All Comments Due by October 9

Food safety attorney Bill Marler has posted the full 22-page draft and is asking cheesemakers, retailers, public health officials, physicians and consumers to tell him what is wrong with it before he files. The request follows the E. coli O26 outbreak linked to Graziers raw milk cheese that has sickened 13 people in nine states, most of them children five and under, and the firm's retention this week by the family of a child with kidney failure.

BAINBRIDGE ISLAND, Wash., Sept. 29, 2026 /PRNewswire/ -- Marler Clark, Inc., PS today opened a public comment period on a draft citizen petition asking the U.S. Food and Drug Administration to require a warning statement on cheese made from unpasteurized milk. The draft petition, with 47 footnotes to public sources, and the request for comments are posted on Marler Blog. Comments may be sent to [email protected] through Friday, October 9, 2026. Managing partner William "Bill" Marler has said he will revise the petition where commenters persuade him and file it with FDA under 21 CFR 10.30 in October.

"Every fact in this petition is footnoted, and most of the sources are FDA's own," Marler said. "Before I ask the agency to act on it, I want the people who make, sell, regulate, treat the victims of and eat this cheese to tell me where it is wrong. I would rather fix it now than read the objection in the docket."

Why is this important now?

On September 25 the Centers for Disease Control and Prevention and FDA announced 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: 13 people sick in California, Colorado, Georgia, Kentucky, Michigan, Nevada, Oregon, Tennessee and Utah, eight hospitalized, and three with hemolytic uremic syndrome, a form of acute kidney failure. More than half of the sick are five years old or younger. FDA contacted the company on September 24, eleven weeks after the first illness, and the company recalled all four Graziers raw milk cheeses the same day. The cheese was aged at least 60 days, as federal law requires of a raw milk cheese, and the package said so.

This week Marler Clark was retained by the family of a child who developed hemolytic uremic syndrome after eating Graziers raw milk cheese. The firm is not identifying the child. Marler also represents a claimant in the 2025 Twin Sisters Creamery raw milk cheese outbreak in Washington and Oregon; both representations are disclosed in the petition.

"A family bought a cheese whose label told them it followed the federal rule, and their child is in kidney failure," Marler said. "The label did not tell them what FDA wrote in 2015: that the rule was presumed to control pathogens, that the data said otherwise, and that E. coli O157:H7 survives 60 days in cheddar. That sentence belongs on the package, and it is the only thing this petition asks a cheesemaker to add."

What does the petition include?

Since 1987 FDA has prohibited unpasteurized milk in interstate commerce, with one exception the regulation itself calls an "alternative procedure to pasteurization": cheese cured at least 60 days. The petition documents four E. coli outbreaks in 31 months linked to cheese that met that requirement, 43 people sick, 17 hospitalized and at least six children with kidney failure, and rests on the agency's own record: the 2015 joint FDA/Health Canada risk assessment finding that 60 days of aging can increase listeriosis risk in soft-ripened raw milk cheese; the agency's 2015 request for comment on the 60-day rule, which drew 75 comments and no proposed rule; FDA's own sampling of 1,606 aged raw milk cheeses; and an FDA-funded Cornell University study published in Nature Medicine in October 2025 finding that 60 days of aging does not eliminate viable H5N1 avian influenza virus. It notes that California's raw milk warning law, in force since 1991, expressly exempts cheese aged 60 days, and that Washington's applies only to containers of milk.

The petition asks FDA to amend 21 CFR 101.17, the regulation that has carried the unpasteurized juice warning since 1998 and the shell egg safe handling statement since 2000, to require on cheese made from unpasteurized milk:

"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."

It asks that cut-to-order cheese be covered by a counter placard, that imports be treated like domestic cheese and that online sellers display the statement; exempts cheese made from pasteurized milk or a validated equivalent process; and asks FDA to complete within a year the reevaluation of the 60-day rule it announced in 2013, and to publish the sampling data it already holds, including the 2025 H5N1 results promised for the spring of 2025 and never posted. It does not ask FDA to ban raw milk cheese, lengthen the aging period, or restrict who may buy it.

What comments are being sought?

Marler has asked for specific criticism on five questions, and for any factual error:

• Is the wording of the statement right? FDA's juice warning names children, the elderly and people with weakened immune systems; the draft adds pregnant women and says "older adults." Should it name the diseases?
  
  
• Is a point-of-sale placard workable for cheese cut and wrapped at a service counter, and should the retailer or the cheesemaker be responsible for it?
  
  
• Which validated processes should qualify for the exemption from the statement, and who should validate them?
  
  
• Is one year of placards before labels must change the right compliance period, or too long for public health or too short for a small farmstead cheesemaker?
  
  
• Is any count, date or quotation in the draft wrong? Each is footnoted so it can be checked.

Comments should be emailed to [email protected] by Friday, October 9, 2026. Marler will read all of them and may quote from comments in a follow-up post without attribution unless the commenter agrees to be named. Once the petition is filed, FDA will assign it a docket number on regulations.gov, where anyone may comment formally; the agency is required to respond within 180 days.

"I am not asking FDA to ban anything," Marler said. "Adults who want raw milk cheese can keep buying it. I am asking for the sentence the government has put on unpasteurized juice for twenty-eight years, and I am asking the people who know this product better than I do to help me get it right."

About Marler Clark

Marler Clark, Inc., PS, 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. Managing partner Bill Marler has petitioned FDA and USDA on food safety rules since 2009, testifies before Congress, teaches food safety at the Harvard T.H. Chan School of Public Health, publishes Marler Blog and founded Food Safety News in 2009. His work is the subject of the book and the Emmy Award-winning Netflix documentary Poisoned.

SOURCE Marler Clark, The Food Safety Law Firm