About a week ago I posted drafts of two citizen petitions I intend to file with the FDA – one asking for a warning statement on cheese made from unpasteurized milk, and the other asking for a warning statement on raw and lightly cooked sprouts. I asked for comments and corrections. You delivered.
Many of you took the time to wade through more than 20,000 words of regulatory prose and tell me what I got wrong, what I missed, and what I could say better. Citations were fixed, facts were tightened, and arguments were sharpened (and a few were dropped). Some of you agreed with me, some of you did not, and both kinds of comments made the petitions better. Thank you.
The revised drafts, dated October 3, are here:
Because the comments keep coming – and because new outbreaks keep being announced while the drafts are being written – I am extending the time to weigh in through Thursday, October 15, 2026. I will file shortly after that.
Why these petitions are needed
The two petitions involve different foods, but they make the same basic argument and ask for the same modest thing: a sentence on the label. Neither asks FDA to ban anything. Adults who want raw milk cheese or raw sprouts would remain free to buy them. They would simply be told, at the moment they make the choice, what the government already knows.
- The government already knows the risk. FDA has told children, the elderly, pregnant women and people with weakened immune systems not to eat raw sprouts since 1998, and has never withdrawn that advice. On raw milk cheese, FDA’s own science has found that the 60-day aging rule – written in the 1940s and the legal basis for shipping raw milk across state lines as cheese – does not reliably kill the pathogens it was presumed to control. FDA said in 2013 it would reevaluate that rule. It has not finished.
- The advice has never been on the package. For nearly three decades the warnings have been delivered by press release, talk paper and web page. Almost no one reads those standing in a grocery aisle or at a sandwich counter.
- The outbreaks have not stopped. FDA counts 52 sprout outbreaks and more than 2,700 illnesses between 1996 and 2020, and two more sprout outbreaks are open right now. On the cheese side, four outbreaks in 31 months – in cheese that complied with the 60-day rule – have sickened 43 people, hospitalized 17 and caused at least six cases of hemolytic uremic syndrome, many of them in children under five.
- The label is often the only warning that arrives in time. In outbreak after outbreak, most people are sick before anyone announces a recall. Aged cheese sits in refrigerators for months. Cheese cut and wrapped at a deli counter and sprouts tucked into a restaurant sandwich carry no manufacturer’s label at all, which is why both petitions also ask for point-of-sale signs and online disclosures.
- The precedent is exact. In 1998, after the Odwalla juice outbreak, FDA required a warning on unpasteurized juice. It later required a safe handling statement on shell eggs. Both sit in the same regulation – 21 CFR 101.17 – that these petitions ask FDA to amend. USDA has required safe handling instructions on raw meat and poultry since 1994, after Jack in the Box. The juice warning went from proposal to final rule in about 75 days.
A choice made without the material fact is not really a choice. These petitions are about putting that fact where the decision is made.
Please keep the comments coming
If you have not yet weighed in, please do. If you already have, look at the new drafts and tell me whether I got it right this time. I want to hear from scientists, regulators, public health folks, cheesemakers, sprout growers, retailers, lawyers, and especially from people who think I am wrong. Pointing out an error now is a lot more useful than pointing it out after the petitions are filed.
Call me or email me with your thoughts – bmarler@marlerclark.com or 1-800-884-9840 – any time before October 15.
Thanks again.
Bill