On Friday afternoon San Diego County published a release saying the Food and Drug Administration collected samples inside the hen houses at Eben-Haezer’s Happy Hens in Ramona, that Salmonella turned up in two of the seven houses tested, and that genetic testing linked what was in those barns to the strains in ill San Diegans. The county added that the California Department of Public Health had shared the FDA results with the owners and recommended a voluntary egg recall, and that as of September 4 the farm had not issued one.

On Saturday the farm answered. Co-owner Chloe Nevarez told the Times of San Diego that nobody had asked her for a recall. By her account, officials from the county, the state and FDA called the farm on Friday and asked what Happy Hens thought about a possible recall, but stopped short of requesting one. She said the farm had already pulled eggs from the two implicated houses on its own, that everything still moving had come from unaffected sites, and that the farm has cooperated throughout. A county spokesman referred the paper to CDPH.

I am not going to referee that phone call, and I do not need to. Both accounts can be honestly held. Neither “recommended” nor “asked” is a defined term, nobody was under oath, and there is no document in public view that settles it. What interests me is the reason a dispute like this is even possible.

The argument exists because nobody used the tool that ends arguments

Since January 4, 2011, FDA has had the power to order a food recall. Section 206 of the Food Safety Modernization Act added section 423 to the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. 350l. It applies to FDA-regulated foods other than infant formula. Shell eggs are FDA-regulated foods.

The statute has two findings and two steps. The findings are a reasonable probability that the food is adulterated under section 402, and a reasonable probability that eating it will cause serious adverse health consequences or death. The steps are these: FDA must first give the responsible party an opportunity to voluntarily cease distribution and recall the food, under section 423(a). If the party refuses, or does not act within the time and in the manner FDA prescribes, the agency may order it to stop distributing and to notify others, under section 423(b). The company then gets an informal hearing within two days.

Step one is not a phone call soliciting a company’s thoughts. It is a formal, written opportunity that starts a clock and creates a record, and it is designed so that step two follows automatically when nothing happens. Nobody in this outbreak has suggested a 423(a) letter went out. If one had, we would not be reading two versions of a conversation. We would be reading a date.

How often the government uses it

Almost never. FDA’s most recent annual report to Congress on the use of mandatory recall authority, covering fiscal year 2024, is the twelfth such report, and it says the agency performed no reportable mandatory recall activities for a food product that year. The fiscal 2022 report says the same thing. Food Safety News counted three uses in the authority’s first decade, in 2013, 2014 and 2018. Fifteen years of law, and the number of times a federal agency has ordered contaminated food off the market is small enough to hold in your head.

This would not be a hard case

Take the two findings in order. Adulteration: FDA’s own environmental samples were positive in two of seven houses, and whole genome sequencing tied those isolates to people who got sick. That is better evidence than the agency usually has when it asks. Serious health consequences: twenty-three cases, seven of them hospitalized, in La Mesa, Del Mar, Ramona and Jamul, with a case in Riverside County. Salmonella in eggs is the hazard the entire federal egg rule exists to prevent.

The obvious objection is that the egg tests are still pending, and only the barns have come back positive. The statute anticipated exactly that. It asks for a reasonable probability, not a confirmed product isolate. Congress went further and wrote the point into the reporting requirement itself: section 206(f) directs FDA to describe, each year, any instance in which there was no testing confirming that a recalled food was adulterated. Lawmakers plainly expected orders to issue on inference from the environment, because that is how these investigations actually work. Waiting for the egg to test positive is a policy preference, not a statutory command.

What the agency’s own guidance says about words like this

There is a small irony in FDA’s guidance on mandatory food recalls. Like every FDA guidance, it opens by explaining that when the agency writes “should,” it means something suggested or recommended, but not required. That sentence describes the last six weeks in Ramona better than anything I could write. The state recommended. The farm heard something less than a recommendation. Nothing was required of anyone.

Three things I would like answered

First, did anyone send a 423(a) letter, and if not, what was the reason. That question has a yes or no answer and a date attached to it.

Second, where did the eggs go. The county says its Department of Environmental Health and Quality contacted retail food facilities that may have received Happy Hens eggs. It has published no list. A shopper who bought a carton in July cannot look anything up.

Third, what separates the five clean houses from the two positive ones. The farm says the eggs still on the market came only from unaffected sites. That may well be right, and I have no basis to say otherwise. It is also a claim about the farm’s own segregation practices, made by the farm, and nobody outside the farm has verified it. A recall does not require the company to be at fault. It requires the product to be off the shelf while somebody checks.

I have written before about what the county’s Friday release established, and our firm keeps a page on the Ramona outbreak for people trying to figure out whether they were part of it.

The farm and the county are arguing about a verb. The statute has one, and nobody used it.

Christina Jewett and Julie Creswell of the New York Times obtained Michigan’s outbreak correspondence under the state’s open records law and published the dates on August 15. An epidemiologist on the state’s rapid response team asked Yum Brands for Taco Bell’s supply chain records on July 1. She asked again on July 3. She asked a third time on July 6, and some records arrived that day. FDA asked for more on July 8. FDA had everything it needed on July 13.

Twelve days from the first request to a complete answer.

What the rule would have required. Section 204 of the Food Safety Modernization Act — the Food Traceability Rule — requires covered businesses to hand FDA or an authorized representative an electronic, sortable spreadsheet of the required records within twenty-four hours of a request, or within a reasonable time the agency agrees to. Leafy greens are on the covered list. Restaurants are covered too, and that matters more than it sounds, because before this rule farms and restaurants were exempt even from the old one-up, one-back recordkeeping. The compliance date was January 20, 2026. In March 2025 the administration moved it thirty months, to July 20, 2028. Last November, Congress went further and barred FDA from spending appropriated funds to administer or enforce the rule before that same date.

Now the counterfactual, and I am going to do it honestly. Records arriving on July 2 does not mean a recall on July 3. Traceback still takes time after the paper is in hand, and anyone who says otherwise has never watched one. But the interval is not a guess here, because this outbreak ran it. FDA had complete records on July 13. On July 16 the agency announced that its traceback had converged on a single supplier. On July 17 Taylor Farms de Mexico was named and the recall began. That is three to four days from a complete record set to a recall. Give the same three to four days to a July 2 answer and the recall lands in the first week of July.

What sits in the eleven days between. FDA’s own advisory says distribution of the recalled iceberg lettuce ran from June 29 through July 16, confirmed into thirty-one states and possibly eight more. That is an eighteen-day shipping window, and product was still moving the day before the recall. A recall in the first week of July takes the back eleven days of that window off the road. The lettuce in those eleven days is not a projection. It shipped, it was invoiced, and FDA has the customer file.

Who that would have helped, and who it would not. Honesty costs something here and it should be paid. Michigan’s own scientists, working with the state agriculture department, CDC and the University of Michigan, published an interim report last week describing a bimodal curve: illness onsets ran from May 10 through July 18, with distinct peaks from June 21 to 27 and from July 5 to 11. Those exposures were eaten in the middle and end of June. Nothing anyone could have done in July reaches them. CDC says the same thing in plainer words on the outbreak page — most of these illnesses began before the recall. An earlier answer does not undo the first several thousand illnesses, and I am not going to pretend that it does.

What it reaches is the tail, and the tail was not small. On July 16 this outbreak was 1,644 people in five states. It closed at 11,458 laboratory-confirmed Cyclospora illnesses in twenty states, 495 hospitalizations and two deaths, with the last illness onset recorded on August 15. Georgia, Tennessee and Texas were added on August 27. The company’s own recall notice lists best-if-used-by dates running to August 3, on the retail bags and on the foodservice cases alike. People were still eating this lettuce weeks after the recall, and every case of it came out of that June 29 to July 16 window.

The uncomfortable part of that arithmetic is that Michigan would have gotten the least out of it. Michigan found the signal, Michigan did the interviews, Michigan wrote the three emails, and Michigan’s own curve had largely already happened. The people an earlier answer would have spared were mostly in the nineteen other states that came later.

The federal government’s answer. Donald Prater, FDA’s acting deputy commissioner for food, told the Times that even if the twenty-four-hour rule had been in effect it would not have made a major impact on this response. The dates are July 1, July 3, July 6, July 8 and July 13. 

I would like to know which of the five he thinks stays where it is.

And the twenty-four hours is not really the point. A company can answer in a day only if the records already exist in sortable electronic form before anyone asks. That is what the rule builds, and that is what the delay postponed. The clock is just the visible part of it.

Taco Bell says it acted immediately, voluntarily and proactively to protect its guests and support health officials. Set that sentence beside a third email from a state epidemiologist on July 6 and let it sit there.

None of this is the fault of the people who worked the outbreak. Nobody on Michigan’s rapid response team voted to move the traceability rule to 2028. Nobody running a traceback wrote the appropriations language forbidding its enforcement. The failure is architectural, and the people who built it were not in the room in July. I have written separately about the other two delays in this outbreak, the fourteen days between a state health department raising public notification with the company and the day the public was told, and the sixty hours lost at the end while the White House read the agencies’ draft press releases. This post is about the first one, because the first one is the one with a rule attached to it.

The argument I would make to the industry, one more time. Traceability draws a line. It says what the problem is, and it says what everything else is not. Without the line the warning has to be categorical, and a categorical warning prices a whole category. Lettuce sales fell everywhere this summer, for growers in Salinas and Yuma who had nothing to do with Guanajuato. The rule the trade associations asked Congress to postpone is the one that would have drawn a line around one plant and left everybody else’s lettuce alone.

Eleven consumer, public health and labor groups asked Congress last month to rescind the funding rider. Nothing has happened. The Food Traceability Rule is law, it is on the books, and FDA may not spend a dollar enforcing it until July 20, 2028. That is next summer, and most of the summer after that.

Credit where it is owed. The Michigan correspondence was first obtained by Bloomberg News, which published it on August 3, and which I missed at the time. Christina Jewett and Julie Creswell reported it out for the Times on August 15, with Caroline Hopkins Legaspi contributing. Neither newsroom found a secret. They found a state health department asking a restaurant company a reasonable question three times in six days, and a rule that would have answered it on the second, sitting on a shelf until 2028.

The New Lede reported last week on a Farm Forward analysis of USDA sampling data that ought to end a long-running argument about how we measure progress on Salmonella in poultry. Between 2014 and 2025, three serotypes — Infantis, Enteritidis and Typhimurium — went from roughly 25 percent of the Salmonella found in the poultry industry to about 68 percent. Those are the three most commonly found to make people sick. Over the same period, the share of Salmonella-positive poultry resistant to at least one antibiotic important in human medicine rose from 48 percent to more than 73 percent.

USDA’s answer, as always, is that prevalence is down. Both things are true. The number of chicken samples testing positive fell by half between 2017 and 2021 and has held roughly steady since. We did not clean up chicken. We selected for the strains that hurt people, and we made them harder to treat. That is why the illness curve has not moved in twenty years while the prevalence curve has.

It is worth setting out where the fight over Salmonella as an adulterant has actually been, because the record is not what most people think it is.

What we asked for, and what happened

On January 19, 2020, we petitioned FSIS on behalf of Rick Schiller, Steven Romes, the Porter family, Food & Water Watch, the Consumer Federation of America and Consumer Reports. We asked the agency to declare 31 outbreak serotypes of Salmonella to be adulterants in meat and poultry under the Federal Meat Inspection Act and the Poultry Products Inspection Act. We asked for it jointly or serotype by serotype, whichever the agency preferred.

This was not a novel request. FSIS declared E. coli O157:H7 an adulterant in ground beef in 1994 through exactly this mechanism, and a federal court upheld it. FSIS extended adulterant status to the six non-O157 STEC strains in 2012 after a petition from our firm. Both times the industry predicted ruin. Both times the outbreaks stopped instead. Ninety percent of my firm’s caseload used to be E. coli in hamburger. Today it is almost none. That is the best thing that has happened in food safety in my lifetime, and it happened because a pathogen was called what it is.

FSIS denied the petition without prejudice on May 31, 2022. The stated ground was that there was not sufficient data to support what the agency called the sweeping action we requested. But the letter also said FSIS was reevaluating its approach to Salmonella in poultry, was reconsidering whether Salmonella should be an adulterant in any poultry product, and would apply the same factors it used for the STEC strains. In other words: not now, because we are working on it.

What FSIS did do — and then stopped doing

It then did something remarkable, and almost nobody outside this world noticed. On May 1, 2024, FSIS issued a final determination that not-ready-to-eat breaded stuffed chicken products containing Salmonella at 1 colony forming unit per gram or higher are adulterated under the PPIA. First time ever for a class of raw poultry. The agency grounded it in the added-substance reasoning of United States v. Anderson Seafoods — the same case it had brushed aside in our denial eleven months earlier — and in the point our petition made, that Salmonella is not ordinarily found in the muscle tissue of healthy birds. And it applied the standard regardless of serotype, which is broader than anything we asked for.

That determination is still on the books. It took effect May 1, 2025. It is binding law today.

What happened next is the part that matters. FSIS delayed verification sampling from May 2025 to November 2025. Then, on December 2, 2025, it delayed sampling indefinitely, with no new date, saying available test methods have accuracy limitations and produce false positives at low levels. In the 2024 final determination, the agency had said a validated method existed. Consumer Reports raised the contradiction at the January 2026 public meeting and asked FSIS in June to release the validation data behind both positions. As far as I know, that request has not been answered.

Separately, the broader Salmonella Framework for Raw Poultry Products, proposed in August 2024, was withdrawn in April 2025 after more than 7,000 comments. A USDA spokesperson told The New Lede that the framework was never a rule and therefore had no impact. That is technically correct and quietly damning. Strip it down and the agency’s position is: we won’t act on your petition because we’re working on a framework, we killed the framework, the framework never mattered anyway, and we’ll have something in a couple of years.

Nothing enforceable has changed since January 19, 2020.

What is still available

Plenty, and not all of it requires a rulemaking.

Enforce what is already law. FSIS does not need a new rule to begin verification sampling on breaded stuffed chicken. It needs to publish its testing data and start. If the method is sound, sample. If it is not, say so with evidence.

Extend the standard the agency already adopted. The 1 CFU/g adulteration finding rests on legal reasoning that does not stop at breaded stuffed products. Chicken parts and comminuted poultry carry more Salmonella than carcasses do, by FSIS’s own sampling. Consumer Reports, one of our co-petitioners, has already asked the agency to apply the same standard to other poultry products. The agency drew a product-specific line based on consumer handling. That line deserves to be tested against eleven years of data showing the organism itself has changed.

Use the government’s checkbook. USDA buys enormous volumes of poultry for school lunch and food assistance. Purchase specifications are not rulemaking. No notice and comment, no litigation, no form-letter campaigns. AMS could require serotype screening in its next solicitation. Farm Forward documented that AMS has supplied poultry from plants with repeated Salmonella failures to the National School Lunch Program and the Emergency Food Assistance Program. Buying chicken for schoolchildren from plants that fail federal standards month after month is not a defensible use of public money, and it does not require anyone to first accept the adulterant argument.

Buyer specifications. Large retailers and restaurant chains already impose supplier requirements stricter than USDA’s. Farm Forward’s look at a single Costco supplier shows what a serotype-level audit turns up. Three big buyers adopting a serotype-based rejection spec would change plant behavior nationally without a word from Washington.

Close the evidence gap. The denial rested on insufficient data. Farm Forward has now shown the shift on the product side. CDC holds the illness side. Nobody has published the study that connects them — resistant Infantis in FSIS product sampling mapped against human hospitalization and treatment failure over the same years. That paper would make insufficient data unavailable as an answer.

And refile the petition. The 2022 denial was without prejudice and expressly invited a revised filing. Its stated premise — that FSIS was reevaluating through its own initiative — no longer exists, and the agency has said so itself. A new petition built on the agency’s own STEC factors, on a record that includes the resistance data, forces FSIS either to act or to explain in writing why an eleven-year shift toward the exact serotypes that sicken Americans still isn’t enough.

The part that never changes

Gail Hansen made the point in The New Lede that federal agencies have largely told consumers this is their problem to cook their way out of. Thirty-plus years in, I can tell you where that argument ends. It ends with Rick Schiller drafting a will on his phone in an emergency room. It ends with Rose Porter watching her ten-year-old daughter airlifted to a hospital in Costa Rica, convinced she had poisoned her own child.

Nobody at FSIS has ever sat in a room with them. That is still the shortest path to a decision, and it is still the one nobody takes.

  • Extraordinary Circumstances

Infant botulism is normally sporadic; most cases involve one infant, one household, and no single identified commercial source. Bacterial spores are widely present in soil and dust around the country and therefore may cause sporadic, random infections. A multistate outbreak of infant botulism tied to a manufactured infant formula is therefore unusual. The Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) concluded that epidemiologic and laboratory evidence showed ByHeart Whole Nutrition infant formula was contaminated with C. botulinum and made infants sick. Outbreaks like this have, historically, been uncommon.[1] According to the FDA, this is the first known botulism outbreak tied to infant formula anywhere in the world since the condition was first described about fifty years ago.[2]

  • The Outbreak Summary

In October 2025, California’s Infant Botulism Treatment and Prevention Program noticed that three infants with suspected infant botulism had all been fed the same powdered formula. State officials alerted the CDC, and a multistate investigation followed. The case total was revised as the investigation widened, the case definition was expanded to capture earlier illnesses, and some early-suspected cases were later reclassified.[3]

FeatureSummary
ProductByHeart Whole Nutrition powdered infant formula (cans and single-serve “Anywhere Pack”); on sale nationwide since March 2022
Case Count (final)48 infants — 28 confirmed and 20 probable. Reduced from an interim 51 infants after record review applied additional case-definition criteria and three cases from three states were diagnosed with other illnesses and excluded (review completed Feb. 26, 2026)
Locations (17 states)AZ, CA, ID, IL, KY, MA, MI, MN, NC, NJ, OR, PA, RI, TX, VA, WA, WI
OutcomesAll 48 infants hospitalized and treated with BabyBIG; no deaths reported
Illness OnsetDecember 24, 2023 – November 29, 2025 (most clustered August–November 2025)
Investigation StatusCDC declared the outbreak over on February 26, 2026; no new cases added since December 10, 2025
Toxin TypeBoth toxin type A and type B recovered from outbreak cases. The strains that matched clinical isolates by whole-genome sequencing were type A (subtype A1), although ByHeart’s own testing also reported type B in finished product and in the whole-milk powder; the unusual appearance of a type A strain in locations where type B strains normally dominate was a key outbreak signal
Laboratory EvidenceC. botulinum detected in infant formula (multiple lots), in opened and closed formula samples, in the base mix, and in the organic, whole-milk powder ingredient; whole-genome sequencing (WGS) has identified 17 distinct strains across patient, product, and ingredient samples
SourceWhole-genome sequencing links the outbreak pathogen across clinical, formula, base-mix, and ingredient samples, with strong matches to organic, whole-milk powder supplied to ByHeart; as of Feb. 26, 2026, the FDA had not yet determined a single root cause and the investigation continues
RecallTwo lots of formula were recalled on Nov. 8, 2025; all ByHeart products were recalled on Nov. 11, 2025
SignificancePer the FDA, this is the first identified botulism outbreak tied to infant formula since infant botulism was first described ~50 years ago

Sources: See note 36, infra.[4]

  •  
    • The Investigation (FDA/CDC, February 26, 2026)

The FDA and CDC—in collaboration with the California Department of Public Health (CDPH), the Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners—investigated the multistate infant botulism outbreak and concluded that ByHeart Whole Nutrition infant formula was its source. On February 26, 2026, the CDC declared the outbreak over. 

Public health officials reviewed the medical records of the 51 infants initially included in the investigation and applied additional case-definition criteria; no new cases have been added since December 10, 2025, and three previously reported cases from three states were ultimately diagnosed with other illnesses and excluded. The final case count is 28 confirmed and 20 probable cases of infant botulism—48 in all—with all 48 infants hospitalized, no deaths reported, and the last known illness onset on November 29, 2025.[5]

Cases were reported across seventeen states: Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.[6]

Whole-genome sequencing tied patients, finished product, and ingredients together to the outbreak. As of February 26, 2026, two isolates from one lot of organic, whole-milk powder—collected by the FDA at Dairy Farmers of America, the processor for Organic West Milk, which supplied ByHeart—matched a cluster of clinical and food isolates that the FDA had first reported on January 23, 2026. That cluster also included an unopened powdered-formula sample tested by ByHeart; a closed, powdered-formula sample tested by the New York State Department of Health, Wadsworth Laboratory; one clinical isolate; and three isolates from one lot of organic, whole-milk powder tested by ByHeart.[7]

Additional clinical isolates analyzed by CDPH matched clusters including product-samples: One clinical isolate matched a cluster that now includes three clinical isolates and an opened powdered-formula sample (tested by CDPH and reported positive on November 18, 2025). A second clinical isolate matched a cluster that now includes one clinical isolate, four isolates from one lot of powdered formula tested by ByHeart, and one sample of the base mix, used to make the powdered formula, tested by ByHeart.[8]

The FDA has cautioned that testing for C. botulinum in infant formula and its ingredients is complex. To date, WGS has identified 17 different strains of the bacterium across patient, finished-product, and ingredient samples. While those results add to the evidence needed to investigate the outbreak’s origin, the FDA stated that, given the complexities of C. botulinum and the limited scientific evidence currently available, it has not yet determined a root cause of contamination, and that additional analysis and research is necessary. The agency has transitioned from its initial emergency response to post-incident surveillance, prevention, and compliance activities while continuing to investigate the root cause.[9]

  • Suspected Source

Milk and milk powder is the suspected root cause. Investigators detected C. botulinum type A in finished ByHeart formula, and the New York State Wadsworth Center reported that WGS of an isolate from a sample of the organic, whole-milk powder—collected at a processor supplying ByHeart—matched the strain from the finished formula and from a sick infant. Contaminated milk powder used as an ingredient is the leading explanation for how the pathogen contaminated the product, even though, as noted above, the FDA has not formally declared a single root cause as of its February 26, 2026 update. The full source investigation remains ongoing.[10]

Because spores can be unevenly distributed through a batch of powder, not every infant who consumed the contaminated formula became ill. All infants were nonetheless considered at risk, which is why every ByHeart product was recalled and parents were urged to stop using it and to discard it.[11]

  • Why Formula—Normally So Safe—Was Vulnerable Here

Powdered infant formula is not sterile. The pathogens usually watched for (such as Cronobacter and Salmonella) do not form spores and are killed by pasteurization. Spore-forming bacteria, like C. botulinum, are different: their heat-resistant spores can survive normal processing. The 2025 event prompted the FDA and international food-standards bodies to begin a formal risk assessment of spore-forming organisms in powdered infant formula.[12]

The literature establishes both the historical rarity of C. botulinum in commercial dried milk and formula, and the singular significance of the 2025 outbreak:

  • Until 2025, C. botulinum was essentially never found in commercial dried milk or formula. Dedicated surveys—including nonfat dry milk, evaporated milk, and canned formula—historically tested negative.[13]
  • The 2025 ByHeart outbreak is the turning point and the strongest evidence of milk-powder risk to date. Whole-genome sequencing tied type A C. botulinum in organic, whole-milk powder to the strain in finished formula and to the strain in sick infants across multiple states—a tight genetic match across ingredient, product, and patient.[14] [15]
  • Earlier formula links were single cases with caveats. A 2001 United Kingdom case and a 2023 Chinese investigation each recovered the organism from formula milk powder, but causation was never firmly proven.[16]
  • Fluid and raw milk can carry the organism and toxin in the case of bovine botulism, and these spores also survive pasteurization, although pasteurization strongly degrades pre-formed toxin.[17]

Related findings in soft, high-moisture dairy products, such as Italian mascarpone cheese, and in raw milk during herd botulism confirm that C. botulinum can and does contaminate a dairy matrix when conditions allow.[18] The studies significant to the link between botulism and milk/formula, beyond the current outbreak, are summarized below:

SourceWhat was testedKey finding
Harris et al., Front. Microbiol., 2026 (USA)Unopened formula containers and bulk “base powder” (formula before packaging)C. botulinum found in both finished product and base powder, even where the usual indicator organism was non-detectable, so standard screening would have missed it.
Brett et al., J. Med. Microbiol., 2005 (UK, 2001 case)14 home foods from a 5-month-old with infant botulismType B C. botulinum recovered from an opened can of infant formula milk powder; two product isolates WGS-matched the infant’s isolate. The link was never definitively proven.
Luo et al., Chinese J. Food Hygiene, 2023 (China)30 batches of infant formula milk powder from a company tied to a botulism caseWhile toxin was not detected directly, C. botulinum (type B) was isolated from one batch of milk powder.
Barash et al., J. Pediatr., 2010 (USA)30 patient-used formula samples and nine market-bought formulasClostridium spores in 17% of patient-used and 78% of market formulas—but none were C. botulinum (they were related Clostridium species).

Full citations for the studies above appear at notes 45–48, infra.[19]

In short, across decades of surveys, the detection of C. botulinum in commercial dried milk or formula was possible but vanishingly rare until 2025. That consistently rare baseline is precisely what makes the widespread genetic evidence in this outbreak—milk powder to finished formula and base mix to sick infants—so indicative of the formula’s defective and adulterated condition, notwithstanding that the FDA has not yet announced the formal root cause. 

  • Post-Outbreak Developments

Developments after the outbreak was declared over have reinforced that ByHeart’s formula was the vehicle of contamination and that a contaminated dairy ingredient was the likely source. The FDA completed its onsite inspections of ByHeart’s manufacturing facilities and reported that it did not identify any facility deficiency that could explain the root cause of the outbreak; the agency’s continuing root-cause investigation is instead focused on incoming ingredients, and in particular on the dairy supply chain. 

The FDA and ByHeart sampled dairy ingredients at Dairy Farmers of America — the processor for ByHeart’s supplier, Organic West Milk — and whole-genome sequencing showed that two isolates from a single lot of organic, whole-milk powder matched a clinical isolate and a finished-formula sample isolate. The absence of any facility-based explanation, coupled with the genetic linkage running from the milk-powder ingredient to the finished product to sick infants, points squarely to a contaminated dairy ingredient.[20]

Significantly, in June 2026, the FDA and CDC opened a second multistate infant-botulism investigation. This one was linked to a different brand, Nara Organics Whole Milk Organic powdered infant formula, and involved four confirmed C. botulinum type A infections from California (two), Pennsylvania, and Washington, with illness onsets in April and May 2026. Laboratory testing has since confirmed Clostridium botulinum in an open can of Nara Organics formula that had been fed to one of the sick infants. That outbreak has since been declared over, and the sequencing results that accompanied its closeout are set out below. There is a further, troubling connection between the two brands. When ByHeart recalled its formula in November 2025, it did not simply direct affected families to generic alternatives; it affirmatively steered them to Nara Organics. In a November 11, 2025 Instagram post, ByHeart recommended Nara Organics products and offered ByHeart customers a 20% discount code “to help and support ByHeart families make a smooth transition to a new formula.” That post was later deleted. ByHeart has since maintained that the two companies are entirely separate and that it merely shared a discount code as a resource; but the practical effect was that families fleeing one botulism-linked formula were pointed toward a second formula drawing on the very same organic-whole-milk supply chain — a chain that would, months later, be tied to a second infant-botulism outbreak.[21]

Nara Organics and ByHeart share the same dairy suppliers: Organic West Milk and its processor, Dairy Farmers of America. During the ByHeart investigation, Organic West Milk gave the FDA an incomplete customer list that failed to disclose that its milk was also being supplied to the manufacturer of Nara Organics formula. That two separate infant formula brands drawing from the same organic-whole-milk supply chain each became associated with type A infant botulism is powerful corroboration that the dairy ingredient — not some idiosyncratic feature of one manufacturer’s plant — is the common thread, and it strengthens the inference of source in the recent infant botulism outbreaks.[22]

These events also underscore the outbreak’s gravity. The 2025 ByHeart event is the largest infant-botulism outbreak ever documented in the United States and the first botulism outbreak tied to infant formula anywhere in the world, and it has prompted an international response: at the FDA’s urging, the Codex Committee on Food Hygiene and the joint FAO/WHO expert body (JEMRA) undertook a formal risk assessment of spore-forming pathogens, including C. botulinum, in powdered infant formula. ByHeart, for its part, has stated that it will not resume production without a new C. botulinum-specific testing protocol applied to every dairy ingredient and every finished batch before release — an implicit acknowledgment that the controls in place during the outbreak could not detect the hazard.[23]

The FDA has since gone further, issuing a formal warning to the entire industry. On July 13, 2026, the agency sent a letter to the infant formula industry — addressed to manufacturers, packagers, distributors, exporters, importers, and retailers involved in the manufacture or distribution of infant formula and infant formula ingredients — over the signature of Acting Deputy Commissioner for Food Donald A. Prater, DVM. The FDA framed the letter as a response to several serious public health events: the two multistate outbreaks of infant botulism linked to powdered infant formula, and a separate cereulide intoxication event traced to a contaminated formula ingredient. The agency wrote that these events highlight risks manufacturers should consider when selecting ingredients and ingredient sources, that the consequences of safety failures in this product category are severe and, in some cases, life-threatening, and that a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier, and every link in the supply chain.[24]

The letter also confirms, in the agency’s own words, several facts central to this claim. The FDA states that the ByHeart outbreak was the first botulism outbreak definitively tied to infant formula in the United States since infant botulism was first described as a distinct clinical entity nearly fifty years ago. It states that its inspections of ByHeart’s manufacturing facilities led to the identification of Clostridium botulinum in organic whole milk powder used as an ingredient; that it inspected and collected samples at Dairy Farmers of America, the processor for Organic West Milk, which supplied ByHeart; and that two samples from one lot of organic whole milk powder matched a clinical sample and an infant formula sample by whole-genome sequencing. It states that its ongoing root-cause investigation is focused on ingredients and their production environments. And it confirms that Organic West Milk also supplied Nara Organics, which voluntarily recalled all lots of its powdered infant formula after the June 2026 outbreak.[25]

The FDA further situates the botulism outbreaks within a broader pattern of ingredient-borne failure in this industry. Between December 2025 and February 2026, nearly 150 suspected and confirmed cases of cereulide intoxication — cereulide being a toxin produced by Bacillus cereus — were reported across ten countries and resulted in global recalls of contaminated infant formula, all traced to contaminated arachidonic acid (ARA) oil. The a2 Milk Company recalled certain batches of its imported powdered infant formula from the United States market on May 2, 2026, and on May 12, 2026 all ARA oil products from CABIO Biotech (Wuhan, China) became subject to FDA Import Alert 99-51, which provides for detention without physical examination of human food that appears to have been prepared, packed, or held under insanitary conditions resulting in chemical contamination. Taking these events together — two infant botulism outbreaks potentially linked to a shared dairy ingredient supplier, and a global contamination event linked to an ARA supplier — the FDA identified a pattern in which, in each case, the risks were introduced through the supply chain, and in each case the consequences fell on infants.[26]

Most significant for present purposes, the letter states plainly what the FDA expects of a formula manufacturer with respect to the ingredients it buys. Reiterating its March 2023 letter to the powdered infant formula industry, the agency states that suppliers of raw materials or other ingredients that will not receive a lethal treatment at the infant formula manufacturing facility are an extension of the infant formula manufacturing process, and that this principle is the foundation of the regulatory framework governing infant formula manufacturing. Under 21 C.F.R. Part 106, manufacturers must maintain production and in-process controls at every stage from receipt of raw materials through distribution of finished product, including developing and enforcing ingredient specifications, quarantining and dispositioning ingredients that fail to meet those specifications, and conducting regularly scheduled audits to verify compliance with current good manufacturing practices and quality control procedures. Under 21 C.F.R. Part 117, manufacturers and their supply chain partners must implement a food safety plan that includes a hazard analysis, preventive controls, and, where applicable, a risk-based supply chain program requiring them to identify and evaluate hazards associated with raw materials and ingredients, approve suppliers, and conduct supplier verification activities such as onsite audits by qualified auditors. The letter separately reminds manufacturers of their obligation under section 424(b) of the Federal Food, Drug, and Cosmetic Act to develop, maintain, and implement a redundancy risk management plan, and instructs that the requirement be treated as a meaningful risk management tool rather than a paper exercise.[27]

The FDA also directs manufacturers to stay abreast of recall notifications, outbreak investigations, and import alerts, which may serve as safety signals that an identified ingredient or supplier presents risk, and it warns that experience has shown that ignoring or downplaying such signals can lead to public health events that could have been avoided. The agency expects substantive oversight of suppliers — understanding where ingredients come from, how they are produced, what risks they may carry, and whether those risks are being effectively controlled — and expects manufacturers to act swiftly to assess and address the risk when a contaminated ingredient or supplier concern is identified, whether by the FDA or through the manufacturer’s own monitoring. Finally, the letter catalogs the scientific work the agency has set in motion since these outbreaks, acknowledging the difficulty of managing spore-forming microbes in formula ingredients and that there may be no single approach to doing so: support for the Codex Committee on Food Hygiene’s request for JEMRA scientific advice on C. botulinum and Bacillus cereus in powdered infant formula, covering every stage from primary production and packaging through reconstitution and including environmental monitoring programs; engagement with external researchers on the presence and control of C. botulinum on dairy farms and in milk and milk powders; engagement with Cornell University’s Pathogenic Spore Consortium on strategies and training to reduce spore-formers in milk; and a request that the International Commission on Microbiological Specifications for Foods revisit its publication on the usefulness of testing for C. botulinum in powdered infant formula and dairy-based ingredients in light of the recent outbreaks. Each of these steps is an acknowledgment that the controls in place when these infants were poisoned were not adequate to the hazard.[28]

That scientific work has now begun to produce results. The joint FAO/WHO expert meeting convened in Rome from June 15 to 19, 2026, and issued its summary and conclusions in July 2026. The Expert Group formally added botulinum neurotoxin-producing clostridia to the priority list of hazards for powdered formula alongside Salmonella and Cronobacter — a list that had not previously included them — and concluded that dairy ingredients have been demonstrated as a vehicle for such spores resulting in contamination of powdered formula, with other potential sources of contamination requiring further investigation. It further found that these spores had been detected in powdered formula in the past but had not been definitively linked to infant botulism cases prior to 2025. The Expert Group directed that powdered formula manufacturers should implement supplier risk management programs addressing botulinum neurotoxin-producing clostridia, that control of these spores starts with on-farm practices, and that mitigation strategies can potentially reduce spores prior to drying. It also concluded that hygiene indicators such as Enterobacteriaceae monitoring do not replace or reduce the need for pathogen-specific testing during environmental monitoring — the precise failure documented in this outbreak, where C. botulinum was present in both finished product and base powder while the usual indicator organism was non-detectable. The Expert Group acknowledged that powdered formula production processes are not designed to eliminate these spores and that the low concentrations involved present real challenges for detection and enumeration; but that is an argument for controlling the hazard upstream, at the farm and at the ingredient, which is precisely what both the Expert Group and the FDA say was required, and what ByHeart’s own post-outbreak commitment to C. botulinum-specific testing of every dairy ingredient concedes was not being done. The Expert Group separately concluded that current consumer preparation recommendations, which were designed to reduce the risk posed by Salmonella and Cronobacter spp., may not be effective for the control of botulinum neurotoxin-producing clostridial spores. And it recommended that Codex revise the Code of hygienic practice for powdered formulae for infants and young children (CXC 66-2008) throughout to address these clostridia, add a section addressing steps during primary production that may reduce spore load, and expand the roles of governments, industry, and consumers to include additional on-farm practices to reduce spore loads on dairy ingredients destined for powdered formula production.[29]

On August 27, 2026, the Centers for Disease Control and Prevention declared the Nara Organics outbreak over. It closed with four confirmed cases of infant botulism among infants in California, Pennsylvania and Washington who had consumed Nara Organics Whole Milk Organic Powdered Infant Formula, with illness onsets on April 20, May 17, May 20 and May 31, 2026. All four infants were hospitalized. No deaths were reported. CDC stated that epidemiologic, traceback and laboratory data showed that the formula was contaminated with Clostridium botulinum and made infants sick.[30]

The finding that accompanied that closeout is the most consequential development in this record since the ByHeart outbreak was itself declared over. The FDA reported that whole genome sequencing of one clinical sample from an infant in the Nara Organics outbreak matched a clinical sample from an infant in the 2025 ByHeart outbreak, a powdered infant formula base sample collected during the ByHeart investigation, and four samples of unopened cans of ByHeart powdered infant formula. CDC described the same result in more general terms, stating that whole genome sequencing analysis linked a patient sample from this outbreak to a patient sample, product samples and an ingredient sample collected during the investigation of the 2025 ByHeart outbreak. The agency further confirmed through traceback that the Nara Organics lots linked to those illnesses were manufactured with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America — the same suppliers of organic whole milk and organic whole milk powder implicated in the November 2025 ByHeart outbreak — and stated that the matching sequencing results, together with the supply chain commonalities, indicate a common source of contamination between the two outbreaks. CDC stated the traceback finding more broadly still, reporting that the infant formulas sold by both Nara Organics and ByHeart — not merely the Nara Organics lots linked to illness — were made with that milk and dried by that processor. The FDA stated that there is not yet sufficient evidence to determine whether the milk was contaminated before drying or during the drying process, and that its root cause investigation remains open.[31]

Every counterpart in that match set is a ByHeart sample. The strain recovered from an infant who never consumed ByHeart formula is genetically indistinguishable from the strain in ByHeart’s base powder and in four sealed, unopened cans of ByHeart’s finished product. Three consequences follow for this claim. First, the recovery of the outbreak organism from unopened cans forecloses any suggestion that the contamination was introduced in the home, at retail, or after the seal was broken; the product left ByHeart’s control in a contaminated condition. Second, the second outbreak supplies an independent check on causation that cannot be attributed to anything peculiar to ByHeart’s own facility. The two infants were fed different brands, manufactured by different companies on different continents, in outbreaks seven months apart, and the only route between them is the dairy ingredient they shared. Third, the persistence of a single strain through that ingredient stream — across two manufacturers, and across the entire period of ByHeart’s recall and the closeout of its own outbreak — is the opposite of the isolated or incidental contamination a defendant would need to establish.[32]

The FDA’s own internal closeout record, obtained under the Freedom of Information Act, confirms these conclusions in the agency’s words. FDA released the Executive Incident Summary prepared by its Coordinated Outbreak Response and Evaluation (CORE) Network for the ByHeart outbreak, CORE Incident No. 1350, dated May 1, 2026, together with the incident command records, the Human Foods Program whole-genome sequencing report of February 24, 2026, and the Health Hazard Evaluation of December 5, 2025.[33] The summary concludes: “Epidemiological, laboratory and traceback evidence indicate that consumption of ByHeart powdered infant formula resulted in this multistate infant botulism outbreak. The outbreak strain was isolated from finished product ByHeart PIF, base powder mix and whole milk powder (ingredient). Whole genome sequencing matched strains in whole milk powder, finished powdered infant formula product, and an infant botulism clinical isolate.” It acknowledges that, “[e]ven though there are several hypotheses, investigational findings could not identify the source or root cause of contamination of the powdered infant formula.”[34]

The record quantifies the product evidence. At least seventeen product samples tested positive for C. botulinum — eight finished-formula samples, four base-mix samples, and five whole-milk-powder samples — collected and analyzed by the FDA, CDC, state laboratories, and ByHeart’s contract laboratory. The FDA’s own 26 samples yielded two positives, a base-mix retain from Blendhouse Allerton, Iowa, and a powdered-milk retain from Dairy Farmers of America, Fallon, Nevada. Two of five samples analyzed at the New York State Wadsworth Center were positive: an unopened can collected from an Arizona case household, lot 206VABP/251481P2, and a second Dairy Farmers of America milk-powder retain. ByHeart’s own testing reported a total of twelve positive samples across finished product, base powder, and organic whole-milk powder, including toxin type A in finished lots 251131P2 and 251261P2, toxin type B in finished lot 252161P2, and toxin types A and B in the whole-milk powder. Seven cases reported exposure to lot 206VABP/251261P2, which tested positive for toxin type A and was sequenced. ByHeart also reported to the FDA that one of its positive lots bore a November 15, 2024 production date, establishing that contaminated formula had been manufactured and sold at least a year before the recall.[35]

The Human Foods Program sequenced 37 C. botulinum isolates — sixteen clinical and twenty-one product — and sorted them into seventeen strains. Four of those strains link infants directly to product or ingredient. Strain 6: clinical isolates from California, Oregon, and Arizona match the opened formula can from a California case at a mean of seven SNPs. Strain 8: a California clinical isolate matches four ByHeart finished-product isolates and a ByHeart base-powder isolate at a mean of four SNPs. Strain 11: two FDA isolates from a Dairy Farmers of America milk-powder retain, three ByHeart whole-milk-powder isolates, a ByHeart finished-product isolate, the unopened Arizona can, and a New Jersey clinical isolate match one another at a mean of 7.5 SNPs. Strain 2: a ByHeart finished-product isolate from lot 251261P2 matches a second Dairy Farmers of America milk-powder retain at eight SNPs. The summary’s traceback finding is that “[s]ampling results confirmed contamination was present in finished product, base mix, and organic milk powder,” and that “[t]he distribution and comingling of ingredients likely contributed to the widespread nature of the contamination.”[36]

The incident records also document what the FDA knew about ByHeart’s facilities and what it found there. Before the outbreak, the FDA’s February 2025 inspection of the Allerton, Iowa base-powder plant was classified Voluntary Action Indicated, with a three-item Form 483 citing an ingredient not held under conditions to prevent adulteration, failure to eliminate rodent harborage areas when rodent issues arose during 2024–2025, and inadequate floor monitoring where Cronobacter sakazakii had been confirmed; a 2022 inspection of the same plant cited insanitary conditions and inadequate written preventive controls and was followed by a regulatory meeting. During the outbreak inspection itself, the FDA issued a Form 483 at Allerton on January 22, 2026, for failure to have a qualified individual document corrective actions, failure to ensure all food-contact surfaces were cleaned and sanitized, and failure to review and evaluate the public health significance of process-specification deviations.[37] Although the FDA has stated that none of these findings explains the root cause, they are the conditions under which the product was made. The investigators also recorded the epidemiological signal that prompted the response: ByHeart accounted for an estimated one percent of powdered infant formula sales in the United States, yet of the 36 infants treated with BabyBIG between August 1 and November 10, 2025 who had any powdered-formula exposure, fifteen — more than forty percent — had consumed ByHeart, which the FDA described as “highly unusual” and “a significant epidemiological signal.”[38]

The record further shows that the FDA, not ByHeart, requested the recall. CORE held its first call with ByHeart on the evening of November 7, 2025 to request a voluntary recall of two lots; on November 10 the FDA requested recall of all lots within expiry, which ByHeart announced the following day. The FDA’s Health Hazard Evaluation records that on November 19, 2025, after ByHeart’s own testing found the organism in five of 36 unopened cans spanning three lots, the company “amended their recall press to remove exculpatory statements regarding sampling.”[39] That evaluation, signed on December 5, 2025 by the Chief Medical Officer of the FDA’s Human Foods Program, classified the hazard as life-threatening and the probability of harm as likely to occur, concluding that contamination of ByHeart formula “presents a severe health hazard to infants consuming this product” and that the resulting illness “almost always requires medical intervention, with most affected infants needing hospitalization and many requiring intensive care or mechanical ventilation due to the risk of rapid respiratory failure or death.”[40]

Finally, the record shows how the Nara Organics link was missed. On January 28 and February 3, 2026, CORE issued traceability assignments to six firms, whose identities the FDA redacted, that had received Organic West Milk lots of whole-milk powder that tested positive for C. botulinum, requesting all distribution of that powder to infant formula manufacturers over the prior two years. The result: “None of the firms identified any infant formula manufacturers as customers that were supplied whole milk powder.” Nara Organics formula had been on sale through Target and its own website since July 2025, squarely within that window, and the first Nara-associated illness began about eight weeks after the last of those assignments closed.[41]

The record also fixes the reach of the outbreak in time. On December 5, 2025, CDC expanded the case definition back to March 23, 2022, the date ByHeart began manufacturing the formula. On December 10, 2025, the FDA and CDC updated their public postings to reflect that expansion: case counts had previously included only illnesses from August 1, 2025 onward, and under the expanded definition CDC and state partners identified ten additional cases with onsets from December 2023 through July 2025, all ten confirmed infant botulism with documented exposure to ByHeart formula. No cases were identified between March 2022 and December 2023.[42] Those ten children fell ill during a period in which contaminated product was demonstrably on the market: ByHeart’s own testing found C. botulinum in a lot bearing a November 15, 2024 production date, and the recall, when it came, reached only lots “currently within expiry.” The infants sickened in 2023 and 2024 were therefore fed formula that was never recalled from production runs that were never tested and were counted as part of this outbreak only when the agencies looked backward.[43]

Two limits on this evidence should be stated plainly, because they are limits of scope and not of causation. The FDA has not announced a root cause, and it has not determined whether the milk was contaminated before drying or during the drying process. That open question governs how responsibility is ultimately apportioned among ByHeart and its upstream suppliers. It does not bear on whether ByHeart’s formula was contaminated with C. botulinum when it was sold — which the sequencing of ByHeart’s own unopened cans and its own base powder establishes — and it does not bear on whether that formula made infants sick, which the FDA and CDC concluded in February 2026 and have not retreated from since.

Those two limits do not reach Dairy Farmers of America or Organic West Milk. The FDA collected retain samples of organic whole-milk powder at the Dairy Farmers of America plant in Fallon, Nevada, and two of those retains tested positive for C. botulinum type A. One matched, by whole-genome sequencing, ByHeart’s whole-milk powder, ByHeart finished formula, an unopened can from an Arizona case household, and a New Jersey infant’s clinical isolate; the other matched ByHeart finished formula from lot 251261P2, the lot most often reported by ill infants. The record describes the chain: liquid whole milk from twenty dairies is delivered to Dairy Farmers of America, where it is spray-dried into organic whole-milk powder; Organic West Milk, acting as broker, delivers that powder by third-party carrier to Blendhouse Allerton, where it is incorporated into the base mix for ByHeart formula.[44] Whether the spores entered the milk on the farm, in transit, or at the dryer is a question about origin, not about defect. The powder Dairy Farmers of America manufactured and sold contained viable C. botulinum; it was defective and unreasonably dangerous when it left that plant, and the manufacturer of a component that is itself defective is strictly liable for the harm the defect causes once the component is integrated into the finished product. Organic West Milk, as the seller that placed the powder into the stream of commerce and the supplier with which ByHeart contracted, stands in the position of any other commercial seller of a defective product. Neither is excused by the possibility that the raw milk carried the spores before it reached them; strict liability attaches to the condition of the product sold, not to fault in causing that condition. The FDA’s finding of no objectionable conditions at the Dairy Farmers of America plant, and its inability to determine whether contamination occurred before or during drying, bear on negligence and on apportionment among the defendants. They do not bear on whether the ingredient was defective, which the FDA’s own sampling established.[45]

[1]           Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

[2]           U.S. FDA, Outbreak Investigation of Infant Botulism: Infant Formula (November 2025), https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; Contemporary Pediatrics, Infant botulism outbreak linked to powdered formula under FDA investigation, https://www.contemporarypediatrics.com/view/infant-botulism-outbreak-linked-to-powdered-formula-under-fda-investigation

[3]           Khouri JM, et al., Multistate Infant Botulism Outbreak Associated with Powdered Infant Formula, NEJM Evidence (2026), https://evidence.nejm.org/doi/full/10.1056/EVIDpha2600020; CDC, Investigation Update: Infant Botulism Outbreak, November 2025 (final case data, Mar. 4, 2026), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/investigation.html

[4]           U.S. FDA, supra note 19; CDC, supra note 18; Khouri JM, et al., supra note 35; New York State Dept. of Health, Wadsworth Center, Biodefense Laboratory Identifies Contamination Source in Multistate Infant Botulism Outbreak (2026), https://www.wadsworth.org/news/wadsworth-center-biodefense-laboratory-identifies-contamination-source-multistate-infant. 

[5]           CDC, Outbreak of Infant Botulism Linked to ByHeart Infant Formula — Food Safety Alert and Investigation Update (outbreak declared over Feb. 26, 2026), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-nov-2025/index.html; U.S. FDA, FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (Feb. 26, 2026 update), https://www.fda.gov/food/outbreaks-foodborne-illness/fdas-actions-respond-clostridium-botulinum-illnesses-associated-consumption-powdered-infant-formula; FDA, Whole Genome Sequencing (WGS) Program, https://www.fda.gov/food/microbiology-research-food/whole-genome-sequencing-wgs-program. 

[6]           CDC and U.S. FDA, supra notes 18–19.

[7]           U.S. FDA, supra note 19.

[8]           U.S. FDA and California Dept. of Public Health, supra note 19.

[9]           U.S. FDA, supra note 19.

[10]         U.S. FDA, supra note 19; New York State Dept. of Health, Wadsworth Center, supra note 36.

[11]         CDC, supra note 18; U.S. FDA, supra note 19.

[12]         U.S. FDA, FDA’s Actions to Respond to Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula, https://www.fda.gov/food/outbreaks-foodborne-illness/fdas-actions-respond-clostridium-botulinum-illnesses-associated-consumption-powdered-infant-formula ; Contemporary Pediatrics, supra note 34.

[13]         Guilfoyle DE, Yager JF, Survey of infant foods for Clostridium botulinum spores, 66 J. Assoc. Off. Anal. Chem. 1302 (1983), https://pubmed.ncbi.nlm.nih.gov/6355058/; Barash JR, et al., Clostridial spores in powdered infant formula, J. Pediatr. (2010), https://www.jpeds.com/article/S0022-3476(10)00070-3/fulltext. 

[14]         U.S. FDA, supra note 19; Harris RA, et al., Detection and characterization of Clostridium botulinum isolated from powdered infant formula, Front. Microbiol. (2026), https://www.frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2026.1800624/abstract. 

[15]         Harris, R. A., & Dabritz, H. A. (2024). Infant botulism: in search of Clostridium botulinum spores. Current Microbiology, 81(10), 306. https://link.springer.com/article/10.1007/s00284-024-03828-0

[16]         Brett MM, et al., A case of infant botulism with a possible link to infant formula milk powder, J. Med. Microbiol. (2005), https://pubmed.ncbi.nlm.nih.gov/16014431/ ; Johnson EA, et al., Characterization of Clostridium botulinum Strains Associated with an Infant Botulism Case in the United Kingdom, 43 J. Clin. Microbiol. 2602 (2005), https://pmc.ncbi.nlm.nih.gov/articles/PMC1151885 ; Luo H, et al., Isolation and typing of Clostridium botulinum from milk powder of an enterprise associated with a case of infant botulism, 35 Chinese J. Food Hygiene 1475 (2023), https://doaj.org/article/30d4cb5e20434fad9a47a75d7afcd132. 

[17]         Böhnel H, et al., Presence of Clostridium botulinum and botulinum toxin in milk and udder tissue of dairy cows with suspected botulism, Vet. Rec. (2013), https://pubmed.ncbi.nlm.nih.gov/23585115/ ; Lindström M, et al., Clostridium botulinum in cattle and dairy products, 50 Crit. Rev. Food Sci. Nutr. 281 (2010), https://pubmed.ncbi.nlm.nih.gov/20301016/ ; The Case of Botulinum Toxin in Milk: Experimental Data, 76 Appl. Environ. Microbiol. 3293 (2010), https://aem.asm.org/content/76/10/3293.full. 

[18]         Franciosa G, et al., Clostridium botulinum spores and toxin in mascarpone cheese and other milk products, 62 J. Food Prot. 867 (1999), https://pubmed.ncbi.nlm.nih.gov/10456738/; Aureli P, et al., An outbreak in Italy of botulism associated with a dessert made with mascarpone cream cheese, 16 Eur. J. Epidemiol. 913 (2000), https://pubmed.ncbi.nlm.nih.gov/11338122/ .

[19]         Harris RA, et al., supra note 46 (C. botulinum present in finished product and bulk “base powder,” with genetic identity between a finished lot and a base powder, and detectable even where the usual indicator organism, sulfite-reducing clostridia, was non-detectable — such that standard screening would have missed it).

[20]         U.S. FDA, Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula (onsite inspections of ByHeart facilities concluded; no facility deficiency identified that could explain the root cause; ongoing root-cause investigation focused on incoming ingredients and the dairy supply chain; WGS match between two isolates from one lot of organic whole milk powder sampled at Dairy Farmers of America and a clinical isolate and a positive finished-formula sample), https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered; see also After Infant Botulism Outbreak, FDA Shares Root Cause Analysis Findings from ByHeart Formula Plants, Food Safety Magazine (June 10, 2026).

[21]         See Alison Young, ByHeart recommended its customers switch to Nara. Now a second infant formula is linked to botulism, Healthbeat (June 15, 2026), https://www.healthbeat.org/2026/06/15/nara-baby-formula-recall-botulism-cases-raise-safety-oversight-questions/ (ByHeart encouraged customers to switch to Nara Organics; a Nov. 11, 2025 ByHeart Instagram post recommending Nara products and offering a 20% discount code was deleted after the connection was reported); For Second Time in 7 Months, Baby Formula Linked to Infant Botulism Is Recalled, Truthout (June 2026) (ByHeart statement that the companies are “completely separate” and that it “shared a Nara discount code as a resource to help its customers find alternative options quickly”); see also New infant botulism outbreak puts fancy formulas under scrutiny, STAT (June 18, 2026) (noting ByHeart “directed customers to Nara during its recall last year, with Nara offering a 20% discount”).

[22]         U.S. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (initially three confirmed type A infant-botulism cases in California, Pennsylvania, and Washington linked to Nara Organics Whole Milk Organic powdered infant formula, onsets April–May 2026; Organic West Milk and its processor, Dairy Farmers of America, identified as suppliers shared with ByHeart; Organic West Milk’s earlier customer list to FDA was incomplete and omitted Nara Organics), https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026; see also New infant botulism outbreak puts fancy formulas under scrutiny, STAT (June 18, 2026). The CDC’s investigation update, last revised July 6, 2026, reports four confirmed type A cases (California (2), Pennsylvania (1), and Washington (1)), all hospitalized and treated with BabyBIG, and states that laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants, with the FDA testing an unopened can from the same lot. CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (last updated July 6, 2026), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html.

[23]         Khouri JM, et al., Multistate Infant Botulism Outbreak Associated with Powdered Infant Formula, NEJM Evidence (2026); Codex Committee on Food Hygiene / FAO-WHO Joint Expert Meetings on Microbiological Risk Assessment (JEMRA) risk assessment of spore-forming pathogens, including C. botulinum, in powdered infant formula (undertaken at FDA’s urging); ByHeart, Inc., public statements regarding its post-outbreak Action Plan (new C. botulinum-specific testing protocol applied to every dairy ingredient and finished batch prior to release).

[24]         Letter from Donald A. Prater, DVM, Acting Deputy Comm’r for Food, U.S. Food & Drug Admin., Human Foods Program, to Infant Formula Industry 1 (July 13, 2026), https://www.fda.gov/media/193534/download (letter directed to manufacturers, packagers, distributors, exporters, importers, and retailers involved in the manufacture or distribution of infant formula and infant formula ingredients; issued in response to two multistate outbreaks of infant botulism linked to powdered infant formula and to cereulide intoxication associated with a contaminated ingredient in infant formula; stating that FDA holds infant formula manufacturers to the highest standards of safety and quality and that this responsibility extends to every ingredient, every supplier, and every link in the supply chain).

[25]         Id. at 1–2 (ByHeart outbreak was the first botulism outbreak definitively tied to infant formula in the United States since infant botulism was first described as a distinct clinical entity nearly 50 years ago; FDA’s inspections of ByHeart’s manufacturing facilities led to the identification of Clostridium botulinum in organic whole milk powder used as an ingredient; FDA inspected and collected samples at Dairy Farmers of America, Inc., the processor for Organic West Milk, which supplied ByHeart; two samples from one lot of organic whole milk powder matched a clinical sample and an infant formula sample by whole genome sequencing; FDA’s ongoing root-cause investigation is focused on ingredients and their production environments; Nara Organics voluntarily recalled all lots of its powdered infant formula and Organic West Milk also supplied Nara Organics).

[26]         Id. at 2 (from December 2025 to February 2026, nearly 150 suspected and confirmed cases of cereulide intoxication reported across 10 countries, resulting in global recalls of infant formula contaminated with cereulide, a toxin produced by Bacillus cereus, traced to contaminated arachidonic acid (ARA) oil; the a2 Milk Company’s May 2, 2026 voluntary recall of certain batches of imported powdered infant formula from the U.S. market; FDA Import Alert 99-51 applied as of May 12, 2026 to all ARA oil products, including ARA oil powder, from CABIO Biotech (Wuhan, China); FDA’s conclusion that in each event the risks were introduced through the supply chain and the consequences fell on infants).

[27]         Id. at 2–3 (reiterating FDA’s March 2023 Letter to the Powdered Infant Formula Industry that suppliers of raw materials or other ingredients that will not receive a lethal treatment at the infant formula manufacturing facility are an extension of the infant formula manufacturing process, and describing that principle as the foundation of the regulatory framework governing infant formula manufacturing; summarizing production and in-process control obligations under 21 C.F.R. Part 106 and food safety plan, preventive control, and supply-chain program obligations under 21 C.F.R. Part 117, including subpart G supplier verification; and citing the redundancy risk management plan requirement of section 424(b) of the FD&C Act, 21 U.S.C. § 350m(b), as added by the Food and Drug Omnibus Reform Act of 2022).

[28]         Id. at 3–4 (recall notifications, outbreak investigations, and import alerts may serve as safety signals, and ignoring or downplaying them can lead to public health events that could have been avoided; FDA expects substantive supplier oversight and swift action when a contaminated ingredient or supplier concern is identified; describing FDA’s support for the Codex Committee on Food Hygiene’s request for scientific advice from the Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) regarding Clostridium botulinum and Bacillus cereus in powdered infant formula, its engagement with external researchers and with Cornell University’s Pathogenic Spore Consortium, and its request that the International Commission on Microbiological Specifications for Foods revisit its publication “Usefulness of testing for Clostridium botulinum in powdered infant formula and dairy-based ingredients for infant formula” in light of the recent U.S. infant botulism outbreaks).

[29]         Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) on Powdered Formula for Infants and Young Children, FAO HQ, Rome, Italy, June 15–19, 2026, Summary and Conclusions (issued July 2026) (adding botulinum neurotoxin (BoNT)-producing clostridia and Bacillus cereus sensu lato (cereulide) to the priority hazard group for powdered formula; finding that dairy ingredients have been demonstrated as a vehicle for BoNT-producing clostridial spores resulting in contamination of powdered formula; finding that such spores had previously been detected in powdered formula but were not definitively linked to infant botulism cases prior to 2025; recommending supplier risk management programs addressing BoNT-producing clostridia; stating that control starts with on-farm practices and that mitigation strategies can potentially reduce spores prior to drying; stating that hygiene indicators such as Enterobacteriaceae monitoring do not replace or reduce the need for pathogen-specific testing during environmental monitoring; noting that current consumer preparation recommendations designed for Salmonella and Cronobacter spp. may not be effective against BoNT-producing clostridial spores; and recommending revisions to CXC 66-2008, including a primary production section addressing reduction of spore load and expanded on-farm practices for dairy ingredients destined for powdered formula production). The summary notes that a full report will be published by FAO and WHO, and its Annex 2 recommendations carry the disclaimer that they may be updated following availability of risk assessment results.

[30]         Centers for Disease Control and Prevention, Infant Botulism Outbreak Linked to Powdered Infant Formula, June 2026, and its investigation, locations and timeline subpages, update of Aug. 27, 2026, https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/index.html; investigation update at https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html (whole genome sequencing link, traceback findings, and statement that the outbreak is over).

[31]         U.S. Food and Drug Administration, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026), update of Aug. 27, 2026, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-powdered-infant-formula-june-2026; CDC, supra note 62.

[32]         FDA, supra note 63; U.S. Food and Drug Administration, Post-Outbreak Response Activities: Clostridium botulinum Illnesses Associated with Consumption of Powdered Infant Formula, https://www.fda.gov/food/outbreaks-foodborne-illness/post-outbreak-response-activities-clostridium-botulinum-illnesses-associated-consumption-powdered (FDA and ByHeart sampling at Dairy Farmers of America; two samples from one lot of organic whole milk powder matched a clinical sample and a positive infant formula sample by whole genome sequencing; root cause investigation ongoing with a focus on ingredients).

[33]         U.S. Food and Drug Administration, Coordinated Outbreak Response and Evaluation (CORE) Network, Executive Incident Summary: Clostridium botulinum/Infant Formula/Nov 2025, CARA #1350 (May 1, 2026), released with Incident Objectives (ICS 202, Operational Period #7), Incident Briefing (ICS 201, CORE Incident No. 1350), Human Foods Program Signal Detection & Bioinformatics Branch, WGS Analysis Report: WGS-Report-ByHeart-260224 (Feb. 24, 2026), and Human Foods Program Health Hazard Evaluation, HHE #11418, RES #97959 (Dec. 5, 2025), in response to FOIA Request No. 2026-4033 (redacted under 5 U.S.C. § 552(b)(4), (b)(5), (b)(6) and (b)(7)(D)) [hereinafter CORE Record].

[34]         CORE Record, Executive Incident Summary at 11 (Conclusions).

[35]         Id. at 5–7, 9–10 (Laboratory Sample Overview, Tables 1–4, and Traceback Abbreviated Summary); CORE Record, ICS 202, entry of Nov. 20, 2025 (ByHeart reported that its five positive samples corresponded to three lots, two of which were in the initial recall, and that the third lot code indicated a Nov. 15, 2024 production date).

[36]         CORE Record, Executive Incident Summary at 8–10 (WGS analysis; Traceback Abbreviated Summary); see also CORE Record, WGS Analysis Report (Feb. 24, 2026) (phylogenetic clusters 1 through 4).

[37]         CORE Record, ICS 201 at 5–6 (Firm Summary); Executive Incident Summary at 3 (Field Investigations & Findings, assignment 1); ICS 202, Operational Period #6 (entry of Jan. 22, 2026).

[38]         CORE Record, ICS 202 (General Situational Awareness).

[39]         CORE Record, ICS 201 at 5 (Incident Overview and Early Actions Timeline); ICS 202, entries of Nov. 7–11, 2025; Health Hazard Evaluation, HHE #11418, at 1–2 (Nature of Problem).

[40]         CORE Record, Health Hazard Evaluation, HHE #11418, at 3–4 (Items 10–11 and Conclusion) (signed by CAPT Steven M. Grube, MD, MPH, Chief Medical Officer and HHE Board Chair, Human Foods Program, Dec. 5, 2025).

[41]         CORE Record, Executive Incident Summary at 4–5 (Field Investigations & Findings, assignments 7–12); ICS 202, entry of Jan. 28, 2026 (“None of the firms identified any infant formula manufacturers as customers that were supplied whole milk powder.”); FDA, supra note 63 (Nara Organics formula distributed through Target retail stores, Target.com, and Nara.com between July 2025 and June 2026).

[42]         CORE Record, ICS 202, entries of Dec. 5, 2025 (case definition expanded to March 23, 2022; ByHeart began manufacturing on that date) and Dec. 10, 2025 (ten additional confirmed cases, Dec. 2023 through July 2025; none between March 2022 and Dec. 2023); Executive Incident Summary at 2 (case definition covering onsets between December 2023 and February 2026; onset range Dec. 24, 2023 to Nov. 29, 2025).

[43]         CORE Record, ICS 202, entries of Nov. 10–11, 2025 (FDA request and ByHeart recall of “ALL LOTS of ByHeart Powdered Infant Formula currently within expiry”) and Nov. 20, 2025 (Nov. 15, 2024 production date in the batch code of a positive lot); see also Executive Incident Summary at 10 (Product & Firm Actions).

[44]         CORE Record, Executive Incident Summary at 3–6, 8–9 (assignments 3–5; Tables 1–2; WGS strains 2 and 11; Traceback Abbreviated Summary); ICS 202, entries of Nov. 25, 2025 (traceback records: liquid whole milk supplied by twenty dairies to Dairy Farmers of America, Fallon, Nev., where it is spray-dried into organic whole-milk powder; Organic West Milk acts as a broker and uses a third-party carrier to deliver the powder to Blendhouse Allerton, where it is incorporated into the base mix), Jan. 21, 2026 (FDA firm call informing Dairy Farmers of America, ByHeart, and Organic West Milk of the positive sample and whole-genome sequencing results), and Feb. 9, 2026 (FDA firm call with Dairy Farmers of America and Organic West Milk on FDA Sample #1319424).

[45]         Restatement (Third) of Torts: Products Liability § 5 (1998) (one engaged in the business of selling a component is subject to liability for harm caused by a product into which the component is integrated if the component is itself defective and the defect causes the harm); id. § 2(a) (a product contains a manufacturing defect when it departs from its intended design even though all possible care was exercised in its preparation and marketing); Restatement (Second) of Torts § 402A & cmt. f (1965) (rule applies to any person engaged in the business of selling products for use or consumption, including any wholesale or retail dealer or distributor); see also CORE Record, Executive Incident Summary at 4 (assignment 4: full preventive-controls inspection at Dairy Farmers of America found no objectionable findings); FDA, supra note 63 (not enough evidence to determine whether the milk was contaminated before drying or during the drying process).

The 2026 cyclosporiasis season closed on August 31. Between July 14 and August 13, thirteen letters went from members of the House and Senate to the Secretary of Health and Human Services, to the acting heads of FDA and CDC, and twice to the chief executive of Taylor Farms. Eight of them set a date. Every one of those dates has now passed, the last on August 27. I cannot find a published answer to any of the thirteen, and I cannot find notice of a hearing anywhere. What is left is arithmetic.

The arithmetic

CDC last updated its national case data on September 1. Since May 1 it has received reports of 18,445 laboratory-confirmed cases of cyclosporiasis acquired in the United States, with 990 hospitalizations and two deaths, across forty-nine states and the District of Columbia. For the same stretch of 2025 the number was 1,180. 

This season is more than fifteen times last season.

The count does not stop there. CDC lists another 3,491 laboratory-confirmed cases still being sorted into domestic or travel-related and says it is aware of at least 13,505 additional cases that are not, yet laboratory confirmed or are waiting on a patient interview. Added up, that is 35,441 people the agency knows about. Another 1,900 travel-associated cases, with 66 hospitalizations, sit outside that total. The median patient is 46 years old, and the range runs from 1 to 99. The median illness began July 8. The most recent one CDC has recorded began August 22, nine days before the calendar said the season was over.

The outbreak FDA and CDC attribute to recalled Taylor Farms de Mexico iceberg lettuce is a subset of that: 11,458 illnesses in twenty states, at least 495 hospitalizations, and both deaths. FDA’s investigation page has not moved since August 27.

State numbers are bigger, and they are not wrong. Michigan alone reported 14,718 cases and 366 hospitalizations as of September 3 — more than the entire national laboratory-confirmed count, because the state counts every case reported during its outbreak investigation while CDC counts only cases that meet its own confirmation criteria. Both numbers are honest. Only one of them is the number most people see.

The thirteen letters, and where they stand this morning

This is the same list I published on August 25. Nothing in the middle column has changed. The column on the right is the one to read.

DateWho wrote, and to whomDeadlineStatus
Jul 14Sen. Klobuchar to CDC and FDANone setNo answer found
Jul 15Rep. Stanton to Sec. KennedyAug 3Passed, no answer found
Jul 16Sen. Ossoff to Sec. KennedyJul 19Passed, no answer found
Jul 17Reps. Dingell, McDonald Rivet, Scholten and Tlaib to CDC and FDAJul 24Passed, no answer found
Jul 20Rep. Gottheimer to CDCNone setNo answer found
Jul 20Sens. Blumenthal and Booker to CDCUndatedNo briefing found
Jul 24Sen. Ossoff, second letter, to Sec. KennedyNone setNo answer found
Jul 27Rep. Garcia, Oversight Ranking Member, to Bruce TaylorAug 10Passed, no production found
Jul 28Sen. Gillibrand to CDC and FDAJul 31Passed, no answer found
Jul 30Sen. Blumenthal, PSI Ranking Member, to FDAAug 13Passed, no answer found
Jul 30Sen. Blumenthal, PSI Ranking Member, to Bruce TaylorAug 13Passed, no production found
Jul 30Reps. Veasey, Dingell and Sewell with about fifty colleagues, to CDC and FDANone setNo answer found
Aug 13Sen. Warren to Sec. KennedyAug 27Passed, no answer found

“No answer found” means exactly that and nothing more. An agency can answer a member privately, and often does, and neither side has to publish it. If you have an answer to any of these, send it to me and I will correct this post and say plainly that I had it wrong. That is the column I would like to see.

The answers keep arriving somewhere else

Taylor Farms revised its Cyclospora information hub again, and the page now carries a September 1 date. Two things on it are new since I last wrote. The statement and the false-positive answer both now report that, according to FDA, there are no confirmed positive sample results for product testing for Cyclospora as of August 27, 2026 — the same day Senator Warren’s deadline ran out. And a new question takes on FDA’s “overwhelming epidemiological data” language head-on, arguing that epidemiology identifies a pattern but cannot confirm a specific product without a positive laboratory test. In answering it, the company discloses that its own testing, roughly 2,000 samples taken in central Mexico since May, returned zero positives.

Read that against the letters. Rep. Garcia asked for facility records going back to 2013. Sen. Blumenthal asked FDA and the company, separately, for all communications with the White House. Sen. Warren asked for the July call. None of it has been produced to anyone. The results of a sampling program have been produced, voluntarily, on a corporate website — unsworn, undated as to who tested what, written by the party with the most at stake, and revisable in place at two in the morning with no version history and no correction note.

I would rather have it than not have it. That is not my complaint. My complaint is that this is what the record looks like when nobody with subpoena power has asked for one.

Meanwhile the federal pages are slowing down

CDC’s iceberg lettuce outbreak page, updated September 3, says the agency is reducing the frequency of its web updates and that they will no longer take place on a weekly basis. FDA’s page has not been updated since August 27. The counting has not stopped, whatever the publishing schedule does. It takes about six weeks from the onset of symptoms to the day CDC receives a case, so illnesses that started in August are being added this month, and September cases are coming after those.

What would still work, and who is holding it

None of this needs a fourteenth letter. The Senate Permanent Subcommittee on Investigations can issue a subpoena; Sen. Blumenthal wrote as its ranking member and copied Chairman Ron Johnson on both July 30 letters, and a ranking member cannot subpoena alone while a chairman can. The House Oversight majority can adopt Rep. Garcia’s document request and make it the committee’s request. The Senate HELP Committee has jurisdiction over both agencies. And Congress can strike Section 780 from the next funding bill rather than leave enforcement of the traceability rule barred until July 2028 — the provision that made this outbreak so much harder to trace in the first place.

That same subcommittee held a hearing on Cyclospora in imported raspberries in July 1998. Same subcommittee, same parasite, imported produce, twenty-eight years ago. The witnesses are identified. The questions are drafted, nine of them by Sen. Warren alone. What is missing is a room and a date.

Counting

A season is a bookkeeping convention. It tells CDC when to start a comparison and when to stop one, and it lets a health department decide the extra work is finished. It does not tell a parasite anything and it does not close a file. Two people are dead. Nine hundred ninety went to a hospital. Eighteen thousand four hundred forty-five have a laboratory-confirmed case with their name on it, and at least thirteen thousand five hundred more are still waiting to be counted. Nobody had to answer a letter this summer, and nobody did. Somebody should still have to answer for the rest of it, out loud, on a date certain, under oath.

We Need Someone Who Reads 4,000 Pages of Medical Records and Finds the One That Matters.

Marler Clark represents people sickened by E. coli, Salmonella, Listeria, Cyclospora, Vibrio and botulism — from a single family to a thousand-plaintiff outbreak, tens of thousands of clients and over $850 million recovered since 1993. The companies on the other side are ones you already know — Jack in the Box, Cargill, Dole, Nestlé, Walmart, Wendy’s, McDonald’s, Yum Brands, and this year Taylor Farms and Boar’s Head. The cases are won or lost in the details, and the details live with our paralegals.

Right now, the details include a Cyclospora outbreak the fifty state health departments count at 31,521 people while the federal government counts 9,481, Salmonella Javiana in Sinaloa jalapeños that has sickened 431 in 32 states and set off a recall that now runs to more than 160 grocery products, infant botulism cases against ByHeart and Nara Organics, Listeria from Boar’s Head, Salmonella from nineteen million recalled eggs, and E. coli from beef kofta, romaine and frozen blueberries. Spend ten minutes on marlerblog.com and you will see the month we just had. Every one of those numbers is a person with a chart, a bill, a lien and a phone number.

The other half of this office is advocacy, and it runs on the same skills. Public records requests to state and county health departments. FOIA to FDA and USDA for inspection reports and environmental assessments and sometimes records in Spanish from a growing region in Mexico — Spanish is a real plus. Fifty health department dashboards read and reconciled every morning. Exhibits and family declarations assembled for a rulemaking petition, a congressional hearing, or a bill. FDA and USDA dockets tracked, and comment letters filed on deadline. The last time we petitioned USDA, six strains of E. coli became adulterants in American beef. That file had to be built by somebody. The same goes for the Outbreak Database and Food Safety News — this office built both and still feeds them. People here get their names on that work, and anyone who wants to speak or write about it is pushed forward, not held back.

We are hiring a paralegal with at least ten years of experience in plaintiffs’ personal injury or complex litigation. Ten years, because we need someone who already knows what a lien is, what a hospital billing department will and will not send you, and how to keep sixty clients straight without losing one. Ten years also because nobody here is going to look over your shoulder — you will run your own files.

Here is what you will not do here. No billable hours and no timesheets — nobody in this office bills by the tenth of an hour. No committee, and no layer between you and the person who decides; when you need an answer you walk down the hall and get one. And no volume: we turn down cases every week that we could not do right, because a file nobody has time for is worse than no file at all.

Our office is on Bainbridge Island, and we would like you to live here rather than commute here. We are a few minutes’ walk up from the ferry terminal — thirty-five minutes from downtown Seattle by boat, a town you can cross on foot, and a trip to work that is a walk or a short drive instead of an hour on I-5. People who make the move tend to stay. But the right person matters more to us than the right zip code: if you are elsewhere in Puget Sound and can be here most days, we should talk, and we will help you get here.

What you’ll actually do: run intakes with families who are frightened and exhausted, chase and chronologize medical records, build the damages and lien files that become the settlement demand, assemble the minor’s compromise petitions that put a child’s settlement in front of a judge, manage e-discovery and document productions, calendar and cite-check, coordinate with experts and state health departments, keep cases moving in courts in a dozen states, and travel with us when one of them goes to trial. The work has gone international too — outbreaks in Europe, Asia and Africa.

What you need: a decade in the trenches, mastery of medical records and chronologies, real lien experience — Medicaid, Medicare, ERISA plans and, more often than you would think, the federal government — e-discovery platform experience, absurd organizational instincts, and genuine kindness on the phone: the person calling you may have just buried someone.

What we offer: Competitive salary depending on experience, plus bonus; medical, dental and vision; 401(k) with match; paid vacation and holidays; and the rare paralegal job where the work actually changes how food is made in this country.

And one last thing. This is not a file-management job. One of our clients wrote that I came to the hospital while their son was there, and that somebody from this office was in touch every step after. Being that somebody is the job. The people who last here take it personally — they still remember a client’s child by name a year after the case settles, and they are angry that any of it happened at all. If that is you, you will fit here.

The job is open now. Resume and a short note to bmarler@marlerclark.com — in the note, tell me about the hardest lien you ever cleared or the record you had to fight hardest to get. marlerclark.com and billmarler.com if you want to know more before you write. No recruiters.

Equal opportunity employer.

Want to Put Us Out of Business? Come Help Us Try.

Marler Clark has been suing the companies that poison people since 1993 — since a nine-year-old girl named Brianne Kiner nearly died from a hamburger. Sixteen years later it was Stephanie Smith, a children’s dance instructor paralyzed by a hamburger, whose case put the grinding of American beef on the front page of The New York Times and won Michael Moss a Pulitzer Prize. Thirty-plus years later we are still the only law firm in the country that does nothing but foodborne illness — tens of thousands of clients and over $850 million recovered — and there is more work than there are lawyers to do it. The names on the other side are ones you already know: Jack in the Box, Cargill, Dole, Nestlé, Walmart, Wendy’s, McDonald’s, Nebraska Beef, Yum Brands, and this year Taylor Farms, Taco Bell and Boar’s Head.

As I write this, on August 19, 2026: a Cyclospora outbreak the fifty state health departments now count at 31,521 people and rising. The federal government called it 1,947 in nine states until it changed what qualifies as a case in August; its own number is now 9,481 in seventeen states, 398 hospitalized, two dead. Michigan by itself reports 13,909 cases — more than the federal government counts for the entire seventeen-state outbreak. We have five cases filed against Taco Bell, four different franchise operators and Taylor Farms, and more than two hundred other people in twenty-six states have retained us to find out how they were poisoned. Salmonella Javiana in jalapeños grown in Sinaloa — 431 sick in 32 states, Chipotle and QDOBA — which Minnesota epidemiologists and a company traceback found before it ever reached FDA’s outbreak table; a month later the grower still has not been named and the recall of what it sold has spread to more than 160 grocery products. Infant botulism litigation against ByHeart and Nara Organics. Listeria out of Boar’s Head. E. coli O157:H7 from beef kofta and from romaine. Salmonella from nineteen million recalled eggs and from a Lexington pie shop. E. coli O145 in frozen blueberries. Vibrio from raw seafood in Queens. Read a month of marlerblog.com. Clients in need find us; that has never been the hard part.

Finding the defendant is. Nobody hands you one in a foodborne case. You will read FDA inspection reports and environmental assessments, USDA establishment records, whole genome sequencing and PulseNet clusters, epidemic curves built by state health departments, and — this summer — the sanitation and rainfall records of a Mexican municipality where the lettuce was grown and the traceback on a lot of peppers out of Sinaloa. That work gets done before the complaint is filed, not in discovery. You will also have the Outbreak Database, which this office built and still maintains — decades of outbreaks, searchable, and no other firm in the country has it. Spanish is a real plus.

And half of this job is not litigation at all. E. coli O157:H7 became an adulterant in American beef in 1994; six more strains followed because we petitioned USDA to make them so. We helped pass FSMA in 2011, petitioned — so far without success — to have outbreak strains of Salmonella declared adulterants in 2019, and pushed hepatitis A vaccination for food workers in 2020. This year alone: an infant formula bill in the House, a food safety bill in the Senate, the Stop Foodborne Illness petition pending at FDA asking it to tell the public where recalled food went, comment letters on the traceability rule Congress delayed to 2028, and a standing demand that CDC count Cyclospora again. I publish Food Safety News, I have written over 6,000 posts on Marler Blog since 2004, I speak all over the world, and I teach food safety at the Harvard T.H. Chan School of Public Health. You will do this too — including writing here under your own name, where reporters will read it. Within a few years it will be you the conference invites, the health department calls and the reporter quotes; our lawyers speak to industry groups, public health audiences and university classes, and that platform is handed over, not loaned. Work out of this office has been cited in more than a thousand media reports. We also correct in public: when a poultry veterinarian wrote in last month to tell me a post of mine was wrong, we ran the correction louder than the original. Being right matters less here than getting it right. Cases fix one company; the rest fixes the industry.

If you want to know what that adds up to, read the testimonials page on billmarler.com and pay attention to who is on it: a former FDA food safety czar, a former USDA food safety official, the retired head of the Produce Marketing Association. Michael Pollan wrote that the federal watchdog on food safety is asleep at the switch and we are what is left. One of the lawyers who defended the other side in the Jack in the Box cases became my law partner. You will spend your career arguing with the food industry, and some of the people you argue with will end up thanking you for it.

We are looking for an associate with at least five years of litigation experience — personal injury, product liability, med-mal, or complex tort — who is ready to run cases, not just paper. We are a handful of lawyers, not a floor of them: you will carry your own docket from the start.

Here is what you will not do here. There is no billable hour requirement and no origination credit to chase — the clients find us, and the firm carries the cost of every case out of its own pocket until it resolves. There is no committee, no partner standing between you and the person who decides, and no waiting your turn: when you need an answer you walk down the hall and get one. And there is no volume. We turn down cases every week that we could not do right, because a file nobody has time for is worse than no file at all.

Our office is on Bainbridge Island, and the honest truth is that we want you here — living on the island, not commuting to it. We are a few minutes’ walk up from the ferry terminal, thirty-five minutes across the water from downtown Seattle, in a town where you can walk to work, walk to lunch, and walk home. Most people who make the move do not move back. But the right lawyer matters more to us than the right zip code: if you are elsewhere in Puget Sound, or willing to relocate, and can be here most days, we should talk, and we will help the right person get here. 

What you’ll actually do: file in federal and state courts across the country, write the settlement demand letters that resolve most of our cases before anyone sees a courtroom — the medical chronology, the liability analysis, the damages model, all of it yours — take and defend depositions of plant managers and epidemiologists, work up hemolytic uremic syndrome, Listeria meningitis and Salmonella reactive arthritis cases with the best experts in the field, sit with families in hospital rooms, and try cases. The docket is national; you will be on airplanes. It has been international as well — outbreaks in Europe, Asia and Africa. You will be trusted early and often.

Many of our clients are children, and on those cases the last thing you do is the hardest. A settlement for a child has to be approved by a judge, cleared of Medicaid, Medicare, ERISA and sometimes federal military liens, and structured — now and then into a special needs trust — so the money is still there decades later, when the kidney an outbreak took finally has to be replaced. If you have never done a minor’s compromise, you will.

What you need: licensed and in good standing somewhere, admissible pro hac vice everywhere else — Washington admission is not required; real deposition experience; the writing chops to draft a complaint that reporters quote; and the stomach for what an outbreak does to a child. A science background is a bonus, not a requirement — we’ll teach you the microbiology.

What we offer: Competitive salary depending on experience, plus bonus; medical, dental and vision; 401(k) with match; paid vacation and holidays; bar dues and CLE; and cases that end up in The New York Times, in front of Congress, and in Poisoned, the Netflix documentary about this work — watch it before you apply. Also: a commute that involves a ferry or no ferry at all, and a firm that goes home for a safer dinner because of you.

One last thing, and it is the whole thing. Nobody here treats this as a practice area. Everyone here can name the child whose case they will never forget. That is why they stay. A client wrote to us that I came to the hospital while their son was there, and that somebody from this office was in touch every step after; that somebody is going to be you as often as it is me. I am not looking for a lawyer who wants a job. I am looking for one who cannot look away from it and wants to spend the next thirty years making a difference.

The job is open now. Resume, writing sample and a short note to bmarler@marlerclark.com — in the note, pick any case or outbreak off marlerblog.com and tell me what you would do with it first. The rest of it is public too: marlerclark.com and billmarler.com. No recruiters. Equal

Equal opportunity employer.

Saturday, September 5, 2026

This is the ninth Saturday column. Last Saturday’s edition ran under the headline The Federal CyclosporaOutbreak Added 528 People, 41 Hospitalizations and Three New States on the Last Thursday of the Season, and it closed on a prediction: the season CDC defines would end Monday, and nothing else would. That held. The season closed August 31 and the national count went up 1,265 the next morning. What changed this week is who is holding the paper. In three outbreaks a regulator asked for a recall, or the evidence plainly called for one, and none came: a San Diego County egg farm whose barns carry the outbreak strain, an Idaho sprouter on its third outbreak in fifteen years, and a seed supplier that has not answered FDA’s recall recommendation at all. Then on Thursday CDC said it would stop updating the largest outbreak of the year every week. The recall became optional and the count became occasional, in the same seven days.

On Friday afternoon San Diego County said the thing it had been unable to say since July 28. FDA sampled the hen houses at Eben-Haezer’s Happy Hens in Ramona beginning August 17 — floors, perch rails, nest boxes — and Salmonella was found in two of seven houses. Genetic testing linked it to the strains from the sick. The outbreak stands at 23 cases and seven hospitalizations, and for the first time the County said where they live: La Mesa, Del Mar, Ramona, Jamul, and one in Riverside County. Eighteen ate the raw-egg mayonnaise at Ramona Family Naturals Market; five got sick from the eggs themselves. The California Department of Public Health gave the results to the owners and recommended a voluntary recall. As of Friday the farm had not issued one, and results on the eggs are still pending. In December the same two state agencies got a genetic match at Vega Farms, the firm recalled, and CDPH published a warning with the handler code and Julian dates on it. Here the farm announced FDA’s two positives itself, on Instagram, before any agency had said a word. I wrote it up Friday night: the epidemiology already linked those people to those eggs, and a genetic match is the point at which a recall stops being a judgment call.

Sixteen people in Washington, Montana and Idaho are sick from broccoli sprouts, and nobody has recalled them. Washington’s Department of Health posted the outbreak Wednesday: thirteen Washington residents in seven counties, two hospitalized, onsets July 7 to August 18, plus two in Montana and one in Idaho, all Salmonella Bovismorbificans, all pointing at broccoli sprouts from Evergreen Fresh Sprouts of Moyie Springs, Idaho. Montana followed Thursday. Both states say do not eat them and told retailers not to sell them. There is no recall, and as of Friday neither FDA nor CDC had posted a line. This is the company’s third outbreak since 2011 — 25 sick with Salmonella in 2011, when it declined to recall until FDA issued a public warning of its own, and 19 with E. coli O121 in 2014 — roughly sixty people over fifteen years from one sprouter that is still shipping.

The alfalfa seed behind the Minnesota outbreak went to at least two sprouters, and the supplier has not answered FDA. FDA’s August 31 update says the Everything Sprouts alfalfa does not explain all 55 illnesses, that traceback found at least one more grower using the same seed lot from a common supplier, and that FDA recommended the supplier recall the lot and tell its customers to recall what they grew from it. The supplier has not responded, has sent no recall notice, and has instructed nobody. Neither the supplier nor the second grower is named. The count holds at 55 in fifteen states, four hospitalized, and on August 28 the recall grew a fourth product, Robust Radish mix in four lots that shipped through August 26, four days after the alfalfa came off the shelf. I wrote Monday that FDA has held mandatory recall authority over that seed lot since 2011. A recommendation that goes unanswered is the case for using it.

The season closed Monday, the count rose Tuesday, and on Thursday CDC said the weekly updates would stop. CDC’s national page moved September 1 to 18,445 confirmed cases, 990 hospitalizations and two deaths in 49 states and the District of Columbia — up 1,265 confirmed and 68 hospitalizations in a week, with Hawaii joining the map and 13,505 more cases CDC says it is aware of and has not confirmed. Last year’s May-to-August total was 1,180. The federal outbreak page stayed at 11,458 sick, 495 hospitalized, two dead and twenty states, the August 27 numbers, and on Thursday CDC added a line saying it is reducing the frequency of updates as new reports decline. Michigan is at 14,718. Indiana closed its count Wednesday at 2,104. Only thirteen of the forty-one states that ever published a number still maintain a page, and the fifty-state floor is 33,525, nearly three times what the federal outbreak attributes to the lettuce. Nearly 7,000 confirmed illnesses have no source on any page. Shoppers have noticed: the salad aisle is down double digits and July brought the largest one-month lettuce price drop on record.

The research that would explain the parasite is being shut down while the parasite is still moving. Politico reported, and Reuters carried it Sunday, that two of USDA’s three Cyclospora research projects at Beltsville were not funded in this year’s agriculture appropriations and are closed, and the third moves to Iowa this fall without one of its scientists agreeing to go. USDA’s spokesperson said none of the research is disrupted. I said what I thought of that Sunday.

The egg outbreak that took seven months to find is over at 134. CDC closed the Midwest Poultry Services investigation Thursday: 134 sick in eighteen states, 34 hospitalized, no deaths, onsets from November 21, 2025 to August 12, 2026 — three weeks past the July 22 recall of more than 1.5 million dozen eggs. Eighty-five percent of those interviewed ate eggs. FDA’s advisory for the same outbreak still reads July 24 and 98 cases, and its investigation table still carries the file as ongoing. Across the Atlantic the UK’s imported-egg outbreak is at 528 confirmed and two deaths as of September 1, 67 admitted to hospital, and still no importer, no country of origin and no recall named.

The frozen blueberry outbreak added five people and a Walmart lot. CDC’s Thursday update puts the E. coli O145:H28 outbreak from Frutas y Hortalizas del Sur of San Carlos, Chile, at 17 sick — thirteen in Florida, four in Georgia — six hospitalized, onsets May 11 to August 2. On Wednesday the firm expanded the recall to one lot of Great Value Organic Triple Berry Blend sold at Walmart stores in sixteen states, with a best-by date in February 2028. FDA never walked the Chilean plant; it did a remote assessment and put the firm on an import alert. The map and the epi curve are here.

Three smaller files moved, and one of them got no headline at all. CDC’s hepatitis A outbreak from La Serranita frozen conchas negras now stands at 37 sick in four states, thirty of them hospitalized — an eighty-one percent hospitalization rate on an imported frozen clam that dealers in New Jersey and New York have recalled. In Washington, four E. coli cases with onsets in late May and early June trace to raw milk from Dungeness Valley Creamery in Sequim, the dairy’s fourth outbreak since 2009; a June sample came back negative, so there was no recall and no press release either. And in northern Utah the Bear River Health Department has 21 confirmed cases of Salmonella in Cache and Box Elder counties with no source, no serotype and no date range published, in a district that averages about 35 cases a year.

The file with no food named grew again. FDA’s investigation table was updated Wednesday: the Salmonella Newport file posted August 26 went from 84 to 97 cases with traceback only and no food, and the Salmonella I 4,[5],12:i:- file went from 41 to 43. CDC’s dashboard was working 40 multistate investigations as of Wednesday — 24 Salmonella, seven E. coli, seven Listeria, two Campylobacter — none with a product named, and USDA’s table lists nothing open at all. I put the three pages side by side Wednesday night. The empty USDA page is what continuous inspection of beef bought, and it is the page the proposal below would refill.

The recall ledger, with Phyllis Entis at eFoodAlert keeping it as she does every week. Beyond the radish mix and the Walmart berries: Panorama Produce of Mamaroneck, New York, recalled 302 boxes of Martina-brand mangoes from Mexico sold at Walmart stores in Connecticut, New York, New Jersey and Pennsylvania after FDA found Salmonella in mangoes from the same farm; Northwest Naturals of Portland recalled raw chicken cat food and dog food that tested positive for Salmonella and Listeria; and on Friday Foods Alive of Angola, Indiana, recalled organic moringa leaf powder shipped nationwide from January 27 to August 7 after its supplier found Salmonella in a retail sample — the third recall this summer to trace to the same moringa ingredient, no illnesses reported, no supplier named. Her ledger is here, and it was the first place I saw the Evergreen story treated as what it is: a second sprout outbreak running alongside the first.

The proposal to let beef bypass inspection got a Monday follow-up that did not mention inspection. The President wrote on August 28 that he was authorizing documents to let farmers and ranchers process their own food, and the Secretary of Agriculture answered that she was on it. Her Monday announcement was an insurance endorsement, a loan program and a procurement preference — nothing about the Federal Meat Inspection Act, which is a statute, and nothing about custom-exempt slaughter. Representative Massie says it takes a bill, not an order; the Meat Institute and the cattlemen came out against weakening inspection. I explained last Friday what continuous inspection did to my hamburger practice, and I would rather it stay explained.

The formula botulism outbreaks got a report this week, and the report got no rule. The Reagan-Udall Foundation published a 44-page report from a July roundtable paid for by ByHeart and the International Dairy Foods Association: 22 recommendations, all voluntary, and not one parent among the 24 contributors. It landed a week after ByHeart said FDA had no further questions about its root-cause submission, a document nobody outside the company and the agency has read. Fifty-two babies were hospitalized across the two brands, and the testing rule still names Salmonella and Cronobacter and not the organism that paralyzed them. Here is what I would do with the report. The t-shirts go to every member of Congress this month.

Peter Barton Hutt died Wednesday at 91. He was FDA’s chief counsel from 1971 to 1975, the lawyer who persuaded the agency it could write binding regulations, a Covington partner for nearly five decades, co-author of the casebook, and a Harvard Law teacher for thirty years. I spent a career across the table from his work and never doubted he knew the statute better than anyone in the room. I wrote about him Friday. Two more items, compressed: Harvard’s Food Law and Policy Clinic read the FRESH Act’s preemption clause line by line and found it reaches state pathogen standards, restaurant inspection and the right to sue; and on Tuesday the firm files three complaints in San Diego Superior Court for people sickened in the Ramona outbreak, one amended to carry Friday’s genetic match and two new. We are still hiring; the ad from two weeks ago stands, and bmarler@marlerclark.com is the address.

That’s the week — a genetic match in two of seven hen houses and an egg recall the state asked for and did not get, a sprouter on its third outbreak with sixteen sick and no recall, a seed supplier that has not answered FDA, a Cyclospora count that reached 18,445 the day after the season ended and a federal outbreak page that will now update when it updates, an egg outbreak closed at 134 seven months after it began, a 97-case Salmonella file with no food named, a formula report with 22 recommendations and no rule, and the passing of the man who wrote the food law the rest of us practice. The season is over on paper. Check back next Saturday.

About Bill Marler

William “Bill” Marler has spent more than thirty years as a food safety lawyer and advocate—work that began with the 1993 Jack in the Box E. coli outbreak and has never really stopped since. In the years that followed, he has represented victims in nearly every major foodborne illness outbreak in the United States. That case, and the movement it launched, is the subject of the book “Poisoned” and the Emmy Award–winning Netflix documentary of the same name. Bill’s work has been profiled in The New Yorker (“A Bug in the System”), the Seattle Times (“30 years after the deadly E. coli outbreak, a Seattle attorney still fights for food safety”), the Washington Post (“He helped make burgers safer. Now he’s fighting food poisoning again”), and many others.

Dozens of times a year, Bill speaks to industry, regulators, and universities across the United States, Canada, Europe, Africa, China, and Australia about a simple idea: outbreaks are preventable. He has testified before Congress on the Food Safety Modernization Act and teaches food safety at institutions including the Harvard T.H. Chan School of Public Health. He writes regularly about food litigation and food safety at Marler Blog, and in 2009 he founded Food Safety News, which he continues to publish.

San Diego County published a new release at 4:37 this afternoon, and it closes the hole that has sat in the middle of this outbreak for six weeks. The U.S. Food and Drug Administration collected samples inside the Happy Hens hen houses in Ramona. Salmonella was found in two of the seven houses tested. Genetic testing linked the Salmonella from the farm to the strains from ill San Diegans. The California Department of Public Health gave those results to the owners of Happy Hens and recommended that the farm issue a voluntary egg recall. As of today, the farm has not issued one.

What the County said

FDA went out to the farm beginning on August 17. The County describes that visit as a routine inspection unrelated to the outbreak. Samples were collected from the floor and from the perch rails and nest boxes of the hen houses, where droppings accumulate, to check whether the flock was infected. Two of seven houses came back positive, and sequencing tied the farm isolates to the human cases. Test results on eggs distributed by the farm are still pending.

The outbreak now stands at 23 cases with seven hospitalizations, up from the 13 cases and four hospitalizations the County first reported on July 28 and the 21 cases it reported on August 17. For the first time the County has given the geography: La Mesa, Del Mar, Ramona, Jamul, and one case in Riverside County. The County also says its Department of Environmental Health and Quality has now reached out to all retail food facilities to make sure Happy Hens eggs associated with the outbreak are not used or distributed to the public until safe to do so.

One wrinkle for the record. On August 21 a California Department of Food and Agriculture spokesperson told the Union-Tribune that FDA inspected the farm after being notified of the outbreak. Today the County calls that visit routine and unrelated. Both statements are public, and the samples are the same samples either way.

What actually changed today

For six weeks the entire public defense of this farm rested on one sentence: no sample from our farm has ever tested positive. It was said on camera, said on the record to reporters, and repeated on social media. There is now a positive sample, and the genetics tie it to the people who were hospitalized.

I have argued for weeks that the epidemiology was already enough — patients linked to each other by whole genome sequencing, exposure histories pointing at one supplier, and traceback to one ranch is the standard proof package in a foodborne outbreak. A product-side match is confirmation, not a prerequisite. What it does is remove the last public argument for doing nothing.

Worth remembering who announced these results first. The farm did, on its own Instagram account, on August 31, before any agency said a word — nine days after circulating the claim that no sample from the farm had ever tested positive. Today is the first time a public health agency has confirmed the genetic link.

A recall was requested. The farm said no. There is a next step.

A voluntary recall is the first move, not the only one. Under the Food Safety Modernization Act, when FDA determines there is a reasonable probability that a food is adulterated and that eating it will cause serious adverse health consequences, the agency must first give the responsible party a chance to cease distribution and recall. If the company refuses, FDA may order it to stop distribution and notify everyone holding the product, hold an informal hearing, and issue a recall order. 21 U.S.C. § 350l. That statute exists precisely for the situation the County described this afternoon.

A laying operation of this size is federally regulated. 21 C.F.R. part 118 requires a written Salmonella Enteritidis prevention plan, environmental testing of each poultry house, and, when an environmental sample is positive, egg testing with diversion of the eggs to pasteurization until the testing clears. Whether that happened here is a question for the inspection record, which nobody outside the agencies has seen.

California ran this exact play nine months ago

In December, CDPH and CDFA investigated a Salmonella Enteritidis outbreak tied to eggs from Vega Farms in Dixon. They identified the supplier, inspected the operation, and collected egg and environmental samples. Multiple samples were positive, and whole genome sequencing matched at least one of them to the strain in the sick people. The firm recalled on December 5, and on December 12 CDPH issued its own consumer warning — brand name, handler code, Julian dates, sell-by dates, the kinds of stores that got the eggs, and a complaint hotline for anyone who still found them for sale. Sixty-three Californians sick, thirteen hospitalized.

That was a California-only outbreak, run by the same state department that made the recall request in Ramona this week. Same commodity, same pathogen, same category of evidence. Nine months later the state has the match and has asked, and there is still no recall and no consumer warning.

The federal side looks the same. CDC declared the Midwest Poultry Services shell egg outbreak over on September 3 with 134 people sick. FDA inspected and collected environmental samples; three matched the outbreak strain; the company recalled more than 1.5 million dozen eggs; the outbreak closed. A match produces a recall. That is the ordinary course, not an aggressive one.

What is still not public

There is no recall. There is no published list of the stores, farmers markets, and restaurants that received these eggs. This is a county and state investigation, so nobody should expect to find it on FDA’s multistate outbreak page — the agency holding the consumer-warning role here is CDPH, the same agency that recommended the recall, and it has published nothing of its own in this outbreak. A family in La Mesa or Del Mar with a carton of Happy Hens eggs in the refrigerator right now has nothing to check that carton against.

The County’s consumer advice is unchanged and worth following: cook eggs until both yolk and white are firm, throw out cracked or dirty eggs rather than washing them, wash hands and surfaces after handling raw eggs, and keep eggs at 45 degrees or below.

Our cases: amending Hight, and filing Dye and Terrell on Tuesday

We filed the first case in this outbreak for Whitney and Casey Hight in San Diego County Superior Court on August 18. On Tuesday we will file a First Amended Complaint adding what the County announced today — the two positive hen houses, the genetic match to the patient strain, the recall recommendation and the response to it — along with other facts developed since, including the farm’s own August statements about the investigation and its sales to the deli.

Two new complaints go on file the same day, both against Ramona Family Naturals, Inc. and Eben-Haezer’s Happy Hens, with Frederic L. Gordon as local counsel.

Julie Dye is a registered nurse with nineteen years of experience and the nurse educator of the emergency department at Sharp Grossmont Hospital. She ate the Market’s apple walnut chicken salad during the week of June 21. She was admitted with septic shock and acute kidney failure, spent seven days in the hospital, and was discharged on July 3, her fifty-first birthday. She had been diagnosed with triple-negative breast cancer in May, and the bilateral mastectomy scheduled for July 2 had to be postponed.

Virginia Ann Terrell ate the Market’s egg salad and tuna salad and had bought Happy Hens eggs directly for years. She became ill on June 28 and went to the emergency department on July 1. Her husband Andrew brings a consortium claim, as does Julie Dye’s husband, Michael.

The claim against the Market is straightforward, and it is written into California law. Health and Safety Code section 114012 requires a food facility to substitute pasteurized eggs for raw shell eggs in foods that are not thoroughly cooked, and it names mayonnaise as the example. The only lawful way around it is a written variance from the local enforcement agency. The claim against the farm is that the eggs it shipped were contaminated with the organism that put these people in the hospital, which is now, by the County’s own account, a matter of genetic record.

If you got sick

Anyone with diarrhea, fever, or abdominal cramps after eating undercooked eggs should see a doctor and report it to the County Department of Environmental Health and Quality at (858) 505-6814 or through itsonline form. Ask for a stool culture. An isolate is what connects one person’s illness to everyone else’s.

Twenty-three people are sick. Seven went to the hospital. The strain has been found in the barns, and it matches. The eggs are still in commerce. A recall is a phone call.

Peter Barton Hutt died on Wednesday, September 2, 2026. He was 91. The Critical Path Institute, where he sat on the board, announced it the next day. The Personal Care Products Council called him the “Father of Modern Food and Drug Law,” which is less marketing copy than job description.

If you work anywhere near food safety in this country, you have spent your career standing on ground Peter graded, whether or not you knew his name.

A milk route into food and drug law

He grew up just north of Buffalo, New York, the son of a retail dairyman, and delivered milk on summer vacations. He went to Phillips Exeter, then Yale, then Harvard Law, then NYU for a master’s degree in food and drug law, spending a year reading English food law from Magna Carta forward. He landed at Covington & Burling in 1960 by knowing more than the interviewing partner did about federal milk marketing orders. Except for the four years in government, he stayed at that firm for the rest of his life, retiring in October 2024 as its first “Retired Partner in Residence” — and then showing up at the office five days a week anyway.

Four years that built the modern FDA

From 1971 to 1975, Peter was Chief Counsel of the Food and Drug Administration. Those four years did more to shape how our food is regulated than any four years since 1938.

His central move was legal and, to non-lawyers, invisible. He reinterpreted the informal rulemaking authority buried in the 1938 Federal Food, Drug, and Cosmetic Act to allow FDA to issue legally binding substantive regulations under the Administrative Procedure Act. Before that, FDA largely made policy one seizure at a time, in court, against one company. After it, FDA could write rules that governed the entire food supply. Every food regulation any of us has argued about since — preventive controls, produce safety, traceability — rests on the door he opened.

He then walked through it. Under Peter, FDA issued the regulations implementing the GRAS review of food ingredients, required nutrition labeling on half the food supply, redefined “imitation” food, modernized the food standards, and established emergency permit control for low-acid canned foods — the rules that sit between the canned goods aisle and botulism. He is the reason there is a nutrition label on the box, and his explanation never got more complicated than this: people ought to know what they are eating.

He also created the regulatory letter — what we now call the warning letter — as a cheap, fast alternative to litigation. On his way out, he wrote the procedural regulations that govern FDA administrative action. They still do.

His name is on the brief in United States v. Park

The piece of his work I reach for most often is United States v. Park, decided June 9, 1975, squarely inside his tenure. Acme Markets and its president, John R. Park, were charged under Section 301(k) with causing food held in Acme’s Baltimore warehouse to be exposed to rodent contamination. Acme pleaded guilty. Park went to trial, where he conceded that sanitary conditions were something he was responsible for in the entire operation of the company, and that it was one of the many phases he had assigned to dependable subordinates. The Fourth Circuit reversed his conviction and ordered a new trial, holding that the jury should have been instructed the government must prove wrongful action. The Supreme Court reversed that, 6 to 3, reaffirmed United States v. Dotterweich, and gave us the Park doctrine: a corporate officer who had the authority and responsibility to prevent or correct a violation can be convicted without proof of intent or personal participation.

The reporter’s note in the U.S. Reports records that Allan Abbott Tuttle argued the case for the United States and lists on the briefs with him Solicitor General Bork, Assistant Attorney General Kauper, Howard E. Shapiro — and Peter Barton Hutt. By his own account, he is the reason the Solicitor General agreed to defend FDA’s stringent criminal enforcement policy at the Court at all.

Notice what the case turned on. FDA had written Park in April 1970 about insanitary conditions at Acme’s Philadelphia warehouse; a year later inspectors found the same thing in Baltimore. That letter came in over objection, and the Fourth Circuit had called admitting it reversible error; the Supreme Court held it was proper rebuttal to Park’s defense that he had justifiably relied on subordinates. The letter predates Peter’s arrival at FDA, but the instrument and the doctrine fit together, and he is the one who made that instrument standard practice. The warning letter is what forecloses the delegation defense later.

One more thing about that brief. The amici urging the Court to side with Park included the National Association of Food Chains, the National Canners Association, and the Grocery Manufacturers of America. Peter was on the brief against all three and then spent the next forty-nine years representing the industries those groups spoke for. Park is the tool I keep asking the Justice Department to pick back up. He is a large part of the reason it is still sitting there to be picked up.

The teacher

Beginning in 1994, he taught the winter-term Food and Drug Law course at Harvard Law School — the whole history of government regulation of food and drugs, from antiquity to last week. He was still listed on the Harvard Law faculty as a Lecturer on Law for 2026-2027, with Food and Drug Law on the schedule for the spring term.

He was lead co-author of Food and Drug Law: Cases and Materials, first edition 1980, fifth edition 2022. When he started that book, two law schools in the country taught the subject. He wrote it, he said, so the field would be taken seriously and taught everywhere. It worked. Nearly every food lawyer practicing today — on my side of the table and the other — learned from that casebook or from someone who did.

We were not on the same side, and he was still worth listening to

Peter spent most of his career representing the industries FDA regulates, including the national trade associations for food, drugs, supplements, and cosmetics. I have spent mine representing the people those industries sickened. We were opponents by definition.

He was also willing to say things his clients did not enjoy hearing. In a keynote at a Harvard conference in February 2014, he called the Food Safety Modernization Act “poorly drafted and poorly conceived,” written like a regulation instead of a statute and pointed out that the 1938 Act covered all food in four of its nineteen pages while FSMA spent 88 on food safety alone. His bottom line was that the statute was neither necessary nor desirable: after the Second Circuit’s 1977 Nova Scotia decision, he argued, FDA already had the authority to write those rules itself, and the two together left it the most powerful agency in the federal government. He also predicted implementation would take ten years at best and could take twenty-five.

His long-running argument was that FDA needed money more than it needed new statutes. He sat on the FDA Science Board subcommittee whose analysis, by his account, helped push Congress to roughly double the agency’s appropriation between 2008 and 2013.

FDA had that authority for thirty-four years after Nova Scotia and did not write preventive controls, and the people I represent are the reason we stopped waiting. On the money he was right, and it has aged well. Watching FSMA’s traceability rule get delayed and its enforcement starved this year, I keep coming back to his point: an agency handed enormous power, and no resources is a promise nobody intends to keep.

Hong Kong, 2014

A dozen years ago, Peter and I shared a stage – I admit I was a bit star struck. In June 2014 we were both speakers at the First International Conference on Food Safety at the University of Hong Kong, June 16 to 18 — a meeting on global food safety, international harmonization, and the farm-to-table chain. The speaker list ran from Peking University to the Korea Food Research Institute to the Max Rubner Institut and included a former Chief Counsel of the FDA and a plaintiffs’ lawyer from Bainbridge Island.

We came at that audience from opposite ends of the same problem — he from the statute and the rulemaking record, me from the hospital charts and the depositions. What stayed with me is that he never treated the other side of the room as an inconvenience. He wanted the argument. He was also, at 79, the best-prepared person in the building.

The objection was there on day one

His industry ties were a scandal before he had unpacked his office. On September 17, 1971, about a week after he started, the Michigan Daily ran an editorial calling his appointment one of the clearest examples of industry influence on FDA. He had come to the job representing the Institute of Shortening and Edible Oils. His predecessor as chief counsel, William W. Goodrich, had left to become president of that same trade association. Representative Benjamin Rosenthal called it a game of musical chairs and predicted Hutt would have to disqualify himself from three-quarters of the cases coming before the agency. The Senate Commerce consumer affairs subcommittee held a hearing on the appointment that day; because the chief counsel job needed no Senate confirmation, asking questions was all Congress could do.

The editorial’s specific fear is the part worth reading twice. FDA had finally begun moving on ingredient labeling for processed foods, and the paper predicted the industry’s man would tell the agency it lacked the legal authority to write such a rule.

However, he told the agency it had the authority — and used it to put nutrition labeling on half the food supply.

What he leaves

He testified before the House and Senate more than 100 times. Legal Times called him the dean of the food-and-drug bar; Chambers called him a legend. By his own account, he was in the mix to be FDA Commissioner three separate times and never got it — twice because Senator Kennedy would not let anyone who had represented the regulated industry through: in 2001 by refusing to hold a hearing, in 2005 by promising all-out opposition.

That was the objection for nearly fifty years. The man who wrote the rules that made the modern FDA possible was never allowed to run it, because he had spent his career on the industry side. I would still rather have had him in the building.

The food safety world is small. It has a handful of people who can tell you not just what a rule says but why it was written, who fought it, and what the agency gave up getting it. We are down one.

Rest well, Peter.  Condolences to his wife, family and friends.