I read Fast Food Nation before it was a book. Eric and I have known each other a long time, and we talked through parts of Food, Inc. before it was filmed. He has been making the same argument for twenty-five years — that the structure of the meat industry decides who gets sick — and he has been right about it longer than almost anyone writing today. His September 7 guest essay in the New York Times, “Why Did Trump Order Up 660 Million Pounds of Mystery Meat?”, is worth your time.

Five days ago, I wrote about his piece in The Atlantic and turned it into a list of three fights worth having right now — Cyclospora and the traceability rule, botulism testing in infant formula, and Salmonella in chicken. Here is a fourth, and it turns out to be the same fight.

What follows is not a disagreement with Eric. It is the other half. His piece is about labeling, concentration, and how the decision got made. Mine is about the pathogen.

What is actually coming in

The proclamation signed in late August temporarily expands the tariff-rate quota for lean beef trimmings by 300,000 metric tons — about 660 million pounds. The window runs 90 days beginning September 1, capped at 100,000 tons per month, and the effect is to waive the 26.4 percent out-of-quota tariff. Ground beef averaged $6.89 a pound in July.

Eric is right that these are not rib-eyes. They are trimmings — the raw material of hamburger. And that single word is the whole food safety story.

Trimmings are not a detail

E. coli O157:H7 lives in cattle manure and gets onto meat during hide removal. It ends up on the outside surfaces of the carcass, which is exactly what lean trim is. Trim is the highest-risk raw beef component there is, and the entire federal architecture built after 1994 exists because of it: adulterant status for O157 and, later, for six non-O157 serotypes; N-60 excision sampling of trim lots; test-and-hold; and recordkeeping that lets an investigator trace a grinder’s source lots backward.

That architecture reaches imports. FSIS runs a dedicated sampling program for imported beef manufacturing trimmings (MT51), and since February 1, 2023 those samples are analyzed for O157:H7 plus O26, O45, O103, O111, O121 and O145, with Salmonella co-analysis.

I spent from the 1993 Jack in the Box outbreak to the 2002 ConAgra recall doing little else. Hamburger E. colicases are now close to zero in my practice — it is the best thing that has happened in food safety in my lifetime. That did not happen because cattle got cleaner. It happened because the trim gets tested, the lot gets held, and somebody keeps the records.

The one time we actually measured

In March 2017, after Brazilian federal police raided meatpacking plants over allegations that inspectors were being bribed, FSIS put 100 percent reinspection on all Brazilian meat arriving here. The results are public. FSIS refused entry to 11 percent of Brazilian fresh beef — against roughly 1 percent for shipments from the rest of the world — turning back 106 lots and about 1.9 million pounds for public health, sanitary and animal health violations. On June 22, 2017, USDA suspended fresh beef from Brazil altogether. The agency’s own 2017 audit report lists what was being turned away: pathological lesions in raw beef, contaminated beef, off-condition product.

The suspension was lifted on February 21, 2020, after an on-site equivalence verification audit found corrective actions in place. Since then, Brazilian beef has been subject to routine reinspection at ports of entry, like everyone else’s.

Hold those two facts next to each other. “Equivalent” is a finding about a system, made on paper, at a point in time. Routine port-of-entry reinspection is a statistical sample — it is not an inspection of the box that becomes your dinner. The one time we looked at every lot, the failure rate was about ten times the rest of the world’s. We are now inviting up to 100,000 metric tons a month for three months.

Two regulators, one-week, opposite directions

On September 3, the European Commission’s suspension of Brazilian meat, eggs and honey took effect — Brazil was removed from the authorized list because it could not give sufficient guarantees on antimicrobial use in food animals. The American window opened September 1.

I have nothing to add about the White House meetings Eric describes; that reporting is his and Maggie Haberman’s and Jonathan Swan’s, and you should read it there. My point needs no one’s motive. Two competent regulators looked at the same supply chain in the same week and went in opposite directions. Only one of them was looking at it as a food safety question.

What I would ask USDA to do

Not a ban. Four things, all inside existing authority, none of which requires new legislation:

One. Put trimmings entering under the expanded quota at an increased level of reinspection for the full 90 days, rather than the normal sampling plan.

Two. Publish the results monthly — lots presented, lots sampled, lots refused, by country and by foreign establishment. If the beef is as good as we are told, the numbers will say so.

Three. Publish the date and findings of the most recent on-site equivalence audit for every country eligible to ship raw beef here. Consumers are entitled to know how old the paper is.

Four. Confirm on the record that grinder recordkeeping applies with full force to imported source material, and that a source lot can still be identified when a child ends up in a hospital.

The fourth one is the one that decides cases. Eric writes that these grinders combine pieces of tens of thousands of cattle from multiple countries. I have litigated what that sentence means in practice. The only thread running from a sick child back to a slaughterhouse is the grinder’s source-lot record. Every additional foreign supplier makes that thread thinner and the traceback slower — and an outbreak that takes longer to trace is an outbreak that gets bigger.

Two friendly amendments

First, on labeling. I support the Thune–Booker bill to restore country-of-origin labeling, and I have said for years that its repeal in 2015 was a mistake. But be precise about what it buys. A label tells you which borders the meat crossed. It does not tell you whether the meat carries O157:H7. Provenance and contamination are different problems with different fixes. Pass the bill because consumers deserve an honest market — not because it is a control measure, because it is not one.

Second, on the butcher shop. Eric closes by suggesting readers buy American cuts from a local butcher and have them ground on the premises, or grind at home. I understand the impulse, and it does answer the question of what is in the package. It does not answer the safety question. Freshly ground whole muscle from a good local shop has caused outbreaks; I have handled those cases too. Grinding one animal instead of ten thousand narrows how many people get hurt when something goes wrong. It does not make the meat safe. The one thing that makes a hamburger safe is 160°F, measured with a thermometer. Buy from your butcher if you want to know where your beef came from. Then cook it to 160 anyway.

Every item on the list I published five days ago came down to one sentence: finish the rule and put a test in it. Beef is the one place we already did that, and it is the reason those cases left my practice. It would be a strange thing to spend thirty years building that system and then wave 660 million pounds past it because hamburger got expensive.

Eric has spent a quarter century arguing that the shape of this industry determines who gets sick — that consolidation, speed and anonymity are not abstractions but the mechanism by which a pathogen from one animal reaches a thousand people. Six hundred sixty million pounds of anonymous trimmings, arriving in ninety days, into a system that samples a fraction of what crosses the dock, is the newest proof of the thing he has been saying since before most of us were paying attention.

A tip of the pen this morning to Matthew Perrone at the Associated Press, who has been on the lettuce Cyclospora outbreak since July and did not walk away from it when the case counts slowed down. His piece today takes the outbreak and asks the question that outlasts it. How often does anyone from our government actually look at the foreign farms and plants that feed us?

The answer, from agency records he reviewed, is less often every year. Inspections of foreign food sites are down nearly 35 percent since 2019. They fell another 17 percent last year, to 1,140 in fiscal 2025. FDA inspectors reached the Taylor Farms site in Guanajuato in mid‑August, roughly a month after the July 17 recall, and it was the first time anyone from the agency had been there since 2019. Seven years.

This is not new, and I have written about it before

The Government Accountability Office laid it out in January of last year, and I posted it then. From fiscal 2018 through fiscal 2023, FDA averaged 917 foreign food inspections a year against a statutory target of 19,200. That is about five percent. The best year in the set was fiscal 2019, at 1,727, or about nine percent. As of July 2024 the agency had 432 investigators to cover both domestic and foreign work. FDA has told GAO for years that the 19,200 figure is unrealistic and unachievable. GAO recommended in 2015 that the agency tell Congress what a realistic number would be. It still has not.

The arithmetic, which is what a hearing is for

CBS News reported FDA’s own cost estimate last month. An average of $38,700 per foreign inspection. Meeting the mandate Congress wrote into law would run about $743 million a year, more than ten percent of the entire FDA budget. In its most recent budget request, the agency asked for an additional $9 million to expand foreign inspection capacity. The human foods appropriation for this fiscal year is roughly $1.17 billion for the whole program.

Put those numbers side by side. Congress set a target of 19,200 inspections, directed the hiring of 5,000 inspectors under FSMA, and then never appropriated the money for either. The agency now asks for nine million dollars against a mandate that costs seven hundred forty three million. Everyone involved understands the target is fiction, and nobody has to say so on the record because nobody has been asked in a room with a transcript.

That is the hearing. Not a scolding, an appropriation. Ask FDA to state, under oath, the number of foreign inspections it believes is defensible, what that number costs, how many investigators it requires, and what it will take to keep them, given that people in those jobs can spend half or more of their working time traveling. Then ask the appropriators whether they intend to pay for it. If the answer is no, the public deserves to hear that plainly instead of reading a target nobody funds.

What I would not pretend at that hearing

An inspection of that packing operation probably would not have found this parasite. Cyclospora travels through water and human waste, there is no validated test that reliably finds it in irrigation water, and a facility walkthrough is not built to catch it. I have said before that FDA should be looking at foreign growers and their water, not only the packing plants, and before an outbreak rather than five weeks after a recall. A hearing that only counts inspections will miss that.

The list of questions is short. What is the right annual number of foreign inspections, and what does it cost? What does the new one‑day inspection pilot actually document, and what does it miss? Why did it take four weeks to get investigators to Guanajuato, and how much of that was the elimination of the staff who used to book their travel? What would it cost to inspect grower water in the countries that supply our produce? And what would it cost to enforce the traceability rule that Congress has prohibited FDA from spending a dollar to enforce until July 20, 2028?

Invite a consumer

One more thing, and it is the part that always gets left off the witness list. The table at these hearings is agency officials, former agency officials, academics and trade associations. Every person seated at it is paid to be there. I have testified in front of Congress more than once, and the most useful voice in the room has never been mine.

Seat someone who spent July on a bathroom floor. Ask her what the emergency room visit cost, how many weeks of work she lost, and how many doctors she saw before anyone ordered the right test, because routine stool panels do not look for this parasite unless someone asks. Michigan has reported two deaths in this outbreak. Ask that family. CDC counted 18,445 lab‑confirmed cases between May 1 and August 31, with 990 hospitalizations, across 49 states and the District of Columbia. The lettuce outbreak alone accounts for 11,458 of them in 20 states, with 495 people hospitalized. There is no shortage of witnesses.

Thirteen members of Congress wrote to FDA, CDC, HHS and Taylor Farms this summer, and not one published answer has appeared. Letters are the polite instrument. A hearing is the next one, and a subpoena is the one after that.

The AP reports that FDA is studying how many foreign inspections it should conduct each year so that oversight of imported food is comparable to what we expect at home. Good. Finish the study, bring the number to Congress with a price tag attached, and say it out loud in a hearing room, with a consumer sitting at the same table. Thank you, Mr. Perrone, for staying on it.

I have been writing this blog since 2004. Something north of five thousand posts. Nearly all of them are about somebody getting sick from something they ate, and too many are about somebody dying from it.

Here is what I actually did yesterday on Labor Day. I reviewed a life care plan for a woman who will never walk again or care for herself, because of Listeria in deli meat. I worked up the lifetime costs for three children with hemolytic uremic syndrome, caused by E. coli in a romaine lettuce outbreak that FDA never told the public about. I spent an hour on the phone with a woman who is still testing positive for Salmonella after eating mayonnaise made with raw eggs, and who has had to delay her cancer treatment because of it. And I edited a dozen lawsuits to be filed in the ByHeart and Nara infant botulism outbreaks.

Four files, one holiday Monday. Cyclospora in lettuce, Salmonella in peppers and sprouts will wait until today. That is not a complaint. It is the argument for everything that follows.

We tell ourselves we have the safest food supply in the world. Maybe we do. No two countries count illness the same way, so the claim cannot really be tested, and in my experience, it gets used less as a fact than as a reason to leave things alone. What can be tested is our own number, and our own number has not moved.

In April 2025 CDC published its first full rebuild of the burden estimates since 2011, using 2019 data and seven major pathogens: 9.9 million domestically acquired foodborne illnesses, 53,300 hospitalizations, 931 deaths. Norovirus leads both illnesses, at 5.5 million, and hospitalizations, at 22,400. Then Campylobacter at 1.9 million, Salmonella at 1.3 million, Clostridium perfringens at 889,000, and STEC at 357,000. Salmonella kills the most, at 238.

CDC’s consumer page still carries the older 48 million figure, and it is not out of date. Four-fifths of that number was a bucket called unspecified agents — the gastroenteritis nobody ever identifies — and the new paper did not re-estimate it at all. Compare like with like and the picture is worse than a drop. In 2011 CDC put 31 known pathogens at 9.4 million illnesses, 55,961 hospitalizations and 1,351 deaths. Today six pathogens account for 9.9 million. Norovirus was about 5.5 million then. It is 5.5 million now.

That is the scoreboard, and an agenda is serious only if it is scored against it. Here is mine, ranked by what the data says rather than by what makes news.

1. Since it’s Labor Day — start with the people who handle the food.

Norovirus is the largest single line on the scoreboard and puts more people in the hospital than any other foodborne pathogen. CDC examined 800 restaurant outbreaks from 2017 through 2019: roughly 40 percent of those with a known cause involved a worker who came in sick, norovirus accounted for 47 percent of them, and only about 44 percent of managers reported offering paid sick leave. Eighty-five percent said they had a policy against working sick, which tells you the policy is not the binding constraint. The paycheck is.

The fix: paid sick leave for food workers, by state law where Congress will not act. It is the cheapest intervention available and aims at the biggest number on the board.

Two more belong in the same item, because a worker who cannot speak up and cannot get vaccinated is not much safer than one who cannot afford to stay home.

Whistleblower protection. FSMA gave food workers anti-retaliation rights in 2011, enforced by OSHA, and they are narrower than they sound. The complaint has to sound in the Food, Drug and Cosmetic Act, the filing window is 180 days, and workers in meat and poultry plants, which answer to a different statute, are largely outside it. Widen the coverage and lengthen the window. The people who see the problem first are standing on the line, and today most of them are better off saying nothing.

Hepatitis A vaccine. It is the only common vaccine-preventable foodborne disease in this country, and CDC still declines to recommend the shot for food service workers on the ground that they face no increased occupational risk. That answers a question nobody asked. They are not at greater risk of getting it. They are a risk of giving it, and about a quarter of infections are asymptomatic, so neither the cook nor the manager knows. St. Louis County has required the vaccine since 2000 and has not had a hepatitis A outbreak since. Famous Anthony’s in Roanoke had one infected cook: fifty-two sick, thirty-six hospitalized, four dead, six million dollars in acute medical bills and a chain in Chapter 11, over a shot that costs thirty dollars. I have written about this again this week.

2. Fix chicken.

Campylobacter and Salmonella together are roughly a third of the scoreboard, and Salmonella kills more Americans than any other foodborne pathogen. Interagency attribution work puts more Salmonella illness on chicken, at 19.1 percent, than on any other food. FSIS determined in 2024 that Salmonella at 1 colony-forming unit per gram in not-ready-to-eat breaded stuffed chicken is an adulterant, and it is still law. In December 2025 FSIS indefinitely delayed the sampling that would enforce it.

The fix: enforce the rule FSIS already wrote, extend it to chicken parts and ground poultry, and publish the validation data behind both positions. I drafted a FOIA asking for exactly that. Then make the worst FSIS performance category disqualifying for federal poultry purchases, with a defined path back. A purchasing specification takes a phone call. Rulemaking takes a decade.

3. Fix leafy greens, including the imported ones.

Attribution puts 67.9 percent of E. coli O157 illness and 27.4 percent of Listeria illness on vegetable row crops. That is lettuce and spinach, increasingly grown outside the United States. Guanajuato iceberg and Sinaloa jalapeños both landed here this summer.

The fix: pre-harvest agricultural water is the known route, and those standards have been delayed twice. Finish them, fund foreign inspection and FSVP audits, and restore the enforcement money Congress restricted for the Produce Safety Rule.

4. Fix the two recurring Listeria sources: dairy and deli.

Dairy carries 31.9 percent of attributed Listeria illness, and ready-to-eat deli meat is the other source that keeps coming back. It is why I spent part of Labor Day reading a life care plan. CDC researchers calculated that unpasteurized dairy causes 840 times more illnesses and 45 times more hospitalizations than pasteurized, out of a sliver of consumption. I am handling raw goat milk and raw milk cheese cases right now.

The fix: enforce the existing interstate raw milk ban, stop the state-by-state expansion of herd shares and retail sales, and require ready-to-eat processors to publish environmental sampling results. Adults may decide for themselves. A four-year-old on dialysis decided nothing.

5. Count the sick.

FoodNet is the only active foodborne disease surveillance we have, and on July 1, 2025 it dropped from eight pathogens to two. Cyclospora and Listeria were both cut. Barb Kowalcyk put it more precisely than I would have: it was never funded well enough to carry eight in the first place.

The fix: fund it for eight and fund the state labs that feed it. CDC asked for roughly 72 million dollars for food safety in fiscal 2026. You cannot take down a number you have stopped counting.

6. Keep the isolates.

Clinical laboratories have moved to culture-independent tests. They are faster and better for the patient, and they produce a result without producing a bacterial isolate. PulseNet needs the isolate. No isolate, no genome, no cluster, no outbreak. CDC says plainly that without isolates PulseNet cannot keep detecting clusters, and clinical microbiologists have called the transition a threat to foodborne disease surveillance since 2016. Whole genome sequencing is how the patients in that romaine outbreak were tied to one another in the first place. That only works if somebody cultured the specimen.

The fix: require reflex culture and isolate submission on CIDT-positive specimens for the PulseNet pathogens, and pay the laboratories for it. The unreimbursed cost is the real obstacle and it is a small one. Counting the sick is worth very little if you cannot tell which sick people belong together.

7. Turn the traceability rule on.

Traceability does not prevent the first illness. It prevents the three hundredth, and it keeps fear from pricing a whole category when the problem sits in one facility. Congress set a January 2013 deadline. The rule issued in 2022 only after a nonprofit sued and a judge set a schedule, compliance was pushed to July 2028, and Congress barred FDA from enforcing it. A Congressional Research Service report this January, citing a Government Accountability Office finding, says FDA still has not built the internal tracing system the statute required. Deadline to enforcement: fifteen and a half years.

The fix: repeal the funding prohibition and build the system.

8. Tell the public what you know, when you know it.

The romaine in my opening paragraph was never announced. Eighty-nine sick across fifteen states, thirty-six hospitalized, seven with hemolytic uremic syndrome, one dead, and in January 2025 FDA and CDC closed the investigation recording the vehicle as romaine from a common supplier. No grower, no processor, no advisory. FDA’s position is that it names firms when there is actionable advice to give consumers, and that the product was gone before investigators confirmed the source. Those families learned what happened from a lawyer. It took a records request and our litigation to get the names out from behind the gray boxes.

The fix: name the firm and the product when the agency knows, even after the product is gone, because the public record is what makes the next one preventable. Publish retail consignee lists the day a recall is announced. Transparency is the cheapest enforcement there is, and an item here that needs no new statute.

9. Fix GRAS and be honest that it is a different number.

Self-affirmation lets a company decide privately that a novel substance is safe and never tell FDA. That is how tara flour reached Daily Harvest Crumbles. We represented 339 of the roughly 470 people sickened, and nearly forty of them lost their gallbladders. FDA’s proposed rule uses tara as its lead example, and it is progress that stops short: mandatory notification is not premarket approval, and a company may still ship first and notify later.

The honest part: the scoreboard above is pathogens. Chemical exposure is a real problem measured in chronic disease over decades, not in emergency rooms this week. Both deserve fixing, and neither should be funded out of the other’s budget.

10. Set the target and make somebody answer for it.

Federal reduction goals exist for four pathogens. None has been met, and Campylobacter and STEC appear to have gone the wrong way. Nobody loses a job over it, because no single official owns the number. Thirteen members of Congress wrote to FDA, CDC and HHS about this summer’s outbreak. Not one published answer.

The fix: one published national figure, one annual public accounting, and one agency answerable for it. I have argued for a single food safety agency for twenty years without success, so here is the fallback — pass the bills already written. H.R. 7867, the Infant Formula Safety Modernization Act, is one of them, and I have said so to the Energy and Commerce Committee.

What is not on this list

Plenty. Chronic disease and diet are not here, and they belong in any honest accounting of what food does to Americans. Neither is antibiotic resistance, or the safety of the people who work in the plants and the fields. I picked these ten because they are the ones where the evidence is clear, the fix is known, and the obstacle is a decision rather than a discovery. I would rather be argued with about the ranking than be vague about the method.

The method is the whole point, and it is not complicated. State the problem in plain terms. Propose a solution a reasonable person can defend. Execute it. Then measure whether the number moved. That work does not belong to any one of us: industry, government and consumers all have to want a fact and science based answer more than they want to win the argument about the last outbreak. Almost none of the last thirty years of that argument has been about preventing the next one. Reactive is how we got a number that has not moved since I started writing.

None of this is exotic. E. coli O157:H7 became an adulterant in ground beef in 1994, and that one decision took a large part of my practice away. I have never been happier to lose business, and it is still the only item on this list that has actually been done.

Twenty-two years. Five thousand posts. Four files on a holiday Monday. Do something, and one of these years I will take Labor Day off.

Every so often someone asks me why a recall they saw all over the news barely exists in FDA’s files, or why a recall they stumbled on in an FDA database never made the news at all. The answer is that FDA keeps two recall lists. They are built differently, they are filled in by different people, and only one of them is complete.

The page most people mean

When people say, “the FDA recall page,” they almost always mean Recalls, Market Withdrawals, & Safety Alerts. FDA describes it as information gathered from press releases and other public notices, and every entry on it carries the same disclaimer: when a company announces a recall, FDA posts the company’s announcement as a public service, and FDA does not endorse the product or the company. FDA also says outright that not all recalls have press releases or are posted on this page. It is a bulletin board. If a company writes nothing, there is nothing to pin up.

The page almost nobody reads

The other list is the weekly Enforcement Report, published under 21 CFR 7.50. This one is FDA’s own, and it includes all recalls the agency monitors — Class I, II, III, or not yet classified. It is searchable back to June 8, 2012, exports to CSV, and has an API. It is also written in lot codes and batch ranges, it appears only after FDA works through classification, and no ordinary consumer has ever read it.

FDA is explicit on one point that matters here: classification and posting in the Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning. Deciding a recall is Class I does not send anybody back to warn the public.

Here is what the split looks like in practice, using two recalls from this year.

The recall you saw

On September 6, Made Fresh Salads Inc. of Bay Shore, New York recalled all of its ready-to-eat deli style salads and cream cheese over possible Listeria monocytogenes contamination. Environmental sampling by FDA and the company had turned up positive areas in the facility. The products went to Brooklyn, Queens, the Bronx and New York City by direct delivery to retail stores and distributors, in 5-pound and 30-pound tubs and half-size aluminum pans, with expiration dates running from September 3 to September 18. Stores repack it, so as the company notes, retail packaging and coding vary by location. No illnesses have been reported to date.

That recall got the full treatment: a press release on the recall page, sixty-eight product lines named one by one, dozens of product photos, refund instructions and a consumer phone number. Whatever hazard class FDA eventually assigns it, the public already knows.

The recall you did not

Recall H-0909-2026 was initiated on May 6 by The Coffee Connexion Co., Inc. of Lebanon, Tennessee — 913 cases of alfredo sauce in 3-pound 7-ounce sealed poly bags, twelve bags to a case. The sauce contained dry milk powder caught up in the California Dairies Inc. bulk recall of April 20, which covered bulk powdered milk and buttermilk sold to wholesale distributors and manufacturers, reported at roughly 2.7 million pounds. The alfredo went to forty-one states. On June 4, FDA classified it Class I — the category for a reasonable probability of serious adverse health consequences or death.

The Enforcement Report record has a field for the press release. It reads: Press Release Not Issued For This Recall.

It is not on FDA’s Major Product Recalls hub for the California Dairies event either. That page lists eleven downstream companies — Ghirardelli, Utz, Sanfilippo, Pork King Good and the rest — and every one of them links to a company announcement, because the table is assembled out of announcements. The alfredo also carries its own event number, unlinked to the parent recall, so nothing in the database connects it to the milk powder except a sentence of free text in the reason field.

The difference is not what you would guess

It is not hazard. The alfredo is a federally designated Class I. The salads had not been classified at all.

It is not reach. The alfredo went to forty-one states. The salads went to four boroughs.

It is not whether a consumer could recognize the product. Neither is recognizable. Both are bulk packs that get repacked, plated or ladled onto something else before anyone eats them.

The difference is that one company wrote a press release and the other did not. FDA can issue its own public warning under 21 CFR 7.42(b)(2), but the agency reserves that for urgent situations where other means of preventing use of the product appear inadequate, and it almost never uses it. A firm that can telephone every consignee on its invoice list is treated as having taken care of the problem.

What this does to the numbers

Recall counts get thrown around constantly as proof that the food supply is getting safer or getting worse. Almost nobody says which list the count came from. They should, because the two lists cannot be compared.

They count different things. The press release page counts companies willing to publicize. The Enforcement Report counts recalls.

They count in different units. Made Fresh Salads is one press release covering sixty-eight product lines, and in the Enforcement Report product lines generate their own records. The alfredo sauce is a single product record inside a larger recall event. Depending on which page you use and what you treat as one recall, these same two matters can be counted as two, or as dozens.

They run on different dates. The press release page is dated when the company announced. The Enforcement Report turns on the classification date, which for the alfredo landed twenty-nine days after the recall started. A recall initiated in December gets classified in January and shows up in the next year’s tally.

And the lag always flatters the present. Any count of the current year is missing every recall still sitting in the queue unclassified. The recent past will always look calmer than it later turns out to have been.

When someone tells you recalls are at a multi-year low or an all-time high, three questions settle it: which database, counted in what unit, keyed to which date. Most of the time the person making the claim cannot answer any of the three.

What ought to change

A Class I recall means FDA believes the product can kill someone. There is no defensible reason for one of those to pass without public notice. Make the announcement mandatory for Class I or let FDA issue it when the company will not. Give downstream sub-recalls the parent event number so an ingredient recall can be followed to the end of the chain. And make press-release status a searchable field, so anyone can pull the list of Class I recalls the public was never told about.

I do not know whether anybody got sick from that alfredo sauce. Neither does anyone else, which is the point. Somebody who ate it in a cafeteria in May and spent a week very sick has no way to connect that week to a record that surfaced in June, in a database they have never heard of, on a page FDA does not expect them to read.

The cyclosporiasis season closed on August 31. The counting did not. CDC now reports 18,445 laboratory-confirmed cases of domestically acquired cyclosporiasis since May 1, with 990 hospitalizations and two deaths across forty-nine states and the District of Columbia. The comparison figure for the same four months of 2025 is 1,180. The total will keep climbing for weeks, because CDC says it takes about six weeks from the start of symptoms to the day a case reaches the agency, so illnesses that began in late August will not finish arriving until October.

The Taylor Farms lettuce is not the whole of it, and that distinction is where the next several months of work sit. CDC, FDA and state officials have linked 11,458 of those illnesses in twenty states, with 495 hospitalizations and both deaths, to processed iceberg lettuce from Taylor Farms de Mexico, recalled on July 17. That leaves close to seven thousand laboratory-confirmed cases with no food named at all. The two counts carry different as-of dates, so treat the subtraction as an estimate rather than a figure and add to it the 3,491 confirmed infections CDC is still sorting into domestic or travel-related and the at least 13,505 further cases the agency says it is aware of. Epidemiologists will be working through the unattributed cases into the fall and the winter, and so will I.

Every one of them is a person who ate something. The open question is what.

Congress spent the same week doing something else. On September 1 the House cleared the Senate’s continuing resolution by 370 to 48, and the President signed it the next day. It funds the federal government at fiscal 2026 levels through December 11, thirty-eight days after the midterm elections. Section 780, the provision barring FDA from spending a dollar to administer or enforce the Food Traceability Rule before July 20, 2028, is a fiscal 2026 provision. No member voted to keep it this month. It survived because a stopgap carries the prior year forward, and because nobody asked.

While that was happening, Taylor Farms posted on its own website that it fully supports and endorses the Food Traceability Rule, that it implemented traceback protocols ahead of the compliance deadline, and that each of its products can be traced to grower, ranch, lot, harvest date and time. Read that beside the paragraph above. The company at the center of the largest foodborne outbreak of the year says it can already do the thing Congress has forbidden the FDA to require.

I am, by disposition, a hopeful person. It is getting harder. Eighteen thousand people are confirmed sick, two are dead, an industry has lost a season of consumer confidence, and the federal answer has been to keep the lights on until December.

Here are ten things that would have prevented this outbreak or made it smaller. Not one of them requires an invention. They run roughly in order of how much illness they would have stopped, which is not the same as the order of how easily they can be done.

What would have kept the parasite out of the lettuce.

1. Fix sanitation in the growing region. Humans are the only known host of Cyclospora cayetanensis. Every oocyst that reached an American plate came out of a person. That makes this a question of field toilets, handwashing, sewage and irrigation water, which is uncomfortable to say and not remotely mysterious.

2. Treat agricultural water against the actual hazard. The leafy greens marketing agreements require an antimicrobial validated against generic E. coli, a bacterial indicator scored by a bacterial test. FDA has said plainly that traditional fecal-indicator testing will not find this parasite. We are measuring the wrong organism and reporting the result as safety.

3. Verify the foreign supplier, which was already the law. An importer owes a duty under the Foreign Supplier Verification Programs rule to analyze the known or reasonably foreseeable hazards in what it brings in, and FDA’s own list of those hazards names parasites first. Cyclospora on imported produce has been known and foreseeable since the 1996 raspberries, and this company’s own 2013 outbreak was notice in writing. That obligation needed no rulemaking, no compliance date and no act of Congress. It has been on the books since 2017.

4. Make import surveillance of Mexican leafy greens permanent. After the 2013 Cyclospora outbreak traced to the same company, FDA announced increased surveillance. Thirteen years later it announced increased surveillance again. It worked both times. What did not exist was the thirteen years in between.

5. Fund the research. Two of the three federal Cyclospora research projects were defunded in fiscal 2026, and the third is being moved out of Beltsville. There is no culture method and no animal model for this parasite. That work is the only route to a validated kill step, and it was cut in the year of the largest outbreak ever recorded.

What would have made the outbreak smaller once it started. This is the group you and I can still move.

6. Put the Food Traceability Rule back on schedule and take Section 780 off. Lot-level records, producible in twenty-four hours, leafy greens on the covered list, compliance January 20, 2026. A coalition of consumer, public health and labor organizations asked Congress to rescind the rider on August 12, pointing directly at this outbreak, and has had no answer. December 11 is the next date on which it can be undone. After that the calendar runs to July 2028 by itself.

7. Write it into the purchase order. Nothing stopped any large buyer from making parasite-specific water treatment and verified sourcing a condition of purchase. Private contracts move faster than FDA ever will, and the biggest customers in this supply chain have the leverage to write the specification in an afternoon.

8. Name the food faster. The first illness began June 14. FDA announced its investigation July 16. A month of exposure ran in between, and the records that would have closed that gap are the ones the rule requires and the rider forbids paying for.

What would have let us see it while it was happening.

9. Get the test ordered and publish one national number. Routine stool panels do not always screen for Cyclospora, so a clinician has to ask for it specifically. CDC advised clinicians in July. Forty-one states carried cases, a shrinking handful still maintain a public page, and CDC has now come off a weekly schedule on the largest outbreak of the year. The public cannot measure a thing it cannot see, and neither can Congress.

10. Make the test affordable. People without insurance do not pay out of pocket for a stool panel to diagnose a diarrheal illness they expect to outlast. Every untested case is a case that never counts, and the count is the only thing that moves an agency.

Four dates describe this summer better than any argument I can make. June 14, the first person got sick. June 15, FDA convened a public meeting on making lot-level traceability easier. July 15, the comment period on that meeting closed. July 16, FDA announced it was investigating. The meeting about relieving the industry of the requirement opened the day after the first person fell ill and closed the day before the government said out loud that there was an outbreak. The lobbying record explains how the dates got that way.

None of the ten is a lawsuit and none of them is mine to accomplish. Thirteen members of Congress have written about this outbreak and not one has a published answer. The trade associations that spent the summer explaining what else it might have been could spend the fall asking for the rider to come off, and the companies that say they already comply have the strongest standing of anyone to ask. December 11 is the date. After that, everybody gets to be surprised again next June.

Newsweek reported this morning, in a piece by Aliss Higham, that a new GS1 US survey of 1,000 U.S. adults found 94 percent concerned about the frequency of food recalls, up from 93 percent in 2025 (Newsweek, September 7, 2026). The headline number is not the one that should worry the food industry. The number underneath it is: the share of Americans who believe recalls are effective at protecting public health and safety fell from 85 percent to 80 percent in a single year. People are not only worried about how often food gets pulled off the shelf. They are losing confidence that pulling it off the shelf accomplishes anything.

The behavior numbers in the GS1 US release are worse. Sixty-seven percent said they had avoided an entire food category after a recall, up from 60 percent last year. Sixty-six percent said they were hesitant to buy the same product or brand again, up from 59 percent. Fifty-nine percent said they had thrown out recalled food even when their own state was not affected. Among women, 71 percent said they had walked away from a whole category, against 63 percent of men. Only 9 percent said they would never buy a recalled brand again, which is the most revealing figure in the set. This is not shoppers punishing one company. It is shoppers backing away from an aisle.

GS1 US is the barcode and data standards organization, and it has a position: it wants the FSMA Section 204 traceability rule implemented and 2D barcodes adopted. It does not make the numbers wrong, and I agree with where GS1 lands on traceability.

Six other surveys this year found the same thing.

Quinnipiac surveyed 963 registered voters from July 23 through July 27, in the last full week of the worst summer of foodborne illness in three decades, and asked about confidence in government oversight of food safety. Twelve percent said a lot and 31 percent said some. Twenty-five percent said not so much and 30 percent said none at all. Thirty percent of American voters have no confidence at all, and that is the number I would tape to the wall.

Gallup has asked about confidence in the federal government to ensure the safety of the food supply since 1999. It ran near eight in ten from 1999 through 2006 and about seven in ten from the 2007 Salmonellaoutbreak through 2019, when it was 68 percent. It fell to 57 percent in 2024 and 53 percent in July 2025, the lowest in the twenty-six years Gallup has asked. In 2024, 37 percent said they had thrown out or returned food over a recall or advisory and 53 percent said they had avoided certain brands or types of food. The 2026 wave was fielded in July, during this outbreak, and has not published.

The International Food Information Council, which is industry funded, has tracked confidence in the safety of the U.S. food supply since 2012, when it stood at 78 percent. It was 70 percent in 2023, 62 percent in 2024 and 55 percent in 2025. KFF found in April that 46 percent of voters approve of the administration’s handling of food policy, and that voters split 31 to 27 on whether they trust Democrats or Republicans to keep food additives and pesticides safe, with 31 percent trusting neither. Navigator Research found in May that 51 percent are confident their food is safe and 46 percent are not, and that when asked who is to blame, 46 percent named large food corporations, 46 percent named chemical and pharmaceutical companies, and 4 percent named farmers. A new Word In Black survey published this month found more than 60 percent of Black Americans reporting concerns about the nation’s food safety.

Two qualifications, because I want this right. The collapse is in confidence in government, not in the food itself. Gallup asks separately whether the food sold in most grocery stores is safe to eat, and that number stood at 73 percent in 2025, against 72 percent the year before, though both are down from 81 percent in 2019. And a good share of the decline in confidence in government is partisan rather than parasitic. Gallup attributes much of the 2024-to-2025 drop to Democrats reacting to a change of administration, and that reading was taken a year before this summer. The Quinnipiac number is a single question with no trend line behind it, the last of thirty-three in a survey otherwise about the war with Iran.

Here is what federal officials were saying while that polling was in the field.

On August 11, Kyle Diamantas, the acting FDA Commissioner, went on CNBC and said, “We have the safest food supply in the world. Full stop”. He said Americans should feel confident eating fresh produce including leafy greens, and he told the network, “Americans should have full confidence in the food supply in this country”. HHS, which Robert F. Kennedy Jr. runs, posted the same day that “Cyclospora: contained, American food: safe”. Diamantas allowed that the outbreak had made people more aware of foodborne illness. He did not say what the agency was doing to keep the food safe in the first place.

Diamantas, a lawyer by training and formerly the Deputy Commissioner for Human Foods, has been acting Commissioner since Marty Makary resigned on May 12. The President nominated Heidi Overton for the permanent job on August 19, and she has not been confirmed.

The claim has a factual basis. That is not the same as it being an answer.

FDA has made a version of this claim for years, and it is not made up. In 2022 Commissioner Robert Califf wrote an FDA Voices piece pointing to the Economist’s Global Food Security Index, where the United States ranked joint first on the food safety indicator. Three things about that index. It is sponsored by Corteva Agriscience, an agricultural inputs company. The 2022 report was its eleventh edition and, as far as I can find, its last, which makes the evidence four years old. And in that same edition the United States ranked thirteenth of 113 countries overall. Note the wording too. Califf wrote that we have one of the safest food supplies in the world. Diamantas said the safest, full stop. Meanwhile the standing CDC estimate has not moved: roughly 48 million Americans get sick from food every year, 128,000 are hospitalized and 3,000 die.

Public opinion cannot refute a safety claim. The illness numbers can.

CDC’s case data page, updated September 1, counts 18,445 laboratory-confirmed domestically acquired cyclosporiasis cases between May 1 and August 31, with 990 hospitalizations, two deaths and cases in 49 states and the District of Columbia. The comparable figure for the same stretch of 2025 was 1,180. The iceberg lettuce outbreak that CDC and FDA have tied to Taylor Farms de Mexico accounts for 11,458 of those illnesses, 495 hospitalizations and both deaths, across 20 states. That leaves roughly 7,000 confirmed cases this summer with no food named at all. At the same time, an FDA investigation of Salmonella in jalapeños sourced from Mexico has reached 431 illnesses in 32 states with 57 hospitalizations.

Newsweek also carried a Trace One analysis of FDA and USDA data putting total recalls at 505 in 2021 and 613 in 2025, a 21.4 percent increase, with Class I recalls, the ones for products most likely to hurt someone, up 36.4 percent. Third-party recall tallies vary depending on whether you count events or products, so treat the trend rather than the decimal. The trend is up.

What moves these numbers is not messaging.

Ninety-four percent concern and 30 percent no-confidence-at-all are not a communications failure. They are an accurate read of a summer in which tens of thousands of people got sick, most of them will never be told what they ate, and the traceability rule written to answer exactly that question has been pushed to July 20, 2028. Growers and processors should be testing agricultural water and finished product for the pathogens that actually turn up in leafy greens, and publishing what they find. The buyers who lost sales this summer should write those tests into their supplier specifications and refuse product from anyone who will not run them. That is what the beef buyers did after 1993, once USDA declared E. coli O157:H7 an adulterant in ground beef in 1994, and it worked. I wrote about the produce aisle side of this last week, in Shoppers Are Walking Past the Produce Aisle.

Telling people the food supply is the safest in the world, while roughly 7,000 of them have a confirmed parasite and no explanation, does not restore confidence. It spends it. The polling is not consumers being irrational. It is consumers keeping score.

Lena H. Sun and Paige Winfield Cunningham walked through each of the childhood vaccines the CDC stopped broadly recommending, in the Washington Post. Their piece is what prompted this one. It is worth your time in full. But the hepatitis A entry runs a few paragraphs in a survey story, and hepatitis A is the one item on that list I have spent my whole career on.

On January 5, 2026, the administration rewrote the childhood immunization schedule, and hepatitis A was one of the vaccines demoted. CDC no longer recommends it for all children 12 to 23 months. The only children it is now affirmatively recommended for are those traveling internationally to places where the virus is common. Every other child falls into shared clinical decision-making. The number of vaccines routinely recommended for all children dropped from 17 to 11, and the Advisory Committee on Immunization Practices, which has made these calls since 1964, was not consulted.

A vaccine this country adopted because hepatitis A was a domestic food-safety problem has been reclassified as a travel vaccine. I have spent twenty-eight years on the other side of that decision.

The rarity argument eats itself

The assessment behind the change says the “benefit-risk ratio is at best very low for most children”, on two grounds: thin safety data, and a rare disease.

Hepatitis A is rare in American children because we vaccinate American children. ACIP recommended routine vaccination at 12 to 23 months in 2006, and reported cases fell about 95 percent; infection rates dropped roughly 97 percent between 1995 and 2015. Citing the low case count as grounds to stop is like disbanding the fire department because the building has not burned. As for thin data, the vaccine has been licensed since 1995 and given routinely to every toddler since 2006 — hundreds of millions of doses. If that is insufficient, nothing will ever be sufficient.

CDC’s own material notes children under six usually have no symptoms. The new guidance treats that as a reason the shot does little for them. It is the reason to give it. An unvaccinated toddler with no symptoms is a silent carrier who brings the virus home from day care to parents and grandparents, where hepatitis A means jaundice, weeks of lost work, hospitalization, and for older adults and anyone with liver disease, death.

Where this stands today

On March 16, 2026, Judge Brian Murphy in the District of Massachusetts stayed the January changes and the thirteen ACIP appointments. The schedules reverted to their pre-January form. The government appealed to the First Circuit in late April and moved to expedite in late August; no ruling yet. ACIP has had no quorum since March and has not met since December 2025. The universal recommendation survives, held up by a district judge, while the committee that should own the question cannot convene.

Thirty years of cases that a vaccine would have prevented

Here is what this looks like from my desk. Every one of these is on our outbreak roster, and every one of them was preventable by a shot that costs $30 to $120.

Contaminated food. Chi-Chi’s at the Beaver Valley Mall in Monaca, Pennsylvania, 2003 — green onions from Mexico, more than 650 cases, four deaths, a liver transplant, and over 9,000 people lined up for immune globulin. It was the largest single-source hepatitis A outbreak in American history. We resolved 78 victim claims and recovered $6.25 million for Richard and Linda Miller; Mr. Miller lost his liver. Townsend Farms frozen berries sold at Costco, 2013 — pomegranate seeds from Turkey, 165 cases in ten states, eight individual suits and nine class actions. Tropical Smoothie Café, 2016 — Egyptian frozen strawberries, 134 cases in nine states, 52 hospitalized; we represented about 75 people. Genki Sushi on Oahu and Kauai, 2016 — imported frozen scallops, 292 cases, 74 hospitalized, one death; we represented roughly 85 people including the family of the man who died. Then blackberries at Fresh Thyme and Woodman’s in 2019, fresh organic strawberries in 2022, frozen organic strawberries in 2023.

An infected worker. My first was a Seattle Subway in 1998: 30 people exposed, and a child who went into acute liver failure and needed an emergency liver transplant. Then McDonald’s in Washington and Taco Bell in Florida, Maple Lawn Dairy and Quizno’s in 2004, Houlihan’s in 2007, McDonald’s in the Quad Cities, Olive Garden in North Carolina, Alta and New Hawaii Sea in 2013, Red Robin in Missouri, the Mendham Golf & Tennis Club in New Jersey, 555 East American Steakhouse in Long Beach, Gino’s Ristorante & Pizzeria.

And then Famous Anthony’s in Roanoke in 2021. One infected cook worked three locations. Fifty-two people sick, at least 36 hospitalized, four dead. One family buried two of its members. One survivor needed a liver anda kidney transplant. Acute medical bills passed $6 million. The chain went into Chapter 11. All of it because one employee did not get a $30 shot.

I took this to CDC myself — with t-shirts

In June 2023 I flew to Atlanta with arguments, a letter to the ACIP Secretariat, medical summaries for 31 Famous Anthony’s victims and families, and a box of t-shirts. I have never been above using a t-shirt to make a point. The ask was modest: not a mandate from CDC, just a recommendation that food service workers be vaccinated. The answer has not changed. CDC says food handlers face no increased occupational risk. That answers a question nobody asked. They are not at greater risk of getting hepatitis A. They are a risk of givingit, and about a quarter of infections are asymptomatic, so neither the carrier nor the manager knows.

The places that require it — and the one that quit

You asked whether anyone actually does this. A few do, and the record is striking.

St. Louis County, Missouri passed its ordinance in December 1999, effective 2000, after a decade of food-handler outbreaks that ordinary interventions could not stop. The county’s case rate fell from 3 per 100,000 to 1. Fifteen food handler cases were reported in the region in 1999 and five in 2000; between 2001 and 2017 there were five total, three of whom worked outside the county. The region has not had a hepatitis A outbreak since 2000. That is a twenty-five-year natural experiment and it came out one way.

Franklin County, Missouri followed on July 30, 2019 after more than 50 cases: ninety days to the first dose, records for inspectors, $20 doses for the uninsured, covering restaurants, hospital cafeterias, school kitchens, day cares, nursing homes and sandwich carts. Boyd County, Kentucky and neighboring Ashland did the same in 2018. That is close to the whole national list.

Clark County, Nevada is the cautionary tale. Las Vegas required the two-dose vaccine for every food handler card starting in 1999, covering more than 125,000 workers a year. Case rates dropped and hit historic lows by 2010. The Southern Nevada Health District’s own history of the card shows the vaccine requirement ended in 2012, with the proof-of-vaccination rule formally eliminated in 2017 on the reasoning that there was no longer a public health benefit. Clark County then became part of the national outbreak. It still requires two doses of hepatitis A vaccine for its schoolchildren, but no longer for the people cooking their food.

Run the numbers

Two doses. Ninety-five percent protection after the first, ninety-nine after the second, lasting fifteen to twenty years. Thirty to a hundred and twenty dollars, or $20 in Franklin County if you are uninsured. Against that: $6 million in acute bills from one Roanoke restaurant chain, four funerals, transplants, free post-exposure clinics on the taxpayer every time a food handler tests positive, and litigation that ends companies. I have worked the expensive end of that comparison for most of my career.

Hepatitis A is the only common vaccine-preventable foodborne disease in the United States. It is the one bug where we can simply decide to stop having outbreaks. Narrowing the childhood shot to children with plane tickets, while still refusing to recommend it for the people who handle this country’s food, gets the question wrong twice, in opposite directions, at once.

The vaccine works. Requiring it is the whole point.

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.[1] Until 2025, it had never happened. According to the FDA, the November 2025 ByHeart outbreak was the first botulism outbreak tied to infant formula anywhere in the world since the condition was first described about fifty years ago.[2] The Nara Organics outbreak of 2026 is the second, and it followed the first by seven months. It is also, so far as the published record shows, the first in which whole genome sequencing has tied an infant fed one brand of formula to sealed cans of a different brand, through the dairy ingredient the two brands shared. The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) concluded that epidemiologic, traceback and laboratory evidence showed Nara Organics Whole Milk Organic Infant Formula was contaminated with C. botulinum and made infants sick, and that the data indicate a common source of contamination for this outbreak and the 2025 ByHeart outbreak.[3]

The Outbreak Summary

On Friday evening, June 12, 2026, the FDA and CDC contacted Nara Organics with information about three infants in California, Washington and Pennsylvania who had been hospitalized with infant botulism after consuming Nara formula. Nara recalled every lot on the market the next day. A fourth case was added in July, and on August 27, 2026, the CDC declared the outbreak over.

FeatureSummary
ProductNara Organics Whole Milk Organic Powdered Infant Formula, 700g (UPC 860013251901) and 400g (UPC 860013251918); manufactured in Germany; sold nationally through Target retail stores, Target.com and Nara.com from July 2025 to June 2026; not distributed outside the United States
Case Count (final)4 infants, all confirmed; no cases added after the July 6, 2026 update
Locations (3 states)California (2), Pennsylvania (1), Washington (1)
OutcomesAll 4 infants hospitalized and treated with BabyBIG; no deaths reported
Illness OnsetApril 20, May 17, May 20 and May 31, 2026
Investigation StatusCDC declared the outbreak over on August 27, 2026; FDA’s root cause investigation remains open
Toxin TypeType A
Laboratory EvidenceC. botulinum detected in an open can of Nara formula fed to one of the ill infants; whole genome sequencing of one infant’s clinical isolate matched a clinical isolate from the 2025 ByHeart outbreak, a ByHeart base powder sample, and four samples of unopened cans of ByHeart formula
SourceThe Nara lots linked to illness were made with organic whole milk supplied by Organic West Milk and spray dried by Dairy Farmers of America — the same suppliers implicated in the 2025 ByHeart outbreak; FDA concluded the sequencing match and the shared supply chain indicate a common source of contamination between the two outbreaks; FDA has not determined whether the milk was contaminated before or during drying
RecallJune 13, 2026: all sixteen lots then on the market, including the three lots the first three infants were fed (709125280E14F2, 709125288E14F2 and 708125174E14F2)
SignificanceThe second botulism outbreak ever tied to infant formula, genetically linked to the first; fifty-two infants hospitalized across the two outbreaks

Sources: See note 37, infra.[4]

The Investigation (FDA/CDC, June 12 – August 27, 2026)

Nara Organics’ June 13, 2026 recall notice, posted by the FDA, records how the outbreak surfaced. Late on Friday, June 12, the FDA and CDC told the company that three infants who had consumed Nara formula had been hospitalized with infant botulism and treated with BabyBIG in California, Washington and Pennsylvania. The three lots those infants had been fed were 709125280E14F2, 709125288E14F2 and 708125174E14F2. Nara recalled all sixteen lot codes then on the market — every can it had sold through Target stores, Target.com and Nara.com since July 2025 — while stating that, “[t]o date, Nara infant formula has not tested positive for C. botulinum.”[5]

The FDA’s initial outbreak posting the same month reported three confirmed type A cases with onsets in April and May 2026, and reported two facts about the supply chain. First, the Nara lots linked to illness had been made 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 ByHeart outbreak. Second, the customer list Organic West Milk had given the FDA during the ByHeart investigation was incomplete: it did not disclose that Organic West milk was also being supplied to the manufacturer of Nara Organics formula.[6]

On July 6, 2026, the CDC added a fourth case, bringing California to two, and reported that laboratory testing had detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants. The FDA was testing an unopened can from the same lot.[7]

On August 27, 2026, the CDC declared the outbreak over and, for the first time, stated causation affirmatively: epidemiologic, traceback and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick. CDC reported that whole genome sequencing had 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, and that the formulas sold by both Nara Organics and ByHeart — not merely the Nara lots tied to illness — were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America.[8] The FDA’s closeout the same day was more specific. One clinical sample from a Nara infant is a genetic match to a clinical sample from an infant in the 2025 ByHeart outbreak, to a powdered infant formula base sample from the ByHeart investigation, and to four samples of unopened cans of ByHeart powdered infant formula. The FDA concluded that the matching sequencing results, together with the supply chain commonalities, indicate a common source of contamination between the two outbreaks, while stating that there is not yet enough evidence to determine whether the milk was contaminated before drying or during the drying process. Its root cause investigation remains open.[9]

Two items in the public record remain unaccounted for and are the subject of the first discovery requests in this matter. The July 6 report that C. botulinum was recovered from an open can of Nara formula, and that an unopened can from the same lot was under FDA testing, does not reappear in either agency’s closeout, and neither closeout reports the result of the unopened-can test or a sequencing match for any Nara product or ingredient sample.[10]

The Common Source: Organic West Milk and Dairy Farmers of America

The ingredient that connects the two outbreaks is organic whole milk powder. The FDA’s incident record for the ByHeart outbreak, obtained under the Freedom of Information Act, describes the chain: liquid whole milk from twenty dairies is delivered to Dairy Farmers of America’s plant in Fallon, Nevada, where it is spray dried into organic whole milk powder; Organic West Milk, acting as broker, sells that powder to formula manufacturers and delivers it by third-party carrier.[11]Nara’s own account of its supply chain confirms that it occupied the same position ByHeart did: from October 2024 to April 2025, Nara purchased whole milk from Organic West, which was turned into milk powder at Dairy Farmers of America in Nevada, and that powder went into the formula Nara manufactured in Germany and sold in the United States from July 2025 forward.

The ByHeart record establishes that the powder from that chain carried viable C. botulinum. At least seventeen product samples tested positive in the ByHeart investigation, five of them organic whole milk powder. The FDA’s own sampling produced a positive retain of powdered milk at Dairy Farmers of America in Fallon, and a second Dairy Farmers of America milk-powder retain was positive at the New York State Wadsworth Center. Whole genome sequencing sorted the outbreak isolates into seventeen strains, and two of those strains run from the Dairy Farmers of America retains through ByHeart’s milk powder and finished product to an unopened can from an Arizona case household and to a New Jersey infant. The FDA completed its onsite inspections of ByHeart’s facilities without identifying any facility deficiency that could explain the root cause, and has said that its root cause investigation is focused on incoming ingredients and the dairy supply chain.[12]

The record also shows how Nara was missed. On January 28 and February 3, 2026, CORE issued traceability assignments to six firms that had received Organic West Milk lots of whole milk powder that tested positive for C. botulinum, asking for 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.” Separately, the customer list Organic West itself had given the FDA during the ByHeart investigation omitted Nara. Nara 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.[13]

What the FDA was not told, the public was. In late January 2026, the Associated Press reported that Organic West Milk and Dairy Farmers of America’s Fallon, Nevada plant were the source of the botulism-positive milk powder in the ByHeart outbreak, and quoted Dairy Farmers of America’s statement that the powder had met all required tests.[14] Nara has acknowledged that it learned from those media reports “in early 2026” that Organic West and Dairy Farmers of America supplied ByHeart. The company says it then conducted a “rigorous review” of its existing formula containing Organic West milk, confirmed that its whole milk powder lots did not overlap with the ByHeart lots, reviewed its sulfite-reducing clostridia results, and “determined that Nara formula could stay on the market.” As late as June 23, 2026, ten days after the recall, Nara was still stating that “to date, there have been no positive tests or evidence of c. botulinum in Nara’s formula supply chain.”[15] The four Nara infants became ill in April and May 2026, while formula made with that milk remained on sale.

Every counterpart in the FDA’s Nara-to-ByHeart match set is a ByHeart sample: a ByHeart infant, ByHeart base powder, and four sealed, unopened cans of ByHeart finished product.[16] Three consequences follow. First, the recovery of the outbreak organism from unopened ByHeart cans forecloses any suggestion that the strain that colonized the Nara infant was introduced in a home, at retail, or after a seal was broken; it was present in formula made from this milk before that formula left the manufacturer. Second, the second outbreak supplies an independent check on causation that cannot be attributed to anything peculiar to either company’s plant. 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.

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 ByHeart event prompted the FDA and international food-standards bodies to begin a formal risk assessment of spore-forming organisms in powdered infant formula.[17]

The literature establishes both the historical rarity of C. botulinum in commercial dried milk and formula, and the singular significance of the 2025 and 2026 outbreaks:

  • 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.[18]
  • 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.[19]
  • The 2026 Nara Organics outbreak extended that chain across a second brand: an infant who never consumed ByHeart formula carried a strain indistinguishable from the one in ByHeart’s sealed cans and base powder, with the shared milk powder as the only common element.[20]
  • 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.[21]
  • 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.[22]

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.[23] The studies significant to the link between botulism and milk/formula, beyond the current outbreaks, 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 51–54, supra.[24]

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 genetic evidence in these two outbreaks — milk powder to finished formula and base mix to sick infants in one, and from a sick infant back to sealed cans of the other brand made with the same milk — so indicative of the formula’s defective and adulterated condition, notwithstanding that the FDA has not yet announced the formal root cause.

Nara’s Own Account, and Why It Does Not Answer the Evidence

Nara has published three statements that bear on this claim: its June 13, 2026 recall notice, its June 23, 2026 supply chain page, and its August 27, 2026 update announcing that it intends to return the product to market with European dairy and “rigorous C. botulinum testing protocols.” Each should be read against the agency record.

The recall notice stated that Nara formula “has not tested positive for C. botulinum.” Within four weeks, the CDC reported that it had: the organism was recovered from an open can of Nara formula fed to one of the ill infants.[25]

The August 27 update describes the FDA’s finding as one that “may be linked to one of our former dairy suppliers.” The FDA states the finding without qualification: the matching sequencing results and the supply chain commonalities indicate a common source of contamination between the two outbreaks. The update then devotes most of its length to what the sequencing did not show — that the matching infant’s strain does not match the open can from that family’s home, that the other two infants’ strains match nothing in the NCBI database and do not match each other, and that the open can matches nothing either — and closes with the statement that FDA’s tests on sealed cans of Nara formula “have returned negative for C. botulinum toxin type A and toxin type B.”[26]

None of that answers the evidence. Infant botulism is caused by swallowed spores that germinate and produce toxin inside the infant’s intestine; the toxin is made in the baby, not in the can. A toxin assay on a sealed can is therefore the wrong test for the hazard that injured these infants, and a negative toxin result says nothing about whether the can contained spores.[27] Spores in dried milk powder are not evenly distributed: the FDA identified seventeen distinct strains across patient, product and ingredient samples in the ByHeart outbreak and attributed the breadth of the contamination to the distribution and comingling of ingredients.[28] An open can sampled from a home weeks after the fact carrying a different strain than the one that colonized the infant is what that record would predict, and a clinical strain absent from a public database of environmental C. botulinum sequences means the database is thin, not that the illness is unexplained. What the update does not mention is the one match the FDA did find, which runs from a Nara infant to four sealed cans of ByHeart formula made from the same milk. And the update’s own list concedes that C. botulinum was recovered from a can of Nara formula in a patient’s home.

The update’s account of the dairy switch confirms rather than limits the exposure. Nara states that it stopped sourcing from U.S. dairy suppliers in April 2025 and that its newer EU-dairy batches were not yet on sale when the recall came. Nara launched in July 2025 and sold through June 2026. By the company’s own description of its production lead time — nearly a year from purchase order to product on the shelf — every can Nara sold in the United States was made with Organic West milk dried at Dairy Farmers of America. The switch to European dairy was a supply decision made before the ByHeart outbreak, not a response to it, and its practical effect was that the implicated product stayed on sale for the eleven months it was on the market, from July 2025 until the June 13, 2026 recall.[29]

The testing Nara relies on is the testing that failed. Nara screens each batch for sulfite-reducing clostridia as a proxy for C. botulinum and reports every result at or below the limit of detection. That program was in place when the outbreak lots were made and released, and it did not stop them. The 2026 JEMRA expert group concluded that hygiene indicators do not replace or reduce the need for pathogen-specific testing, and the peer-reviewed analysis of the ByHeart product found C. botulinum in finished formula and base powder where the usual indicator organism was non-detectable.[30] Dairy Farmers of America likewise told the Associated Press that its powder met all required tests. Both companies in this chain have pointed to the tests as proof of safety; the tests were the problem.

One further connection between the two brands should be noted. When ByHeart recalled its formula in November 2025, it steered its customers to Nara: a November 11, 2025 ByHeart Instagram post recommended Nara products and offered a 20% discount code, and was later deleted. Families leaving one botulism-linked formula were pointed toward a second formula drawing on the same organic whole milk supply chain.[31]

Regulatory and Scientific Developments

On July 13, 2026, the FDA 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 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 a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier, and every link in the supply chain.[32]

The letter confirms, in the agency’s own words, facts central to this claim. It states that FDA inspected and collected samples at Dairy Farmers of America, the processor for Organic West Milk; that two samples from one lot of organic whole milk powder matched a clinical sample and an infant formula sample by whole genome sequencing; that its ongoing root-cause investigation is focused on ingredients and their production environments; and that Organic West Milk also supplied Nara Organics, which recalled all lots of its formula after the June 2026 outbreak.[33]

The letter also states what the FDA expects of a formula manufacturer with respect to the ingredients it buys. Reiterating its March 2023 letter to the industry, the agency states that suppliers of ingredients that will not receive a lethal treatment at the formula plant are an extension of the manufacturing process, and that this principle is the foundation of the regulatory framework. Under 21 C.F.R. Part 106, manufacturers must maintain production and in-process controls from receipt of raw materials through distribution, including ingredient specifications, quarantine and disposition of nonconforming ingredients, and scheduled audits. Under 21 C.F.R. Part 117, manufacturers and their supply chain partners must implement a food safety plan with a hazard analysis, preventive controls and a risk-based supply chain program that identifies hazards in ingredients, approves suppliers and verifies them, including by onsite audits.[34]

Most significant for this claim, the FDA directs manufacturers to stay abreast of recall notifications and outbreak investigations, which “may serve as safety signals” that an ingredient or supplier presents risk, and warns that ignoring or downplaying such signals can lead to public health events that could have been avoided. The agency 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.[35] Nara had exactly such a signal. Its milk supplier and spray dryer were publicly identified as the source of botulism-positive milk powder in January 2026. By its own account Nara reviewed the signal, relied on the same indicator testing that had failed to detect the hazard in ByHeart’s product, and left the formula on the market. The four Nara infants became ill over the following four months.

The scientific response has reached the same conclusions. The joint FAO/WHO expert meeting convened in Rome in June 2026 formally added botulinum neurotoxin-producing clostridia to the priority list of hazards for powdered formula, concluded that dairy ingredients have been demonstrated as a vehicle for such spores, directed that manufacturers implement supplier risk management programs addressing them, stated that control starts with on-farm practices, and concluded that hygiene indicators do not replace or reduce the need for pathogen-specific testing. Each of these findings is an acknowledgment that the controls in place when these infants were fed were not adequate to the hazard.[36]

[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] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; Letter from Donald A. Prater, DVM, Acting Deputy Comm’r for Food, U.S. Food & Drug Admin., Human Foods Program, to Infant Formula Industry (July 13, 2026), https://www.fda.gov/media/193534/download, at 1 (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).

[3] 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 (epidemiologic, traceback, and laboratory data showed that Nara Organics Whole Milk Organic Infant Formula was contaminated and made infants sick; data indicate a common source of contamination for this outbreak and the 2025 ByHeart outbreak).

[4] 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; 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; CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html; Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk(company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk; Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (formula manufactured in Germany; Organic West Milk purchased October 2024 to April 2025 and spray dried at Dairy Farmers of America in Nevada).

[5] Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (FDA and CDC contacted Nara Organics late Friday, June 12, 2026 with three cases; the three infants were hospitalized and treated with BabyBIG in California, Washington, and Pennsylvania; exposure lots 709125280E14F2, 709125288E14F2 and 708125174E14F2; sixteen lot codes recalled; distribution through Target retail stores, Target.com and Nara.com between July 2025 and June 2026).

[6] U.S. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (initial June 2026 posting: 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.

[7] CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html.

[8] 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 (no new cases added since the July 6, 2026 update; four cases; whole genome sequencing linked a patient sample from this outbreak to a patient sample, product samples, and an ingredient sample collected during the 2025 ByHeart investigation; the formulas sold by both Nara Organics and ByHeart were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America).

[9] 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 (one clinical sample from an infant in this outbreak is a genetic match to a clinical sample from an infant in the 2025 ByHeart outbreak, a powdered infant formula base sample from the ByHeart investigation, and four samples of unopened cans of ByHeart powdered infant formula; Nara Organics lots linked to illness were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America; matching WGS results and supply-chain commonalities indicate a common source of contamination; not enough evidence to determine whether milk was contaminated before drying or during the drying process; root cause investigation ongoing).

[10] Compare CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html (open can of Nara Organics formula positive; unopened can from the same lot under FDA testing) with 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 and 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 (neither closeout reports the result of the unopened-can test or a sequencing match for any Nara product or ingredient sample). Both agencies’ closeouts also misname the spray dryer as “Dairy Farms of America”; the entity is Dairy Farmers of America, Inc.

[11] 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), 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). 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].

[12] CORE Record, Executive Incident Summary at 5–10 (Laboratory Sample Overview, Tables 1–4; WGS analysis; Traceback Abbreviated Summary) (at least seventeen product samples positive for C. botulinum: eight finished-formula, four base-mix, five whole-milk-powder; FDA’s two positives were a base-mix retain from Blendhouse Allerton, Iowa and a powdered-milk retain from Dairy Farmers of America, Fallon, Nevada; a second Dairy Farmers of America milk-powder retain was positive at the New York State Wadsworth Center; strain 11 links two FDA milk-powder isolates, three ByHeart whole-milk-powder isolates, a ByHeart finished-product isolate, an unopened can from an Arizona case household, and a New Jersey clinical isolate at a mean of 7.5 SNPs; strain 2 links a ByHeart finished-product isolate from lot 251261P2 to a second Dairy Farmers of America milk-powder retain at eight SNPs); see also 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 (two isolates from one lot of organic whole milk powder sampled at Dairy Farmers of America matched a clinical isolate and a positive finished-formula sample; no ByHeart facility deficiency identified that could explain the root cause; ongoing root-cause investigation focused on incoming ingredients and the dairy supply chain).

[13] 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.”); U.S. FDA, Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) (initial June 2026 posting: 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 (Organic West Milk’s customer list was incomplete and omitted Nara Organics); Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (Nara Organics formula distributed from July 2025).

[14] Associated Press, Companies that supplied dried milk powder linked to botulism outbreak identified, republished by ABC News (Jan. 2026), https://abcnews.go.com/US/wireStory/companies-supplied-dried-milk-powder-linked-botulism-byheart-129650215 (naming Organic West Milk and the Dairy Farmers of America plant in Fallon, Nevada as the source of the botulism-positive milk powder; Dairy Farmers of America statement that the milk powder met all required tests).

[15] Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (“When we learned from media reports in early 2026 that Organic West and DFA supplied ByHeart, we immediately began a rigorous review to determine the safety of Nara’s existing formula containing Organic West milk”; “it was determined that Nara formula could stay on the market”; whole milk powder lots did not overlap with ByHeart’s; sulfite-reducing clostridia results ≤10 CFU/g on every batch; “to date, there have been no positive tests or evidence of c. botulinum in Nara’s formula supply chain”).

[16] 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; Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026 (Nara’s own summary of the FDA sequencing: one clinical sample “clustered with a strain of C. botulinum found in a ByHeart clinical patient sample from 2025, as well as base powder and unopened cans of ByHeart formula powder”; the other two clinical isolates and the open-can isolate matched nothing in the NCBI database).

[17] 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, 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.

[18] 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.

[19] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025; 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.

[20] 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 (one Nara Organics clinical isolate matched four samples of unopened cans of ByHeart formula and a ByHeart base powder sample).

[21] 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.

[22] 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.

[23] 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/.

[24] Harris RA, et al., supra note 52 (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); Brett, Johnson and Luo, supra note 54; Barash, supra note 51.

[25] Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (“To date, Nara infant formula has not tested positive for C. botulinum.”); compare CDC, Investigation Update on Infant Botulism Outbreak, June 2026 (update of July 6, 2026) (four confirmed type A cases: California (2), Pennsylvania (1), Washington (1), all hospitalized and treated with BabyBIG; laboratory testing detected Clostridium botulinum in an open can of Nara Organics formula fed to one of the infants; FDA testing an unopened can from the same lot), https://www.cdc.gov/botulism/outbreaks-investigations/infant-formula-june-2026/investigation.html.

[26] Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026.

[27] Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026 (“All their tests on sealed cans of Nara infant formula have returned negative for C. botulinum toxin type A and toxin type B.”); CDC, Clinical Overview of Infant Botulism, supra note 7 (infant botulism results from ingestion of spores that germinate and produce toxin in the intestine).

[28] FDA. Outbreak Investigation of Infant Botulism: Infant Formula (November 2025). Content current as of June 3, 2026. https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025 (whole-genome sequencing identified 17 distinct strains across patient, product, and ingredient samples in the ByHeart outbreak); CORE Record, Executive Incident Summary at 10 (“[t]he distribution and comingling of ingredients likely contributed to the widespread nature of the contamination”).

[29] Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (Organic West milk purchased October 2024 to April 2025; EU dairy sourced since July 2025; “almost a year from the time we place a purchase order to a milk source showing up in the formula that customers purchase”; most recent EU-dairy batches not yet available for sale at the time of the recall); Nara Organics, Nara Organics Recalls All Lots of Nara Infant Formula Because of Possible Health Risk (company announcement posted by FDA, June 13, 2026), https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/nara-organics-recalls-all-lots-nara-infant-formula-because-possible-health-risk (product distributed July 2025 to June 2026); Nara Organics, August 27 Update (Aug. 27, 2026), https://nara.com/pages/formula-recall-update-august-27-2026 (EU-dairy batches “weren’t yet available for sale in June 2026 and were not part of the recall”).

[30] Nara Organics, Nara’s Whole Milk Supply Chain (June 23, 2026), https://nara.com/pages/nara-organics-whole-milk-supplier (ICMSF-recommended sulfite-reducing clostridia screening at a suggested maximum of <100 CFU/g; all Nara batches ≤10 CFU/g, the limit of detection); 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) (hygiene indicators such as Enterobacteriaceae monitoring do not replace or reduce the need for pathogen-specific testing during environmental monitoring); Harris RA, et al., supra note 52.

[31] 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/ (Nov. 11, 2025 ByHeart Instagram post recommending Nara products and offering a 20% discount code, later deleted); New infant botulism outbreak puts fancy formulas under scrutiny, STAT (June 18, 2026).

[32] Letter from Donald A. Prater, DVM, Acting Deputy Comm’r for Food, U.S. Food & Drug Admin., Human Foods Program, to Infant Formula Industry (July 13, 2026), https://www.fda.gov/media/193534/download, at 1 (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; a manufacturer’s responsibility for safety and quality extends to every ingredient, every supplier, and every link in the supply chain).

[33] Id. at 1–2 (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; ongoing root-cause investigation focused on ingredients and their production environments; Organic West Milk also supplied Nara Organics, which voluntarily recalled all lots of its powdered infant formula).

[34] 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; production and in-process control obligations under 21 C.F.R. Part 106; food safety plan, preventive control, and supply-chain program obligations under 21 C.F.R. Part 117, including subpart G supplier verification; redundancy risk management plan requirement of section 424(b) of the FD&C Act, 21 U.S.C. § 350m(b)).

[35] Id. at 3–4 (recall notifications, outbreak investigations, and import alerts may serve as safety signals that an identified ingredient or supplier presents risk; ignoring or downplaying such signals can lead to public health events that could have been avoided; FDA expects manufacturers to act swiftly to assess and address the risk when a contaminated ingredient or supplier concern is identified, whether by FDA or through the manufacturer’s own monitoring).

[36] 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-producing clostridia to the priority hazard group for powdered formula; finding that dairy ingredients have been demonstrated as a vehicle for such spores resulting in contamination of powdered formula; recommending supplier risk management programs; stating that control starts with on-farm practices; stating that hygiene indicators do not replace or reduce the need for pathogen-specific testing; noting that current consumer preparation recommendations designed for Salmonella and Cronobacter spp. may not be effective against these spores; recommending revisions to CXC 66-2008). 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.

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.