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

What the County said

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

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

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

What actually changed today

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

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

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

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

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

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

California ran this exact play nine months ago

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

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

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

What is still not public

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

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

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

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

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

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

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

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

If you got sick

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

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

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

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

A milk route into food and drug law

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

Four years that built the modern FDA

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

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

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

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

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

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

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

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

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

The teacher

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

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

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

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

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

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

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

Hong Kong, 2014

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

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

The objection was there on day one

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

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

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

What he leaves

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

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

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

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

I have spent more than 30 years suing food companies that poisoned people. I have said, more times than I can count, that my goal is to be put out of business by an industry that stops making people sick. So, when Joelle Mosso — Associate Vice President of Science Programs at Western Growers, and one of the sharpest scientific minds working in produce safety — writes a piece asking, “What if prevention actually paid?”, I pay attention.

Her August 31 post, “The Food Safety Fast Pass: What If Prevention Actually Paid?”, makes an argument that I think is fundamentally correct: our system is built almost entirely on penalties, while the economic rewards still flow to whoever produces food fastest and cheapest. The company that invests in agricultural water monitoring, environmental surveillance, real traceability, and transparent data sharing bears the full cost of those investments — while the benefits accrue to public health and to the food system as a whole. Meanwhile, the company that cuts corners undercuts them on price at the buyer’s desk.

She’s right. That is a broken incentive structure, and I have watched it play out in my law practice for three decades. The companies I sue are rarely the ones that spent too much on food safety.

Her proposal — preferential access to market development programs, reduced crop insurance costs, infrastructure grants, and a verified “green lane” for importers with years of demonstrated preventive controls — deserves serious consideration. And her most important insight is one that too many people in industry and government still get wrong: the metric cannot be “no positives.” A system that rewards clean test results rewards companies for not testing. The safest operation is not the one that never finds a problem. It’s the one that looks hard enough to find problems early and knows what to do when it does. I have deposed enough executives to tell you that “we never had a positive” usually means “we never looked.”

So, consider this a genuine endorsement of the idea. Now let me offer a few caveats from the plaintiff’s side of the courtroom.

First, who verifies? Any fast-pass system is only as good as the auditing behind it, and the food industry’s track record with third-party audits is, to put it charitably, mixed. Peanut Corporation of America had a “superior” audit rating while it was shipping Salmonella-laced peanut paste that killed nine people. Jensen Farms got a 96 out of 100 days before its cantaloupes killed 33 people with Listeria. If the “exceptional, sustained risk management” that earns a company its green lane is documented by an auditor the company itself hires and pays, we will have built a faster lane to the same courthouse. Verification has to be independent, data-driven, and continuous — which, to her credit, is exactly the kind of ongoing data sharing Mosso describes. The details will matter enormously.

Second, the stick cannot atrophy while we build the carrot. Mosso is explicit that this is not deregulation, and I believe she means it. But I have watched too many “risk-based” proposals get repurposed in Washington as cover for cutting inspection budgets. FDA and USDA are already stretched thin. A green lane that lets regulators concentrate resources on the riskiest suppliers only works if those resources actually exist and actually get concentrated — not quietly eliminated in the next appropriations cycle. If “fewer routine inspections for good actors” becomes “fewer inspections, period,” consumers lose and the fast pass becomes a fig leaf.

Third, benefits must be revocable — fast. Any company enjoying expedited entry or reduced oversight needs to know that the moment its data goes dark, its testing frequency drops, or its traceability degrades, the pass is gone. The privilege has to be easier to lose than it was to earn. Otherwise, we’ve created a class of companies that are politically difficult to police.

Fourth, don’t forget the small guys. The growers who most need help paying for water treatment systems and surveillance infrastructure are often the ones least able to navigate a federal incentive program. If the fast pass ends up as one more advantage for the largest, best-lawyered operations, we will have made the market less fair without making the food much safer. The shared infrastructure grants Mosso mentions — like cooperative agricultural water monitoring — may be the most important piece of her whole proposal, precisely because they help the operations that can’t do it alone.

Here is the bottom line. For 30-plus years, I have been the most expensive food safety consultant in America — companies pay my clients tens of millions of dollars for lessons they could have learned for a fraction of the cost. Litigation is a blunt, slow, after-the-fact instrument. It compensates the injured, and it concentrates the minds of executives, but it arrives only after a child is on dialysis or a family is planning a funeral.

If Joelle Mosso’s fast pass — done honestly, verified independently, and backed by a regulatory system that keeps its teeth — moves investment in prevention upstream of the outbreak, then I am all for it. Make prevention pay. Make transparency a market advantage. Reward the companies that look for problems instead of the ones that look away.

And if it works, maybe it finally puts me out of business.

I’ve been waiting a long time.

On September 2 the Washington State Department of Health posted an outbreak notice linking thirteen Salmonella Bovismorbificans illnesses in seven Washington counties to broccoli sprouts produced by Evergreen Fresh Sprouts, LLC of Moyie Springs, Idaho. Two more people are sick in Montana and one in Idaho, sixteen in all. Illnesses began between July 7 and August 18. Two Washington patients have been hospitalized, no one has died, and no recall has been issued.

The company name should be familiar. Evergreen Fresh Sprouts was the grower behind a 2011 SalmonellaEnteritidis outbreak that sickened 25 people in five states and a 2014 E. coli O121 outbreak that sickened 19 in six. Over three outbreaks and fifteen years, sixty people have been made sick, and the company has recalled product once, in 2011, after first refusing to and after FDA took the unusual step of warning the public directly.

Sixteen sick in three states, and Montana expects its count to grow

Washington interviewed twelve of its thirteen patients. Eight reported eating sprouts from Evergreen Fresh Sprouts; seven ate broccoli sprouts, and the eighth could not say which variety. The sprouts were sold in clamshells and plastic bags at grocery stores and food co-ops and served in restaurants. Samples from Evergreen and from other suppliers are being tested at the Washington State Public Health Laboratory. The state says this outbreak appears unrelated to the multistate Everything Sprouts alfalfa sprout outbreak I have been writing about since August.

Montana’s health department said on September 3 that its two patients bought the sprouts at Montana grocery stores, that local sanitarians are contacting the stores known to have sold them, and that it expects its case count to rise once additional laboratory testing is complete. Idaho, where the company is based, had not posted a notice of its own as of Thursday evening; its single case appears only in the Washington and Montana counts. In Whatcom County, which has three of Washington’s cases, health officials told the Cascadia Daily News they do not have a confirmed list of every place the sprouts were sold or served.

Washington cases by county of residence, as of September 2, 2026 (4 + 3 + 2 + 1 + 1 + 1 + 1 = 13). Source: Washington DOH.

CountyCases
King4
Whatcom3
Spokane2
Skagit1
Snohomish1
Walla Walla1
Yakima1
Total13

2011: Salmonella Enteritidis, twenty-five sick, a refusal, an FDA warning, and then a recall

Between April 12 and July 5, 2011, 25 people in five states were infected with the outbreak strain of SalmonellaEnteritidis: ten in Montana, ten in Washington, three in Idaho, and one each in New Jersey and North Dakota. CDC linked the illnesses to alfalfa sprouts and spicy sprouts sold under the Evergreen Produce label.

On June 27, 2011, FDA warned consumers directly not to eat the sprouts, a step the agency generally takes only when a company will not recall. The company’s co-owner told the Associated Press it had stopped producing the sprouts but would not pull them from shelves, and told The Produce News she had refused FDA’s request because a recall would be “admitting guilt.” On July 1 the company recalled alfalfa and spicy sprouts with expiration dates from June 22 through July 14, distributed in Washington and Idaho to four distributors and three retail stores. That same morning I asked whether FDA would use the mandatory recall authority Congress had given it six months earlier. It did not have to; the company relented.

On October 19, 2011, FDA sent the company a warning letter. Product and environmental samples had not turned up Salmonella, but inspectors documented pipes dripping onto uncovered sprouts and employees who did not put on clean gloves or aprons before handling them, and the agency concluded the sprouts were adulterated under federal law.

2014: E. coli O121, nineteen sick in six states, no recall, and the seed lot stayed in use into July

CDC’s final update on August 1, 2014, counted 19 people infected with Shiga toxin-producing E. coli O121 in six states: eleven in Washington, three in Idaho, two in Montana, and one each in California, Michigan and Utah. Illnesses began between May 1 and May 20. Seven of the sixteen with information, 44 percent, were hospitalized; no one developed hemolytic uremic syndrome and no one died. Thirteen of sixteen people interviewed had eaten raw clover sprouts, against a background rate of no more than eight percent, most of them in sandwiches at Jimmy John’s, Pita Pit and Daanen’s Deli locations in Washington and Idaho. FDA’s traceback found that Evergreen had supplied sprouts to seven restaurants where nine of the sick people ate.

FDA inspected the Moyie Springs facility on May 22 and 23, May 27 through 30, and June 6, 2014. The Form 483 is posted in FDA’s electronic reading room. Investigators observed condensate and irrigation water dripping from rusty valves, a corroded watering system in the mung bean room, tennis rackets with scratches, chips and frayed plastic being used to scoop sprouts, a corroded pitchfork used to move them, and a squeegee of corroded metal and untreated wood used to agitate sprouts in a soak vat.

There was no recall. CDC’s page carries the line “Recall: No.” CDC’s June 27 update reported that the company had continued to produce and distribute clover sprouts from the same seed lot linked to the outbreak, and that sprouts from that lot might still be in the marketplace. The outbreak had been announced May 22. FDA and CDC met with the owner on June 26 to encourage the company to stop using the lot; the owner agreed, and FDA confirmed on July 1 that the lot was gone and a new one had arrived. Marler Clark filed four lawsuits on behalf of people sickened in that outbreak, and I wrote about the company’s history at the time.

Three outbreaks, sixty sick, one recall

Outbreaks linked to Evergreen Fresh Sprouts, LLC, 2011 to 2026 (25 + 19 + 16 = 60). Sources: CDC final updates for 2011 and 2014; Washington DOH and Montana DPHHS for 2026. The 2026 row will change.

YearPathogenProductSick / statesRecallFDA action
2011SalmonellaEnteritidisAlfalfa and spicy sprouts25 in 5July 1, after refusingConsumer warning June 27; warning letter Oct. 19
2014E. coli O121Raw clover sprouts19 in 6None; seed lot dropped July 1Form 483, June 6
2026SalmonellaBovismorbificansBroccoli sprouts16 in 3None as of Sept. 3None posted

Two things show in that table. The first is that in 2011 and 2014 epidemiology and traceback identified the grower while product samples came back negative for the outbreak strain. That is the normal shape of a sprout outbreak: the contaminated lot is eaten before anyone tests it, and contamination clusters in a batch rather than spreading evenly through it. Washington’s samples are pending now. Nobody should wait for them.

The second is what a recall is for. A recall produces lot codes, a distribution list, notification down the chain to every distributor, restaurant and grocer, and an entry in FDA’s enforcement reports. Without one, Washington has no confirmed list of where these sprouts went, Montana’s sanitarians are calling stores one at a time, and the only identifier a consumer has is the company name on the bag. FDA has been able to order a recall since January 2011, six months before the first Evergreen outbreak. I asked whether it would use that power on this company fifteen years ago, and I asked the same question about Everything Sprouts three weeks ago. Same commodity, same company, same question.

What to do if you bought or ate these sprouts

  • Do not eat broccoli sprouts from Evergreen Fresh Sprouts. Throw them away or return them to the store, and wash anything they touched with hot soapy water or in a dishwasher.
  • See a doctor for diarrhea with a fever above 102°F, diarrhea lasting more than three days, bloody diarrhea, vomiting that keeps you from holding down liquids, or signs of dehydration.
  • If you were sick, report it. Washington uses an online Foodborne Illness Notification form; Whatcom County Health and Community Services is at 360-778-6000. Montana and Idaho residents should call their local health department.
  • Keep the package or receipt, or a photo of either, and ask the lab or health department to preserve your isolate. Whole genome sequencing is what ties an illness to this outbreak, and isolates are routinely discarded.

Sixteen is the number today. Montana has already said it will not be the number next week.

Quick answer: As of September 3, 2026, CDC counts 17 people infected with E. coli O145 after eating frozen organic blueberries from Frutas y Hortalizas del Sur S.A. of San Carlos, Chile. Thirteen live in Florida and four in Georgia; six have been hospitalized and none have died. Recalled products are GreenWise frozen blueberries and whole mixed berries sold at Publix in eight states and one lot of Great Value Organic Triple Berry Blend sold at Walmart in 16 states. FDA has placed the supplier on import alert. If any of these berries are in your freezer, throw them out or return them.

The CDC update adds five illnesses and two hospitalizations since the last count. Illnesses began between May 11 and August 2, 2026. Epidemiologic and traceback data point to frozen organic blueberries from a single Chilean supplier. What the update does not say is where the contamination came from, how many of the six hospitalized patients developed hemolytic uremic syndrome, or whether more retailers received the same berries.

Which frozen berries are recalled for E. coli

Recall dateProductLot / date codesWhere sold
July 3, 2026GreenWise Organic IQF Blueberries, 10 oz (Frutas y Hortalizas del Sur S.A.)Lot 60401 (printed 6 040 01); Best By Feb. 9, 2028Publix stores in AL, FL, GA, KY, NC, SC, TN, VA
July 29, 2026GreenWise Organic Whole Blueberries, 10 oz (UPC 41415-06453) and 48 oz (UPC 41415-12053); GreenWise Organic Whole Mixed Berries, 10 oz (UPC 41415-06753) and 48 oz (UPC 41415-12153) (Publix)All lotsPublix stores in the same eight states
Sept. 2, 2026Great Value Organic Triple Berry Blend, 10 oz, strawberries, blackberries and blueberries (UPC 7874211226) (Frutas y Hortalizas del Sur S.A.)Lot 6040 01-6 (front of package); Best If Used By Feb. 9, 2028Select Walmart stores in AL, AR, FL, IL, IN, KY, LA, MN, MS, MO, NC, OH, OK, SC, TX, WI

The September 2 expansion says no illnesses are tied to the Great Value product and the action is precautionary, based on traceback from the July recall. Both Frutas y Hortalizas lots carry a Best By date of February 9, 2028, and the Great Value lot code, 6040 01-6, shares its stem with the original GreenWise lot, 60401. Neither the company nor FDA has explained the relationship, but the codes suggest a common production run.

How the frozen blueberry E. coli investigation unfolded

FDA’s outbreak advisory, updated today, lays out the timeline. On July 1 the Florida Department of Health told CDC it was investigating a cluster of E. coli O145 illnesses; interviews pointed to frozen GreenWise organic blueberries sold at Publix, and Publix pulled the product in an internal stop sale at the end of June. On July 3 Frutas y Hortalizas del Sur recalled the 10-ounce GreenWise blueberries, lot 60401. FDA then counted 12 sick and 4 hospitalized, with onsets from May 11 to June 5; seven of nine people interviewed reported frozen blueberries, and five named GreenWise from Publix.

The July 30 update deserves more attention than it got. FDA conducted a remote regulatory assessment of the Chilean firm and collected records on its hazard controls. Based on what it found, FDA said it had concerns about at least one other lot of blueberries used in additional GreenWise products, which is why Publix recalled every lot of GreenWise Organic Whole Blueberries and Whole Mixed Berries, in 10-ounce and 48-ounce sizes, on July 29. FDA also said it had concerns about other products from the firm that had not yet entered the United States, and added the company’s frozen blueberries to Import Alert 99-35, meaning shipments may be detained at the border without physical examination until the firm shows the conditions have been corrected. On September 2 the supplier added the Walmart lot, and on September 3 CDC moved the count to 17 and 6.

What the epidemiology shows

Of the 13 sick people interviewed, 11, or 85 percent, reported eating frozen blueberries, against the 24 percent of respondents in CDC’s FoodNet Population Survey who report eating frozen berries in a given week. The patients range in age from 2 to 88, with a median of 47; 59 percent are male. Both states with cases are Publix states.

The onset curve tells its own story. Ten of the 17 got sick in a twelve-day window between May 21 and June 1. After that the onsets scatter: June 5, June 10, June 25, June 28, July 1. Then a single onset on August 2, a full month after the first recall and four days after Publix recalled every lot. That last case is why the freezer language matters. One discrepancy to flag: CDC’s timeline data end on August 2, while FDA’s case count box lists the last onset as August 6. One of the two is wrong, and the agencies should reconcile it. CDC also gives its standard caveats: many people are never tested, it takes three to four weeks to link a new illness to an outbreak, and the true count is likely much higher than 17.

What we still do not know

The source of the contamination. FDA’s remote assessment produced enough concern to trigger an all-lots recall and an import alert, but nothing public says what the inspectors found. E. coli O145 is a Shiga toxin-producing E. coli whose reservoir, like O157’s, is cattle and other ruminants. Frozen berries have a long history as vehicles for hepatitis A and norovirus, which travel with infected workers; a STEC outbreak on frozen blueberries is unusual, and freezing does not kill STEC. Whether this was irrigation water, animal intrusion in the field, harvest handling, or something in the packing plant is the question that decides whether it happens again. The 2010 romaine lettuce outbreak, traced back to a single farm in Arizona, was also O145.

The HUS count. CDC does not report hemolytic uremic syndrome cases in this outbreak. Six of 17 hospitalized is a 35 percent hospitalization rate, and the youngest patient is 2. Whether any of these people developed HUS, and how many are children, are numbers the public should have.

Whether the outbreak strain was found in product. Nothing in the CDC or FDA postings reports a positive product sample. The link is epidemiologic and traceback, which is enough to act on, but a product isolate would settle where in the supply chain the contamination sits.

Whether other retailers received berries from this supplier. FDA said on July 6 that the blueberries may have gone to other retailers. The Walmart expansion, two months later, confirmed that at least one did. If the same Chilean lots went into other private-label blends, consumers should hear about it now.

What to do if you bought recalled frozen berries

Check your freezer for the products in the table above and throw them out or return them for a refund. If you froze berries outside the original bag and cannot tell what they are, throw them out. Wash containers and surfaces the berries touched with hot soapy water or run them through a dishwasher. Restaurants and retailers should not sell or serve the recalled products. Anyone who ate recalled berries and has diarrhea lasting more than three days, bloody diarrhea, a fever above 102 degrees, or signs of dehydration should see a health care provider and mention the exposure.

Frozen blueberry E. coli outbreak: questions and answers

What strain of E. coli is in the frozen blueberries? E. coli O145:H28, a non-O157 Shiga toxin-producing E. coli. Symptoms usually begin three to four days after exposure and include severe stomach cramps, diarrhea that is often bloody, and vomiting. Most people recover in five to seven days; some, especially young children and older adults, develop hemolytic uremic syndrome, a form of kidney failure that can require dialysis and can be fatal or cause lifelong kidney damage.

Does freezing kill E. coli in berries? No. Freezing stops bacteria from growing but does not kill them. Recalled frozen berries are unsafe for as long as they are in the freezer.

Are fresh blueberries part of the recall? No. Every recalled product is frozen, and every one traces to a single Chilean supplier. Fresh blueberries and frozen berries from other suppliers are not implicated.

Marler Clark has represented victims of E. coli outbreaks since the 1993 Jack in the Box outbreak, including outbreaks linked to leafy greens, sprouts, ground beef, raw milk and produce. If you or a family member became ill with an E. coli infection after eating frozen blueberries or mixed berries and would like to speak with an attorney, the firm can be reached at 1-800-884-9840 or through marlerclark.com.

The Reagan-Udall Foundation for the FDA has published Applying the Science of Infant Formula Safety, a 44-page report on a July 13, 2026 roundtable about Clostridium botulinum in powdered infant formula. Two lines on the cover tell you how to read it. The first says the meeting was convened in collaboration with ByHeart and the International Dairy Foods Association. The second says ByHeart and IDFA paid for it. The company that recalled the formula that put 48 babies in the hospital, and the trade association for the dairy ingredient that carried the organism, funded the report on their own outbreak.

Twenty-four contributors are listed. They represent the formula industry, academia, one consumer advocacy organization and FDA. Not one is a parent of the 52 infants hospitalized across the ByHeart and Nara Organics outbreaks. Each contributor signed a disclaimer that inclusion does not mean endorsement, and the Foundation says it alone is responsible for the content. The report also says the roundtable focused primarily on formula manufacturers and lists a session with the dairy industry as a future step, even though the contamination came from the dairy side.

What the report recommends to prevent the next outbreak.

Appendix A collects 22 recommendations under four themes. Stripped of the connective tissue, they come to this: 

  • conduct a baseline study of spore prevalence on farms, in the supply chain and in finished goods; 
  • develop screening methods that are specific and sensitive; look for other indicators of spore presence; 
  • monitor environmental and supply changes; increase research funding; 
  • engage a trusted third party to house and anonymize industry testing data; 
  • write governance and confidentiality rules for that data; 
  • validate preventive technologies such as bacterial-removal separators and ultrafiltration; 
  • ask FDA to issue guidance on fit-for-purpose tests and thresholds; 
  • coordinate with CDC and USDA; 
  • hold a similar roundtable with the dairy industry; 
  • work toward accreditation of a validated test; 
  • and gather lessons from outside the United States.

Read them a second time and notice the verbs. Conduct, develop, investigate, explore, establish, nurture, educate, work toward. None of the 22 would require any company to do anything. The word “rule” does not appear. The closest it comes is recommendation 17, which asks FDA for guidance on fit-for-purpose tests and for standardized testing methods and requirements, without saying by what authority or on what schedule. Affordability and supply continuity appear as a theme on nearly every page, and recommendation 16 is simply to maintain them. Page 15 says it plainly: increasingly complex and costly control requirements could cause manufacturers to lose critical supply partners, so risk reduction must be balanced against supply chain sustainability. That is the industry position on regulation, stated in a document the industry paid for, and it is the reason the report asks for studies where a rule is needed.

What the report concedes, and it is more than the recommendations admit.

The appendices are more candid than the body. ByHeart reports roughly 5,000 C. botulinum tests run by IEH Laboratories: nine positives in 4,675 samples, eight of 241 finished-product lots PCR-positive, and one confirmed positive ingredient, organic whole milk powder from Organic West Milk sampled at Dairy Farmers of America. Every sample that tested positive for C. botulinum read under 10 cfu/g on the sulfite-reducing clostridia test, the indicator the industry has relied on for decades. 

The report’s own conclusion is that trace amounts of spores can be present at levels too low for that method to detect, but enough to make infants sick. That finding is now published and it applies to every plant using the method, not just one.

ByHeart’s own open-questions slide states that the entry point of the organism into the ingredient has not been established. FDA’s testing workflow is labeled interim, pending validation. The report says only a limited number of laboratories can run the test at all, and that contamination is non-homogeneous and low-level, which means a negative on any single lot proves little. The opening pages set up the defense ICMSF gave the industry: before November 2025 this organism was not considered a hazard in formula. However, FDA named C. botulinum in a letter to the entire industry on March 8, 2023.

What the report leaves out, because it stopped at July 13.

The report is dated September 2026, and its factual record ends with FDA’s July 13 letter. It does not mention what has happened since. On August 27, CDC and FDA reported that whole genome sequencing links a Nara Organics infant to a ByHeart clinical sample, a ByHeart base-powder sample and four unopened cans of ByHeart formula, and that both brands’ formula was made from Organic West milk dried by Dairy Farmers of America. FDA calls that a common source of contamination. The report refers to recent outbreaks in the plural without ever naming Nara. It does not mention that FDA’s own closeout file, released under FOIA, sorted 37 isolates into 17 strains, recorded a death complaint the final count never resolves, found no root cause, and blacks out the names of six companies that received the contaminated milk powder lots. It does not mention that ByHeart says FDA has no further questions on a root cause submission the public has not seen. And it does not mention that Nara Organics has announced it will sell formula again on the strength of sealed-can tests that look for toxin rather than spores.

A report on C. botulinum in infant formula that omits the government’s finding that two outbreaks were one contamination is out of date on its own subject.

Their list next to mine.

The report and I agree on more than the funding line suggests. Testing alone will not protect formula; the controls have to reach upstream to the dryer and the farm; bactofugation and microfiltration deserve validation; the dairy suppliers belong at the table – along with 52 sets of parents and their babies. Where we part is on whether any of it should be mandatory.

  1. They recommend a prevalence study. I have asked Congress to add C. botulinum to the testing table at 21 C.F.R. § 106.55, which today names Salmonella and Cronobacter and nothing else. That is H.R. 7867, which had its hearing on April 29 and has not moved since.
  2. They recommend that FDA issue guidance on tests and thresholds. I have asked FDA to write a rule, because it has now written the industry three letters about this organism and a company that ignores a letter has broken nothing.
  3. They recommend a trusted third party to collect industry data and anonymize it before anyone sees it. I have asked FDA to release the six company names it redacted, to publish the results of its milk-powder surveillance sampling with the firms identified, and asked ByHeart to release its root cause submission and FDA’s letter accepting it. Anonymized data is what the public has now. It did not stop the second outbreak.
  4. They recommend a second roundtable with the dairy industry. I have asked for an oversight hearing with FDA, Dairy Farmers of America, Organic West Milk, ByHeart and Nara Organics at the table, where the questions are asked by members of Congress and the answers are on the record.
  5. They recommend that any new control be balanced against affordability. I would note that liquid formula already gets the full low-acid canned food regime built to keep botulism out of a sealed can, and nobody argues that made it unaffordable. A tub of powder gets a letter.

They did not invite the parents. I have asked both committees to put them at the witness table, and I have asked every official who touches this to spend one hour with one of these families before deciding what is operationally feasible.

What a report like this is for.

The Foundation is an independent nonprofit chartered by Congress, and convening the industry around a real problem is useful work. A roundtable where the recalled company presents its own investigation, the funders set the agenda, the families are absent and the output is a request for more research is not the same thing as a plan to prevent the next outbreak. The plan exists. It is a bill with a hearing behind it and a rule FDA could write tomorrow. Congress returns this month. The four offices that decide whether H.R. 7867 moves are the same four they were last week, and the report gives every one of them a reason to move: the industry has now put in writing that the test it relies on cannot find this organism. The second week of September, 535 t-shirts arrive on Capitol Hill, one for every member, each rolled inside a plastic baby bottle, and each carrying the same argument in six words: For Babies’ Sake, Test for Botulism in Infant Formula. The report just supplied the footnote.

Here is the Full Report.

Eric Schlosser has a piece in The Atlantic this morning, and if you read one thing about food safety this week, read that. Eric is a friend. He wrote Fast Food Nation a quarter century ago, when fecal contamination of ground beef was a national problem and not a local one, and he has never stopped paying attention. In ten minutes, he does what I have spent a summer trying to do: he puts the Cyclospora outbreak, the two infant botulism outbreaks, the shelved Salmonella rule for poultry and the hollowing out of the agencies that are supposed to catch all of it on one page and shows that they are one story.

He also tells the story of my friend Barb Kowalcyk (another hero of mine), whose two-year-old son Kevin died in 2001 of an E. coli O157:H7 infection from a hamburger, and who went back to school, earned a doctorate and helped push USDA to the test-and-hold rule in 2013. Barb is brilliant, and the result of her work is a fact I repeat every chance I get. I used to be in the beef business. The hamburger E. coli cases that ran from Jack in the Box in 1993 to the ConAgra recall in 2002 are now close to zero for my firm. That is what a rule with a test in it does. Hold that thought, because the three fights below are the same fight.

A word on the numbers. Eric writes about 17,000 lab-confirmed cases. CDC’s September 1 update puts it at 18,445 laboratory-confirmed domestically acquired cases from May 1 through August 31, 990 hospitalizations, two deaths and 49 states plus the District of Columbia, with 3,491 more confirmed cases still being sorted and at least 13,505 beyond that awaiting confirmation. Eric is right that, as pathogens go, this one rarely kills. He is also right that that is not the point. The point is what it says about the system that let it happen, and 990 people in hospital beds is not mild.

Here is what I would do. None of it is new. All of it is on the table right now, and every item has a name and a docket.

Preventing the next Cyclospora outbreak

1. Sample the water where the lettuce grows. Cyclospora has one reservoir, and it is the human gut. There is no kill step: no wash, no chlorine and no post-harvest process removes it, which FDA itself put in print in August. The only place to stop it is upstream, in irrigation water, with tests aimed at the parasite and at human-specific fecal markers rather than the generic E. coli count the industry’s water metrics were built around. I said it at IAFP, and I will keep saying it.

2. Rescind Section 780 and enforce the traceability rule. Congress wrote the Food Traceability Rule into law in 2011, FDA finished it in 2022 with a compliance date of January 20, 2026, and then Congress, in the bill that ended last November’s shutdown, barred FDA from spending a dollar to enforce it before July 2028. The same section restricts enforcement money for the pre-harvest agricultural water requirements, which is item one. This summer Michigan asked for the source of the lettuce three times while people got sick. Eleven consumer groups have asked Congress to stop. Nineteen more signatures would be noticed.

3. Restore the people who count the sick. FoodNet, state epidemiology programs, CDC’s parasitic disease laboratory and USDA’s parasitology labs at Beltsville were all cut in the middle of the largest Cyclospora season on record. A clinic in Lee County, Florida stopped testing because its uninsured patients cannot afford the test, and the cases it saw in its own staff are in nobody’s count. Every number I published this summer is a floor.

4. Name names. An outbreak advisory that says Restaurant Chain A protects no one. FDA and CDC should name the grower, the processor and the restaurant every time, and retailers should be expected to say where their lettuce came from.

5. Answer the mail. Thirteen members of Congress wrote to FDA, CDC, HHS and Taylor Farms this summer, and I could not find one published answer. If the agencies will not answer letters, a subpoena to a hearing will.

Testing infant formula for botulism

Federal regulation, 21 CFR 106.55, requires finished powdered infant formula to be tested for Salmonella and Cronobacter. It does not require testing for Clostridium botulinum. Fifty-two infants were hospitalized with botulism across two brands, ByHeart and Nara Organics, and on August 27 CDC and FDA reported that whole genome sequencing links the two outbreaks to a common source of contamination in a shared milk supply, the one Eric traces from 55 California dairies through Organic West to a Dairy Farmers of America plant in Nevada. I represent more than two dozen of those families.

The fix is written. H.R. 7867, the Infant Formula Safety Modernization Act, introduced by Rosa DeLauro in March, would add C. botulinum to the required testing list and require environmental monitoring inside the plants. The House Energy and Commerce Health Subcommittee held a hearing on it April 29 and has not marked it up. The Senate passed S. 272 unanimously the same day, and it reaches the same two organisms the regulation already names. Eric is right that Congress has held no hearing on the outbreaks themselves, and he is right about the leverage: WIC buys more than half the formula sold in this country, and a buyer that size can set the terms.

I sent 535 t-shirts to Congress, one to every member, each folded into a plastic baby bottle, and they are being delivered this month. Mark up the bill. Hold the hearing. Put the parents at the witness table.

Salmonella in chicken

In January 2020 my firm petitioned FSIS on behalf of three families, Food & Water Watch, the Consumer Federation of America and Consumer Reports to declare 31 outbreak-associated Salmonella serotypes adulterants in meat and poultry. A year later CSPI, CFA, Consumer Reports and Stop Foodborne Illness filed their own. FSIS denied mine in May 2022 without prejudice, then proposed a Salmonella framework for raw poultry in August 2024 that grew out of both. It withdrew that rule on April 25, 2025, with the Meat Institute and the National Chicken Council backing the move, as Eric notes, and held a public meeting in January to start over. CDC puts Salmonella at 1.35 million illnesses, 26,200 hospitalizations and 420 deaths a year, and FSIS attributes more than 167,000 of those illnesses to chicken and turkey. Eric cites Consumer Reports finding it in nearly a third of the ground chicken it bought, and Denmark bringing its broiler flocks from 14 percent contaminated to 0.3 with rules that have teeth.

The ask is simple, and I have been making it for six years. Finish the rule. Declare the outbreak serotypes what the statute already says they are. What test-and-hold did for beef, a test-and-hold standard can do for poultry.

What Eric got right that I want to underline

Industry told Congress in 1906 that it was paying all it cared to pay, and Eric’s point is that it is saying the same thing now with a bigger lobbying budget. The record of this summer backs him up: a traceability rule defunded after the trade associations asked, a poultry rule withdrawn to applause from the same industry it would have covered, and a formula bill with no markup. The people paying instead are 990 people in hospitals, 52 babies, and a mother who has spent twenty-five years fighting to prevent the next one.

Should we be afraid of our food? I would rather we were angry enough to fix it. Read Eric’s piece, then pick one of the three above and call somebody.

On August 27, the same day FDA and CDC declared the Nara Organics infant botulism outbreak over, the company posted an update announcing that it plans to bring its formula back to U.S. shelves with European dairy and what it calls rigorous C. botulinum testing. Newsweek picked it up as a comeback story. I read it as a company working very hard to describe an outbreak without admitting it caused one.

The single most important fact in this story is one Nara never states plainly: the link between the Nara outbreak and the ByHeart outbreak is Dairy Farmers of America and Organic West Milk. Same milk, same spray dryer, two brands, fifty-two hospitalized babies. Here is what the record actually says, and where the company’s version bends away from it.

What FDA found

FDA’s outbreak page is short and unambiguous. Four infants in California, Pennsylvania and Washington developed confirmed botulism after consuming Nara Organics Whole Milk Organic Powdered Infant Formula, with onsets between April and May 2026. All four were hospitalized. Infant botulism is rare enough that four cases sharing one product in two months is, by itself, an outbreak signal.

Then the genetics. Whole genome sequencing of one Nara infant’s Clostridium botulinum matched a clinical sample from the 2025 ByHeart outbreak, a ByHeart base powder sample, and four unopened cans of ByHeart formula. Traceback showed the Nara lots tied to these illnesses were made with milk supplied by Organic West Milk and spray dried by Dairy Farmers of America, the same two suppliers behind the ByHeart outbreak. FDA’s conclusion: the WGS match and the shared supply chain indicate a common source of contamination between the two outbreaks. The only open question is whether the milk was contaminated before drying or during it.

ByHeart, for those who missed it, was 48 infants in 17 states, every one hospitalized. I wrote last week about ByHeart’s own “no further questions” announcement, which landed the day after FDA said the two outbreaks share a common source and did not mention it. Nara’s statement is the same move from the other direction.

How Nara describes the same finding

Nara’s version is that the outbreak “may be linked to one of our former dairy suppliers.” May be. Former. One of. Three qualifiers in a sentence about a finding FDA states without any.

The company then spends most of its update on what the sequencing did not show: that the matching infant’s strain did 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; that the open can matches nothing either; and that sealed cans tested negative for botulinum toxin types A and B. The unstated argument is that nobody can prove the spores were in a Nara can. Read the company’s own list again: it concedes C. botulinum was recovered from an open can of Nara formula in a patient’s home. The company just prefers to talk about which strain it was.

That argument does not survive contact with how infant botulism works. Infants get sick from swallowing spores, not preformed toxin. A toxin assay on a sealed can is the wrong test for the thing that hurt these babies, and a negative result tells you nothing about spores. Spores in dried milk powder are not evenly distributed; FDA’s ByHeart investigation identified seventeen distinct strains across patient, product and ingredient samples. An open can sampled from a home weeks after the fact carrying a different strain than the one that colonized an infant’s gut is exactly what you would expect. And a clinical strain absent from NCBI means the public database is thin on environmental C. botulinum, not that the case is unexplained. Meanwhile the one match FDA did find runs from a Nara baby straight to unopened ByHeart cans made from the same milk. Nara left that sentence out.

The date that gives it away

Nara says 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 hit in June. Read that carefully. Nara launched in July 2025 and reached Target in January 2026. By the company’s own account, every can it ever sold in this country was made with the Organic West and DFA milk that FDA has now implicated in two outbreaks. The switch to Europe was not a response to the outbreak. It was a supply decision that happened to leave the implicated product on shelves for another fourteen months.

The timeline gets worse. ByHeart recalled in November 2025. By late January 2026, the Associated Press had publicly named Organic West and DFA’s Fallon, Nevada plant as the source of the botulism-positive milk powder. Nara formula made with milk from that same supply chain stayed on sale through the spring. The four Nara babies got sick in April and May. Nara’s June 23 supplier page does not explain what the company knew about its own supplier in January, or why lots made with that milk were not pulled then.

FDA’s page adds one more fact Nara did not repeat. During the 2025 ByHeart investigation, FDA asked Organic West which other formula makers it had supplied. The customer list Organic West provided did not include Nara. The company corrected that only during the 2026 investigation. That failure belongs to Organic West, but it does not help Nara: a supplier’s omission kept FDA from calling, not Nara from knowing who made its milk.

About that testing

Nara’s recall page says the company already tests every batch beyond FDA and EU requirements, screening for sulphite-reducing clostridia as a proxy for C. botulinum. That program was in place when the outbreak lots were made and released. It did not stop them. A promise of rigorous testing on relaunch means nothing unless the company says what changed: which method, which sample size per lot, which spore-detection protocol rather than a toxin assay, and whether results will be published lot by lot.

I would add that DFA told the AP in January that the milk powder met all required tests. Both companies in this chain have now pointed at the tests as proof of safety. The tests were the problem.

What a real relaunch would look like

I am not against Nara selling formula again. I am against Nara selling it on the strength of a statement that reads like it was written to survive a deposition. Before this product comes back, the company should name its EU dairy supplier and spray dryer. It should publish its spore-testing protocol and commit to lot-by-lot results. It should wait for FDA to finish the root-cause investigation, since a company that does not yet know where the spores came from cannot credibly say it has designed them out. And Esther Hallam should sit down with the four families whose babies were hospitalized, in person, before the marketing starts.

I represent two of the four Nara families. Erica and Micky Goldfin of Yardley, Pennsylvania sued Nara and Target in the Eastern District of Pennsylvania on June 22. Their son spent two nights in intensive care at Children’s Hospital of Philadelphia on BabyBIG and is still in weekly physical therapy. Jin Nam and Jisun Leeof Lacey, Washington sued in the Western District of Washington on July 25; laboratory testing of the opened can of Nara formula fed to their son found C. botulinum, and weeks later he could not hold his head up or feed normally. I also represent families from the ByHeart outbreak. None of these parents care whose name was on the can. They care that two formula companies bought the same milk from the same two suppliers, that the second kept selling it after the first had recalled, and that fifty-two babies ended up in hospitals.

“We’re grateful to learn that the outbreak is over” is how Nara closed its statement. Grateful is not the word.

Sources: FDA Nara outbreak pageCDC food safety alertFDA ByHeart outbreak pageNara Organics August 27 update.

Consumers are buying less fresh produce this summer, and they are doing it because of what they have read, not because they are confused. Salad-kit purchases, lettuce prices, restaurant traffic and produce shipments all fell after the Cyclospora outbreak went public in July, and the federal response was a slogan. If government and industry want people back in the produce section, the way to do it is to make the count go down, not to tell people how safe the food is.

The New Yorker ran a cartoon (see above without permission) this week that says it better than I can. A couple stands in the produce section with a basket of greens, and one of them tells the other that they have enough groceries that could make them sick right away, and it is time to go pick up some ultra-processed food that will kill them more slowly. The joke lands because everyone standing in front of the bagged salads has had the same thought. That is where thirty years of the safest-food-supply line has gotten us.

What the purchase data shows

The numbers are not anecdotes. Numerator reported that more than 6.5 million American households stopped buying salad mixes and kits during the month that ended July 26, that ten percent of households said they had cut spending on salads and fresh greens, and that more than a quarter said they had stopped buying them altogether. The firm put roughly 280 million dollars a month of produce spending at risk. NielsenIQ had dollar sales of prepackaged salads down 14 percent for the four weeks ended July 25 against the same period a year earlier. Fetch had fresh lettuce down 10 percent, salad mixes down 23 percent and salad kits down 27 percent over two weeks, with the shift going to frozen vegetables. Total Quality Logistics, which handles around 140,000 produce shipments a year, saw shipments drop about 20 percent year over year in the week of July 13 as buyers cancelled orders and some growers dumped product rather than risk it.

The price signal is the sharpest one. Lettuce prices fell 16.4 percent from June to July in the Bureau of Labor Statistics seasonally adjusted data, the largest one-month drop on record. Prices do not fall like that because supply went up. They fall like that because nobody wants it.

Restaurants felt it the same week. Sweetgreen said the outbreak cost it about six percentage points of same-store sales in July and cut its full-year outlook. Chipotle put its hit at around two points in the back half of July even though its lettuce was never implicated. Salad and Go filed for Chapter 11 and closed every location, citing the outbreak on top of its existing problems. Traffic at Chopt fell 24 percent the day after FDA named the outbreak, and Taco Bell, where the traceback began, was still running roughly 20 percent below its normal visit pattern into August.

The Grower Shipper Association said late last month that demand is starting to rebound, and it is honest about why: schools are back in session, and institutional buying is up. That is a calendar effect. The association also said growers remain worried about whether people feel comfortable buying fresh produce. They should be.

What the government said while that was happening

On August 11, with the purchase data already in hand, Acting FDA Commissioner Kyle Diamantas told CNBC that we have the safest food supply in the world, that Americans should have full confidence in it, and that they should feel confident eating fresh produce including leafy greens. HHS posted the same day that the outbreak was contained and American food was safe. CDC published its weekly surveillance count that same Tuesday: 13,895 laboratory-confirmed cases of cyclosporiasis since May 1 and more than 10,000 more under investigation.

Three weeks later, the outbreak is bigger. As of August 27, CDC and FDA put the lettuce outbreak at 11,458 illnesses in 20 states, 495 hospitalizations and 2 deaths, with illness onsets running from June 14 through August 15. Georgia, Tennessee and Texas were added that day. CDC’s national surveillance count stood at 17,180 laboratory-confirmed domestic cases and 922 hospitalizations as of August 26, against 1,180 cases for the same stretch of 2025. Michigan alone reports 14,510 cases and 356 hospitalizations. FDA moved its inspections upstream to iceberg growers in Mexico in the third week of August, five weeks after the recall.

That is one outbreak. FDA’s active investigations table carries nineteen rows this week: the lettuce, a 431-person Salmonella outbreak in 32 states tied to imported jalapeños that pulled products off shelves at seven national grocery banners, a multi-pathogen alfalfa sprout outbreak Minnesota named in August, an 84-person Salmonella Newport cluster posted August 26 with no food identified, and a string of smaller Cyclospora files with the product column blank. A shopper who reads any of this is not being irrational when she reaches for the frozen peas. She is reading the same pages the Commissioner is.

Why the slogan makes it worse

The safest-food-supply line is not new. Every administration has used it, and I have spent most of my career pointing out what it costs. CDC’s own consumer page still says 48 million Americans get sick from food each year, 128,000 are hospitalized and 3,000 die. The most recent Global Food Security Index put the United States third on food quality and safety, behind Canada and Denmark, and thirteenth overall. Third is a respectable score. It is not first, and the index grades laws on paper, not sick people in hospitals.

The deeper problem is that reassurance without results reads as spin, and consumers price spin into their decisions. When the agency says full confidence on a Tuesday and adds 1,449 people to the outbreak the following Thursday, the lesson people take is not that lettuce is safe. It is that the people telling them lettuce is safe are not the ones to listen to. Trust does not come back because someone in Washington says a sentence. It comes back when the count goes down and stays down, and when the reasons it went down are visible.

What would bring people back

I have watched this happen once. Hamburger nearly killed the fast-food business in 1993. USDA declared E. coli O157:H7 an adulterant in ground beef in 1994, the industry fought it, lost, and then built the testing, the hold-and-release programs and the supplier requirements that made the rule work. My firm’s hamburger cases went from a steady docket to almost none after 2002. Consumers came back to hamburger because it stopped making them sick, not because anyone told them it was safe. That is the model, and it took a regulator willing to set a standard and an industry willing to meet it.

For produce, the list is short and none of it is new. FDA should implement the FSMA traceability rule in 2028 without another delay and fund the field staff to enforce it, because a traceback that takes two months from first illness to first advisory is the reason a recall could not catch the lettuce before it was eaten. FDA should be inspecting foreign growers and their water, not just the packing plants, before an outbreak and not five weeks after the recall. CDC and FDA should publish one set of numbers on one schedule, so the public is not reading three counts that do not agree. And the agency should stop declaring outbreaks contained on days its own surveillance page is still climbing.

Industry has the bigger job, because it has the product. Growers and processors should test agricultural water and product for the pathogens that actually show up in leafy greens, including the parasite that has now sickened tens of thousands of people twice in this outbreak’s history, and they should publish what they find. The buyers, the restaurant chains and the grocery banners that lost sales this summer, should write those tests into their supplier specifications the way the beef buyers did after 1994, and refuse product from suppliers that will not run them. A company that finds the problem and says so in public earns more trust than any agency statement can give it.

The couple in the cartoon is the market. They are not going to be talked back into the produce aisle. They will walk back in on their own when the shelves stop sending people to the hospital, and government and industry both know exactly what that would take.

Every Wednesday I read three government pages in a row. Tonight they told three different stories, and the difference between them is the most useful thing on any of them.

The CDC page: forty

CDC updated its current outbreaks page today. The agency does not name the investigations, only counts them by germ: two Campylobacter, seven E. coli, seven Listeria and twenty-four Salmonella. That is forty active multistate investigations. CDC says it typically coordinates between 17 and 40 at any given time, so forty is the top of the range the agency itself calls normal. None of the forty is described. There is no product, no state list, no case count. There is a number, and a note that some investigations become public notices and most do not.

The FDA page: nineteen rows, seven with no food named

FDA’s CORE investigations table was last modified August 26 and has not had its Wednesday refresh as I write this. It carries nineteen rows marked Active. Thirteen are ongoing and six are outbreaks FDA says have ended but has not closed out. Seven of the thirteen ongoing investigations have no product named, and together they account for 486 reported illnesses.

Two of those seven deserve a closer look. Salmonella Newport, reference 1403, was posted August 26 with 84 cases, a blank product column, traceback initiated, and no inspection and no sampling. Salmonella Oranienburg, reference 1387, was posted July 8, sits at 99 cases, and after eight weeks still shows traceback only, with neither an inspection nor a sample collected. Nearly 200 people are sick across those two files and the public has not been told what to avoid.

The row that did move is the sprout file, reference 1394. FDA merged what had been two anonymous E. coli rows, O103:H25 and O26:H11, into a single incident after CDC found four people infected at the same time with three E. coli strains and Salmonella Agona. The advisory names alfalfa sprouts distributed by Everything Sprouts, LLC of Minneapolis, and the company’s recall was added August 24. That is the only row on the table where FDA has initiated all three of traceback, inspection and sampling and also has a recall in hand.

The remaining Cyclospora rows crept: reference 1398 from 17 to 22, reference 1392 from 201 to 203, reference 1385 from 27 to 28. The iceberg lettuce advisory has not been touched since August 20. The requesón Listeria outbreak, the one on this table with a death, is now marked ended, with final information posted August 26.

The USDA page: three for the year, all closed

The FSIS outbreak investigations page lists three investigations for all of 2026, and the Active column says No on every one. In May, Listeria in retail-sliced headcheese, with a public health alert and an Illinois notice. In May, E. coli O157:H7 in beef kofta served at The Kebab Shop, with a public health alert and a California notice. In June, Salmonella Enteritidis in suspected chicken at the Broome County Correctional Facility in New York. That is the whole list. Nothing is open. Marler Clark represents people sickened in the Kebab Shop outbreak, which I note here so you can weigh it.

In fairness, FSIS explains the emptiness. It posts an investigation only when the evidence points to a product it regulates, and a meat or poultry item that got sick from an FDA-regulated ingredient, as happened with the jalapeño public health alert in August, never appears on this table at all. The page describes what gets posted, not the whole food supply.

Even with that caveat, the contrast holds. Here is what the three pages say tonight, side by side.

AgencyOpen filesProduct not yet namedOldest open unnamed cluster
CDC40 active multistate: Salmonella 24, E. coli 7, Listeria 7, Campylobacter 2Not disclosedNot disclosed
FDA CORE19 rows; 13 ongoing, 6 ended7 of the 13 ongoing, carrying 486 illnessesSalmonella Oranienburg, 99 sick, posted July 8, traceback only
USDA FSIS3 for all of 2026; 0 active0None

What the meat table used to look like

I built a law practice on the meat table. From the 1993 Jack in the Box outbreak through the 2002 ConAgra recall, hamburger E. coli O157:H7 cases were the core of what this firm did. They are now close to zero for us. That did not happen by accident. In 1994, USDA declared E. coli O157:H7 an adulterant in raw ground beef. In 1996, the Pathogen Reduction and HACCP rule made every slaughter and processing plant write down its hazards and prove it controlled them, under an inspector who was in the building. In 2011, the agency extended the adulterant rule to six more Shiga toxin-producing serogroups. Test-and-hold followed. The industry fought most of it, then built its operations around it, and the hamburger cases went away. It is the best thing that has happened in food safety in my lifetime, and the empty FSIS page is what it looks like from the outside.

Which is why last Friday matters

On August 28, the President posted on Truth Social that he was authorizing legal documents to be drawn to give farmers and ranchers the right to process their own food, calling the four largest beef processors a monopoly. The post came two days after a radio host told him that inspections are insane and regulations are killing ranchers. Agriculture Secretary Brooke Rollins said announcements would start Monday, including waiving red tape in processing, expanding the ability to sell across state lines, and support for small processors, and on Tuesday said a further announcement on labeling and cross-state sales would come later this week. As of this evening, no rule, order or bill text has been published, and existing federal inspection requirements remain in effect.

The reaction from the people who actually run the meat business was quick. The Meat Institute warned that uninspected meat reaching consumers could damage the country’s food safety reputation, and the National Cattlemen’s Beef Association said weakening federal inspection and food safety standards is not the answer. Representative Thomas Massie, who has spent years pushing the PRIME Act to loosen custom-slaughter rules, called the post a nothing-burger because farmers can already process their own animals; what they cannot do is sell that meat without inspection.

I have no quarrel with more regional processing capacity. Ranchers hauling cattle hundreds of miles because four companies own the plants is a real problem, and Congress has been funding small processors for five years. The way to get there is more inspected plants, more state programs recognized as equivalent to federal inspection, and more inspectors, not fewer. What cannot be on the table is the inspector. The FSIS page is empty because someone is standing in every plant that sells meat across state lines. Take that away and the page fills back up, and I know exactly what it fills up with, because I have the files from 1993 to 2002.

The bottom line

CDC is working forty investigations and will not say what they are. FDA has seven open files with no food named and nearly 500 people in them, including a 99-case Salmonella cluster that has gone eight weeks without an inspection or a sample. USDA has nothing open at all. One of those three agencies has a system that works, and it is the one the President was asked last week to loosen. Whatever gets announced this week, the right question for Secretary Rollins is simple: will every animal sold as meat still be slaughtered under inspection? If the answer is yes, the plan deserves a hearing. If the answer is anything else, look at the FSIS page tonight, because it will not look like that for long.

Sources: CDC current outbreaks (updated September 2, 2026); FDA CORE investigations table (modified August 26, 2026); FSIS outbreak investigationsCNNAgri-Pulse and Iowa Capital Dispatch on the August 28 post and the Secretary’s follow-up.