On October 28, the FDA declared over the E. coli O157:H7 outbreak linked to “multi-ingredient wraps with chicken” – FDA reference #1421, USDA 2026-04. Fifty people sick. Here is the agency’s explanation, in full:
“The wrap identified through the investigation is past shelf life and no longer available for purchase. The implicated wraps were proactively removed from the market before the link to the outbreak was established. At the time of this action, illnesses occurred during one week in August. Since these products were removed from sale and the wraps people ate were out of shelf life, more detailed product information would not have provided consumers with an action they could take to prevent illness. FDA’s outbreak investigation remains active.”
The product column on the FDA table still reads “Multi-ingredient wrap with chicken (suspect).” Suspect. That is five days after USDA’s Food Safety and Inspection Service confirmed to USA Today that the wraps came from Trader Joe’s, eight days after Trader Joe’s told the same paper that FDA had notified it in September and that it had pulled its Tarragon Chicken Salad Wraps from shelves in nine states, and thirteen days after we filed Gottlieb v. Trader Joe’s Co. (I represent the plaintiffs). Food Safety News has the update.
I wrote last week that naming the product cost the government nothing on October 23 and would have cost nothing on September 23. It would cost nothing today. So, let’s take the explanation apart.
“Illnesses occurred during one week in August.” That is the first epidemiological fact FDA has disclosed about this outbreak – not the states, not the hospitalizations, not the HUS cases, just a week. FDA first posted the outbreak on September 23, weeks after the last of those illnesses. It named the food, as a category, on October 7. Of course, the wraps were past shelf life by the time the public heard about them. The delay produced the shelf-life excuse, and now the shelf-life excuse is offered to justify the delay.
“More detailed product information would not have provided consumers with an action they could take.” This assumes the only reason to name a food is so you can throw it out. Fifty people are already sick. Their doctors need to know what they ate. The health departments interviewing them need to know. The people who ate a Trader Joe’s wrap in August, got sick, and were never tested need to know. And anyone who bought another product made with the same contaminated ingredient – which, by FDA’s own account, it is still trying to identify – needs to know.
“No ongoing risk” and “investigation remains active.” Both agencies have said they are looking for a contaminated ingredient and whether it went into other products. If you have not found the ingredient, how do you know there is no ongoing risk?
Frankly, withholding this information is the definition of gross deception of the consumer.
Two days before FDA closed this outbreak, the Department of Justice’s Office of Legal Counsel issued an opinion to HHS on exactly this question. It concluded that FDA’s current regulations largely block disclosure of supply chain information, but that FDA can rewrite them under section 705(b) of the Food, Drug, and Cosmetic Act, 21 U.S.C. 375(b), which lets the Commissioner disseminate information about food “in situations involving, in the opinion of the [Commissioner], imminent danger to health or gross deception of the consumer.” A regulation like that, OLC said, would be “authorized by law” under the Trade Secrets Act.
OLC also said a regulation authorizing disclosure “after a foodborne illness outbreak has already ended would likely be inconsistent with section 375(b).” That is imminent-danger logic. An outbreak’s danger ends. And two days later, FDA declared this one ended.
But the statute has two triggers, and OLC treated them as independent – FDA may authorize disclosure when “either of the statutory conditions” is met. Deception does not end when people stop getting sick. And deception is not only a false statement. It is also an omission.
Think about who the consumer is. It is a parent deciding what to put in a child’s lunch. It is the buyer at Walmart, or for a school district or a hospital, deciding which supplier to keep and which to drop. Every one of them makes that decision on the information available. When FDA knows which company’s food made people sick and keeps it to itself, every one of those decisions is made on a record the government knows is materially incomplete. The parent cannot avoid the brand, and the buyer cannot avoid the supplier, that FDA has already identified. That is deception of the consumer, and when it is about the source of an outbreak, it is gross. Section 705(b) does not say deception by the seller. It says situations involving gross deception of the consumer.
It is not just the chicken wraps. The same week FDA declared #1421 over, it posted an Executive Incident Summary Abstract for an 18-person Cyclospora outbreak traced to a catered lunch. The unredacted text says the traceback ran through a single caterer to its sole produce distributor, that two people were hospitalized, that no samples were collected, and that no product or firm actions were taken. Everything else is blacked out – the health department that investigated, the caterer, the foods of interest, the distributor, where the produce came from, and even the states where people got sick. Every fact a school, a hospital, an employer planning a lunch, or a produce buyer could use to decide whether to keep buying from that caterer or that distributor is redacted.
That is the same pattern as the 2024 romaine outbreak, where the traceback converged on one processor and one grower and the public learned their names more than a year later, through records requests and lawsuits. The government had the answer the whole time.
What I changed in the petitions. I have revised my two pending FDA citizen petitions to put this outbreak, and this argument, on the record:
Outbreak firm disclosure petition. The requested 705(b) rule now rests on both grounds. It asks FDA to define when it will find gross deception of the consumer: when an implicated firm or its customer makes a public statement about the food that the agency’s own investigative record contradicts; when the public record names only a commodity, so consumers blame firms that were not implicated; and when the agency’s own record still calls a food “suspect” after it or a partner agency has confirmed the link. It adds the case where FDA has identified the firm whose food caused an outbreak and withholds it, so that consumers and commercial buyers choose among products and suppliers on a record the agency knows is incomplete. The limiting principle is FDA’s own knowledge: the deception ground reaches what FDA has confirmed, not its working hypotheses. The petition also puts the Cyclospora abstract on the record and asks that FDA’s declaring an outbreak “ended” not, by itself, close the window for disclosure while the contaminated ingredient remains unidentified – which is exactly where #1421 sits today.
Retail consignee list petition. The removal that made the wraps “unavailable” is the same removal that, because no one called it a recall, produced no consignee list. The petition asks FDA to treat the removal of an outbreak-implicated food as what it is – a recall – whatever the firm calls it.
I plan to file both petitions together in November. If you would like a copy of either draft, or have comments, email me at bmarler@marlerclark.com – before October 30, if you can.
Fifty people got sick. The government knows the retailer, the product, and the manufacturer. FDA’s answer is that you did not need to know. The same goes for the people who ate lunch at that catered event. That is not “radical transparency.” It is the definition of gross deception of the consumer. (See also: Fifty Sick in an E. coli Outbreak, Two Federal Agencies, and Still No Names.)
Recent Comments