On October 26, 2026, the Department of Justice’s Office of Legal Counsel issued an opinion to the Acting General Counsel of the Department of Health and Human Services titled Public Disclosure of Supply Chain Information in Foodborne Illness Outbreaks and Recalls. HHS asked a simple question: is FDA authorized by law to tell the public who is in the supply chain of a food that is making people sick?
The answer, in eight pages, is the argument I have been making for years. FDA’s current regulations mostly say no. The statute says FDA can change that. And FDA has not.
That matters right now. Fifty people are sick in the chicken wrap E. coli O157:H7 outbreak, reference #1421, that FDA and FSIS are investigating together. The public learned the wraps were Trader Joe’s Tarragon Chicken Salad Wraps from a lawsuit my firm filed and from a newspaper, not from either agency. In July, FDA told Stop Foodborne Illness that its pending petition on this exact question raised “complex issues.” The government’s own lawyers have now answered the hardest of them.
What the opinion says
First, the problem is FDA’s regulations, not the law. The Trade Secrets Act bars federal employees from disclosing confidential business information only when the disclosure is not “authorized by law,” and a properly issued regulation is enough authorization. FDA’s regulations treat the names and locations of firms in a supply chain as confidential commercial information under 21 CFR 20.61, and they wall that information off. The opinion concludes that, given those regulations, the Trade Secrets Act “largely prevents” FDA from disclosing supply chain information.
Second, the exception FDA leans on barely works. 21 CFR 20.91 lets FDA disclose information to the extent necessary to carry out an enforcement action like a recall. The opinion calls that authority “exceedingly narrow in practice.” It applies only when there is an actual enforcement action. In the opinion’s words, “FDA’s hands are tied before a recall is officially initiated.” And by the time FDA collects the information, it is often no longer “necessary.” The opinion also says the statute “nowhere requires” the case-by-case analysis in FDA’s 2020 consignee guidance, which it calls “arduous.” That is the chicken wrap outbreak in a sentence. The wraps were “proactively removed,” no recall was ever announced, and so nothing was ever disclosed.
Third, FDA can fix it. Section 705(b) of the Food, Drug, and Cosmetic Act lets FDA disseminate information regarding food in situations involving, in the Commissioner’s opinion, “imminent danger to health or gross deception of the consumer.” Combined with FDA’s general rulemaking authority, the opinion concludes, that provision lets FDA amend its regulations to authorize disclosure of supply chain information. Disclosure under such a rule would be “authorized by law” and would not violate the Trade Secrets Act. The opinion adds that this would hardly be a “transformative expansion” of FDA’s power, and that neither the FOIA exemption for commercial information nor the Act’s own trade secret provision stands in the way.
Fourth, in a footnote, the opinion questions whether the identity of a supply chain partner is even the kind of information the Trade Secrets Act protects. Every item the Act lists concerns a company’s internal processes, and who a company buys from or sells to is different in kind. The opinion assumes coverage for purposes of its analysis and notes, fairly, that some appellate courts would likely see it the other way.
Fifth, there is a limit, and I want to be honest about it. The opinion says a regulation “purporting to authorize disclosure after a foodborne illness outbreak has already ended would likely be inconsistent” with section 705(b). The imminent-danger authority is a tool for an open outbreak.
Where disclosure should have happened, and why
The opinion is not an abstraction. Run the outbreaks in my petitions through it and you see exactly where the public was left in the dark, and on what basis it should not have been. FDA, CDC and their partners have named farms, processors and brands at least eight times since 2006 after the product was gone. Here is what happens when they choose not to.
Romaine, fall 2024 (reference #1280). Eighty-nine people sick in fifteen states, thirty-six hospitalized, seven with kidney failure, one dead. FDA closed the investigation with one word: romaine. When the traceback summary was first released, the processor, the grower and the ranch were blacked out. It came out unredacted more than a year later, in stages, and only after three firms in the supply chain signed consents to release their own information. The document showed traceback had converged on a single processor and a single grower. Why it should have been disclosed: while people were getting sick that fall, this was imminent danger by any measure, and a section 705(b) rule would have authorized naming the firms then. Instead, as the opinion confirms, the only route left was the firms’ own consent. The public’s right to know depended on the permission of the companies being named.
Romaine, summer 2026 (reference #1382). Fourteen people sick. For ten weeks the only public record was a single row reading “Not Yet Identified.” On September 10, FDA closed the file, said romaine for the first time, and named no grower and no processor because the lettuce was past shelf life. It never said how many states had cases, how many people were hospitalized, whether anyone developed HUS, or whether traceback converged. Why it should have been disclosed: case counts are not anyone’s trade secret, and FDA published exactly those numbers for a closed romaine outbreak in 2019. Naming the firm after closure is where the opinion’s limit bites, which is precisely why the petition asks FDA to define by rule that an implicated firm’s name is not confidential to begin with.
Salmonella Newport (reference #1403). Posted August 26 with eighty-four cases and the food “not yet identified.” Traceback and sampling began. The count rose to ninety-seven, then 111. On October 21, FDA closed it at 119 cases without ever naming a food. No inspection, no advisory, no CDC notice. Why it should have been disclosed: the name of a food is not confidential commercial information at all. While the count was climbing for two months, this was the textbook open outbreak the opinion says section 705(b) covers. The petition asks FDA to name the suspect food once traceback begins. One hundred nineteen people deserved at least that.
Cantaloupe (reference #1366). Seventy people sick in twenty-five states. FDA said the fruit was likely past shelf life. Yet the importer, Ayco Farms of Pompano Beach, recalled a lot on March 24, 2026, FDA put two Guatemalan growers on import alert, and all three were named. Why this one is the tell: the same year, past-shelf-life romaine got no name. The difference was not the danger. It was whether a recall or an enforcement action happened to attach, which is exactly the narrow 20.91 trigger the opinion describes. And even here, FDA’s executive summary still redacts the states with cases and the other firms in the traceback.
Packaged organic salads (reference #1339). FDA’s own executive summary says traceback converged on a supplier and processor of packaged organic salads, then redacts the name and even the number of traceback legs. Why it should have been disclosed: the work was done and the conclusion reached. All that is missing is a name, and the rule that would require it.
Happy Hens eggs, San Diego County. California named the forty-one stores that received the implicated eggs this September. The federal record named none, and the recalled date codes were packed in August, after nearly every illness. Why FDA could have said the same thing: once a state lawfully publishes the stores, that information has “previously been disclosed in a lawful manner to any member of the public,” one of the exceptions the opinion confirms is authorization by law. FDA did not need a new rule to repeat it. It needed to want to.
Beef kofta, May 2026, and the chicken wraps now. When product is gone, FSIS’s routine is to issue a public health alert naming the establishment. In May it named The Kebab Shop and the producer of beef made four months earlier. In the joint chicken wrap investigation, with fifty sick and the product identified, it has issued nothing. One government, two defaults, and the only difference is who happens to be making the call.
What I am changing in the Outbreak Firm Disclosure petition
A new disclosure rule, exactly as the opinion describes. The petition already asked FDA to declare by rule that an implicated firm’s name is not confidential commercial information, and to make distribution information disclosable whenever an outbreak food is pulled, whatever the company calls the removal. It now also asks for a new regulation under sections 705(b) and 701(a). That regulation would authorize disclosure of the firm’s name, location and distribution information whenever the Commissioner finds an outbreak presents imminent danger. It would also require conforming changes to the three regulations the opinion identifies as the current bars. Each of these three changes is an independent ground. If a court set one aside, the others would still authorize disclosure.
Drawing the line where the opinion draws it, at the outbreak and not the package. The new 705(b) rule applies while an outbreak is open. That means while people are still getting sick or cases are still being found, or while the food or an ingredient may still be in commerce, in homes or in other products. Past its shelf-life date or not. When an investigation closes, naming the firms rests instead on the rule defining what counts as confidential, on the case law holding that a business’s name is not commercial information in itself, and on FDA’s existing exceptions. I took out language that said section 705(b) carries no requirement that an investigation still be open. The petition now cites the opinion’s limit against itself, because a petition that hides the hard part is not worth filing.
“Use the authority you already have” now means the authority the opinion confirms. Until a rule is final, the petition asks FDA to name firms whenever one of four existing authorizations applies. The opinion confirms each counts as authorization by law: information already lawfully disclosed to the public, a court order, the firm’s consent, and an enforcement action under 20.91. The first one is bigger than it sounds. When a retailer tells a national newspaper which product it pulled and in how many states, that information is public. Once Trader Joe’s did exactly that, FDA’s own regulation let it post the same facts on its outbreak table. It still has not.
Two smaller changes. Because the opinion reads 20.91 as requiring an actual enforcement action, the petition no longer asks FDA to treat a whole genome sequencing match as one by interpretation. That request moves into the rule. And because the legal question is now answered, the petition asks FDA to respond with a proposed rule, not another interim letter.
What I am changing in the Recall Consignee List petition
The petition still asks FDA to do by rule what USDA has done since 2008: publish the stores, restaurants, schools, hospitals and other places that received food in every Class I recall, when the recall is announced. It now rests that rule on two authorities instead of one: 20.91, and section 705(b) as the opinion reads it. A Class I recall already means there is a reasonable probability the food will cause serious harm or death. So the petition asks that, when FDA classifies a food recall as Class I, it also state whether the Commissioner finds imminent danger. That way publishing the store list no longer turns on a case-by-case finding that it is “necessary.”
It also uses the opinion to support two requests already in the petition. One is dropping the guidance’s packaging test, the analysis the opinion called “arduous.” The other is confirming that pulling an outbreak food is a recall no matter what the company calls it, because the opinion confirms 20.91 does nothing until a recall is “officially initiated.” And it explains why the rule fits within the opinion’s limit. The list is published when the recall is announced and updated while it is underway, which is when consumers can still use it and health departments are still finding cases.
What is not changing
Both petitions still ask for the same core things. They ask for a written standard with the exemption closed and the burden on the firm. They ask for one business day for a firm to correct errors and a prominent correction if a named firm is cleared. They reach the whole supply chain, from grower to retailer. They ask for case counts and the suspect food while an investigation is open, and an honest account of the traceback when it closes. They still go in together, on the same day. Both now also copy the HHS Acting General Counsel, who asked for the opinion. I still support the Stop Foodborne Illness petition. And S. 4974, passed by the Senate in September, is now less a precondition than a supplement. FDA does not need to wait for Congress.
Read them. Tell me what you think.
If you would like the revised drafts, email me at bmarler@marlerclark.com and ask for the petitions. Please get comments back to me before October 30, 2026.
For years FDA has said its hands were tied. The Justice Department has now said who tied them. FDA did, in its own regulations, and it can untie them by rule. Fifty people are sick from a wrap whose maker the government will not name. The law no longer gives FDA an excuse. Let’s see whether it will act.










