Robert F. Kennedy Jr. has rightly made “radical transparency” the motto of his Division of Well being and Human Providers. HHS even has a web page by that identify. I believe it’s a good motto, and I need to assist Secretary Kennedy and Appearing FDA Commissioner Kyle Diamantas ship on it in meals security, with two citizen petitions that ask for nothing the federal authorities has not already carried out, has not already mentioned it believes in, and, as of October 26, has not been advised by the Division of Justice that it has the authority to do. These petitions are meant as a hand up.
Earlier than attending to the petitions, it’s price the place the phrase got here from and the way it discovered its method into meals security, as a result of HHS and FDA put it there themselves.
The place “radical transparency” got here from
The phrase didn’t begin in Washington. It’s a administration thought popularized by Bridgewater Associates founder Ray Dalio, who constructed his hedge fund round what he known as radical reality and radical transparency and pitched it in a extensively watched 2017 TED speak. Dalio’s personal abstract of the enterprise case is price maintaining in thoughts for what follows: if you’re dealing with issues properly, radical transparency will make that clear, and if you’re dealing with issues badly, it would make that clear too.
Kennedy made it his personal at his affirmation hearings. Earlier than the Senate Finance Committee on January 29, 2025, he promised “radical transparency” throughout the division. Answering Senator Grassley, he mentioned that if Congress needed data, the doorways are open. And he added a line each outbreak investigator ought to tape to the wall: “We should always inform Individuals once we don’t know.”
Three weeks later, in his first deal with to HHS employees on February 18, 2025, he gave the thought its philosophical core: “Solely by way of radical transparency can we offer Individuals with real knowledgeable consent, which is the bedrock and the muse stone of democracy.”
At first, the phrase was largely about Congress, conflicts of curiosity and vaccines. It didn’t keep there.
The way it moved into meals, then into outbreaks and remembers
On March 10, 2025, HHS directed FDA to discover closing the self-affirmed GRAS pathway, and the press launch mentioned HHS and FDA “are dedicated to selling radical transparency to verify all Individuals know what’s of their meals.” That’s the first time I can discover the phrase hooked up to meals.
Marty Makary, then FDA’s incoming commissioner, introduced it with him. In his affirmation testimony he described a generational alternative to usher in radical transparency. Then, on July 9, 2025, FDA despatched a letter to meals trade leaders about recall communications that mentioned this: “On the FDA, we imagine that radical transparency in meals security and vitamin actions is vital to decreasing foodborne sickness and persistent illness.” Learn that once more. Foodborne sickness. Remembers. Radical transparency. FDA’s phrases, not mine.
The following day, FDA revealed greater than 200 drug rejection letters below the headline “FDA Embraces Radical Transparency”, and in September it introduced it could launch them in actual time, calling radical transparency “one of many guiding ideas of this administration.” These letters are redacted for confidential industrial data, however, in FDA’s phrases, they “will include firm names.” Maintain that thought.
On September 24, 2025, FDA’s meals program launched Govt Incident Abstract abstracts for closed outbreak investigations. The constituent replace opened: “The FDA is reinforcing our dedication to radical transparency to make sure Individuals know what’s of their meals and that it’s secure to eat.” Each the recall letter and the abstracts got here out of FDA’s meals program, led on the time by Deputy Commissioner for Meals Kyle Diamantas. By then the phrase had turn into the administration’s model extra broadly; that very same month the Senate HELP Committee held a listening to titled “Restoring Belief Via Radical Transparency.”
The individuals have modified since then; the commitments haven’t. Makary resigned in Could 2026, and Diamantas, the identical official whose meals program wrote radical transparency into the recall letter and the outbreak abstracts, has been performing commissioner ever since. In August, President Trump nominated Dr. Heidi Overton to be the subsequent commissioner. The commitments the company put in writing are nonetheless there for its leaders to construct on, and that continuity is an asset.
In my view, the place to begin is meals security, the place HHS and FDA have already laid a powerful basis in their very own phrases.
The unfinished half
The outbreak abstracts had been an actual step ahead, and FDA deserves credit score for them. The one piece nonetheless lacking is the piece the general public most wants: who and the place. Meals Security Information reported that FDA has withheld firm names in its mango outbreak abstract, and Meals Security Journal described a abstract of a deadly Listeria outbreak through which FDA redacted all key particulars, all the way down to the states the place the sufferers lived. When Cease Foodborne Sickness petitioned FDA in February to cease treating firm names as confidential, invoking radical transparency, FDA answered that the names are protected by the Commerce Secrets and techniques Act. That was an trustworthy assertion of the authorized query the company believed it confronted, and, as I clarify beneath, that query now has a solution.
The price of that hole reveals up in actual outbreaks. In September FDA closed a romaine E. coli investigation and named no grower, no processor and no model. In October, in a 50-person E. coli O157:H7 outbreak linked to rooster wraps, the general public discovered the model from a lawsuit and a newspaper, not from FDA or FSIS – though FSIS later confirmed the supply to a reporter (I signify plaintiffs in that outbreak). Nevertheless, when FDA declared that outbreak over on October 28, its entry nonetheless didn’t identify the model, the maker or the states, and it defined that extra detailed product data wouldn’t have given shoppers an motion they may take to forestall sickness. I perceive the reasoning, however it assumes the one cause to call a meals is so individuals can throw it out. As I clarify beneath, that isn’t the one client who must know.
Not who might need been the supply, however who was
I need to be clear about one factor, as a result of it’s the coronary heart of each petitions. I’m not asking FDA to call each agency that may have been the supply of an outbreak, or to publish working hypotheses whereas an investigation remains to be finding out the info. Everybody remembers the 2008 tomato warning that turned out to be peppers. I’m asking FDA to call the agency its personal investigation discovered really was the supply.
The 2024 romaine outbreak is the clearest instance I do know. That fall, an E. coli O157:H7 outbreak linked to romaine sickened 89 individuals in 15 states, hospitalized 36, brought about seven circumstances of hemolytic uremic syndrome and killed one particular person. FDA closed the investigation with the phrase romaine and nothing extra. When the traceback abstract was first launched, the processor, the grower and the ranch had been blacked out. When it was later launched with out redactions, solely after corporations within the provide chain signed authorizations consenting to the discharge of their very own data, the identical doc confirmed that the traceback had converged on one processor and one grower. There was no uncertainty to guard. The federal government had the reply the entire time, and the general public discovered it by way of information requests greater than a yr later, after the season, the product and any likelihood to behave had handed.
That’s the line the petitions draw: disclosure of what FDA has confirmed, by way of the identical traceback and laboratory proof it depends on to shut an investigation, and never of what it merely suspects.
The 2 petitions
That’s the reason I’m submitting two citizen petitions collectively.
The primary, on outbreak agency disclosure, asks FDA to amend its laws to say that the identify and site of a agency just isn’t confidential industrial data when epidemiologic proof implicates a meals in an outbreak and traceback or laboratory proof, together with complete genome sequencing, identifies the agency because the supply of the contaminated meals. That’s the similar proof FDA already makes use of to shut an investigation, and it isn’t a suspect record. It asks FDA to reveal implicated growers, processors and distributors whether or not or not there’s a recall, and to complete the transparency initiative it began by publishing these abstracts with out redacting agency names.
The second, on recall consignee lists, asks FDA to publish the record of retail shops that obtained a recalled meals in each Class I recall (the type that may trigger critical sickness or loss of life) and to categorise each meals recall, and publish the classification, inside a set variety of days.
That’s it. Neither petition asks FDA to disclose a recipe, a course of, a buyer worth or the rest that may be a real commerce secret. They ask for who and the place.
Why none of that is radical
Begin with USDA. For meat and poultry, FSIS has revealed retail consignee lists in Class I remembers below a remaining rule adopted in July 2008, in the course of the Bush administration. A client who purchased recalled floor beef can discover out whether or not their retailer obtained it. A client who purchased recalled cheese, sprouts or bagged salad normally can’t. Eighteen years on, the meat and poultry industries are nonetheless standing.
Congress observed the hole. Within the Meals Security Modernization Act of 2011, it advised FDA, in its new necessary recall provision, to contemplate USDA’s consignee coverage. FDA did and wrote a steering doc saying it could publish consignee lists in some circumstances.
FDA itself has named farms, processors and types in the identical circumstances it faces in the present day, a minimum of eight occasions since 2006. States do it routinely.
After which there are these drug rejection letters. FDA has already determined, below the banner of radical transparency, {that a} drug firm’s identify just isn’t the confidential a part of a letter rejecting its software. Making use of that very same precept to meals would carry the company’s two halves into line: if a pharmaceutical firm’s identify might be revealed with a failed software, the identify of a farm that complete genome sequencing has tied to kids on dialysis might be too.
None of that is radical. It’s a confirmed apply ready to be adopted.
Good for shoppers
Kennedy mentioned radical transparency is how Individuals get “real knowledgeable consent.” You can not consent to something a few meals when the federal government is aware of who made it and won’t say. A named agency and a broadcast retailer record let a household verify their fridge, let a health care provider join a affected person’s sickness to a supply, and let a well being division discover circumstances it could in any other case miss. Over time, names construct a monitor file, so shoppers can inform which firms maintain turning up in outbreak after outbreak.
Gross deception of the buyer, and who the buyer is
Part 705(b) of the Meals, Drug, and Beauty Act lets FDA share details about meals in conditions involving, within the Commissioner’s opinion, imminent hazard to well being or gross deception of the buyer. A lot of the dialog about outbreak disclosure has centered on the primary of these, imminent hazard. The second deserves simply as a lot consideration, and I believe it’s the extra pure match for what these petitions ask.
Take into consideration who the buyer is. It’s the mother and pa within the grocery aisle attempting to purchase what’s secure for his or her children. Additionally it is the client for Walmart or Taco Bell, or for a faculty district or a hospital, deciding which provider to maintain and which to drop. Each one among them makes that call on the data out there. When FDA has confirmed which firm’s meals made individuals sick and that truth stays within the file, every of these selections is made on a file the federal government is aware of is materially incomplete. The dad and mom can’t steer round a model, and the client can’t weigh a provider’s file, that FDA has already recognized.
Deception doesn’t need to be a false assertion; an omission can mislead simply as absolutely. A commodity-only advisory that leaves consumers blaming each grower of a crop, a agency publicly denying it was the supply whereas the company’s traceback converged on it, or an outbreak desk that also lists a meals as “suspect” after a federal company has confirmed it to the press every leaves shoppers with a false image that FDA holds the file to right. And in contrast to imminent hazard, deception doesn’t finish when individuals cease getting sick. The mum or dad and the client are nonetheless making selections subsequent season.
The limiting precept is FDA’s personal data. This floor reaches what the company has confirmed, not its working hypotheses, which is precisely the road the petitions draw. I wrote about this in additional element when FDA closed the rooster wrap outbreak, and I’ve revised each petitions to relaxation on it.
Good for enterprise
That is the half the trade ought to hear most clearly. When the federal government names a commodity and stops, shoppers keep away from the entire commodity. Throughout this summer time’s Cyclospora outbreak, Numerator knowledge reported by Grocery Dive confirmed that 6.5 million households stopped shopping for salad mixes and kits in a single month. That price fell on each grower and processor within the class, together with those who did every part proper. In 2008, tomato growers misplaced a season to a Salmonella outbreak that turned out to be peppers. Anonymity doesn’t forestall hurt; it spreads one agency’s hurt throughout a complete trade.
A reputation is the one factor that separates the agency that brought about an outbreak from the opponents who didn’t. It lets a purchaser at a nationwide chain weigh a provider’s historical past the way in which a mum or dad weighs a model, lets insurers worth danger and offers each agency a cause to search out its downside earlier than subsequent season. Ray Dalio would acknowledge the logic: if you’re working a secure operation, transparency makes that clear.
Good for HHS and FDA
The businesses promised to rebuild public belief. Few issues would construct belief quicker than the general public listening to the identify of an implicated agency from FDA first, reasonably than from a court docket submitting or a reporter. A transparent rule additionally will get FDA out of the enterprise of constructing advert hoc, case-by-case judgments that look inconsistent from the surface, and it makes the meals program in line with what FDA is already doing for medicine. It lets the company end an initiative it launched itself. And it’s a concrete, announceable win: no new statute, no new appropriation, a rule FDA can write by itself.
And now DOJ says FDA has the authority
The sticking level for FDA has been authorized, and it has been a good one: the company has mentioned the Commerce Secrets and techniques Act ties its palms. On October 26, 2026, the Justice Division’s Workplace of Authorized Counsel answered that argument in an opinion addressed to HHS.
OLC agreed that FDA’s present laws usually don’t authorize disclosure of provide chain data, so the Commerce Secrets and techniques Act largely forbids it, and that the present route by way of 21 CFR 20.91 is exceedingly slim in apply. However it concluded that part 705(b) of the Meals, Drug, and Beauty Act, along with FDA’s rulemaking authority in part 701(a), permits the company to amend its laws to authorize disclosure of the names and places of corporations in a provide chain in conditions involving imminent hazard to well being or gross deception of the buyer. Disclosure below such a regulation, OLC mentioned, could be licensed by legislation and wouldn’t violate the Commerce Secrets and techniques Act.
OLC additionally drew a line: a bit 705(b) regulation authorizing disclosure after an outbreak has already ended would seemingly be inconsistent with the statute. That’s imminent-danger logic, since an outbreak’s hazard ends. However OLC handled the 2 statutory situations as impartial, permitting a regulation that allows disclosure when both one is met, and deception of the buyer doesn’t finish with the final sickness. OLC didn’t determine whether or not its timing restrict reaches the deception floor, and I’ve mentioned so within the petition. The petitions additionally relaxation on a separate rule {that a} agency’s identify and site merely just isn’t confidential industrial data within the first place, so FDA has a couple of sound path.
In different phrases, the impediment has by no means been the statute. It has been FDA’s personal laws, and the Division’s legal professionals have now advised HHS that FDA can change them. The petitions ask it to.
Secretary Kennedy, Appearing Commissioner Diamantas, Dr. Overton
HHS and FDA have already carried out the arduous half: they made the dedication, they usually put it in writing for meals, within the GRAS announcement, within the recall letter to trade and within the launch of the outbreak abstracts. Mr. Diamantas, these final two got here from the meals program you ran. These petitions supply a solution to full that work and put your identify on the end result. You’re additionally a lawyer, the primary to guide the company, and you’ll acknowledge that the OLC opinion clears the authorized path the company has lengthy mentioned it wanted. Dr. Overton, if you’re confirmed, this may be a significant early win to hold ahead. And none of it requires something radical. It’s strange transparency, the type USDA has practiced since 2008, that FDA has used a minimum of eight occasions, that Congress requested you to contemplate in 2011, that you simply already apply to drug firms, and that the Justice Division says you could have the authority to undertake.
Secretary Kennedy mentioned we should always inform Individuals once we don’t know. These petitions ask for the opposite half of that promise, telling them once we do. I hope HHS and FDA will take it, and I’m glad to assist nevertheless I can.
If you need a duplicate of both petition, or wish to file a supportive remark as soon as they’re docketed, electronic mail me at bmarler@marlerclark.com.