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I’ll say this again.  No, Cyclospora is not a food industry conspiracy to keep people from eating real foods.  It is a serious illness that has put plenty of people in hospitals and killed at least two.

At Monday’s MAHA press conference (see yesterday’s post), the FDA announced:

Finally, though not part of today’s announcement, with respect to microbiological food safety, FDA will be publishing tomorrow a final guidance document titled “Guide to Minimize Biological Hazards in ready-to-eat fresh-cut produce.” This final guidance is intended to help manufacturers and processors of fresh-cut produce comply with applicable FDA requirements and 21 CFR Part 117 titles current good manufacturing practices, hazard analysis, and risk-based prevention controls for human food.

The announcement: Guidance: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce

The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

The announcement says the new guidance will:

• Update, correct, and clarify the FDA’s 2018 Guide to Minimize Food Safety Hazards of Fresh-Cut Produce
• Clarify that the guidance applies only to ready-to-eat fresh-cut produce with a water activity above 0.85 (a water content high enough to support microbial growth)
• Add another example of an antimicrobial substance that can be used as a process control in the production of fresh-cut produce
• Provide additional examples of a supply chain program to control pathogens in a fresh-cut processing facility
• Provide additional recommendations on time/temperature controls

The new guidance: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce: Guidance for Industry

These are nonbinding recommendations.

They are aimed at processors and manufacturers, not growers.

They deal with contaminants on produce entering the processing plants and with those that might occur during processing, as a result of:

• Unclean water supply
• Poor worker hygiene
• Inadequate plumbing and sewage disposal
• Inadequate hand washing
• Inadequate product washing

They also cover such matters as supplier verification: conducting hazard analyses, onsite audits, sampling, and testing.

Comment

What they do not do is say anything about irrigation water, the most likely cause of the Cyclospora outbreak.

Here is Bill Marler on the FDA’s recent history of inadequate attention to irrigation water.

Pre-harvest agricultural water is the clearest case of an element written and then withdrawn. The 2015 rule set a geometric mean of no more than 126 colony-forming units of generic E. coli per 100 mL and required growers to test against it. The compliance dates were pushed back, enforcement discretion was announced before the first of them arrived, and in May 2024 the criterion and the testing requirement were replaced outright by an annual assessment in which the grower evaluates his own water and decides for himself what to do about it. I walked through that record this week in connection with the jalapeños out of Sinaloa. Nine years, three delays and a repeal, and not one farm ever had to hit the number.

Let’s hope the FDA gets on this.

It also needs to do a whole lot more than nonbinding guidance.

The FDA needs the authority to require companies to produce food safely, and hold them accountable if they do not.

If it does not have this authority, it needs to get Congress to authorize it.

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RFK Jr held a press conference yesterday to celebrate “the biggest news in food reform in modern history”—requiring food manufacturers to notify the FDA when they are introducing a new food additive they want considered Generally Recognized as Safe (GRAS).

This wasn’t already required?  No, it was not.  This gap is the long-troubling “GRAS loophole.”

Here’s what the press release says (my emphasis):

The FDA issued a proposed rule that would require manufacturers to notify the agency whenever they conclude that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS). The proposal would modernize the GRAS framework, increase transparency, and give the FDA greater visibility into substances entering the food supply.

Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to reach their own conclusions that certain substances are generally recognized as safe under the conditions of their intended use.

Although the FDA has long operated voluntary notification programs, companies have not been required to notify the agency when making these determinations.

The proposed rule would modernize that framework by making GRAS notifications mandatory and expanding the public-facing inventory of submitted notices, significantly improving transparency while strengthening FDA’s ability to oversee ingredients entering the food supply.

For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited streamlined submission pathway that would allow manufacturers to provide FDA with information about existing uses. This enables the agency to prioritize post-market safety evaluations while minimizing unnecessary regulatory burden.

Comment 

Food advocates for years have called for making GRAS notifications mandatory.  So this move is obvious, and long-awaited.

A reporter sent me an AI transcript of the press conference, which says how this will work (again, my emphasis).

What FDA will do is review a notification within 45 days to ensure that the elements required are in there. We’ll then docket that notification satisfying the requirement. FDA will then, within 180 days, review that notification substantively. If we have issues, we may either send a no questions letter or we may send we may send a letter determining that we don’t believe that the threshold has been established. But again, this is not a pre-market notification program. Companies are not prohibited from entering the market during the tenancy of that process, and they can continue to self-GRAS. What it does is require that companies notify us whenever they are self-GRASing an ingredient, and then we’re going to make that limited information public that’s set more than the regulation in 170.275.

So what’s the big deal?  Well, it’s the first food regulation proposed by the MAHA administration, and it closes the GRAS loophole.

What it does NOT do is keep unsafe additives out of the food supply.  Companies still have plenty of leeway to put whatever they want in their products.  This is not pre-market approval.  The FDA says it has no statutory authority to require that.

So why not go for it when you have the chance?  Despite the MAHA hoopla over the announcement, as Jerry Mande puts it, all this does is continue the FDA’s non-enforcement.

Another question: Does the FDA even have the staff to review food additive submissions, given the thousands who were fired or left?

Making GRAS notifications mandatory is a good thing to do.  Will doing this Make America Healthy Again?  A little, maybe, but it will be extremely hard to prove.

The big, easy-to-demonstrate food safety problems are ultra-processed foods (the FDA says it has sent an as yet unrevealed definition to OMB), and pathogenic microbes, like Cyclospora, with upwards of 25,000m cases so far, hundreds of hospitalizations, and at least two deaths.

And no, Cyclospora is not a food industry conspiracy to keep people from eating real foods–that idea is weird and unsupported by evidence.

Indeed, the FDA says:

Finally, though not part of today’s announcement, with respect to microbiological food safety, FDA will be publishing tomorrow a final guidance document titled “Guide to Minimize Biological Hazards And ready-to-eat fresh-cut produce. This final guidance is intended to help manufacturers and processors of fresh-cut produce comply with applicable FDA requirements and 21 CFR Part 117 titles current good manufacturing practices, hazard analysis, and risk-based prevention controls for human food.

Can’t wait to see this.  Stay tuned.

Resources

• The press release
• The transcript of the call with reporters
• The Federal Register notice
• Stat News on this (I’m quoted)
• FoodNavigator report (I’m quoted)
• CNN on MAHA’s GRAS notification requirement (I’m interviewed)

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Last week, MAHA proudly announced that the FDA Panel appointed by HHS Secretary Robert F. Kennedy Jr had approved 6 of 7 Peptides over the objections of FDA scientists.

The vote is a win for HHS Secretary Kennedy and MAHA, opening a path for compounding pharmacies to prepare BPC-157, TB-500 and four other popular peptides by prescription.”

The vote was close: RFK Jr’s personal appointees outnumbered FDA scientists concerned that the peptides have not been shown to be safe or effective.

RFK Jr believes in peptides and loaded the panel with his appointees; six of his eight appointees sell peptides.

The FDA raised concerns about conflicts of interest, but to no avail.

This panel is strictly advisory.  The FDA does not have to accept its recommendations.

The big question: Will the FDA accept this recommendation or reject it?

• If the acting head of FDA, Kyle Diamantas, accepts the panel’s recommendation, it will be a political, not scientific, decision.
• If he rejects the panel’s recommendation, he risks losing his job.

At stake: the FDA’s role as a science-based regulatory agency.

Principles anyone?

What this is about

Peptides are small proteins (50 or fewer amino acids), some of which have regulatory actions in the body.  The best examples are GLP-1 drugs.

They have to be injected; if swallowed as pills, they would be destroyed by digestive enzymes.

For what this is about, see the excellent account in the New Yorker: Why Are People Injecting Themselves with Peptides?

The ones just approved by the FDA committee are claimed (without much in the way of evidence) to do fabulous things for health.

Peptide sellers have pushed hard for the FDA to approve them.

Comment

There is plenty of anecdotal evidence for the benefits of injected peptides, but no real science.

Peptides are in a regulatory limbo.  Supplements are virtually unregulated as a result of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Consequently, you have no way of knowing if you are getting what the label says you are getting.

But peptides are injected, and not regulated under DSHEA.  That’s what this committee is trying to fix.

Caveat emptor!

I can’t wait to see what Diamantas does on this and what happens to him if he does the right thing and rejects the panel’s recommendations.

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I am outraged by the Cyclospora outbreak.  It has sickened thousands of people so far (>16,000?), and made some of them very sick.

Cyclospora is different from other foodborne pathogens.  It comes from human waste and cannot be removed by washing (although that helps some) or killed by chlorine.  It can only be removed by microfiltration or killed by heat or, maybe, ultra-violet radiation.

It needs to prevented from getting into irrigation water.

Lettuce producers have known about the Cyclospora hazard for more than a decade.  They have not acted, and neither has the government.

Hence, “Lettuce-Gate.”

Background

People are getting sick from eating some green thing—Lettuce? Parsley? Cilantro?—contaminated with a human-specific species of the parasitic microbe Cyclospora, which infects the digestive tract, causes “explosive” diarrhea, and is spread to vegetables via human feces, most likely through irrigation water.  [See: JAMA patient page: What is Cyclosporiasis?]

This outbreak is remarkable, not only for the large number of people affected, but also because of the inadequate, delayed, and chaotic oversight and response.

And the usual denials and finger-pointing.

• HHS Secretary Robert F. Kennedy Jr says the outbreak is “under control.” It is not; cases are still flooding in, many of them from Michigan.
• Mexico says there’s no evidence its lettuce is at fault; of course there isn’t.  It’s been eaten already.
• Taco Bell: Says it is no longer using Taylor Farms lettuce.

The DOGE-decimated CDC only issued its first health advisory two weeks after cases were reported, provides much less information than it used to, and is way behind on its tracking.

• Investigation update
• Notice
• Locations—states where cases are occurring
• Timeline

The equally DOGE-decimated FDA has made a mess of communication.  It first reported finding a positive sample in lettuce from Mexico, but then retracted that result saying it was a false positive.  It also reports much less than it used to about outbreaks under investigation on its website: FDA: Investigation of 5-state outbreak of Cyclospora illnesses: Iceberg lettuce (July 2026).   It still says the contaminated lettuce came from Taylor Farms in Mexico, based on the epidemiology.

For detailed analyses of FDA and CDC failure see Phyllis Entis at eFoodAlert and Bill Marler’s.

Yes, Cyclospora is hard to investigate.  Symptoms do not occur for days or weeks after eating contaminated food.  This means the evidence was eaten or destroyed long before anyone got sick.

Food Safety Rules

Everyone who produces food is supposed to assess the production procedures for places where contamination can occur, take steps to prevent contamination at those places, monitor to make sure the steps were taken, and test to make sure the procedures are working.  The FDA is supposed to inspect to make sure all his is happening.

The Food Safety Modernization Act issued rules for produce safety.  These include standards for irrigation water, but these do not apply well to Cyclospora (because it resists washing and chlorine).

If vegetable producers took appropriate steps, contamination risks would be much lower.

But if there is no federal oversight, no inspection, and no punishment for producing unsafe food, producers won’t bother.

They particularly will not bother to test the irrigation water.  Producers hate testing.  If they find something, they have to issue recalls.  These are complicated and expensive.

Taylor Fresh Foods, Inc

• Was slow to issue a recall.
• Eventually recalled lettuce products in 27 states. 
• Said the FDA apologized for claiming it had found a positive test result (the FDA did not apologize).
• Gave $1 million to president Trump’s campaign (the White House denied involvement).  [Source: Bloomberg]
• Called the White House to try to delay having to issue a recall.
• Did all else it could to prevent having to recall.
• Was warned about Cyclospora hazards in 2013 when the FDA did an  environmental assessment.
• Is located in Mexico 800 feet away from a public swimming pool facility—a potential source of fecal contamination of irrigation water.
• Has a long history of outbreaks since 2009.
• Claims each outbreak as “an isolated event, our branded products are not involved, we acted quickly.”

What don’t we know?

Food safety attorney Bill Marler presents three maps of the United States.

• Confirmed cases from Taco Bell
• Where the recalled lettuce went (many more states)
• All 2026 Cyclosporiasis cases (practically every state)

This predicts lots more cases to come.

The solution?  Treat irrigation water.  Require it to be treated.

Where are the CDC and FDA in all of this? 

• Decimated by DOGE—huge staff losses in both agencies.
• Weakened by cuts to public health spending.
• Handicapped by delays in implementing a federal food traceability rule.
• Not helped by the USDA’s plans to move food safety labs out of Washington DC.

One root cause: consolidation

Farm Action asks: If it isn’t Taylor Farms, then who?  It points out that “Just four companies—Taylor Fresh Foods, Cultrale-Safra, Itochu, and Bonduelle—control 54% of the U.S. fresh-cut salad market.”

The Bigger the Corporation, the Bigger the Diarrhea Outbreak

The fact that lettuce from one farm or one shredding facility could possibly have sickened thousands demonstrates the dangers of concentrating food production among a few large corporations. But the risks of corporate power run even deeper. Taylor Farms and other large produce corporations have long exerted political power to weaken food safety regulations, contributing to crises like this one. Taylor Farms representatives even met with the White House last week in an effort to distance the company from the outbreak…Recent budget cuts to federal and state health agencies further diminish the government’s ability to hold corporations accountable and protect consumers…

Advice to the Produce Industry

• Sales of salads are already down.
• Fix this.  Start testing.

Advice to Eaters

1. Cook your veggies: The New York Times has a handy recipe for stir-fried lettuce.
2. Avoid risky bagged salads and other hazards, and eat other fruits and vegetables.

What is Congress doing?

Writing letters, according to Bill Marler.

But only one of them focuses on traceability.  And we still do not know how Cyclospora got into the lettuce.

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The GRAS (Generally Recognized As Safe) loophole refers to the way the FDA allows food manufacturers basically to decide for themselves whether the additives they are using are safe, voluntarily or not.

Closing the loophole is a key goal of the Make America Healthy Again Movement (MAHA), and HHS Secretary Robert F. Kennedy, Jr., has made closing this loophole a key goal of his administration, and he has directed the FDA to “explore rulemaking” on this issue, meaning write real regulations.

We have yet to see any sign of what the FDA is proposing.

In the meantime, Yuka, maker of the popular product-scanning app, and Consumer Reports have petitioned FDA to get busy on this.

Now, product-scanning app Yuka and watchdog group Consumer Reports are urging the FDA to tighten regulation of food additives and close the GRAS “loophole”, after their investigation found that 25 out of 40 popular food and drink products contain at least one additive at levels identified as concerning by peer-reviewed research.

“Americans shouldn’t need a chemistry degree to eat safely – but today, no one, not even the FDA, can say exactly what’s in our food,” reads the organisations’ petition, which has already surpassed its goal of 35,000 signatures.

This is an old issue.  My contribution to this discussion was published in 2013: Nestle M.  Conflict of interest in the regulation of food safety: a threat to scientific integrity.  JAMA Internal Medicine 2013;173(22):2036-2038. doi:10.1001/jamainternmed.2013.9158.

So what’s the holdup?  Two reasons:

1.  RFK, Jr is on record as saying he doesn’t like regulation.  Regulation is nanny state.  He much prefers education.
2.  Lobbying by the users of unregulated food additives; they like it just the way it is.

NOTUS has a remarkable investigative report on lobbying over the GRAS loophole.  The number of lobbyists on this issue has tripled, it says.

After Kennedy directed the Food and Drug Administration to explore closing the GRAS loophole in March 2025, the number of trade associations, companies and organizations that reported lobbying on the pending regulation have nearly tripled, according to a NOTUS analysis of federal lobbying disclosures.

In-house and hired lobbyists for 35 organizations — from food chemical suppliers to packagers and manufacturers — disclosed lobbying specifically on GRAS reform during the first quarter of 2026, up from 12 during the same period in 2025 and one during the same period in 2024.

NOTUS gives one example:

AFIT [Americans for Ingredient Transparency] paid the Russell Group $240,000 between August 2025 and March, including $170,000 in the first quarter of this year, to lobby on “issues pertaining to ingredient transparency,” according to its quarterly lobbying disclosures.

If MAHA wants to close the loophole, it has to take on the food industry, big time.

No wonder RFK Jr is switching to physical activity: shades of Let’s Move!

Here’s the chronology:

In June, Texas passed the “Make Texas Healthy Again” bill which required food companies to put warning labels on products containing any of 44 ingredients such as artificial additives, dyes, and chemicals.  As I wrote at the time, the label would have to say:

WARNING: This product contains an ingredient that is not recommended for human consumption by the appropriate authority in Australia, Canada, the European Union, or the United  Kingdom.

In December, the American Beverage Association, joined by other food industry groups, sued Texas over this.

In February, a federal district court issued an injunction on First Amendment grounds.

Also in February, Texas issued a final rule on the labeling law.  But this says that “ingredients considered generally recognized as safe or determined to be safe by the FDA or USDA are not subject to the rule requirements.”

Oops.  I’m pretty sure that most of those 44 ingredients are considered GRAS by the FDA.

It will be interesting to watch what the courts decide on this one too.

Interesting times we live in.

Two recent reports say that the FDA is a mess as a result of staff cuts, loss of expertise, and leadership vacuums—a national tragedy by any criterion.

I.  From Timothy Inklebarger at FoodNavigator-USA: Trump purge at FDA and USDA triggers food safety ‘brain drain’: Government data shows deep staff cuts as food safety leaders warn of fewer inspectors, loss of institutional knowledge and delays in lab and outbreak work… Read more

The US Office of Personnel Management’s Federal Workforce Data tool shows the Department of Agriculture and Department of Health and Human Services are among the hardest hit, losing 22,253 and 17,406 jobs, respectively, since the beginning of 2025.

II.  ͏ From Gary Schwitzer’s Health News Review:FDA staff “rife with mistrust and paranoia”: Concern about staff “trampled on…perpetual uncertainty…chaos…no stability.”

It didn’t take Dr. Richard Pazdur long to see that he wanted out of Marty Makary’s FDA. The 26-year FDA veteran was hired in November to be director of the Center for Drug Evaluation and Research. He resigned in December. Why?  …Pazdur, looking distraught, spoke of an agency crumbling, with leaders making up rules as they went and longtime, experienced staff members leaving after layoffs and perpetual uncertainty left them unable to do their jobs. At different points, he described “chaos” at the agency with staff having gone through “a lot of trauma,” and said “you do not have stability.

Comment

If your purpose is to dismantle government, this is how you do it.  As I said, a national tragedy.

HHS issued a press release last week: FDA takes New Approach to “No Artificial Colors” Claims

Companies will now have flexibility to claim products contain ‘no artificial colors’ when the products do not contain petroleum-based colors. In the past, companies were generally only able to make such claims when their products had no added color whatsoever — whether derived from natural sources or otherwise. The agency sent a letter to industry providing notice of the FDA’s intent to exercise enforcement discretion related to these voluntary labeling claims.

..Additionally, the agency today also approved beetroot red, a new color option, and approved the expanded use of spirulina extract, an existing color additive derived from a natural source…This brings the total number of new food color options approved under the current administration to six.

…Ongoing progress in removing petroleum-based colors from the food supply is being publicly tracked by the FDA at Tracking Food Industry Pledges to Remove Petroleum Based Food Dyes.

Natural colors are generally extracted from vegetables, spices, or insects.  They go through industrial processing to extract the pigments and stabilize them.  (A series of videos explains the processes)

Are natural colors healthier?  They might be.  They are not associated with behavioral problems in children.

Are they safer?  Possibly, but they are not as well studied or regulated.  According to Time,

…their natural sources of color do not necessarily mean that they are safer or free of potentially harmful compounds. Natural sources may be treated with pesticides and herbicides, and are also prone to contamination with bacteria and other pathogens…To strip natural products of these contaminants, manufacturers process them with various solvents—some of which could remain in the final coloring and contribute to negative health effects…[and] it generally takes more natural color than synthetic color to make the same shade in a final food.

One additional point: color additives—regardless of source—are an indicator of ultra-processing.

Candy and cereals made with colors extracted from natural sources will still be ultra-processed.

The purpose of food colors—no matter their source—is entirely cosmetic.  They make foods look more appealing and appear to taste better. That’s why the food industry loves added colors.

Removing the more vibrant and more stable petroleum-based colors may reduce sales.

Will doing so Make America Healthy Again?  We shall see.