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One of the underfunded and understaffed FDA’s major responsibility is to ensure the safety of the food supply.  Here’ are the actions the Trump Administration’s FDA is announcing lately.

I.  RUF Releases Produce Safety Roadmap: A Call for Action

The Reagan-Udall Foundation (RUF) for the FDA released its Roadmap to Produce Safety: Summary Report of the Produce Safety Dialogue…the report makes two primary recommendations:

• Implement a shared responsibility approach

• Form a structured, stakeholder-led collaboration

In line with the RUF recommendation, the FDA is calling on growers, buyers, sellers, and federal and state regulators to form a sustainably funded stakeholder collaboration that includes academia and consumer advocates and actively improves conditions and practices to reduce contamination and prevent foodborne illness.

Comment: The RUF is an independent group created by Congress to support the FDA.  Produce safety is a huge issue for the FDA, complicated because oversight is split between it and the USDA.  Produce becomes unsafe when it is exposed to pathogenic organisms spread by animal waste.  Yes, everyone involved in the food chain shares responsibility for safety.  By law, everyone who produces food is supposed to do it safely.  In practice, everyone points fingers at everyone else.  Collaboration would be nice.  But calling for enforcement of existing laws makes more sense.

II.  FDA Releases 2025 Human Foods Program Guidance Agenda

The FDA’s Human Foods Program published their proposed 2025 guidance agenda…These topics are a priority for the agency’s Human Foods Program to complete during 2025. New topics include:

• Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for Industry
• Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
• New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI: Guidance for Industry

Other guidance documents

• Fact Sheet: FDA Good Guidance Practices
• Human Foods Program Regulations Under Development | FDA
• FDA Guidance Documents
• What Does FDA Regulate

Comment:  The list of items under regulatory development is long and involves this one among many others: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Proposed Rule.  I think preventive controls are extremely important in ensuring food safety.  I looked up this one.  It’s written in FDA-speak:

This proposed rule would remove certain requirements that currently apply when a manufacturer/processor of human food has identified a hazard that requires a preventive control, but does not control that hazard. Although that manufacturer/processor would still be required to provide documentation that the food has not been processed to control the identified hazard, that manufacturer/processor would no longer be required to obtain written assurance from the commercial customer that the identified hazard will be controlled.

The FDA announced that it is revoking 52 obsolete standards of identity for food products.  It said it is doing this as part of the Trump Administration’s deregulatory agenda.

“I’m eliminating outdated food regulations that no longer serve the interests of American families,” said HHS Secretary Robert F. Kennedy Jr. “Today marks a crucial step in my drive to cut through bureaucratic red tape, increase transparency and remove regulations that have outlived their purpose.”

Two readers, Sharon Sass and Ashley Schuering, wrote to ask me to comment on this move.

For starters, the purpose of the Standards of Identity for Food (SOI) is to ensure that a product contains what is expected.  The SOI states what a food must contain, what is optional, and, sometimes. the amount or proportion of ingredient, and the method of production or formulation.

Current SOIs are at 21 C.F.R. Chapter 1, Subchapter B, Parts 131-169.

The easiest example is infant formula.  The SOI states the amounts of each nutrient that must or can be in the formula.  Infants depend entirely on those nutrients.  The SOI makes sense.  The FDA is not touching it at the moment.

It is more difficult to make sense of the SOI for fruit preserves and jams.  One of the rules reads like this:

Any combination of apple and one, two, three, or four of such fruits in which the weight of each is not less than one-fifth and the weight of apple is not more than one-half of the weight of the combination; except that the weight of pineapple may be not less than one-tenth of the weight of the combination.

The SOI also specifies the use of these ingredients:

(1) Nutritive carbohydrate sweeteners.

(2) Spice.

(3) Acidifying agents.

(4) Pectin, in a quantity which reasonably compensates for deficiency, if any, of the natural pectin content of the fruit ingredient.

(5) Buffering agents.

(6) Preservatives.

(7) Antifoaming agents, except those derived from animal fat.

This, it seems to me, could use some updating.

A law firm, Morrison Foerster, has a succinct summary of the relevant regulatory history.

FDA recognized the need to modernize its SOIs dating back to 1995. In 2005, FDA and the U.S. Department of Agriculture (USDA) published a proposed rule in an effort to initiate the process of modernizing SOIs. Then, in 2018, as part of the agency’s Nutrition Innovation Strategy, FDA sought to restart its efforts to modernize its aging SOIs. At a public meeting the following year, stakeholders expressed broad support for FDA’s and USDA’s efforts to finalize the 2005 proposed rule and called for a reopening of the comment period for the 2005 proposed rule to collect information on manufacturing, food technology, market trends, and nutrition science. FDA and USDA ultimately reopened the comment period in 2020. Based on the comments received, the agencies withdrew the 2005 proposed rule to “reconsider how best to approach general principles and food standards modernization

Here is the List of Standards Affected by FDA’s First Set of Food Standard Revocation Rulemakings

Comment

I don’t think this makes any difference.  The revocations will give food companies more flexibility in what they put into the listed products, but they will have to disclose the contents of their products on the food label.  Even if they remove real ingredients and substitute additives, they will have to say what is in the products.  The moral: read food labels!

The FDA’s Actions

• A direct final rule revoking standards for 11 types of canned fruits and vegetables that are no longer sold in U.S. grocery stores, including seven standards for fruits artificially sweetened with saccharin or sodium saccharin (and a companion proposed rule in case it needs to adjust this).
• A proposed rule to revoke standards for 18 types of dairy products.
• A proposed rule to revoke standards for 23 types of food products.

__________

Forthcoming November 11, 2025: What To Eat Now

The New York Times Magazine has published an astonishing investigative report about the FDA, totally worth reading: Inside the Collapse of the F.D.A.  How the new health secretary, Robert F. Kennedy Jr., is dismantling the agency.

She begins with RFK Jr’s opening salvo on Twitter (X):

FDA’s war on public health is about to end,” Kennedy wrote. “This includes its aggressive suppression of psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma. If you work for the FDA and are part of this corrupt system, I have two messages for you. 1. Preserve your records, and 2. Pack your bags.

Her major point:

It was easy to paint the F.D.A. as a supervillain (an aggressive suppressor of sunlight, vitamins and exercise, to borrow Kennedy’s language), in part because the truth was so much more complex.

What’s impressive about this piece is its dealing with the complexities.  Here’s the critical one.

On the one hand, the agency’s regulators have a truly enormous remit: Which drugs, medical devices, food, pet food, dietary supplements, tobacco products and cosmetics we can buy — one in every five dollars we spend, by official estimates — comes down to the decisions they make. On the other hand, the agency itself is profoundly under-resourced…In fact, its federal budget is roughly the size of the budget of the local school district in Montgomery County, Md., where it is based.

I could go on quoting but everyone should read this piece to realize what is at stake in the current destruction of the FDA—a lot.  We need the FDA, and we need it to be much, much stronger, not weaker.

I want to add one point not discussed in the article: unlike the other agencies in the U.S. Public Health Service, which get their funding from congressional health committees, the FDA gets its funding from congressional agriculture committees.  This dates back to 1906 when the forerunner of the FDA was created as part of the USDA.   When the FDA was transferred to the forerunner of Health and Human Services, its funding remained with agriculture committees, which could not care less about its functions.

The article is long.  If you don’t want to read the whole thing, here are the take-home lessons:  What to Know About the Collapse of the F.D.A. 

I’m hoping the Making America Healthy Again includes keeping us safe from food pathogens.

Four items relevant to food safety.

I.  Food Safety News: Salmonella outbreak sickens over 100; Animal operations blamed for leafy greens risk.

II. And the FDA is investigating yet another outbreak.

Cucumbers grown by Bedner Growers, Inc., and distributed by Fresh Start Produce Sales, Inc., to retailers, distribution centers, wholesalers, and food service distributors from April 29, 2025, to May 19, 2025. Cucumbers distributed before this timeframe should be past shelf life and should no longer be available on the market…FDA has posted a list of additional recalls being conducted by retailers that may have received potentially contaminated recalled cucumbers from Bedner Growers, Inc. This list includes recalls conducted by companies that further processed the cucumbers by using them as ingredients in new products or by repackaging them.

III.  The Journal of Food Protection just published this article: An Overview of Farm Investigation Findings Associated with Outbreaks of Shiga Toxin-Producing Escherichia coli Infections Linked to Leafy Greens: 2009 – 2021

These investigations showed that the outbreak strain can be found throughout the lifespan of leafy greens products, from the agriculture water used for the leafy greens, sediment from irrigation reservoirs, manure in nearby land, to retail product.

The contaminants come from animal manure leaching into water and soil.  Leafy greens should not be grown near CAFOs (concentrated animal feeding operations).

IV.  And what are FDA (plants) and USDA (animals) doing about all this?  The budget cuts are unlikely to help.

The Department of Government Efficiency (DOGE) recently laid off approximately 6,000 employees of the United States Department of Agriculture (USDA). Additionally, the Trump administration has proposed almost $40 million in budget cuts to the Food and Drug Administration (FDA) and a $1 billion decrease in the USDA budget, which recently resulted in workforce cuts and the suspension of services such as milk quality tests…The budget cuts and layoffs are partially intended to lessen federal government oversight and to shift many of the responsibilities to the state level. However, some states simply do not have the resources to serve as equally effective replacements.

This could have significant impacts on food safety and quality assurance.

How’s that for an understatement?

[Personal note: my graduation address today at Hopkins has been rain-postponed to 1:00 EDT .  It will be streamed here.]

Food safety is always a difficult topic because nobody wants to talk about it.

• We expect the food we buy to be safe (a quite reasonable expection, in my view).
• Food companies, by law, are supposed to produce foods safely.
• Regulators are supposed to make sure they do.

Any breakdown in rules and regulations causes problems.  Three troubling examples:

I.  Sentient Food: Federal Inspectors Found Antibiotics in Beef ‘Raised Without Antibiotics.’ They Took No Action

These letters, recently obtained by the advocacy group Farm Forward through a Freedom of Information Act request, reveal that the world’s largest meat producers — JBS, Cargill, and Tyson — raised cattle that tested positive for antibiotics prohibited under USDA-approved labels advertising the beef as free of antibiotics…These findings were announced last August, but the names of the companies which tested positive for antibiotics were not made publicly available until recently, as part of a new report released by Farm Forward questioning the validity of this popular label.

II.  Phyllis Entis: Manufacturer repeatedly shipped pet food after presumptive-positive pathogen test results

During the 2024 calendar year, Morasch Meats, Inc. (Portland, OR) sold dozens of batches of Northwest Naturals raw pet foods and pet treats after the finished products tested presumptive-positive for Salmonella or Listeria monocytogenes.

Instead of confirming the presumptive result as required by the test kit manufacturer, the company repeated the same rapid test on fresh samples. When the repeat test did not find the pathogen, Morasch released the production batch for sale.

III.  Food Safety News:   Intent or impact? New rules redefine food safety justice

On May 9, President Trump signed Fighting Overcriminalization in Federal Regulations, an executive order directing agencies like the FDA and USDA to limit criminal charges for food safety violations unless companies knowingly break the law. The executive order discourages criminal charges for unintentional violations…while deliberate acts, like falsifying tests, remain subject to prosecution…Critics, including consumer advocates, warn that the executive order, combined with reported cuts to FDA and USDA staff, could weaken deterrence against food safety violations.

Comment: When it comes to food safety, enforcement regulation is essential.  History tells us that unwatched food companies sometimes tend to let safety measures slide.  FDA and USDA food safety inspectors need to be on the job.  FDA inspectors have been cut.  USDA staff cuts undoubtedly will affect meat inspections.   None of this bodes well for the safety of the US food supply.

The FDA is an agency within the Department of Health and Human Services, now headed by Robert F. Kennedy, Jr.  It is getting busy on carrying out Secretary Kennedy’s stated agenda.  It took four actions of interest last week.  Check out #3; it requires action.

I.  Approved Three Food Colors from Natural Sources

Since the HHS and FDA announcement last month during a press conference at HHS on petroleum-based food dyes, more U.S. food manufacturers have committed to removing them within the FDA’s set time frame of the end of next year.

“On April 22, I said the FDA would soon approve several new color additives and would accelerate our review of others. I’m pleased to report that promises made, have been promises kept,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “FDA staff have been moving quickly to expedite the publication of these decisions, underscoring our serious intent to transition away from petroleum-based dyes in the food supply and provide new colors from natural sources.”

FDA approved color additive petitions for:

• Galdieria extract blue, a blue color derived from the unicellular red algae Galdieria sulphuraria (by petition from Fermentalg).
• Butterfly pea flower extract, a blue color that can be used to achieve a range of shades including bright blues, intense purple, and natural greens (Sensient Colors LLC)
• Calcium phosphate, a white color approved for use in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies (Innophos Inc).

II.  Announced top priorities for the Human Foods Program

FoodNavigator-USA report that Mark Hartman, who directs the new Office of Food Chemical Safety, Dietary Supplements, and Innovation, says the FDA soon will:

• Reveal how it will deal with the safety of chemicals in the food supply
• Create a new Office of Post Market Review to conduct risk reviews of chemical additives
• Increase transparency and stakeholder engagement in the review process
• Work through 70,000 comments on the FDA’s proposal for reviewing the safety of chemical additives
• Partner with the NIH to research how food additives affect children’s health
• Work with the food industry to phase out synthetic color additives
• Work through comments on sodium guidance
• Think about ways of addressing added sugars
• Identify ultra-processed foods as an “area of emerging study”

III.  Extended the comment period for front-of-package labeling until July 15

We are taking this action in response to requests to extend the comment period to allow interested parties additional time to submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2024-N-2910.

Recall: This is what the Biden FDA proposed.  Here’s what I said about it (basically, we need something better).

Here’s a real opportunity.  If you want a front-of-package warning label like those in Latin America, here’s your chance to weigh in.

RFK Jr says he wants to Make America Healthy Again.  One way to do that is to discourage sales of food products high in saturated fat, sodium, and added sugars, but also discourage sales of ultra-processed foods.  Identifying foods as ultra-processed, on the basis of their chemical additives as well as their fat, sugar, and salt, would be an excellent step forward.

If you like the warning labels used in Latin American countries, send a note to the FDA Docket.  You have until July 15 to do that.

IV.  Announced a joint research initiative with NIH to address, among other unspecified questions,

• How and why can ultra-processed foods harm people’s health?
• How might certain food additives affect metabolic health and possibly contribute to chronic disease?
• What is the role of maternal and infant dietary exposures on health outcomes across the lifespan, including autoimmune diseases?

Comment

OK.  This represents action or proposed action.  My question: What will the FDA actually do?  I’m particularly interested in the joint NIH research initiative on ultra-processed foods.  Will NIH reverse its stance on Kevin Hall, whose research aimed to answer precisely that question?  I will be watching all this with much curiosity.

It’s not easy to figure out what’s happening on the food front in DC these days, but a lot of it does not sound good.  Here are a bunch from last week.

I.  Food Bank Support. USDA stops $500 million worth of shipments of food to food banks.

Food banks across the country are scrambling to make up a $500 million budget shortfall after the Trump administration froze funds for hundreds of shipments of produce, poultry and other items that states had planned to distribute to needy residents.

The Biden administration had slated the aid for distribution to food banks during the 2025 fiscal year through the Emergency Food Assistance Program, which is run by the Agriculture Department and backed by a federal fund known as the Commodity Credit Corporation. But in recent weeks, many food banks learned that the shipments they had expected to receive this spring had been suspended.

II.  Line speeds in meat processing plants.  USDA announces “streamlined” meat processing.  This is USDA-speak for increasing line speeds in processing plants, something terrifying to anyone who cares about worker safety and food safety.  As Food Safety News puts it, this is unsafe at any speed—again.

Once more, policymakers are making the same catastrophic mistake. Once more, industries are downplaying risk while lives hang in the balance. Once more, we are choosing efficiency over responsibility…It’s a reckless increase in processing speeds that threatens to overwhelm the very safeguards meant to protect both workers and consumers.

III.  Food safety rules.  FDA puts food safety rule on hold

In an announcement on March 20, the Food and Drug Administration said it intends to publish a proposed rule “at a later time.” The rule has already been published and approved and was set to go into effect Jan. 1, 2026. The rule was mandated by the Food Safety Modernization Act, which Congress approved in 2010.

The food industry has been pushing back against the rule since before it was written, citing expenses. Industry groups applauded the FDA’s postponement of enforcement of the rule.

IV.  Seed Banks.  DOGE is trying to fire staff of the USDA’s National Plant Germplasm System, which stores 62,000 seed samples.

Comment

I’m not seeing much about Making America Healthy Again, beyond encouraging the elimination of artificial colors and trying to do something about the GRAS loophole, which lets companies essentially self-determine whether additives are safe.  Those are both worth doing, and have been a long time coming.  I still want to see this administration take strong action on:

• Ultra-processed food
• Food Safety
• School meals
• Support for small and medium farms

The cancelling of funding for the Diabetes Prevention Program, a 30-year longitudinal study, seems at odds with MAHA.  I hope the funding gets restored quicky.

Food Fix broke the news: Jim Jones, FDA Deputy Commissioner for Human Foods , resigned saying that the firings of the staff he had recruited over the last year made his job impossible.

The New York Times quotes Jones. 

They’ve created a real pickle for themselves,” by cutting staff members working on a key priority, Mr. Jones said. “You just can’t do an assessment [of food additives] for free and you can’t ban chemicals by fiat.

But wait!  Maybe you can.

The FDA is an agency of the Department of Health and Human Services (HHS).  And that brings me to its new secretary’s astonishing opening statement on his first day on the job.

I’m totally for making chronic disease a national priority for intervention, for getting conflicts of interest out of the FDA, and for focusing on child health.  And for Making America Healthy Again (MAHA).

I am eager to see what he does.

The FDA has long been plagued by cumbersome procedures (many of which do protect the public), conflicts of interest (especially the “revolving door” between the agency and industry), and apparent capture by the industries it is supposed to regulate.

Can RFK Jr address those problems in a way that promotes the public interest?  We shall see.

In the meantime, Jim Jones is being replaced by Kyle Diamantas, a lawyer from the large firm, Jones Day.

Not much is known about Mr. Diamantas, beyond his hunting turkeys with President Trump.

Food Fix quotes Vani Hari, the Food Babe as saying Diamantas “has a lot of Big Food contacts…I think that actually serves him. It puts him in an interesting position because he understands the stakeholders at play….I think that puts him in a good position to figure this out…He gets this issue.”

The nominee to be the new FDA Commissioner,  Martin Makary, has not yet been confirmed.

So much remains uncertain.  I am following all this with great interest.

Update on the chaos

The FDA has now rehired some of the people who were fired (particularly those supported by user fees).  Presumably, Jim Jones remains out.