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• Action Level for Opiate Alkaloids on Poppy Seeds: Draft Guidance for Industry
• Food Colors Derived from Natural Sources: Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry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.

Jellyfish supplements are a new one to me.  Here’s study claiming that they improve cognitive function and memory.  If only it were that easy.

The study: Neil E. Wolkodoff, Gerald M. Haase, Joyce A. Curry, (2025), Effects of a Jellyfish Collagen-Based Amino Acid Supplement on Cognitive Function and Memory: A Pilot Investigation, J Clinical Research and Reports, 19(5); DOI:10.31579/2690-1919/532

Purpose: The goal of the current study was to evaluate the effects of oral consumption of an encapsulated powder form of a proprietary jellyfish extract on global cognitive parameters during an eight-week open-label trial in middle-aged and older adults.

Method: The study consisted of supplement consumption twice daily for eight weeks with an at-home, computer-based standard cognitive battery completed at pre-study baseline and at the end of the trial.

Results: EEG total reaction times…decreased by 130 milliseconds and combined trail-making scores demonstrated a reduction of test time by 12 seconds. Both were statistically significant…over half the individuals throughout the study period voluntarily reported positive outcomes, especially related to alertness, energy, focus, and sleep/dream patterns.

Conclusions: This pilot investigation showed that taking a proprietary oral jellyfish collagen supplement may offer meaningful benefits for overall cognitive function and brain activity.  The supplement, derived from marine invertebrate collagen, appears to be a promising way to support brain health in healthy middle-aged and older adults.

Comment: This is one of those studies that immediately raises the question: “Who paid for this?”

The funder: The supporting entity, Certified Nutraceuticals, Inc., had no role in study design or execution, data collection or analysis, or manuscript preparation. CN did provide product and testing support for the study.

To this, I say, that’s what they all say.  Sometime it’s actually true, but mostly it’s not.  Funding influences.  And not always in your best interest.

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Forthcoming November 11, 2025

For More Information and Pre-Orders, click here

I made a mistake and did not get this one scheduled correctly.  I’m trying again to get it posted (sigh, my error).

The USDA’s Economic Research Service (what’s left of it) has released its annual report on food assistance, which cost $142 billion in 2024 for all of the 16 programs.

This is a decrease from the $168 billion spent in 2023.

Food assistance accounts for two-thirds of USDA’s budget.

SNAP accounts for 70% of USDA’s food assistance budget.  Its 14% (inflation-adjusted) decline from 2023 “was larger than for any other year on record.”  And that’s before this year’s proposed cuts.

SNAP participation and costs track closely with poverty and food insecurity; when they go up, SNAP goes up.

Comment: The best way to cut SNAP?  Cut poverty.

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Forthcoming November 11, 2025: What To Eat Now

An as yet unpublished evaluation of how well American diets adhere to the dietary guidelines comes to an alarming conclusion: 86.3% are of poor quality.  The study comes from researchers at the Harvard School of Public Health, the University of California San Francisco, and Nourish Science.

The study: Understanding Sociodemographic and Dietary Determinants of Cardiometabolic Risk: Cross-Sectional Evidence from the U.S. Healthy Eating Index to Inform Diet Quality Categories.

Methods: The authors used dietary recall data from the 2009-2018 National Health and Nutrition Examination Surveys (NHANES) and compared participants’ dietary intakes to the Healthy Eating Index.

Results: Compared to adults with high diet quality, those with very low diet quality consumed:

• Less unprocessed or minimally processed foods, fruits, vegetables, whole grains, and seafood
• More ultra-processed foods, refined grains, and red and processed meats

They also were more likely to be overweight, have lower HDL cholesterol, but higher triglycerides, fasting glucose, and hemoglobin A1c (a marker of type-2 diabetes).

The authors explain their study in an Infographic and a YouTube video.

NHANES collects dietary intake information from representative population samples by interview.

The Healthy Eating Index (HEI) was developed in 1995 as a tool to measure adherence to recommendations of the Dietary Guidelines for Americans.  It is calculated on the basis of foods consumed and calories, sodium, saturated fats, and total fats.

The results of this study lead to obvious policy recommendations for healthier eating:

• More unprocessed or minimally processed foods, fruits, vegetables, whole grains, and seafood
• Less ultra-processed foods, refined grains, and red and processed meats

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Forthcoming November 11, 2025: What To Eat Now

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.

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Forthcoming November 11, 2025: What To Eat Now

The USDA has just announced a plan for reorganization that will move most of the agency out of Washington, DC, as flagrant an act of self-destruction as can be imagined.

The ostensible reason for this is to “To bring USDA closer to the people it serves while also providing a more affordable cost of living for USDA employees.”

Forthcoming November 11, 2025: What To Eat Now

A study funded by the Egg Nutrition Center concludes that eating two eggs a day reduces LDL-cholesterol, a risk factor for heart disease.

My NYU colleague, Mitchell Moss, sent me this news release:

Landmark study flips decades of cholesterol panic aimed at eggs:  In a groundbreaking clinical trial, researchers have unraveled the effects of cholesterol and saturated fat, finding that eggs may be far less harmful – and potentially more beneficial – than previously thought. It’s the latest research, using robust scientific work, to recast a nutritional villain in a new light.

My immediate reaction: Who paid for this?

I went right to the study: Impact of dietary cholesterol from eggs and saturated fat on LDL cholesterol levels: a randomized cross-over study, The American Journal of Clinical Nutrition  Volume 122, Issue 1, July 2025, Pages 83-91.

Conclusions: Saturated fat, not dietary cholesterol, elevates LDL cholesterol. Compared with consuming a high-saturated fat diet with only 1 egg/wk, consuming 2 eggs daily as part of a low-saturated fat diet lowers LDL concentrations, which may reduce CVD risk.

Funding.  This work was funded by the Egg Nutrition Center, a division of the American Egg Board. This funding source had no role in the design of this study, and no role in the analysis or interpretation of the data or writing of the manuscript.

Conflict of interest. JDB, AMC and AMH report financial support was provided by Egg Nutrition Center. All other authors report no conflicts of interest.

Comment: This seems like old news.  We’ve known for a long time that saturated fat raises blood cholesterol to a greater extent than does dietary cholesterol.  Eggs are the greatest source of cholesterol in U.S. diets.  But even during the fiercest days of pushing to lower dietary cholesterol, one egg a day was always OK.  Egg consumption has declined and the egg industry wants you to eat more of them.  Does eating two eggs a day really reduce heart disease risk?  It would be nice to have independentlyy funded corroborating research.  This, alas, is an industry-funded study conducted by investigators funded by the egg industry.  The claim that the funding source had no role should raise eyebrows.  Research shows that funding exerts influence, whether recognized by investigators or not.

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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.