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The FDA is starting the regulatory process to close the GRAS Loophole.

This proposed rule, if finalized, would amend the Generally Recognized as Safe (GRAS) regulations in 21 CFR [Code of Federal Regulations] parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.

What?  You mean manufacturers are not already required to tell the FDA when they are putting new additives into foods?

No, they are not.  Hence, the “GRAS Loophole.”  Food manufacturers have been allowed to decide for themselves whether a new additive is safe and also to decide whether to inform the FDA about it.

Closing the loophole is a long-standing goal of food advocates.  Even I got into this one.

In 2013, I wrote a short editorial about the history and significance of GRAS determinations: Nestle M. Conflict of interest in the regulation of food safety: a threat to scientific integrity. JAMA Internal Medicine. 2013;173(22):2036-8. 

Here’s the FDA’s version of this history.

And Food Dive explains: FDA takes first step toward closing GRAS ingredient ‘loophole’

Dive Brief:

• The FDA proposed a rule that companies provide health data and other documentation when declaring a new food ingredient or additive is safe, a step toward eliminating a voluntary approval process decried by Health Secretary Robert F. Kennedy Jr.
• The rule would require companies to submit mandatory notices when declaring an ingredient is Generally Recognized as Safe, or GRAS. Currently, notices are voluntary, though strongly encouraged by the FDA.
• The proposal is included among a list of upcoming regulatory priorities by the Trump administration. In March, Kennedy directed the FDA to explore rulemaking to eliminate companies’ ability to self-affirm that an ingredient is safe.

If the FDA can pull this off, it will indeed be a MAHA Win.

I hope it can, given how many FDA employees are no longer with the agency (~3,500 according to reports).

When I saw this article in the Journal of Nutrition, my first question was, “Who paid for it?”

The article: Yogurt and Reduced Risk of Type 2 Diabetes: Exploring the Food and Drug Administration Qualified Health Claim and Potential Implications for Improving Public Health. Freitas, Miguel et al. The Journal of Nutrition, Volume 155, Issue 8, 2475 – 2484

The premise: “As yogurt is a component of the underconsumed dairy food group within the Dietary Guidelines for Americans, communication on the relationship between yogurt and T2D risk can help encourage the public to increase intake of yogurt and, with it, nutrients of public health concern such as calcium.”

The discussion: the article summarizes a symposium about the FDA’s approval of a qualified health claim for yogurt and type 2 diabetes.

Comment: Danone, of course, makes Dannon yogurt and of course views it as underconsumed.  The company petitioned the FDA to allow these claims on yogurt products:

“Eating yogurt regularly may reduce the risk of type 2 diabetes. FDA has concluded there is limited information supporting this claim.”
“Eating yogurt regularly may reduce the risk of type 2 diabetes according to limited scientific evidence.”

Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes. FDA has concluded that there is limited information supporting this claim.
Eating yogurt regularly, at least 2 cups (3 servings) per week, may reduce the risk of type 2 diabetes according to limited  scientific evidence.”

Danone pretty much got what it wanted.

To understand why I find qualified health claims nutritionally hilarious, I must point out that “may reduce the risk” also means “may not reduce the risk.”

As I endlessly repeat, health claims are not about health; they are about marketing.

David Kessler, a physician, lawyer, and former FDA Commissioner, has done a great service for the Make America Healthy Again movement.  He has written a letter to RFK Jr presenting a Citizen’s Petition to the FDA: “Petition to Limit the Exposure of Refined
Carbohydrates used in Industrial Processing in order to Prevent Obesity, Diabetes, and Cardiovascular Disease in Children and Adults.”

His petition argues that processed refined carbohydrates should no longer be considered Generally Recognized As Safe (GRAS).

These are:

1) refined sweeteners, including corn syrup, corn solids, glucose syrups, dextrose, invert sugar, xylose, maltose, and high fructose corn syrups; and maltodextrin

2) refined flour and starches that are subjected to food extrusion technology, including wheat, corn, tapioca, oat and potato  flour, and starches that are processed by extraction or similar technology, and

3) sucrose, refined flours, or starches that are used with emulsifiers (e.g. mono- and diglycerides of fatty acids, DATEM, sodium stearoyl lactylate, polysorbates); dough conditioners and strengtheners (e.g. azodicarbonamide, L-cysteine, calcium peroxide); humectants (e.g. propylene glycol); stabilizers and gums (e.g. carboxymethylcellulose, methylcellulose); or modified starches and fillers (e.g. regelatinized starch, modified food starch, dextrins).

The carefully argued and lengthy petition makes a strong case for the unhealthy nature of processed refined carbohydrates.

Wow.

If the FDA agrees—and it has to deal with the petition within 180 days—these ingredients would no longer be GRAS and foods containing them would be considered adulterated and illegal to sell.

Here’s what I said to the press:

• This would cover an extraordinarily large percentage of foods that are ultraprocessed…an extraordinarily impressive document” (New York Times).
• Kessler has given the FDA a way to define the vast majority of ultra-processed foods. In doing so, he has handed RFK Jr a huge gift on the path to regulating these products. It’s just what MAHA has asked for. I hope they take it seriously (CNN).

Can’t wait to see how RFK Jr and the FDA handle this.

The safety of pet food matters because we have one and only one food supply.  If pet food is unsafe, our safety is at risk.

You don’t believe me?  Try this: Darwin’s raw pet food linked to human case of E. coli O157:H7 in four-year-old child

The US Food and Drug Administration (FDA) is advising the public not to feed certain lots of Darwin’s Natural Pet Products raw food to their pets after a four-year-old child became ill with E. coli O157:H7…The child was hospitalized, and developed a severe case of hemolytic uremic syndrome (HUS), requiring dialysis. He spent a total of six weeks in hospital and is at risk of permanent injury to his kidneys.

The world of people who care about this sort of thing and demand that authorities do something about it is a small one.  I learned about this from Phyllis Entis, author of  TAINTED. From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures and TOXIC. From Factory to Food Bowl, Pet Food Is a Risky Business.

She learned about it from food safety advocate Bill Marler.  As the food alert explains,

The contamination came to light after food-safety attorney, William Marler, initiated third-party testing of an previously unopened package of BioLogics All-Natural and Grain Free, Beef Recipe for Dogs found E. coli O157:H7 in the raw, frozen product. Whole genome sequencing (WGS) confirmed that the strain found in the pet food was a match for the strain recovered from the child…when Marler reviewed the files once more, he noted that the family had a dog, and…learned that the dog exclusively ate Darwin’s pet food, and had begun vomiting one day before the child fell ill…Marler arranged for an accredited third-party laboratory to test the sealed packages of food that were still in the family’s freezer.

Marler has plenty of work to do.  He now asks: After Listeria, Salmonella and E. coli positive samples, and HUS in a child, why no mandatory recall by the FDA?

In less than one year Darwin’s Natural Pet Products have been found to be contaminated with Listeria, Salmonella (three times) and E. coli O157:H7.  This year Dawin’s pet food has been epidemiologically and genetically linked to kidney failure in a young child in Utah.

Yet, although Darwin’s has refused voluntary recalls in both instances, the question must be asked, why has the FDA not used its mandatory recall authority?

Comment: It’s great that Bill Marler took lthis on but shouldn’t this be the FDA’s responsibility?  Producers are supposed to produce foods safely—by law.  The FDA is responsible for making sure they do.  Its responsibilities apply to pet foods and well as human foods.  Raw pet food is uncooked and potentially risky; it requires vigilant attention to prevention controls.  This line of pet foods is not getting needed attention to food safety.  The FDA should be enforcing food safety rules, vigilantly, and yes for pet foods too.  What happened to this child and his family was entirely preventable.

Note to dog lovers: if you feed your pet raw food, you are taking a risk, and not only to your animal.

Forthcoming November 11, 2025

For Information and Pre-Orders, click here

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?