by Marion Nestle

Search results: Complaint

Jun 2 2021

The latest complaints about the FDA’s non-action on GRAS ingredients

NutraIngredients.com had an intriguing (to me, at least) article about the latest complaints about FDA’s lack of action on GRAS ingredients—those Generally Recognized As Safe.

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make changes, the authors found.”

The article referred to a this paper, Ten years post-GAO assessment, FDA remains uninformed of potentially harmful GRAS substances in foods.

The starting point for this paper is a study done by the Government Accountability Office (GAO) ten years ago: FDA Should Strengthen Its Oversight of Food Ingredients Determined to be Generally Recognized as Safe (GRAS)

The new paper argues that ten years later, the FDA has done little to address the GAO’s concerns.

Since 2010, FDA has addressed only a few of the criticisms regarding its process for establishing a food substance as GRAS. …most critically, FDA has chosen to remain uninformed about food substances self-determined as GRAS by manufacturers…FDA cannot fulfill its statutory obligation for ensuring the chemical safety of the U.S. food supply if it does not know which substances, in which quantities, have been added to foods.

This took me right back to a blog post I did in 2016: The FDA’s unfortunate ruling on GRAS regulations.

The FDA has announced its Final Rule on Substances Generally Recognized as Safe (GRAS).

The FDA explains: “Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards as approved food additives…The GRAS criteria require that the safe use of ingredients in human and animal food be widely recognized by the appropriate qualified experts.”

Uh oh.  “Appropriate qualified experts?”  Like those selected by the companies themselves?  The FDA has failed the public on this one.

In my 2016 post, I explained the complicated backstory of the FDA’s non-action on GRAS ingredients.

The FDA’s final GRAS rule is the result of a settlement agreement following a 2014 lawsuit filed by the Center for Food Safety. The basic issue: GRAS substances are not subject to FDA premarket approvals required for food additives.  Manufacturers are allowed to decide for themselves whether their additives are GRAS without informing the FDA. The new rules confirm this self-managed GRAS notification procedure.

I wrote about this issue in an editorial for JAMA Internal Medicine in 2013 when I commented on a study by Tom Neltner and his colleagues on the blatant conflicts of interest in FDA approval of GRAS substances…My editorial reviewed the lengthy history of FDA’s dithering about the GRAS process.  None of this would matter if all food additives were safe.  But some are not…The FDA’s decision is a loss for public health.

As I said then, this constitutes yet another reason not to eat ultra-processed food products with long lists of additive ingredients.

Tom Neltner, the director of chemicals policy for the Environmental Defense Fund (EDF), suggests 10 ways new FDA head should protect people from toxic chemicals in food.  He lists first:

  1. Stop letting industry decide for themselves, in secret, whether chemicals are safe and can be added to food. EDF, represented by Earthjustice, and the Center for Food Safety, have sued the agency to close the dangerous “Generally Recognized as Safe” (GRAS) loophole.
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Sep 1 2025

It’s Labor Day: Let’s talk about ICE versus farm workers

I’m indebted to Errol Schweizer, Grocery Nerd, for pointing out in response to my post on we need more vegetables, that if we want more vegetables, somebody has to pick them.  Raids by ICE on farmworkers are not helping this situation; they are wrong, morally and legally, and must stop.

Schweizer writes:  RFK Betrays/ICE Terrorizes Food Workers.

The Border Patrol and Immigration Customs and Enforcement (ICE) division continue to kidnap, persecute and traffic hard working, law-abiding essential food supply chain workers for no just cause.

Now is the time for the grocery industry, including retail and CPG executives, essential workers, brand founders and Make America Healthy Again (MAHA) advocates to stand up against these flagrant violations of human rights, due process, civil liberties and just plain decency.

From the New York Times: Wilted Lettuce. Rotten Strawberries. Here’s What Happens When You Round Up Farmworkers

Bottom line, it isn’t easy for farmers and ranchers to replace farmworkers if they’re deported or don’t show up. These positions require experience, endurance and specialized knowledge; as anyone who has worked on a farm will tell you, farm work is not unskilled labor.

From FoodPrint: How the current immigration crackdown is impacting food and farmworkers

Around 40 percent of farmworkers in the U.S. are undocumented. The numbers are similar in many other parts of the food system, especially meatpacking, where undocumented immigrants fill an estimated 23 percent of jobs. ..For the most part, farmers supported the Trump administration in the election, with many believing the president’s claims that he would spare farmworkers from promised mass deportations, focusing instead on “dangerous criminals”….[But] ICE agents began aggressively targeting worksites, visiting farms and packing sites in California and a meatpacking plant in Nebraska on June 10. Those raids generated an immediate flurry of complaints from farmers and the food industry.

From Civil Eats: ICE Raids Target Workers on Farms and in Food Production: A Running List

Immigration enforcement actions at workplaces are likely to increase as the agencies attempt to meet new White House goals of 3,000 arrests per day. We are keeping a record of those actions here.

Here is Civil Eats’ list for August, with contact information for Lisa Held, who is keeping track of all this.

August 7, 2025 – Pittsburgh, Pennsylvania – ICE detains 16 workers during raids of two Mexican restaurants

August 8, 2025 – Woodburn, Oregon – ICE detains four immigrant farmworkers on their way to work at a blueberry farm

August 11, 2025 – Anchorage, Alaska – ICE officials arrest an asylum seeker outside sushi restaurant

August 14, 2025 – Kent, New York – ICE raids Lynn-Ette Farms—where United Farm Workers have been organizing— and detains seven workers

Want to send us a tip about immigration enforcement in your community? Email tracker@civileats.com or securely contact Lisa Held on Signal at @lisaelaineh.47. (Link to this post.)

Enjoy the Labor Day holiday, but then do what you can to make this stop.

Feb 12 2025

The new A-Word: Advocacy

As a long-time proponent of food advocacy, I’ve been collecting suggestions for what you and I can do to stop or counter presidential decrees that we think damaging to Americans and American democracy.

A lot of this is easy.  Do it!

  • State your opinion to Washington: Call the Capitol switchboard: (202) 224-3121.
  • State your opinion to your representatives. To find your representative, click here.  To find your Senator, click here.
  • Protect the vulnerable in your community; Urge your state’s attorney general to file complaints, injunctions, and restraining orders. To find your state attorney general, click here.
  • Join with others in your community to protest what needs to be protested. To find local organizations working on such issues, click Indivisible here.
  • Boycott companies enabling the illegal government takeover. Click here to find out a corporation’s politics.
  • Support groups doing the litigating. Track federal cases here.
  • Speak truth to power. Get news from reliable sources; spread it.
  • Take care of yourself; stay strong.

Much of this has been inspired by Robert Reich’s daily comments on current events, and his summary of needed actions. 

He says,

We will get through this, and we will prevail.”

But it will require confidence, courage, and tenacity. We need to stay healthy for this fight. We need to be fortified by those we care about. And we need to be there for those we love.

His final piece of advice: “keep the faith.”

Do not give up on America. Do not fall into the traps of cynicism and defeatism. Remember, Trump won the popular vote by only 1.5 points. By any historical measure, this was a squeaker…America has deep problems, to be sure. Which is why we can’t give up on it — or give up the fights for social justice, equal political rights, equal opportunity, democracy, and the rule of law.

Dec 18 2024

The first lawsuit against ultra-processed foods

The Dietary Guidelines Advisory Committee may not think there is much to ultra-processed foods (UPF), but companies making them have just been served with a lawuit.

I learned about this from a tweet (x) from Carlos Monteiro, the Brazilian public health professor who coined the UPF term.

CMonteiro_USP (@Carlos A. Monteiro) posted: A first-of-its-kind lawsuit against 11 UPF industries alleging they engineer their UPF products to be addictive with details on the actions taken to target children including internal memos, meetings & the research conducted to create addictive substances.

The lawsuit, filed by several law firms, is aimed at Big Food: Kraft, Mondelez, Post, Coca-Cola, PepsiCo, General Mills, Nestle, Kellanova, WK Kellogg, Mars, and Conagra.

The suit charges that these firms, through their deliberate marketing, are making people sick.

Due to Defendants’ conduct, Plaintiff regularly, frequently, and chronically ingested their UPF, which caused him to contract Type 2 Diabetes and Non-Alcoholic Fatty Liver Disease Plaintiff is now suffering from these devastating diseases, and will continue to suffer for the rest of his life.

The suit makes interesting reading.

Some examples:

  • Big Tobacco companies intentionally designed UPF to hack the physiological structures of our brains.  These formulation strategies were quickly adopted throughout the UPF industry, with the goal of driving consumption, and defendants’ profits, at all costs.
  • The same MRI machines used by scientific researchers to study potential cures for addiction are used by UPF companies to engineer their products to be ever more addictive.
  • Big Tobacco repurposed marketing strategies designed to sell cigarettes to children and minorities, and aggressively marketed UPF to these groups.
  • The UPF industry now spends about $2 billion each year marketing UPF to children.
  • UPF increase the risks of disease because they are ultra-processed, not because of how many grams of certain nutrients they contain or how much weight gain they cause. Therefore, even attempts to eat healthfully are undermined by the ultra-processed nature of UPF. One cannot evade the risks caused by UPF simply by selecting UPF with lower calories, fat, salt, sugar, carbohydrates, or other nutrients.
  • The UPF industry is well aware of the harms they are causing and has known it for decades. But they continue to inflict massive harm on society in a reckless pursuit of profits.

Can’t wait to see what happens with this one.  Stay tuned.

Resources

Consumer Federation of America: “Ultra-processed Foods: Why They Matter and What to Do About It.”

With government officials reluctant to issue advice on ultra-processed foods (UPFs), Consumer Federation of America aims to raise awareness about research on UPFs, explain the leading theories of how they harm health, and build support for public policies to reduce harms from UPFs in our diet.

The report pushes back on arguments that researchers have not consistently defined UPFs, or that the categorization lacks scientific rigor. In fact, researchers have operationalized the “Nova classification” system behind UPFs in a largely consistent manner, defining foods based on whether they contain ingredients that are “industrial formulations” or “rarely used in home kitchens,” with little serious disagreement about which ingredients should be considered “ultra processed.” Consumers can take CFA’s online quiz to test their knowledge of which ingredients are markers of “ultra processing.”

New research: Trends in Adults’ Intake of Un-processed/Minimally Processed, and Ultra-processed foods at Home and Away from Home in the United States from 2003–2018.  J Nutr 2024, https://doi.org/10.1016/j.tjnut.2024.10.048.  The data show that 50% or more of calories are consumed from UPF at home, away from home, and by pretty much everyone.

New research: Hagerman CJ, Hong AE, Jennings E, Butryn ML. A Pilot Study of a Novel Dietary Intervention Targeting Ultra-Processed Food Intake. Obes Sci Pract. 2024 Dec 8;10(6):e70029. doi: 10.1002/osp4.70029.  Behavioral interventions to reduce UPF intake cut calories by about 600 calories per day.

My post summarizing the three studies demonstrating that diets high in UPF induce intake of an excess of 500, 800, and 1000 calories per day.

Oct 16 2024

Pet Food I. Is the FDA doing enough to ensure its safety?

Two items about pet food this week.  Today: safety.  Tomorrow: environmental sustainability.

I have a long-standing interest in pet food, which I view as an integral—essential—component of our overall food system , not least because pet food uses food components that would otherwise be wasted.  I co-authored a book about pet food issues: Feed Your Pet Right.

If there are problems with the safety of pet food, you can bet those problems will occur in the food supply for humans.  I wrote a book about that too: Pet Food Politics: The Canary in the Coal Mine.

I am not the only one interested in such topics.  Phyllis Entis has written two books crticizing the safety hazards of pet foods.

She keeps me up-to-date on the latest problems that arise.

I don’t know how closely you’re watching the pet food industry these days, but I thought this piece I just posted might interest you: When ‘truths’ collide: Darwin’s, ANSWERS, and the FDA

This was an account of an FDA Advisory and its non-consequences: Do Not Feed Certain Lots of Darwin’s Natural Selections Pet Food Due to Salmonella and Listeria monocytogenes.

The U.S. Food and Drug Administration is cautioning pet owners that FDA samples of five Darwin’s Natural Pet Products raw cat and dog food made by Arrow Reliance, Inc. tested positive for Salmonella and a sixth FDA sample tested positive for Salmonella and Listeria monocytogenes (L. mono)…If you have any of the Darwin’s Natural Selections pet food product listed above, stop feeding the product to your pets and throw it away in a secure container where other animals, including wildlife, cannot access it. Do not donate the food.

The bigger story here, as Phillis Entis explains, is that the FDA did not force the company to recall the products; it asked Darwin to rissue a recall volunarily.

But in this case, the company resisted.  It voluntarily decided not to do the recall.  Pet Food Industry (an essential source of information) tells this story.

In a September 20, 2024, memo from the company to consumers which was sent to Petfood Industry, Darwin’s Natural Pet Products had this to say given the FDA’s public notice regarding the affected lots of cat and dog food.

The memo is worth a look.  It says things like this:

  • At Darwin’s, the health and safety of your pets is our absolute top priority, and we take rigorous steps to support their well-being and to foster strong lines of communication with you and our fellow community members.
  • It is also very important to know that the FDA has received no consumer complaints regarding any of these lots.
  • We find the FDA’s public notice to be wholly unnecessary, and ultimately, based on flawed regulatory decision-making, and we have taken steps to make this position clear to the agency.

Oh.

Food safety lawyer Bill Marler asks: Will the FDA use its Recall Authority to Mandate a Pet Food Recall due to Salmonella and Listeria?   .The FDA has that authority.  It did not use it.

That leaves you on your own to make sure you do not buy Darwin products for your pet.

The FDA provides plenty of information as a basis for you taking responsibility for such things.

Its advisory asks this question: Why is the FDA concerned about Salmonella and L. mono in pet food?

Pet foods contaminated with Salmonella and L. mono are of particular public health importance because they can affect both human and animal health. Pets can get sick from Salmonella and may also be carriers of the bacteria and pass it on to their human companions without appearing to be ill…The Federal Food, Drug, and Cosmetic Act requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. Refrigeration or freezing does not kill Salmonella or L. mono.

It provides  these resources:

Do we need more forceful regulation of pet food?  Of course we do.

Sep 3 2024

The Boar’s Head Listeria recall

A reader writes:

Can you address the current food crisis outlining the many foods, long time frame, economic impact, and personal effort involved in this event?

I did not realize until I read the NPR email news brief this morning that one factory is the source of nine  deaths,  that multiple meat products are suspect, that many stores are involved, that sell-by dates extend into October, that products may be in appliances at home, and that all food in the appliance must be disposed of and that the empty appliance must be thoroughly cleaned.

My immediate response was to say that this is yet another recall due to foodborne illness and I’ve written previously about lots of these.  But this one is especially tragic.

  • The products—meat contaminated with Listeria—killed people who ate them.
  • The plant in which they were produced is inspected daily by an on-site USDA inspector.
  • Even so, the plant was especially dirty and unsafe.

The CDC reports: “Epidemiologic, laboratory, and traceback data show that meats sliced at delis, including Boar’s Head brand liverwurst, are contaminated with Listeria and are making people sick.”

This particular outbreak began in June.

The USDA issued a recall notice at the end of July.

FSIS [USDA’s Food Safety and Inspection Service] is concerned that some product may be in consumers’ refrigerators and in retail deli cases. Consumers who have purchased these products are urged not to consume them and retailers are urged not to sell these products with the referenced sell by dates. These products should be thrown away or returned to the place of purchase. Consumers who have purchased these products are also urged to clean refrigerators thoroughly to prevent the risk of cross-contamination.

Boar’s Head published a list of the recalled products.  These include several brands and product types.

CBS used FOIA to request USDA’s records of Boar’s Head inspection results.  These take up 44 pages.

Food Safety News did a summary: “Inspection report reveals history of sanitation issues at Boar’s Head plant linked to deadly Listeria outbreak.”

Over a year of repeated sanitation failures — totaling 69 violations — at Boar’s Head’s Virginia plant, appears to have fueled the ongoing Listeria outbreak that has sickened 57 people across 18 states and claimed nine lives…The violations documented in the report include the presence of mold and mildew on surfaces that employees use to wash their hands, on the outside of steel vats and in holding coolers between smokehouses. These conditions are particularly concerning given the ability of Listeria monocytogenes to thrive in cold, moist environments.

CBS did a news video on the inspection results: “Mold, mildew and bugs linked to listeria outbreak, records show.”

Food safety lawyer Bill Marler is calling for a Congressional Investigation.

…years of inspection reports leave little doubt that the Boar’s Head plant’s HACCP [required safety plan] must have been either non-existent or used for toilet paper. It is hard to wrap your head around how food could be produced in these conditions by this company and under the un watchful gaze of FSIS inspectors.

Today’s New York Times points out that food safety recalls have additional consequences.  The economic viability of the town that houses this Boar’s Head plant depends on it for employment and purchases of local services.

Comment

Few of the food safety issues I’ve written about recently involve meat.  This is because of a major overhaul of USDA requirements for meat safety in the 1990s.  Once the USDA required meat producers to develop and use HACCP [Hazard Analysis and Critical Control Point] safety plans, outbreaks due to contaminated meat declined.  When done right, these plans are highly effective.  They require producers to identify places in production where contamination could occur, take steps to prevent contamination at those critical control points, and monitor to make sure those steps were taken.  USDA inspectors are supposed to make sure all that happens.

But the inspection system has a built-in conflict of interest.  The system is voluntary.  The USDA cannot force compliance or order recalls.  All it can do is to withdraw its inspectors, thereby forcing the plant to close.  Nobody ever wants to do that.

The food safety system, divided between two agencies as it is (with different legislative mandates and different powers), needs an overhaul.  Lives are at risk.

If you have any Boar’s Head products in your freezer, better take a look at what they are and get rid of any on the recall list.

And let your congressional representatives know that you want better food safety oversight.

Additions

Thanks to Michael Jacobson for sending a link to the Boar’s Head website and the company’s promotional video.  After seeing it, this feels like even more of a tragedy.

Here’s Bill Marler’s legal complaint, just filed.

7-31-24: USDA withdraws inspectors

9-13-24: Boar’s Head announces plant closure

Aug 27 2024

Kroger v. the Federal Trade Commission: Not a pretty story

Recall that the large grocery chain, Kroger, proposed a couple of years ago to acquire another large grocer, Albertsons, for about $25 billion.

The FTC did not think this was a good idea.  It FTC filed a suit to prevent the proposed merger on the grounds that it would make the US supermarket landscape even less competitive than it already is.  It would be likely to raise prices for consumers, reduce wages for employees, and (as I’ve written previously) lead to the closure of many stores.

Kroger is fighting back.  It filed an injunction arguing that blocking the merger violates the constitution. 

In its news release, Kroger said

“The merger between Kroger and Albertson’s is squarely focused on ensuring we bring customers lower prices starting day one while securing the future of good-paying union jobs,” said Rodney McMullen, Kroger Chairman and CEO. “We stand prepared to defend this merger in the upcoming trial in federal court – the appropriate venue for this matter to be heard – and we are asking the Court to halt what amounts to an unlawful proceeding before the FTC’s own in-house tribunal.”

In the meantime, BIG, a newsletter on the politics of monopoly power, reports

After two years of investigations and negotiations over court logistics, next week, the Federal trial for the $24 billion Kroger-Albertsons supermarket merger begins. And this one’s really bitter, with new revelations emerging a few days ago from the Federal Trade Commission that a group of Albertsons executives, including CEO Vivek Sankaran, have been deleting text messages relevant to the trial that the court ordered them to preserve. That’s a big legal no-no.

A big legal no-no indeed. This from the FTC’s complaint (references omitted)

On January 17, 2024, the FTC requested a detailed accounting from Albertsons about how responsive documents were lost and what efforts had been taken to recover lost documents. Albertsons did not respond for nearly four months. When they finally responded, they detailed efforts to recover deleted messages from Mr. Broderick’s and Vivek Sankaran’s phones. . Although Albertsons was able to recover approximately 70 text messages from Mr. Sankaran’s phone, further efforts proved unsuccessful…For months, Plaintiffs have tried to seek information about the extent to which Albertsons’ text messages were deleted, obtaining a court order in the Administrative Adjudication requiring production of texts from potential trial witnesses,  and raising repeated inquiries about inexplicably missing documents.

This is what the USDA says consolidation in the grocery industry looks like now.  The proposed merger will only add to monopoly power int he grocery industry.  For the record, Walmart accounts for about 25% of grocery sales int he US.

The share of food sales at supermarkets, other grocery stores, warehouse clubs, and supercenters of the top 4, 8, and 20 retailers trended upwards for the last three decades

Is the Kroger-Albertson’s merger likely to be good for the public?  The FTC does not think so and neither do I.

Jul 25 2024

Red Yeast Rice supplements: oops

I saw this on FoodNavigator–Asia, a newsletter to which I subscribe.

Red yeast rice impact: Kobayashi Pharmaceutical records nearly US$25m losses in Q1: Kobayashi Pharmaceutical reported an “extraordinary loss” of nearly US$25m (JPY$3.86bn) in its Q1 results due to the recall of its contaminated red yeast rice products, raw materials, and compensation of medical expenses. Read more

Red yeast rice is a dietary supplement with a statin-like component observed to reduce blood cholesterol levels, although not nearly to the same extent as statin drugsConsumer Lab tests show at least half not to contain what they say they do.

Now, on top of that, the supplements were associated with kidney disease (at least 50 cases) and deaths (at least 2) among takers in Japan.

Comment: Dietary supplements are the wild west of the food supply.  Anyone can make and sell them.  Because they are mainly harmless, nobody much bothers to test them, even major pharmaceutical companies.  Problems with red yeast rice supplements have been known for a long time.  As a result, supplements are risky.  How risky?  Nobody knows.  I don’t recommend them.