As of November 19, the FDA says 31 infants have botulism most likely as a result of exposure to ByHeart Whole Nutrition infant formula.  The CDC investigation details are here.

In its most recent letter to customers, ByHeart is finally taking some responsibility for this disaster.

When I wrote about this on November 12, I tried hard to give ByHeart the benefit of the doubt.  I had some sympathy for the difficulty of testing for botulinum spores (seeds) in infant formula.  The tests can only measure the toxin produced by the organisms that develop from the germinated spores (infants consume spores; when the spores germinate, the organisms produce the toxin).

But then I became less sympathetic, for two reasons.

The first is the company’s sloppy production practices.  I had forgotten about my post in November 2023 about the FDA’s warning letter to ByHeart (and other formula companies) for violating basic food safety standards during production.

The New York Times has written about more recent food safety violations: Infant Formula Company Tied to Botulism Outbreak Had Known Problems.

The second is the “it’s not our fault” stance of the company in its “Update for our ByHeart Family” [My comments]

Today, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. We are treating the CDPH’s test result very seriously.  [Right.  Of course you are].

However, testing from a previously-opened can lacks scientific basis to establish causation between the product and illness. We know that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can can be contaminated in multiple ways. [Great.  Let’s blame parents for sloppy formula dilution]

Currently global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum, and no U.S. or global infant formula company tests for Clostridium botulinum. [Are you really saying that this isn’t your fault, it’s the FDA’s?]

Today, the Lancet publishes three major papers on ultra-processed foods and human health: science, policy, and politics (I am a co-author on the policy and politics papers).  Here’s Peter Bond’s photo, the logo for the series.

THE PAPERS

I.  SCIENCE

Ultra-processed foods and human health: the main thesis and the evidence. Carlos A Monteiro, Maria LC Louzada, Euridice Steele-Martinez, Geoffrey Cannon, Giovanna C Andrade, Phillip Baker, Maira Bes-Rastrollo, Marialaura Bonaccio, Ashley N Gearhardt, Neha Khandpur, Marit Kolby, Renata B Levy, Priscila P Machado, Jean-Claude Moubarac, Leandro F M Rezende, Juan A Rivera, Gyorgy Scrinis, Bernard Srour, Boyd Swinburn, Mathilde Touvier.

This first paper defines ultra-processed foods and diets as including three specific elements:

• Industrially produced
• Made from cheap ingredients extracted from whole foods, combined with additives
• Designed to maximize industry profits

It presents the evidence in support of three hypotheses about ultra-processed dietary patterns.  These:

• Globally displace traditional diets based on whole foods.
• Reduce dietary quality.
• Are a key driver of the escalating global burden of diet-related chronic diseases.

II.  POLICY

Policies to halt and reverse the rise in ultra-processed food production, marketing, and consumption. [Full text here] Gyorgy Scrinis, Barry M Popkin, Camila Corvalan, Ana Clara Duran, Marion Nestle, Mark Lawrence, Phillip Baker, Carlos A Monteiro, Christopher Millet, Jean-Claude Moubarac, Patricia Jaime, Neha Khandpur.

This paper presents evidence in support of policies to:

• Reduce intake of ultra-processed foods as well as those high in sugar, salt, and fats.
• Restrict the marketing, availability, and affordability of ultra-processed foods (examples: taxes, warning labels, advertising bans, limits on use in schools, etc).
• Restrict the marketing and political power of transnational food corporations (manufacturers, retailers, fast food chains, agricultural producers).
• Support the production, availability, and affordability of minimally processed foods.

III.  POLITICS

Towards unified global action on ultra-processed foods: understanding commercial determinants, countering corporate power, and mobilising a public health response.  [Full text here] Phillip Baker, Scott Slater, Mariel White, Benjamin Wood, Alejandra Contreras, Camila Corvalán, Arun Gupta, Karen Hofman, Petronell Kruger, Amos Laar, Mark Lawrence, Mikateko Mafuyeka, Melissa Mialon, Carlos A Monteiro, Silver Nanema, Sirinya Phulkerd, Barry M Popkin, Paulo Serodio, Katherine Shats, Christoffer Van Tulleken, Marion Nestle, Simón Barquera.

This paper describes how the food industry is the main barrier to reducing intake of ultra-processed foods.

Food companies exert political power through corporate political activities, coordinated through a global network of front groups, multi-stakeholder initiatives, and research partners.  They:

• Engage in direct lobbying,, infiltrate government agencies, and litigate
• Promote corporate-friendly governance models, forms of regulation, and civil societies
• Frame debate, generate favorable research evidence, and manufacture scientific doubt

To counter such corporate practices, actions are needed to

• Disrupt the ultraprocessed business model
• Redistributing resources to other types of food producers
• Protect food governance from corporate interference
• Implement robust conflict of interest safeguards in policy making, research, and professional practice.

This paper also addresses and responds to criticisms of the ultra-processed concept.

KEY MESSAGE: Reducing production and consumption of ultra-processed foods is a priority global health issue.

Thereore, ultra-processed foods require a global response to:

• Confront corporate power,
• Reclaim public policy space
• Restructure food systems to prioritize health, equity, and sustainability over corporate profit.

No excuses.  Get to work!

RESOURCES

It’s a brave new world out there and I’m not having an easy time with it.

I’ve already told you about the DeepFake Instagram post using my image.

Now, there’s more!

Would you believe DeepFake books?

When I went on the Amazon book site on the publication date for What to Eat Now (November 11), my new book was listed first, and still is, at $25.20.

But immediately following it were these [Amazon has since taken down the listings].

Who the enterprising Mateo Velasquez and Shanz Noor might be, I have not the slightest idea.

Curious to know what this was about, my partner, Mal Nesheim, ordered copies right away and got them before the listings disappeared.

The first is a paperbound of 100 pages of blank lined paper—a blank notebook with my cover on it!

The workbook has an enticing table of contents (“Choosing real food in a complex world,” “Understanding labels and marketing tricks,” “Practicing mindful and joyful eating,” etc), but each of those headings is followed by precisely the same page and a half of “reflections” (“Awareness is the first step to reclaiming control over your nutrition and health”) and blank lines, repeated over and over.

I suppose I should feel flattered.

The moral: Caveat emptor!

Pet food?  Yes, pet food.

I subscribe to Pet Food Industry, an exceptionally intelligent and informative newsletter.

This piece caught my eye: Study: Farmer’s Dog finds fresh dog food boosts hydration more than kibble.

One great thing about this publication is that its writers get right to the point:

Company published research showing fresh diets increase total water intake in dogs compared to dry food.

The Farmer’s Dog announced research showing that fresh diets help dogs stay more hydrated than traditional dry food. The company said the findings are among the first to directly measure total water intake in dogs across different diets.

Farmer’s Dog sells freshly made meals for dogs.

• The study:  Rae Sires, Ryan Yamka, Joe Wakshlag. Feeding fresh food and providing water ad libitum is clinically proven to exceed calculated daily water requirements and impact urine relative supersaturation in dogs. Front. Vet. Sci., 06 November 2025. Volume 12 – 2025 | https://doi.org/10.3389/fvets.2025.1675990
• Method: “Ten dogs were used in a single cross-over study design to quantify and compare feeding a fresh food (71.1% moisture) versus a dry kibble food (6.1% moisture) on total daily water consumption (drinking + food moisture).”
• Results: “…dogs consuming the fresh food consumed significantly more total water daily on average per day.”
• Conclusion: “…fresh food can impact urine relative supersaturation and help support hydration in healthy adult dogs or those that are at risk of dehydration and water loss.”
• Funding: “The author(s) declare that financial support was received for the research and/or publication of this article. This series of studies was fully funded by The Farmer’s Dog. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.”
• Conflict of interest: RS and RY were employed by The Farmer’s Dog. RS and RY are employed within the Research Department of The Farmer’s Dog and conduct nutrition research for potential use in future commercial fresh dog food applications and products.

Comment

Disclosure: I met the founders of Farmer’s Dog years ago when they first started the company, and have followed its progress with great interest. Their company has done well.  Its freshly made meals are not cheap.  To find out what they cost, you have to fill out a lengthy form about your dog.  For the chapter on pet food in What to Eat Now, I invented and filled out the form for a 20-pound, moderately active dog.  Its meals cost $5 a day in 2024 ($1800 a year).

As for this study: it is a standard example of industry-funding, conducted by employees of the funder, with a predictable outcome favoring the sponsor’s product.  A second study compared Farmer’s Dog food to canned food; in this one dogs eating the canned food took in more water.  But the overall conclusion makes perfect sense; if you feed dogs more water, they take in more water.

Several readers have written to ask for links to media appearances related to What to Eat Now.  

I’ve been trying to keep a list.  Here’s what I have so far.  Enjoy and thanks for asking!

• Nov 12: Nutrition Action, Bonnie Liebman
• Nov 11:  NPR’s Fresh Air, Tonya Mosley (audio). Transcript.
• Nov 11:  Amanpour & Co (video). Excerpt.
• Nov 11:  Consumed, Elizabeth Dunn
• Nov 10: A1, Alison Brody (audio).
• Nov 10: Maria Shriver’s Sunday Paper, Meghan Rabbitt
• Nov 5:  Washington Post, Anahad O’Connor 
• Sep 18: Science Magazine

From earlier this year

• May 2: New Yorker Radio Hour (audio), Dhruv Khullar
• Apr 7:  New York Times profile, Elizabeth Dunn

As I noted last May, I get asked all the time about what they will say, but have no inside information.  But this may be a good time to go over the clues.

The process

• A scientific advisory committee reviews the research and writes a report.  This was released in December.
• Unspecified (to date) people in USDA and HHS write the guidelines.

The promises

• They will come out “hopefully early fall” (this did not happen)
• Now, according to Reuters, the new dietary guidelines will be released some time in December.

What they won’t say

• They will not continue the tradition of “leftist ideology”  [I think this must mean plant foods]
• They will not promote seed oils (RFK Jr prefers beef tallow).
• They will not promote sugar; RFK Jr says sugar is poison.  [But declared a MAHA Win for Coca’ Cola’s replacement of high fructose corn syrup with cane sugar]
• They won’t say anything about sustainability [anything about climate change is forbidden]

What they will be about

[According to Reuters] Kennedy said the new guidelines would change the kind of food served to military service members and children in schools, but gave no details on the new recommendations.

“If we want to solve the chronic disease crisis, we have to tackle obesity,” Kennedy said. “Obesity is the number one driver of chronic disease,” he said, adding that 50% of the adult U.S. population was obese or overweight, driving costs up for diabetes care and cardiac diseases.

What they might say

Beef

• In its Plan to Fortify the Beef Industry, the USDA says the 2025–2030 Dietary Guidelines will “encourage protein as the foundation for every meal.”
• In an announcement to ranchers, USDA quotes RFK Jr, “we are restoring whole foods as the foundation of the American diet and ending the decades-old stigma against natural saturated fat in beef and dairy products. We will strengthen America’s ranching industry so families can choose nutrient-dense, minimally processed foods.”

Dairy

In a news conference, officials gave some clues.

We are going to be there for the dairy industry…our agencies are about to release more dietary guidelines in the next several months that will elevate those products to where they ought to be…There’s a tremendous amount of emerging science that talks about the need for more protein in our diet, and more fats in our diet, and there’s no industry that does that better than this industry.

Speculation

When RFK Jr first talked about the new guidelines, he said they would ignore the scientific advisory committee report and would be simple, short (5 pages), easy to understand, and out by September.  I’m guessing that the conflict between the science and ideology is proving more difficult to resolve than anticipated.

The science continues to argue for a largely (but not necessarily exclusively) plant-based diet, reduced in meat and ultra-processed foods from current levels.  RFK Jr initially talked about the need to reduce intake of ultra-processed foods, but the second MAHA report merely asked for a definition.

This administration seems obsessed with protein, a nutrient already in excess in US diets.

If it wants to do something about obesity, it needs the guidelines to suggest ways to reduce calories.  Nobody has mentioned that word so far.

As I keep saying, I can’t wait to see what the new guidelines will look like.  Stay tuned.

I first learned about this from food safety lawyer Bill Marler: Botulism Alert: ByHeart—brand powdered infant formula linked to 13 illnesses in 10 states.

All 13 cases included in this outbreak are reported to have consumed ByHeart-brand powdered infant formula. Officials in several states have collected leftover infant formula for testing. This testing is underway, and results are not yet available. [Note: Cases are now up to 15].

The FDA announced the out-of-caution recall.

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possibly respiratory arrest.

• The FDA has an ongoing investigation of infant botulism among babies in the U.S.
• The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism.
• ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.

But then: Breaking News: Tested sample of ByHeart powdered infant formula linked to illnesses – preliminary tests are positive for Botulism 

CDPH [California Department of Public Health] has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases.

On its website, ByHeart has “an update for our ByHeart Family.”

Today, we were made aware by the California Department of Public Health (CDPH) that a single, previously-opened sample from one of the two recalled batches of ByHeart formula tested positive for Clostridium botulinum, the bacteria that causes infant botulism. We are treating the CDPH’s test result very seriously.

However, testing from a previously-opened can lacks scientific basis to establish causation between the product and illness. We know that Clostridium botulinum is a bacteria that exists naturally in the environment—in places like soil, dust, and even vegetables—meaning that an opened can can be contaminated in multiple ways.

Currently global regulatory and scientific authorities do not recommend testing powder infant formula for Clostridium botulinum, and no U.S. or global infant formula company tests for Clostridium botulinum.

I looked up ByHeart Formula.  It claims to be a healthier alternative to commercial infant formulas:

• Closest-to-breast-milk patented protein blend (alpha-lac, lactoferrin, partially hydrolyzed proteins)
• Made with organic whole milk (not skim)
• Clinically proven benefits (easy digestion, less spitup, softer poops, more efficient weight gain, supports brain & eye development, immune health and gut health).

Clinically proven?  By Heart has a clinical trial to prove it, in which infants were fed By Heart or a commercial formula.

Conclusions: “The SF [study formula] resulted in improved parent-reported gastrointestinal tolerance and more efficient growth with less daily formula and protein intake supporting that this novel formula may potentially reduce the metabolic burden of protein overfeeding associated with infant formula.”

Sources of Funding: “This trial was funded by ByHeart, Inc. No funding was received from National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute, or other sources.”

Conflicts of interest: At least five of the authors report honoria for serving on the By Heart Scientfic Advisory Board.

OK, so this is a standard industry-funded study with results interpreted as favoring the sponsor’s interests.

But take a look at the accompanying editorial.  Its authors note that the effects of the By Heart formula are “almost identical” to those of the comparison commercial formula.

“There were no consistent differences in any of the growth parameters measured….no data are presented supporting that this formula achieves outcomes closer to the breastfed reference than did the control formula.”

By law, the contents of infant formula are tightly regulated; formula-fed infants are entirely dependent on formula for their survival.

That’s why this situation is such a tragedy.

Let’s hope ByHeart can figure out a way to make sure this never happens again.

Resources: Bill Marler’s additional links

• FDA Dashboard – ByHeart – you have some issues
• ByHeart Cronobacter Recall 2022 and FDA Warning Letter 2023 predates Botulism Outbreak 2025 
• What is BabyBIG? Treatment of choice for Infant Botulism 
• What you need to know about Botulism during an Outbreak

Today marks the official publication of my new book, What to Eat Now!  All 703 pages of it!

Here’s the press release.

Order it—ISBN 9780374608699—from Amazon   Barnes & Noble   Books-a-Million   Bookshop   Powells   Target

It’s a thoroughly revised version of What to Eat, published in 2006.

A lot has changed, much more than I imagined when I set out to do this.  I thought it would be a six-month project, but it’s now four years later.

The big changes?  Ultra-processed, plant-based, and cannabis, for starters.  But there’s much, much more.

This is a book about how to think about food issues.  Come with me on a trek through supermarkets to see what today’s food marketing looks like, and its effects on our health and that of the environment.

I’m collecting information and reviews on this page.

Come to the event at NYU:

The Culinary Historians of New York and the NYU Department of Nutrition and Food Studies invite you to the semi-official launch of the book: The Politics of Your Plate: A Conversation with Dr. Marion Nestle, 6 p.m. to 8 p.m., NYU Bobst Library, 70 Washington Square South, Richard A. Chase North Reading Room, 2nd Floor.  Register here.

Enjoy!!!