Thursday, 25 June 2026

Latest from Food Politics: The latest on closing the GRAS loophole

The GRAS (Generally Recognized As Safe) loophole refers to the way the FDA allows food manufacturers basically to decide for themselves whether the additives they are using are safe, voluntarily or not. Closing the loophole is a key goal of the Make ...
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By Marion Nestle

The latest on closing the GRAS loophole

The GRAS (Generally Recognized As Safe) loophole refers to the way the FDA allows food manufacturers basically to decide for themselves whether the additives they are using are safe, voluntarily or not.

Closing the loophole is a key goal of the Make America Healthy Again Movement (MAHA), and HHS Secretary Robert F. Kennedy, Jr., has made closing this loophole a key goal of his administration, and he has directed the FDA to “explore rulemaking” on this issue, meaning write real regulations.

We have yet to see any sign of what the FDA is proposing.

In the meantime, Yuka, maker of the popular product-scanning app, and Consumer Reports have petitioned FDA to get busy on this.

Now, product-scanning app Yuka and watchdog group Consumer Reports are urging the FDA to tighten regulation of food additives and close the GRAS “loophole”, after their investigation found that 25 out of 40 popular food and drink products contain at least one additive at levels identified as concerning by peer-reviewed research.

“Americans shouldn’t need a chemistry degree to eat safely – but today, no one, not even the FDA, can say exactly what’s in our food,” reads the organisations’ petition, which has already surpassed its goal of 35,000 signatures.

This is an old issue.  My contribution to this discussion was published in 2013: Nestle M.  Conflict of interest in the regulation of food safety: a threat to scientific integrity.  JAMA Internal Medicine 2013;173(22):2036-2038. doi:10.1001/jamainternmed.2013.9158.

So what’s the holdup?  Two reasons:

  1.  RFK, Jr is on record as saying he doesn’t like regulation.  Regulation is nanny state.  He much prefers education.
  2.  Lobbying by the users of unregulated food additives; they like it just the way it is.

NOTUS has a remarkable investigative report on lobbying over the GRAS loophole.  The number of lobbyists on this issue has tripled, it says.

After Kennedy directed the Food and Drug Administration to explore closing the GRAS loophole in March 2025, the number of trade associations, companies and organizations that reported lobbying on the pending regulation have nearly tripled, according to a NOTUS analysis of federal lobbying disclosures.

In-house and hired lobbyists for 35 organizations — from food chemical suppliers to packagers and manufacturers — disclosed lobbying specifically on GRAS reform during the first quarter of 2026, up from 12 during the same period in 2025 and one during the same period in 2024.

NOTUS gives one example:

AFIT [Americans for Ingredient Transparency] paid the Russell Group $240,000 between August 2025 and March, including $170,000 in the first quarter of this year, to lobby on “issues pertaining to ingredient transparency,” according to its quarterly lobbying disclosures.

If MAHA wants to close the loophole, it has to take on the food industry, big time.

No wonder RFK Jr is switching to physical activity: shades of Let’s Move!

The post The latest on closing the GRAS loophole appeared first on Food Politics by Marion Nestle

Now Available: What to Eat Now

My new book, What to Eat Now, is officially out!

It's both a field guide to food shopping in America and a reflection on how to eat well—and deliciously.

For more information and to order, click here.

You can explore the full archive of this (almost) daily blog at foodpolitics.com, where you'll also find information about my books, articles, media interviews, upcoming lectures, favorite resources, and FAQs.
​​​​​​​

Marion Nestle

Paulette Goddard Professor of Nutrition, Food Studies, and Public Health at New York University, Emerita

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Wednesday, 24 June 2026

Latest from Food Politics: Botulism in infant formula: Companies must prevent this. Now.

I know I just wrote about botulism in powdered infant formula but it upsets me so much that I have to do it again. We now have a second outbreak, first ByHeart now Nara, both linked to contaminated organic whole milk from the same German supplier. Yes, ...
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By Marion Nestle

Botulism in infant formula: Companies must prevent this. Now.

I know I just wrote about botulism in powdered infant formula but it upsets me so much that I have to do it again.

We now have a second outbreak, first ByHeart now Nara, both linked to contaminated organic whole milk from the same German supplier.

Yes, botulism in infant formula is rare, but not nearly rare enough.  You do not want your infant to be one of the unlucky ones.

I’m trying to understand how this could happen and how it can be stopped.

The clearest explanation comes from food safety lawyer, Bill Marler, who represents families of those unlucky babies.

Let me summarize.

  • Botulism comes from bacterial spores (“seeds”) that can germinate in an infant’s intestine, releasing botulinum toxin.
  • The spores came from Clostridium botulinum in dirt.  Somehow, the dirt got on the cows and the spores got into their milk.
  • Spores resist drying and heat; they survive Pasteurization and the drying that happens when milk is turned into powder.
  • Spores can germinate in infants’ digestive tracts and produce botulinum toxin (older children and adults have immunity)
  • The fat in whole milk may protect the spores (the ByHeart and Nara formulas are whole milk)
  • Pasteurized powdered milk is not sterile; it can contain botulinum spores.

What can parents of bottle-fed infants safely feed them?

The only option is an expensive one: Ready-to-feed formula previously sterilized at temperatures high enough to kill spores.

How about preventing spores in the first place?

This is not easy, according to a study of just this question in the International Dairy Journal: Towards low-spore milk powders: A review on microbiological challenges of dairy powder production with focus on aerobic mesophilic and thermophilic spores (Thanks to Kristin Schill for sending).

Here’s what this study says needs to be done to keep spore levels low:

  • Membrane filtration or bactofugation
  • Validation of cleaning protocols to avoid recontamination
  • Sterilisation of heating equipment
  • Development of evaporators that are to be sterilised
  • Ensure the plant design is hygienic
  • Avoid long production cycles for temperature-sensitive steps, i.e., separation, pasteurisation and evaporation
  • In other words, prevention requires a clean farm, clean udders, filtration, a clean plant, and quick processing.

What about testing?  It comes too late in the process and can’t always find rare contaminants.

And formula companies would rather not test for pathogens; if they find some, they have to issue recalls.

They also do not like to take responsibility; they would much rather finger point.

; Nara did not want to reveal the name of its European supplier.

The risk of botulinum spores has been known for a long time, at least since 2013.

Marler, who keeps track of all the problems with powdered infant formula in the past few years, thinks Congress needs to pass the Infant Formula Safety Modernization Act of 2026, which requires much, much higher standards for and oversight of infant formula.

Here is Marler’s letter to Congress summarizing the rationale for and evidence in support of this act.

Congress: Please pass this, and right away.  It will force formula companies to do what they should have been doing all along.

The post Botulism in infant formula: Companies must prevent this. Now. appeared first on Food Politics by Marion Nestle

Now Available: What to Eat Now

My new book, What to Eat Now, is officially out!

It's both a field guide to food shopping in America and a reflection on how to eat well—and deliciously.

For more information and to order, click here.

You can explore the full archive of this (almost) daily blog at foodpolitics.com, where you'll also find information about my books, articles, media interviews, upcoming lectures, favorite resources, and FAQs.
​​​​​​​

Marion Nestle

Paulette Goddard Professor of Nutrition, Food Studies, and Public Health at New York University, Emerita

© Marion Nestle. You're receiving this email because you've signed up to receive updates from us.

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Latest from Food Politics: The latest on closing the GRAS loophole

The GRAS (Generally Recognized As Safe) loophole refers to the way the FDA allows food manufacturers basically to decide for themselves wh...