by Marion Nestle

Currently browsing posts about: GRAS

Aug 11 2026

Closing the GRAS loophole? It’s about time, but is that all?

RFK Jr held a press conference yesterday to celebrate “the biggest news in food reform in modern history”—requiring food manufacturers to notify the FDA when they are introducing a new food additive they want considered Generally Recognized as Safe (GRAS).

This wasn’t already required?  No, it was not.  This gap is the long-troubling “GRAS loophole.”

Here’s what the press release says (my emphasis):

The FDA issued a proposed rule that would require manufacturers to notify the agency whenever they conclude that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS). The proposal would modernize the GRAS framework, increase transparency, and give the FDA greater visibility into substances entering the food supply.

Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to reach their own conclusions that certain substances are generally recognized as safe under the conditions of their intended use.

Although the FDA has long operated voluntary notification programs, companies have not been required to notify the agency when making these determinations.

The proposed rule would modernize that framework by making GRAS notifications mandatory and expanding the public-facing inventory of submitted notices, significantly improving transparency while strengthening FDA’s ability to oversee ingredients entering the food supply.

For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited streamlined submission pathway that would allow manufacturers to provide FDA with information about existing uses. This enables the agency to prioritize post-market safety evaluations while minimizing unnecessary regulatory burden.

Comment 

Food advocates for years have called for making GRAS notifications mandatory.  So this move is obvious, and long-awaited.

A reporter sent me an AI transcript of the press conference, which says how this will work (again, my emphasis).

What FDA will do is review a notification within 45 days to ensure that the elements required are in there. We’ll then docket that notification satisfying the requirement. FDA will then, within 180 days, review that notification substantively. If we have issues, we may either send a no questions letter or we may send we may send a letter determining that we don’t believe that the threshold has been established. But again, this is not a pre-market notification program. Companies are not prohibited from entering the market during the tenancy of that process, and they can continue to self-GRAS. What it does is require that companies notify us whenever they are self-GRASing an ingredient, and then we’re going to make that limited information public that’s set more than the regulation in 170.275.

So what’s the big deal?  Well, it’s the first food regulation proposed by the MAHA administration, and it closes the GRAS loophole.

What it does NOT do is keep unsafe additives out of the food supply.  Companies still have plenty of leeway to put whatever they want in their products.  This is not pre-market approval.  The FDA says it has no statutory authority to require that.

So why not go for it when you have the chance?  Despite the MAHA hoopla over the announcement, as Jerry Mande puts it, all this does is continue the FDA’s non-enforcement.

Another question: Does the FDA even have the staff to review food additive submissions, given the thousands who were fired or left?

Making GRAS notifications mandatory is a good thing to do.  Will doing this Make America Healthy Again?  A little, maybe, but it will be extremely hard to prove.

The big, easy-to-demonstrate food safety problems are ultra-processed foods (the FDA says it has sent an as yet unrevealed definition to OMB), and pathogenic microbes, like Cyclospora, with upwards of 25,000m cases so far, hundreds of hospitalizations, and at least two deaths.

And no, Cyclospora is not a food industry conspiracy to keep people from eating real foods–that idea is weird and unsupported by evidence.

Indeed, the FDA says:

Finally, though not part of today’s announcement, with respect to microbiological food safety, FDA will be publishing tomorrow a final guidance document titled “Guide to Minimize Biological Hazards And ready-to-eat fresh-cut produce. This final guidance is intended to help manufacturers and processors of fresh-cut produce comply with applicable FDA requirements and 21 CFR Part 117 titles current good manufacturing practices, hazard analysis, and risk-based prevention controls for human food.

Can’t wait to see this.  Stay tuned.

Resources

____________________

Arriving Sept 8. For a 30% discount, pre-order here using code UCPSAVE30.

Tags: , ,
Jun 25 2026

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!

Tags: , , ,
Apr 29 2026

Preempting the GRAS loophole: not a good idea

One of the reasons for Monday’s rally at the Supreme Court (see Monday’s post) is the food industry’s efforts to be able to continue to use whatever additives it chooses, without regulatory oversight.

A press release from the Environmental Working Group warns: ‘FRESH’ and Affordable Foods Act is rotten to the core.

This refers to a a draft bill introduced by Rep. Kat Cammack (R-Fla.) designed to preempt all state food chemical laws.

States have been passing inconvenient laws banning food dyes and chemicals.  The industry want this to stop.

According to the EWG’s analysis, the bill would do things like this (and more):

  • Allow new food chemicals linked to cancer and reproductive harm to be considered “safe.”
  • Retroactively approve all food chemicals currently considered generally recognized as safe (GRAS).
  • Allow new chemicals to be added to food if the FDA does not respond to a GRAS notice within 90 days.
  • Allow new chemicals reviewed by industry-funded expert panels – including the flavor industry’s notorious “expert” panel – to be automatically GRAS and used in food immediately.

Under the “GRAS loophole,” which Secretary Robert F. Kennedy, Jr, has vowed to close (this has not happened yet), chemical companies – not the FDA – decide whether a food chemical is safe. For new chemicals, companies submit a GRAS notice to the FDA, and the FDA responds with a “no questions” letter.

As an EWG analysis found, since 2000, almost all new chemicals – nearly 99% –  have come onto the market through the GRAS loophole.

The system is already inadequate; this act would make it worse (here’s my contribution to this discussion from more than a decade ago).

Helena Bottemiller Evich says in Food Fix: Food industry quietly advances its preemption push in Washington

Right now, preemption is becoming even more critical for industry because MAHA groups and consumer advocates have been having a ton of success in state legislatures. In many cases, the industry is actually getting creamed outside of Washington.

She notes that the New York legislature has just required companies to publicly disclose any additivies they self-determine to be GRAS (it also bans Red 3, propylparaben, and potassium bromate in the state).

This kind of action makes the food industry long for federal preemption.

Secretary Kennedy and the MAHA movement have promised to fix all this.  Will they be able to?

Stay tuned.

Tags: , ,
Feb 24 2026

60 Minutes: RFK Jr on non-regulation of ultra-processed food

On February 15, CBS News’ Bill Whitaker interviewed RFK Jr, former FDA Commissioner David Kessler, and journalist Michael Pollan about ultra-processed foods and what to do about them.
As far as I am concerned, this is the money quote:
This is classic RFK Jr: put everything on personal responsibility, never mind how hard it is for people to resist eating unhealthfully in today’s food environment.
As I explained last August, David Kessler gave RFK Jr a gift.  He sent him a letter presenting a  Citizen’s Petition arguing that if the FDA wanted to help people reduce consumption of ultra-processed foods, all it had to do was to define ultra-processed foods as Not GRAS.
The FDA is required to respond to citizens’ petitions within 180 days.
During the 60 Minutes program, RFK Jr said:
We will act on– on David Kessler’s petition. And the questions that he’s asking are questions that FDA should’ve been asking a long, long time ago.
“Act on?”  What does this mean?
Will the FDA act to regulate ultra-processed foods?
I will believe it when I see it.

Food Industry Comments (thanks to the invaluable Hagstrom Report)

Tags: , ,
Oct 8 2025

A MAHA Win? Beginning to close the GRAS loophole.

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).

Tags: , ,
Aug 14 2025

David Kessler hands RFK Jr and MAHA a gift: Define Ultra-Processed Foods as Not GRAS

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.

Tags: , , , ,
May 21 2024

FDA unapproves tara flour as a food ingredient

Last week, the FDA essentially took tara flour out of the food supply.

Today, the U.S. Food and Drug Administration (FDA) posted on its website its determination that tara flour in human food does not meet the Generally Recognized As Safe (or GRAS) standard and is an unapproved food additive. The FDA’s assessment of the ingredient is detailed in a memo added to the agency’s public inventory.

The FDA explained what this is about.

In 2022, Daily Harvest used tara flour in a leek and lentil crumble product which was associated with roughly 400 adverse event reports. The firm took prompt action to voluntarily recall the product and conduct their own root cause analysis, during which they identified tara flour as a possible contributor to the illnesses. To date, the FDA has found no evidence that tara flour caused the outbreak; however, it did prompt the agency to evaluate the regulatory status of this food ingredient.

Daily Harvest makes frozen vegan meals for home delivery.  One of these meals contained tara flour.  Of 26,000 such meals sent out, 400 caused eaters to become desperately sick, some needing hospitalization, some needing surgery (I’ve met some of them).

In my posts, I speculated about why tara flour could cause such severe reactions.

Bill Marler, the food safety lawyer representing a great many of the victims, pushed the FDA to get tara flour out of the food supply before anyone else got sick.  His December 2023 letter reviews what is known about this situation to date.  The FDA paid attention!

Now, two years later, the FDA is doing what it can to prevent tara flour from getting into the food supply.  Good.

Here’s what I’ve had to say about this:

Here’s what Food Safety News has to say.  It notes more cases than are reported by the FDA, many of them represented by food-safety attorney Bill Marler.

Daily Harvest seems to have survived this tragedy, is still in business, and right on top of currents trends.  Its latest:

Daily Harvest’s January Jumpstart program features GLP-1-focused meal plans:  Daily Harvest’s debut of its GLP-1 Companion Food Collection as part of its quick-to-prep January Jumpstart plan includes “meals made with only real foods that are calorie-conscious while delivering ample vitamins and minerals,” Carolina Schneider, MS, RD, Daily Harvest’s nutrition advisor, told FoodNavigator-USA…. Read more

Tags: , ,
Jun 7 2023

The Daily Harvest mystery—a cause at last?

Thanks to Bill Marler for keeping us all up to date on the Daily Harvest saga.  He keeps up with the literature and writes, Is the Tara mystery closer to being solved?

My most recent post on this mystery was almost a year ago.

To review: Daily Harvest is a company that makes and ships preprepared vegan frozen meals, one of which, French Lentil + Leek Crumbles, has been recalled after several hundred people who ate it developed serious problems with their livers and gall bladders.

This was no trivial incident.  The FDA reported “As of 10/18/2022, there were 393 adverse illness reports in 39 states with 133 hospitalization and 0 deaths.”  But it could not detrmine the specific cause or route of contamination.

My post had breaking news:

The ingredient that caused the illnesses among people who consumed Daily Harvest’s French Lentil + Leek Crumbles has been identified, sort of.  As suspected, it’s the tara flour.  But what’s the toxin in the tara flour?  That, we still don’t know.

Now we have a new study: Is Baikiain in Tara Flour a Causative Agent for the Adverse Events Associated with the Recalled Frozen French Lentil & Leek Crumbles Food Product? A Working Hypothesis. 

In summary, the results of these initial studies support a working hypothesis that the adverse events reported by individuals consuming the Daily Harvest Crumbles product originate from the tara flour ingredient and are due, at least in part, to high levels of nonprotein amino acids (e.g., baikiain). It is further hypothesized that in vivo metabolism of metabolically unstable baikiain results in a toxic metabolite(s) that depletes glutathione and/or is an irreversible enzyme inhibitor (for L-pipecolate oxidase), resulting in adverse events which are dependent on the dose consumed and potentially exacerbated for individuals that have specific genetic predispositions.

Baikiain, which I had never heard of, is an analog of the amino acid proline.  In bacteria, it catalyzes proline destruction.  If it does this in humans, it also might account for the liver toxicity experienced by people who ate the Daily Harvest frozen meals containing tara.

The authors of the tara flour study identified baikiain in the flour.  They gave baikiain to mice, who did not fare well with it.

The hypothesis here is that some people are more susceptible to the toxic effects of baikiain than others.  The French Lentil + Leek Crumbles were sent to 26,000 customers, of which 400 or so got sick, more than 100 of them badly enough to have to be hospitalized; some required surgery.

The lesson here is that food ingredients need better testing.   Whoever makes tara must consider it GRAS (generally recognized as safe) for human consumption.

As Tom Neltner writes,

Tara flour is yet another example of how FDA’s GRAS program is broken—putting the health of Americans at unnecessary risk. FDA should use its big food reboot to fix the program so that we can have confidence in the safety of our food. The agency should also work with members of Congress who have introduced bills intended to fix GRAS and to have FDA reevaluate old food safety decisions in light of new science.

Amen to that.

Tags: ,