Talk:Generally recognized as safe

Where is the GRAS list?

Whenever I come to this Wiki page, I am looking for a link to the GRAS list, but never find it. I am not looking for the FDA.gov main page, or the enabling legislation, or FDA regulations, or FDA decisions about certain food additives, or commentaries/complaints about GRAS, or news items about certain GRAS chemicals, or FDA paper publications. All I want is the GRAS list itself, in alphabetic order by chemical name and common name for each of the 700+ food additives, with a brief description of each chemical and its uses in food. It is probably a PDF file with an index. Where on the Internet can I find the GRAS list itself? Greensburger (talk) 17:32, 17 March 2013 (UTC)

Either ref. #7 in the Article or the EAFUS list now corrected as a link in External Links.[1] --Zefr (talk) 20:44, 17 March 2013 (UTC)

Note: updated GRAS inventory as of September 2025. Zefr (talk) 00:22, 7 November 2025 (UTC)

Criticism

This wiki page describes the process as intended but food manufacturers have largely circumvented this law. It seems like this should be included in the wiki page.

Is https://www.ewg.org/news-insights/news/2025/03/what-gras an allowed source for wikipedia?

part of what they say is

"When Congress created the GRAS food category in 1958, it was meantto apply only to ingredients widely recognized as safe, such as salt, water, yeast and chicken breast. While the FDA must approve any substance added to food, GRAS ingredients are exempt, leaving food companies to police themselves.

In 1997, the FDA further weakened oversight by creating a voluntary notification system that lets manufacturers bypass federal regulators’ review. Companies can use new GRAS ingredients without informing the FDA. Even if a company does voluntarily notify the agency, it can withdraw the submission for review if the FDA starts asking questions about the company’s safety data – shutting down the review.

This broken process has led to hundreds of chemicals being added to food products without FDA oversight – and without the public knowing of the potential health risks.

Since 2000, food and chemical companies have used the GRAS loophole and FDA’s voluntary submission process to approve nearly 99 percent of new food chemicals, according to a 2022 EWG analysis. But those are just the chemicals we know about. Companies can add substances to food without ever notifying the FDA, leaving both the public and the regulators in the dark."

I'm not sure what to do with this, any thoughts from anyone else?

I'm a newbie : ) Jerryada (talk) 22:45, 6 November 2025 (UTC)

That EWG piece on GRAS is heavily slanted against the overall process, seeming to be more about WP:ADVOCACY rather than a WP:NPOV assessment, and providing no peer-reviewed sources of its own. EWG is not a useful WP:RS source for the article. Zefr (talk) 00:07, 7 November 2025 (UTC)

thanks, that is definitely an opinionated piece. I still think that the gras system is broken. Maybe I can find a better source. Jerryada (talk) 02:27, 7 November 2025 (UTC)

You’ve identified a valid content gap. Criticism of the GRAS process is notable. Maybe add a short "Criticism" section summarizing the issues. int21h (talk · contribs · email) 01:54, 8 November 2025 (UTC)

If I knew of such a WP:RS source, I'd discuss it. If there's a better national system than GRAS (also borrowed for ingredient regulations in other countries), what is it? Zefr (talk) 03:53, 8 November 2025 (UTC)

The problem with GRAS is it was intended for ingredients like flour, sugar, and salt, but food manufacturers have used it for any ingredient. A better system would be to test ingredients for safety before putting into food. Have FDA review. I will see if I can find a better source. I really appreciate everyone involved with wikipedia.

Since I mention sugar and salt, those have possible safety problems, but that's for another topic. Jerryada (talk) 14:54, 8 November 2025 (UTC)

Is this a better source https://pmc.ncbi.nlm.nih.gov/articles/PMC10481496/

They conclude "In this Commentary, we show that bias and conflicts of interest keep shaping food safety in the United States. Safety decisions continue to be made by individuals with strong financial conflicts of interest such as ingredient manufacturers and supported by experts that have made GRAS panel participation their source of income for more than 20 years. Even worse, the safety determination is supported by employees of the company profiting from sales of the ingredient, or employees of a hired third-party with a strong interest in looking out for its client. It is of great concern that a cadre of people is deciding on the safe use of substances that could potentially impact the health of millions of Americans [16]. And it is hard to fathom that there is such a small pool of experts qualified and available to provide independent opinions on food substances safety assessments that reflect the broader scientific community." Jerryada (talk) 23:01, 8 November 2025 (UTC)

The source was published in a reputable journal, justifying a criticism sentence, as suggested by user int21h. In the cited paper, the authors criticize the FDA's dependence on consultants assessing GRAS applications, yet the authors are all consultants. Authors Maffini and Neltner have a 12 year history of criticizing the GRAS process. A separate review recommending several oversight and policy options was published in 2024.

Jerryada - might be good if you were to offer a draft section for review here on the talk page. Thanks for raising this issue. Zefr (talk) 23:55, 8 November 2025 (UTC)

okay, I'll try doing that, thanks Jerryada (talk) 00:02, 9 November 2025 (UTC)

Is this a good source https://www.cspi.org/cspi-news/how-food-companies-sneak-new-ingredients-past-fda#:~:text=The%20FDA%20also%20created%20a,a%20chemical%20to%20be%20GRAS.

"Legal loopholes in the food ingredient approval process

At first, the FDA maintained some control over the GRAS process, publishing lists of substances that the agency confirmed were “generally recognized as safe.” But in 1997, the FDA gave up any claim to controlling the process, proposing new rules that gave the food and beverage industries the authority to self-certify that a new food chemical was safe—legally GRAS—without any FDA oversight. The FDA also created a voluntary notification system through which a company could inform the FDA, if the company chose to do so, that it had determined a chemical to be GRAS.

Once a GRAS notice is submitted, the FDA has 30 days to review, and can respond with a letter stating that the FDA has no questions about the basis for the GRAS determination. Alternatively, the FDA can question whether the notice provides a sufficient basis for a GRAS determination. Either way, the company is free to start using the substance since the GRAS determination is made by the company—not the FDA. This is the second pathway that companies can follow in order to add new ingredients to our food.

The third route is even more problematic: Given that GRAS notices are entirely voluntary, a food company can simply choose not to notify the FDA after it makes a GRAS determination. The company can then start using the substance in food without the FDA’s knowledge, let alone its approval (we call this pathway within the GRAS loophole the “secret GRAS” pathway). The public cannot know how many of these secret GRAS determinations occur every year because there is no requirement to report them." Jerryada (talk) 00:01, 9 November 2025 (UTC)

CSPI is mainly a WP:ADVOCACY organization, and is typically not regarded as WP:NPOV; in my opinion, it is not WP:RS.

The language of your draft has a tone of emphasizing FDA inadequacies, which also is a non-neutral opinion. One could say that the FDA follows its mandate from the Federal Food, Drug, and Cosmetic Act, which was intended to monitor a safe food supply and meanwhile allow innovation and consumer preferences (such as for added salt, sugar or fats desired in common snack foods).

If there are problems with an ingredient, it is publicly revealed, possibly withdrawn under FDA enforcement (example, red food dye No. 3), and can be penalized in various ways, as discussed under 'Enforcement'.

I propose to keep the section brief with the section named, Concerns, having a few main points:

1. published critical reports (2024 example below) have identified the GRAS system to enable loopholes, conflicts of interest, lack of transparency, and excessive leniency in premarket review of ingredients
2. there exists non-rigorous postmarket review of novel substances in the food supply until a safety concern is revealed
3. proposals for a revised GRAS framework have been published: example: a 2024 review, including new procedures for premarket and postmarket surveillance, and Congressional approval to expand resources
4. however, in 2025, a contrast to the 3rd point: the US government fired 3,500 FDA employees, which will impact efficiencies and surveillance of GRAS ingredients.

In the background of modifying GRAS practices with a reduced workforce, the US government issued a Spring 2025 rule change that proposes mandatory review of all future GRAS substances. Zefr (talk) 17:26, 9 November 2025 (UTC)

I am distracted for a couple days, let me think about this ~2025-32184-60 (talk) 14:41, 10 November 2025 (UTC)

I have a proposal. This needs some work.

under History:

remove: In May 2025, FDA announced it was planning a systematic post-market review process.[22][23]

add:

In 2016 the FDA issued a ruling that creates the Self-affirmation without FDA notification process. "We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use." [2]

In 2021 a number of consumer protection groups sued that this ruling subdelegates the FDA authority but the judge ruled against them. The law did not require that manufacturers notify the FDA, so the court defers to the agency to decide how to follow the law. This is called "the chevron deference" [3] [4]

In 2025 a proposal was made by HHS to eliminate the Self-affirmation without FDA notification process [5]

Add a section:

Concerns

The Self-affirmation without FDA notification process results in an unknown number of unknown ingredients. Consumer groups claim this poses significant health risks.[6]

Analysis of voluntary GRAS submissions claims that they have conflicts of interest and bias. Most submissions relied on panels of experts to provide an opinion about the submission. The FDA has issued guidance on how these panels should operate, but this analysis shows that the GRAS submissions are inconsistent with the FDA guidance. The same members are used on most of the GRAS notifications, the FDA guidance is to use different people. Panels are standing panels with financial ties to the consultants, the FDA guidance is to use short term independent panels to reduce bias. Manufacturers often use employees or GRAS consultant employees for panels that have a financial interest in a positive decision. [7]

Consultants recommend that clients first try to get voluntary GRAS approval because there is less liability risk and it makes it easier to sell to other countries. If the FDA asks questions they don't want to answer, they can just withdraw the voluntary GRAS submission and do a Self-affirmation without FDA notification. The vast majority of GRAS submissions are accepted without question. In about 5% of the submission the FDA asks some questions and the submission is withdrawn. In another about 5% of the submissions, the FDA rejects the submission. [8][9]

In 2025 the federal government laid off about 3500 employees which would make it more difficult for the FDA to review GRAS notifications. [10]

The FDA said that "the US food supply is increasingly associated with diet-related diseases, toxicity, cancer, and other health harms. These public health concerns are partly attributable to a loophole in federal law." They propose more review of GRAS substances, both with and without FDA notification. [11] ~2025-32184-60 (talk) 16:43, 11 November 2025 (UTC)

With Special:Diff/1321796546, I revised the History section and added the 'Concerns' section, trying to maintain WP:NPOV. Some of your points and sources, e.g., EWG, impress as WP:ADVOCACY, so were not included. The Neltner publication is as much an opinion (about consultants, written by a consultant) as it is confirmation about COI - I don't think it's a useful source. Zefr (talk) 19:13, 12 November 2025 (UTC)

Thanks, much better now.

I thought it was okay to state that consumer groups claim that GRAS without notification poses significant risk because that is a fact, because that's what they claim. And putting an example of that is okay. But using their arguments violates wp:advocacy - I have to find the original source of the information that's not biased, don't rely on a wp:advocacy source

But, what you said is fine, it doesn't add much to the topic to point out that consumer groups have complained about it. ~2025-32184-60 (talk) 20:56, 12 November 2025 (UTC)

But, I still have one problem. Under "History" - "In 1997, the FDA replaced the affirmation petition process with the current GRAS notification process (as of 2025) because it was slow, resource-intensive, and offered little added public health benefit, while a simpler notification would free resources, encourage industry disclosure, and maintain the same legal safeguards." is incorrect.

Actually, in 1997 they created the Self-affirmation with FDA notification process but not the Self-affirmation without FDA notification process. That was created in a 2016 decision. And a lawsuit opposed that but the judge ruled that it was okay in 2021. I think those are important parts of this subject.

Therefore, under history, the 1997 entry should be "In 1997, the FDA replaced the affirmation petition process with the Self-affirmation with FDA notification process because it was slow, resource-intensive, and offered little added public health benefit, while a simpler notification would free resources, encourage industry disclosure, and maintain the same legal safeguards."

And two paragraphs should be added:

In 2016 the FDA issued a ruling that creates the Self-affirmation without FDA notification process. "We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use." [12]

In 2021 a number of consumer protection groups sued that this ruling subdelegates the FDA authority but the judge ruled against them. The law did not require that manufacturers notify the FDA, so the court defers to the agency to decide how to follow the law. This is called "the chevron deference" [13] [14] ~2025-32184-60 (talk) 21:09, 12 November 2025 (UTC)

Special:Diff/1321830014 added some of these details. I omitted the "Chevron" deference out of concern for WP:EXCESSDETAIL. Zefr (talk) 22:32, 12 November 2025 (UTC)

Thanks, better now.

This is sort of a nit, but "In 1997, the FDA replaced the affirmation petition process with the current GRAS notification process because it was slow, resource-intensive, and offered little added public health benefit, while a simpler notification would free resources, encourage industry disclosure, and maintain the same legal safeguards." is incorrect

it doesn't replace with the current GRAS process, it only replaces with the Self-affirmation with FDA notification process. The Self-affirmation without FDA notification was added in 2016.

so it should say something like "In 1997, the FDA replaced the affirmation petition process with the Self-affirmation with FDA notification process because it was slow, resource-intensive, and offered little added public health benefit, while a simpler notification would free resources, encourage industry disclosure, and maintain the same legal safeguards." ~2025-32184-60 (talk) 14:56, 13 November 2025 (UTC)

Revised for accuracy and to clarify with Special:Diff/1321964744. Zefr (talk) 17:11, 13 November 2025 (UTC)

okay, that's better. By the way, I like your words and organization of paragraphs better than my proposals.

It says "to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use"

That is what the FDA said.

But, actually. the word replace would mean the voluntary process would be deleted. Actually, the voluntary process continued and the voluntary notification process was added.

Maybe I'm being too nit picky. In casual conversation I'd just ignore this, but since it's a written document, I think it should be 100% correct. If I'm being too picky you can just ignore it.

Maybe replace that quoted sentence with an unquoted - to add the voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use ~2025-32184-60 (talk) 17:34, 13 November 2025 (UTC)

The history order for GRAS revisions was

1. 1997, "the FDA replaced the resource-intensive affirmation GRAS petition with an interim notification procedure"
2. from 1997-2016, this affirmation process remained in use (absence of additional published rules)
3. 2016, FDA implemented an amendment "to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use".

The 2016 Federal Register document , part 19 (3) mentions further that there must be "convincing evidence" for GRAS in the voluntary notification. I edited the FDA quote and included this specification in Special:Diff/1321974943. Zefr (talk) 18:28, 13 November 2025 (UTC)

all right, good enough ~2025-32184-60 (talk) 20:07, 13 November 2025 (UTC)

One last thing and then I'll move onto something else. I hope I'm not testing your patience with too many changes. We are now getting into diminishing returns.

At the end of history it now says "Despite consumer group objections that this change would soften premarket safety scrutiny on new food ingredients, including a 2021 lawsuit against the FDA, a federal district court found that the FDA did not unlawfully delegate its authority over food safety, and that the rule was compliant with the Federal Food Drug and Cosmetics Act."

I like your reference by the way.

I realize we're getting into excessive detail territory, but adding "The law did not require that manufacturers notify the FDA, so the court defers to the agency to decide how to follow the law. This is called "the chevron deference"" is a significant part of this subject.

Maybe this is just my partisanship - that seems like a bad decision. How can the FDA follow the law and protect consumers from dangerous substances in food if they don't even know about them? The court just takes the FDA opinion without challenge. The law has been gradually weakened over the years. You can't say that in wikipedia because it's not neutral, which I approve of, but a sentence describing the logic of the decision would significantly add to the subject.

The Chevron deference is widely known. It's interesting that this decision is an example of that. ~2025-32184-60 (talk) 21:06, 13 November 2025 (UTC)

GRAS inventory list, September 2025

Dated 30 September 2025, this is the most recent GRAS inventory updated by the FDA. Zefr (talk) 00:22, 7 November 2025 (UTC)