GRAS status means qualified experts generally recognize a specific use of a substance in food as safe. It is not a sticker FDA issues, and it is not a property the ingredient carries into every product. Shehadeh Giannamore, PLLC reviews food formulas for whether each ingredient is an approved food additive, a listed color additive, or GRAS for that use.
Today, telling FDA about that conclusion is voluntary. A company can rely on its own GRAS conclusion, often called self-affirmed GRAS, and market the food without a notice. FDA proposed on August 11, 2026 to make GRAS notices mandatory for many uses. Comments on that proposal are due December 9, 2026. Until a final rule is in effect, the voluntary program is the one that applies.
What GRAS status is
GRAS stands for generally recognized as safe. Congress created the category in the Food Additives Amendment of 1958. A substance added to food is a food additive, and needs FDA premarket approval, unless the use is generally recognized as safe under the conditions of its intended use. That exclusion is in section 201(s) of the Federal Food, Drug, and Cosmetic Act.
The recognition has to match the use. A conclusion for a flavor in a beverage at one level does not cover the same substance as a bulk sweetener, or in a different food, or at a higher level. FDA’s regulations also define safe, for this purpose, as a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use (21 CFR 170.3(i)).
There are two historical paths into that recognition. One is scientific procedures. The other is experience based on common use in food before 1958. Common use requires a substantial history of consumption by a significant number of consumers. FDA has said that basis is seldom used now. Most modern conclusions are scientific procedures.
Scientific procedures demand the same quantity and quality of scientific evidence that a food additive approval would need. The difference is who holds the data and who makes the call. For a food additive, the sponsor sends privately held data to FDA, and FDA decides. For GRAS, the pivotal data have to be generally available, and there has to be a consensus among experts qualified by training and experience. Qualified experts outside FDA can make that call.
What eGRAS means
eGRAS is not a second legal status. People use it for an electronic GRAS notice, the file a company submits through FDA’s GRAS notification program. The safety standard is the same whether the conclusion sits in a private binder or in a notice FDA posts.
A notice, as FDA has described the program, includes a GRAS exemption claim. That claim states the substance, the conditions of use, and whether the basis is scientific procedures or common use in food. The rest of the file covers identity, method of manufacture, and the notifier’s reasons, including data that cut against the conclusion and why the notifier still reaches it.
FDA then responds. The response companies look for is a letter saying FDA has no questions about the basis for the GRAS conclusion. A “no questions” letter is not a food additive regulation, and it is not an FDA approval of the ingredient for every later use. FDA can also say the notice does not support the conclusion, or it can stop the review if the notifier asks it to. The public inventory lists notices and the agency’s responses.
The August 11, 2026 proposal would require electronic submission of GRAS notices if it is finalized. That is a filing rule. It does not create an “eGRAS” category with a lower or higher safety bar.
When you need to notify FDA
Under the rule in effect now, you do not have to notify FDA to market a food on a GRAS conclusion. The 2016 final rule (81 FR 54960, August 17, 2016) set up a voluntary notice program in 21 CFR Part 170 for human food and Part 570 for animal food. It replaced the older GRAS affirmation petitions, which FDA had already stopped treating as its working process.
Voluntary does not mean optional science. If the use is not GRAS and is not an approved food additive or a listed color, the food can be adulterated. Self-affirmed GRAS is only as strong as the public evidence and the expert consensus behind it. A one-page memo that cites no studies is not a GRAS conclusion.
You need a different filing when the ingredient is not on the food path at all. A new dietary ingredient in a dietary supplement follows the new dietary ingredient notice, not a GRAS notice. A substance that imparts color follows the color additive rules even if someone also calls the use GRAS. Section 201(t) has no GRAS exclusion for color additives. A substance can be both.
GRAS reform is the open question. On August 11, 2026 FDA proposed to convert the voluntary program into a mandatory notice program (Docket No. FDA-2025-N-3262). The proposal says that if the notice requirement is not met for a substance’s conditions of use, FDA would treat that as noncompliance. It also says the proposal would not change the criteria for concluding that a use is GRAS. Comments are due December 9, 2026. A proposal is not the rule you comply with today.
Who has to be able to show the conclusion
The company that sells the food is the one FDA will ask. An ingredient supplier’s GRAS packet helps only if it covers your food, your level, and your process. A “no questions” letter issued to another company for a different use does not travel with the drum you bought.
Imported food is held to the same U.S. use. A conclusion accepted in another country is not GRAS status here. If the U.S. use is new, the U.S. file has to exist before the product moves in interstate commerce, whether or not a notice is filed.
That file is part of an FDA ingredient review, which is where a formula is checked ingredient by ingredient before a label is printed.
How this fits a new food launch
GRAS is the ingredient question, not the whole launch. The label, the claims, allergen declarations, and facility registration are separate. A lawful ingredient can still sit on a misbranded label.
For a first production run, the practical order is the formula, then the words on the package. New food product compliance essentials is the broader pre-launch review. This page stays on the GRAS conclusion and the notice.
The same ingredient can change categories if the claims change. A beverage marketed for taste is a food. The same bottle marketed to treat a disease can be a drug. Classification comes before anyone argues about GRAS. The firm’s FDA compliance guide for food, dietary supplements, cosmetics, and OTC drugs sets out those category lines.
What to have in the file before you use the ingredient
Write down the use in one sentence. Name the food, the technical effect, and the maximum level. Then match the evidence to that sentence. Identity and manufacturing come first, because a safety study on a different specification does not support your batch.
Put the pivotal studies where another qualified expert could read them. Private data can corroborate a GRAS conclusion. They cannot be the only basis for it. Note the evidence that points the other way, and say why the conclusion still holds. That discussion is what FDA expects inside a notice, and it is what a private conclusion should contain even when no notice is filed.
Decide whether to file. Under today’s rule, reasons to file include a retailer or importer that will not accept a private conclusion, a use that is close to a food additive use FDA has already questioned, and a record you want in the public inventory. Reasons to wait include a use already listed in an FDA GRAS regulation for that food and level. A listed regulation is not the same document as a “no questions” letter, and neither one is a reason to skip the label.
If you sell the food now on a self-affirmed conclusion, keep the file where you can produce it. GRAS reform, if finalized as proposed, would turn many of those private conclusions into notices. The science standard would stay. The choice to stay silent would not.
Questions about GRAS notification requirements
Is a GRAS notice required today?
No. FDA’s GRAS notification program is voluntary under the 2016 final rule. You can market a food based on an independent GRAS conclusion without filing. The use still has to meet the GRAS standard. A proposed rule published August 11, 2026 would make many notices mandatory if it is finalized. Comments are due December 9, 2026.
What is self-affirmed GRAS?
It is a GRAS conclusion made by qualified experts outside FDA, without a notice. It is not a lesser standard. The pivotal data still have to be generally available, and there still has to be expert consensus for that intended use.
What is eGRAS?
It is a common name for an electronic GRAS notice. It is not a separate FDA category. The proposed rule would require electronic filing if notices become mandatory.
Does a “no questions” letter approve my ingredient?
No. It means FDA did not question the basis for the notifier’s conclusion for the use in that notice. It is not a food additive approval, and it does not cover a different food or a higher level.
Does GRAS status cover a dietary supplement?
GRAS is a food-additive concept. A new dietary ingredient in a supplement is handled under the new dietary ingredient rules, not by calling the ingredient GRAS. A substance that colors a food is a color additive question even when a GRAS file also exists.
Can FDA decide a use is no longer GRAS?
Yes. GRAS depends on a continuing consensus for that use. If the consensus is gone, the use can fall back into food additive status and need approval. FDA has done that with particular substances. A conclusion from ten years ago is not a permanent listing.