If you search for the "GRAS petition process," you'll find a lot of confusion, partly because the term is out of date. GRAS stands for "generally recognized as safe," and for decades there were formal petitions to have a substance affirmed as GRAS. That route was replaced by a notification procedure in 2016. So what people call a GRAS petition today is almost always a GRAS notification, or in some cases a conclusion the company reached on its own.
This matters even more right now, because FDA published a proposed rule in August 2026 that would change how the whole system works. OurMonthly Monitor covers developments like this each month. Here's a plain-English walkthrough of what a GRAS review involves, and what's changing.
Food additives generally need FDA approval before they can be used. A substance that's generally recognized as safe, among qualified experts, for its intended use isn't treated as a food additive, so it doesn't need that premarket approval.
The key phrase is "for its intended use." GRAS status belongs to a substance used in a particular way, at particular levels, in particular foods. The same substance can be GRAS for one use and not for another.
The conclusion that a substance is GRAS has to rest on sound scientific evidence that's generally available and accepted by qualified experts. It isn't enough for a company to simply say a substance is safe.
Under the current system, a company has two options.
Voluntary notification. The company submits a package of evidence to FDA, which reviews it and responds.
Independent determination, often called self-affirmed GRAS. The company decides, on its own, that its substance meets the GRAS standard, and doesn't submit anything to FDA.
Both are legitimate routes today. The difference is that the first one gets FDA's eyes on the conclusion, while the second doesn't.
Whichever route a company takes, the evidence behind the conclusion is largely the same. A thorough package typically covers:
Identity of the substance, including how it's made and its specifications
Intended use, meaning which foods and at what levels
Estimated exposure, meaning how much people are likely to consume
Safety data, such as toxicology studies and published scientific literature
A reasoned argument that qualified experts would generally recognize the substance as safe for that use
Many companies have this evaluated by an independent panel of qualified experts, who review the data and give their own conclusion. That panel's report becomes a central part of the package.
If a company chooses to notify FDA, the steps look roughly like this.
1. Submission. The company sends its notice and supporting evidence to FDA.
2. Filing check. FDA first checks whether the submission contains the required information and is suitable to be filed as a notice. If it isn't, FDA tells the company why it wasn't filed.
3. Evaluation. Once filed, FDA evaluates the company's conclusion. Under current rules, FDA aims to respond within 180 days, with the option to extend once by 90 days. In practice, reviews have often taken longer than these target time frames.
4. Questions and amendments. FDA may raise questions, and the company can respond or amend its notice. This back and forth is often where most of the time goes.
5. Response letter. FDA ends its review with one of three outcomes:
A "no questions" letter, meaning FDA has no questions about the company's conclusion at that time
An "insufficient basis" letter, meaning FDA doesn't think the notice provides enough support for the conclusion
A "cease to evaluate" letter, issued when the company asks FDA to stop reviewing the notice
A "no questions" letter is valuable, but it's easy to overstate. It isn't an FDA approval. It reflects that FDA reviewed the company's notice and had no questions then. The responsibility for the safety conclusion stays with the company, and FDA keeps the ability to revisit a substance later if new information emerges.
Still, the letter carries real weight with customers, retailers and partners, and it gives other companies something concrete to point to.
The older formal route for substances that aren't GRAS is the food additive petition. It results in FDA approval, through a regulation that authorizes the use. It's generally slower and heavier than a GRAS notification, but it ends with a formal authorization, unlike a "no questions" letter.
This difference is the heart of why people care about the GRAS route: it can be faster, but it doesn't deliver FDA approval.
In August 2026, FDA published a proposed rule that would convert the voluntary notification program into a mandatory one. As proposed:
The self-affirmed pathway would end for new substances. Companies that conclude a substance is GRAS would have to notify FDA, unless an exemption applies.
FDA would have a set timeline. It would have 45 days after submission to decide whether to file the notice, then 180 days to evaluate it, with up to two 90-day extensions.
It still wouldn't be premarket approval. FDA has been explicit that notification isn't a pre-approval system, and that the notification requirement is met when FDA files the notice.
There would be exemptions. These are expected to include substances already covered by an FDA regulation or an earlier "no questions" letter, among other defined cases.
Others could rely on an existing "no questions" letter for the same substance and conditions of use.
There would be a transition. If finalized, the rule would take effect 60 days after publication, with an 18-month compliance period.
The proposal is not final. The current voluntary program stays in place until FDA finalizes a rule, and the details could change before then.
GRAS is mostly discussed for ingredients added to food, but it overlaps with food contact compliance in a few ways.
Different routes for different things. Substances in packaging and equipment usually go through the food contact notification route or the food additive regulations, not GRAS. Our article onfood contact notification vs. food contact substance regulations explains how those routes relate.
Shared exemptions. An effective food contact notification and the threshold of regulation exemption are among the situations where proposed GRAS notification wouldn't be needed.
Same underlying question. Both ask whether a substance is safe for its intended use, and both depend on evidence about identity, use and exposure.
If your work touches both ingredients and packaging, understanding where each route applies is a basic skill.
You don't need to wait for a final rule to prepare.
Make a list of substances in your products that rely on self-determined GRAS conclusions, and separate them from those covered by an FDA letter or regulation.
Check the documentation behind each conclusion. Is the evidence current, complete and well organized?
Ask suppliers on what basis they claim GRAS status, and request the supporting documents.
Watch the rulemaking. Final requirements and exemptions will determine what you need to do. Our guide totracking food packaging regulatory changes lays out a routine for staying current
"A GRAS petition is how you get GRAS status." Petitions were replaced by notifications, and a company can also reach a conclusion independently.
"A 'no questions' letter means FDA approved it." It doesn't. It means FDA had no questions about the company's conclusion.
"GRAS status belongs to the substance." It belongs to the substance for specific conditions of use.
"Self-affirmed GRAS means no one checks." Customers, partners and regulators can all scrutinize a conclusion later.
"The new rule is already in force." It's a proposal, and the voluntary program remains until a rule is finalized.
GRAS, food contact notifications and food additive regulations are three routes that people often mix up. The simplest way to keep them straight is to start with the fundamentals and add detail one route at a time.
Build that foundation withFood Contact Compliance 101, which introduces how food contact and ingredient regulation fit together across global markets
