What Does FDA’s Proposed GRAS Rule Mean for Industry?

On August 10, 2026, FDA release a proposed GRAS rule that would make GRAS notification mandatory. Nutritional Outlook’s managing editor, Sebastian Krawiec, spoke with Ashish Talati, founding member of Talati Law Firm and author of the Legal Outlook column to examine the practical implications of FDA's proposed rule mandating notification for substances determined to be Generally Recognized As Safe (GRAS). The rule marks a significant shift for an industry long accustomed to a voluntary, self-determined GRAS pathway, and raises pressing questions for manufacturers, suppliers, and brands alike.

Talati unpacks the legal and commercial implications of the proposed rule, and what companies should be doing to ensure compliance should the rule be finalized. Notably, the proposed rule creates a one-year window for streamlined notification that is less burdensome than a full notification, allows brands to market products/ingredients while FDA reviews GRAS notification, and allows companies to use existing GRAS notices to avoid GRAS notification. While these factors simplify compliance, they also bring up valid concerns. For example, what are the commercial consequences for a company whose ingredient is deemed not GRAS while actively on the market? Or, how will FDA be able to review the influx of streamlined notifications to determine whether the notifier’s ingredient is actually GRAS?

Talati addresses these questions and provides practical advices for what companies should do even before the rule is finalized.

Sebastian Krawiec: They seem to try to make a distinction here between this kind of notification process and kind of a true pre-market approval. So is there any kind of substantive differences between allowing companies to market ingredients while FDA reviews their GRAS notification versus kind of pre-market approval? Is this actually an attractive option?

Ashish Talati: So legally, there is a significant difference, practically or commercially, there may not be. So, FDA expressly states that the proposed rule does not establish a pre-market review program, so a company can still make its own GRAS determination, market the substance without waiting for FDA review or a no question letter. That is fundamentally different from a food additive petition where FDA approval is required before marketing. But commercially, that distinction may be less meaningful. How many companies will launch a new ingredient knowing that FDA could question its GRAS status months later, and how many major customers are retailers will accept that risk. So while this is not legally a pre-market approval system, the practical result could start looking a lot like one.

SK: Say you market a product, you submit a GRAS notification and then you get an insufficient basis letter. You know what happens to a company's supply chain or existing consumer contracts if this happens?

AT: Yeah, and this is where the practical risk becomes significant. First, an insufficient basis letter does not itself mean FDA has concluded that the ingredient is unsafe. But it means based on the information submitted and other available information, the notice does not provide sufficient basis for a conclusion. At the same time, while a company receives that customers may stop purchasing the ingredient, retailers may question products containing it. Contractual provisions concerning regulatory compliance, representations and warranties, indemnification or termination rights may all come into play. So a supplier may need to supplement the scientific record. They may need to narrow the conditions of use, submit a new GRAS notification, reformulate or potentially pursue a food additive petition route. So there's a lot at stake.

Now, FDA itself acknowledges in the economic analysis that insufficient basis determination could cause transfers of market share and revenue between manufacturers. So, this is not just a theoretical concern. And that is why I think that companies commercializing while FDA review is pending, need to treat this not only as an FDA issue, but a supply chain contractual risk issue. So, in addition to this, you know, FDA says that non-compliance is becomes a factor for prioritization in postmarket review if a submission has not been made.

SK: How does this work in a practical sense? You know, how should industry interpret that language in terms of actual enforcement exposure and litigation risk?

AT: I think this is one of the interesting parts of the proposed rule. Earlier, the regulatory agenda suggested that failure to notify would mean the substance was presumed not to be GRAS, but FDA did not include this language in the proposed rule. In the proposed rule, what they're saying is noncompliance would be a factor in prioritizing substances for post-market review. So that distinction could be legally significant because failure to notify does not appear by itself to convert an otherwise GRAS substance into an unlawful food additive. Practically, much will depend on FDA's enforcement approach. What does FDA do if someone doesn't file? Is this going to be where we're in the NDI space where someone not filing an NDI notification really is not much of an enforcement, but what FDA is trying to say is noncompliance will put a spotlight on that ingredient, or it puts it on their radar for postmarket review. But what that means in terms of actual enforcement remains to be seen. FDA does have all the tools to challenge the GRAS status, potentially treat the substance as a not approved food additive.

Companies should also be mindful of one other angle, which is the litigation exposure outside of FDA. Plaintiff's attorneys will undoubtedly look at non-compliance with a mandatory FDA notification requirement as another factual allegation in consumer protection or false advertising cases. Now, whether those theories ultimately succeed is a different question, but I would expect plaintiff's lawyers to use the new requirement.

SK: People who are self-GRAS have a one year window to have a streamlined submission process. So I wonder, is there any kind of concept of what constitutes a so-called streamlined process? Just because it is my understanding that, you know, a good self-determination GRAS should not be substantively different from one that is sent to FDA. So what is the additional burden on there for brands who, you know, are notifying FDA versus just not notifying FDA?

AT: Within that window, we're talking about ingredients that have been grasped already, but not submitted to the FDA. This is, I think, a more of an industry friendly approach where they're essentially saying that if you have a substance that was in interstate commerce, you can utilize this window and submit the basic information. They don't even want a lot of information. They just want, you know, this submitter name, the substance conditions of use categories, use levels, purpose. Some basic information. And that puts you on that list and you're not required to file a full notification. Now, of course, FDA will review that at some point and then ask for more information if they need to. One of the things that I highlighted in my LinkedIn post is that FDA is not requiring a proof of self-GRAS which to which I found to be very interesting. They're essentially saying, give us this basic information and then that's all we need right now. So imagine two different companies. One has gone through the GRAS process, has a dossier, spent significant amount of money. They provide the information. Then you have another player that has not done that and they'll provide that information. They'll claim they have GRAS status and submit it to the FDA. So that's a little bit of a surprise, but again, right now, as it stands, that information is what the FDA is asking within that one-year period. Is basic information.

SK: So, they're not actually really asking for the full dossier. We're assuming they'll access that at a later time if they determine they need to.

AT: So, what it seems like right now is a basically FDA saying, give us all this information and then we'll see if we want to collect any more. And a lot of that depends on FDA's resources. Let's say FDA is expecting about 6,000 submissions on average for the streamlined version, someone will have to go through all of those and make a decision that out of this, the following ten, twenty, thirty, forty hundred, we need to follow up and ask for more. And that's how it seems like the agency's prioritizing, which ingredients they would like to focus on.

SK: So the proposed rule also sets forth some exceptions for mandatory notifications. What do you see as some of the most significant or interesting exceptions in the rule?

AT: All the exceptions that I saw are pretty standard, what we really expected. I would say maybe there are two points I'd like to make on that. First is the reliance on someone else's no questions letter. So, FDA recognizes that GRAS status is not proprietary. So, another company may rely on an existing letter. But that raises a practical question. How does company B know its ingredient is actually the same as company A's? And differences in identity, manufacturing process, specifications, conditions of use, or use levels could mean the prior letter does not apply. But that's one area where I think that companies will try to either claim they're essentially the same. Now branded companies that have gone through the process certainly don't want someone else to rely on their GRAS letter. So, we'll see a little bit of that. And that's not new. We see that right now too. And that's one of the reasons many companies did self-GRAS is because they didn't want someone else to essentially use that information and claim they can rely on it.

The second part, if you really think about that, the streamlined listing is kind of like an exception. You know, once an eligible substance is placed on the public list, another company may rely on that listing for the same substance and conditions of use. But if you are submitting during that period, you're not submitting the entire notice. So that's very useful to companies that are able to utilize that.

SK: With an eighteen month compliance clock, once finalized, what should manufacturers be doing today before the rules even final to sort of get ahead of this?

AT: A lot. I would not be waiting for the final rule. Now, this is just a proposed rule. So, let's go through the process. FDA proposed the rule. There is a comment period. I highly encourage companies to submit comments. The comments could be even questioning if that one-year period for streamlined submission is sufficient. FDA, in their economic analysis, goes on and says maybe it needs to be three years. So that's something companies can ask for. The eighteen-month compliance window; everything is on the table. Even whether FDA has the authority to even require this. Companies should submit those comments. I think building a record is very important.

But beyond that, there is a lot of stuff that companies can do. So the first: they should inventory every substance for which the companies relies on GRAS status, they should identify the regulatory basis. Whether it’s an independent GRAS conclusion, FDA No Questions Letter, FCN. What is it? Then look for those files: the GRAS dossier, the expert panel report, the safety studies. Any supporting documentation. Finished product companies should be requesting this information from their suppliers. Next, make sure the historical GRAS conclusion actually covers today's product. To me, that is crucial. And I don't think that many companies are thinking about that. Where I practice right now, that's exactly what we're doing for a number of our clients, looking at their past self-GRAS, identifying whether they are within the boundary of that self-GRAS or do they have different use, different dose, different intended food categories. And all of that can mean that that self-GRAS dossier may not apply. So that's very important: looking at the older GRAS conclusions making sure they currently apply.

Companies should preserve evidence of interstate commerce, their customer records, invoices, shipping records, all of that. If you're going to apply within that 1-year streamlined submission period, then also look at the FDA history, pull any of the cease to evaluate letters, insufficient basis letters. All those companies should be commenting now, as we just discussed. But there is a lot that they can do to make sure that they are prepared. And it's mostly not even the FDA side of the equation. It's the commercial side of the equation, right? A lot of your customers want to work with companies that are thinking about this, are ahead of the curve, so to speak.