How long does an FDA GRAS notice review take? What the FDA inventory shows

In FDA's GRAS inventory, the median notice closed 176 days after filing, 35% ran past the 180-day clock and 4% past 360 days. Here is what that means if GRAS notification becomes mandatory.

The short answer

In FDA's own GRAS Notice Inventory, the 678 notices that carry both a filing date and a closure date closed a median of 176 days after filing. About 35% ran past the 180-day review clock, 11.8% ran past 270 days (180 days plus one 90-day extension), and 4.0% ran past 360 days. FDA's August 2026 proposed rule, not final as of November 2026, would make GRAS notification mandatory and allow up to two 90-day extensions plus a 45-day pre-filing review, so R&D teams should plan on roughly six to eight months per notice and budget over a year for the slow tail.

Why this question matters now

On August 11, 2026, FDA published a proposed rule, "Substances Generally Recognized as Safe" (91 FR 51834, docket FDA-2025-N-3262), that would convert the voluntary GRAS notification program into a mandatory one for human and animal food. As of November 2026 the comment period is open until December 9, 2026, and the rule is not final.

The main points of the proposal, as summarized by FDA and by law firm analyses:

A GRAS notice would be required for uses that today rely on an independent ("self-affirmed") GRAS conclusion, with exceptions such as uses already covered by an FDA "no questions" letter or listed in 21 CFR parts 182, 184 or 186.
The requirement would count as met only if FDA files the notice. If FDA ceases to evaluate a notice for any reason, whether the notifier asks or FDA acts on its own, the requirement is not met.
FDA would add a 45-day pre-filing evaluation. The existing 180-day review with one possible 90-day extension would gain a second 90-day extension, for up to 360 days after filing.
For one year after a final rule takes effect, companies could make a streamlined submission for uses already in interstate commerce, without the underlying safety data.
Law firm summaries report a proposed effective date 60 days after a final rule is published and a compliance date 18 months after that.
FDA estimates the rule's present-value cost at about $89.6 million over 10 years at a 3% discount rate in 2024 dollars (range $34.9 million to $210.0 million).

If notification becomes mandatory, FDA review time stops being an optional cost and becomes a gate on every new ingredient use. The useful question for a formulator is not what the regulation allows, but how long FDA has actually taken.

What two decades of FDA GRAS data show

SKS analyzed FDA's GRAS Notice Inventory export (FDA last update June 1, 2026), which lists 1,316 notices (GRN 1 to GRN 1316). The export lists a filing date only for older notices (filed 1998-2019). 678 notices have both a filing date and a closure date, and all but five of them were filed by the end of 2016.

Time from filing to closure, all 678 dated notices:

Median: 176 days. Mean: 195 days.
Closed after more than 180 days: 35.0%
After more than 270 days: 11.8%
After more than 360 days: 4.0%
After more than two years: 1.5%

For the 546 dated notices that ended in an FDA "no questions" letter, the outcome a company actually wants:

Median: 178 days
More than 180 days: 38.1%
More than 270 days: 11.0%
More than 360 days: 3.3%

Notices that the notifier withdrew (FDA "ceased to evaluate" at the notifier's request) closed faster, with a median of 98 days. The inventory does not record why notifiers withdrew, and about a fifth of withdrawals still came after more than 180 days.

The trend by filing period:

1998-2005 (188 notices): median 168 days; 23% over 180 days; 3% over 360 days
2006-2011 (222 notices): median 178.5 days; 39% over 180 days; 7% over 360 days
2012-2016 (263 notices): median 174 days; 40% over 180 days; 2% over 360 days

The median has stayed close to the 180-day clock for two decades, but since 2006 roughly four in ten notices have needed more time than the base clock. The share running past 270 days peaked at 17% for 2006-2011 notices and fell to 10% for 2012-2016.

Outcomes and FDA throughput

Outcomes are available for every resolved notice, including recent ones. Of the 1,292 resolved notices in the inventory:

81.0% ended with "no questions" (including letters noting that some uses may need a color additive listing)
17.4% ended with FDA ceasing to evaluate at the notifier's request
1.5% ended with "does not provide a basis for a GRAS determination"

The 17.4% withdrawal share is consistent with the roughly 17% for human food cited in FDA's preliminary regulatory impact analysis, as reported by Gibson Dunn. Under the proposed rule, each of those withdrawals would have left the notification requirement unmet.

FDA's closure volume has grown but is still modest:

2011-2015: 246 closures, about 49 per year
2016-2020: 328 closures, about 66 per year
2021-2025: 344 closures, about 69 per year, with 18.9% ceased to evaluate
2026 through mid-May: 32 closures, with 24 notices listed as pending

At the 2021-2025 pace, every 100 additional notices equal about 1.5 years of FDA's recent GRAS output. The rule summaries we reviewed do not give an expected notice count, and Gibson Dunn notes that the proposal does not estimate the staffing it would need. Review times for notices filed after 2019 cannot be computed from the inventory, because FDA no longer lists filing dates, so the timing figures above are a historical baseline, not a forecast.

What R&D and regulatory teams can do now

Inventory self-affirmed GRAS uses. List every ingredient and use level in your formulas that relies on an independent GRAS conclusion, including conclusions held by suppliers. Check each against existing GRAS notices with a "no questions" letter that cover your use. SKS's GRAS Notice Search searches the same FDA inventory by substance, intended use or notifier, and each result shows FDA's response letter.
Plan launch timelines around the tail, not the median. If a new use needs a notice, a six-month median is realistic, but about one in eight historical notices took longer than nine months. Under the proposal, the worst case would be 45 days before filing plus up to 360 days of review.
Prepare for streamlined submissions. If the rule is finalized as proposed, uses already on the market get a one-year window. Start now: collect evidence that each use was in interstate commerce before the effective date, its conditions of use (foods, levels, purposes), and the GRN of any prior notice that ended in a cease-to-evaluate letter, which the submission must cite.
Treat a withdrawal as a delay, not a fallback. About one in six notices has historically ended in withdrawal. Under the proposal, a withdrawal would not satisfy the requirement, so build time for a revised resubmission into the plan.
Ask suppliers early. Many GRAS conclusions belong to ingredient suppliers. Ask whether they plan to notify and on what timeline, because your launch may depend on their notice.
Comment if this affects you. Comments on docket FDA-2025-N-3262 are due December 9, 2026. Your own review timelines are concrete evidence for a comment.

This is decision support, not legal advice. For specific substances and uses, consult a regulatory expert.

Limits of this analysis

The inventory covers human-food GRAS notices; animal-food notices are tracked separately by FDA's Center for Veterinary Medicine.
Filing dates exist only for older notices, so the timing figures describe historical reviews, mostly of notices filed 1998-2016. FDA's current workload and staffing may give different results.
The days-to-closure measure runs from FDA's listed filing date to the closure letter date. It does not include time before filing, or time a company spends preparing the notice.
The proposal would also let FDA update or rescind "no questions" letters and adds a pre-filing step. Historical outcomes may not predict how FDA reviews notices under a mandatory program.

How SKS analyzed this

SKS used FDA's GRAS Notice Inventory export, last updated by FDA on June 1, 2026 (1,316 notices). Using Python, we parsed each notice's filing and closure dates and computed days from filing to closure for the 678 notices with both dates. We grouped FDA's letter text into four outcomes: no questions, ceased to evaluate, no basis, and pending; the single mixed letter (GRN 13, "no basis" and "no questions") was kept separate. We counted closures per calendar year from closure dates for all notices. FDA is the source of the data. The analysis and groupings are SKS's.

Frequently asked questions

How long does FDA have to respond to a GRAS notice today?

Under the current GRAS regulations, FDA aims to respond within 180 days of filing and may extend that once by 90 days. In practice, the historical median was 176 days, and 11.8% of dated notices took longer than 270 days.

Would mandatory GRAS notification make self-affirmed GRAS illegal?

Not exactly. As proposed, FDA would treat a missing required notice as a factor in prioritizing substances for post-market review. Law firm analyses also note open legal questions about FDA's authority. The rule is not final as of November 2026, so consult a regulatory expert for your products.

What happens to ingredients already on the market under self-affirmed GRAS?

The proposal offers a one-year streamlined submission window after a final rule takes effect. It covers uses already in interstate commerce and does not require the underlying safety data. It is not available for uses that received an FDA "no basis" letter or a not-GRAS determination.

How often does FDA object to GRAS notices?

Rarely in a formal sense: 1.5% of resolved notices received a "does not provide a basis" letter. But 17.4% were withdrawn by the notifier before FDA finished its review. Together, roughly one in five notices did not end in a "no questions" letter.

Sources

"Substances Generally Recognized as Safe" (proposed rule, 91 FR 51834, August 11, 2026), Federal Register. https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe
"Substances Generally Recognized as Safe (Proposed Rule)," economic impact analysis, U.S. Food and Drug Administration. https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/substances-generally-recognized-safe-proposed-rule
"FDA Proposes Mandatory GRAS Notification for Food Substances, with a Time-Limited Streamlined Path," Gibson Dunn, August 2026. https://www.gibsondunn.com/fda-proposes-mandatory-gras-notification-for-food-substances-with-a-time-limited-streamlined-path/
"New GRAS Notification is on the Menu in FDA Proposed Rule (Ultra-Processed Foods on the Side)," Akin Gump, August 2026. https://www.akingump.com/en/insights/alerts/new-gras-notification-is-on-the-menu-in-fda-proposed-rule-ultra-processed-foods-on-the-side
"FDA GRAS Rule Tracker," RegBase, last verified September 2026. https://regbase.com/gras-rule/
GRAS Notices database export (last updated June 1, 2026), U.S. Food and Drug Administration. https://www.hfpappexternal.fda.gov/scripts/fdcc/?set=GRASNotices

Published by SKS Nutrition. Explore the tools behind this research on SKS Nutrition AI.