GRAS Timeline Estimator

Pick your type of ingredient and when you plan to submit. You'll see how long FDA has actually taken to respond to GRAS notices like yours, and how FDA's proposed mandatory-notification rule could stretch that wait.

1. What kind of ingredient?

Classes follow the 15-class codebook used in the study.

2. When will you submit?

3. How much will FDA's review capacity grow?

The rule needs about 2.4× today's throughput just to keep pace with the extra full notices FDA projects.

Worst case: the one-time streamlined submissions share the same reviewers and queue as full notices.

Loaded with an example: A precision-fermentation protein submitted in year 1 of the rule, with no added staff.

— —months, typical

—likely range, receipt to FDA response (middle half of past notices)

—typical review time after filing for this class

—of notices in this class ended with FDA ceasing to evaluate

How to plan for it

The research behind this tool

How Long Will FDA Take on Your GRAS Notice?Plain-language guide: what 1,360 notices show, what the proposed rule could change, and how to plan a launch around it.

Technical report (PDF)GRAS Review Time Technical Report: methods, survival analysis, queue model and limitations.

The dataset (CSV)All 1,360 notices with ingredient class and the receipt and filing dates recovered from FDA letters.