GRAS (Generally Regarded as Safe) Notification

Our FDA Experts analyze your food ingredients, ensure whether GRAS is possible, then prepare a well-organized, GRAS dossier and submit it to FDA to ensure your ingredient qualifies for sale in US.

GRAS Notification

GRAS Notification Overview

“GRAS” is an acronym for ‘Generally Recognized As Safe.’ Any substance to be added to a food product in US must obtain a GRAS status before it (the substance) is added to the product. GRAS status is given to proposed use of an ingredient. In general, two separate ways can be adopted to obtain GRAS recognition.

  1. A GRAS Notification – In GRAS Notification Submission to FDA, the government issues a letter after an assessment.
  2. Self GRAS Determination – In this method, FDA is not involved. The stakeholder is solely liable for verifying safe use with the review of an expert panel.

A self-determination GRAS dossier follows all of the same steps as a GRAS notification and format with the exception that the dossier is not submitted to the FDA. The majority of GRAS dossiers are self-affirmed.  We can help you prepare a self-affirmed GRAS dossier.  

FDA Response to GRAS Notification

FDA responds to GRAS Notifications within 180 days from the date of original filing. However, the Authority also reserves the right to extend the review timeline by 90 days. So the total number of days is 270.

How We Help You In GRAS Notification Process

Our expert team is skilled to help you navigate through the complex GRAS Notification process by assisting with the entire paperwork submission. Our services include:

  • Determine whether GRAS status is required for your ingredient
  • Help with a successful regulatory strategy
  • Detect scientific and technical data gaps and suggest solutions
  • Research for scientific evidence to ensure substance is safe 
  • Prepare and submit GRAS notifications and liaison with FDA
  • Mediate expert panel reports on GRAS conclusions
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