There are 3 basic procedural alternatives available for obtaining GRAS status.

1. Private Self Assertion of GRAS Status

GRAS Associates reviews your manufacturing process, product purity information and accumulated safety data, coupled with conducting a search of the scientific literature and prepares a detailed report of the safety of your product for its intended use. This mechanism has the advantage of protecting your competitive advantage.   GRAS Associates will assign your product to the most appropriate scientists among our panel of experts.

2. GRAS Assertion Published in the Scientific Literature

Similarly or subsequently to the first alternative, GRAS Associates prepares the report in the format of an internationally recognized peer reviewed scientific journal. The assigned panel of experts will defend the manuscript during the peer review process. When the article is accepted, this helps substantiate the GRAS opinion, gives your firm enhanced scientific credibility and makes it more convincing to customers. One respected journal that can be used in this capacity is the Journal of Regulatory Toxicology and Pharmacology.  Click here to learn more about this journal.

3. GRAS Notification to FDA

The third available option is for GRAS Associates to compile the safety assessment into the format of a notification and submit to FDA.  Although FDA procedural regulations are not final for GRAS Notifications, FDA is reviewing notifications submitted and posting their review on the FDA website. The assigned panel of experts will respond to FDA questions on the notification in an effort to get a favorable review by the agency.  Click here to learn more about the FDA GRAS Notification process.