FORC3® Affirmed GRAS

Axitan’s lead product FORC3® has been affirmed GRAS

Axitan has obtained a GRAS Conclusion, from an independent panel of experts, for its lead product FORC3®, an antimicrobial ingredient for poultry feed. As GRAS, FORC3® can now be used in larger scale field trials and sales within the United States.

This major milestone is the first time such a product has been affirmed GRAS. We are looking forward to working with our industry partners to further demonstrate the ability of FORC3® within the context of their large scale operations.

About GRAS

Generally recognized as safe (GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive pre-market approval process. The concept of food additives being "generally recognized as safe" was first described in the Food Additives Amendment of 1958, and all additives introduced after this time had to be evaluated by new standards.

On August 17, 2016, FDA published the Final GRAS Rule in the Federal Register, which became effective on October 17, 2016. FDA outlined the criteria required for a GRAS conclusion, noting that notifying FDA remains a voluntary process. Because of this, companies can satisfy regulatory requirements by attaining an Independent GRAS Conclusion (also referred to as Self-Affirmed GRAS or Self-Determined GRAS) and, if desired, submitting a GRAS Notice to FDA for review.