Food safety is a primary initiative of FDA and as part of that safety documentation, companies seeking to petition FDA's recognition of a new food ingredient must submit data proving the ingredient in review is safe when prepared and used under conditions commensurate with those of the sponsor or petitioning organization.
This definition of food ingredient was expanded into the hemp world when, in late 2018, FDA approved three hemp seed-derived food ingredients, containing only trace amounts of THC and CBD as GRAS, potentially opening the door for other hemp derived ingredients to petition FDA's approval.
EAS provides comprehensive and expansive services through all phases of the highly technical GRAS or Independent Self-GRAS filing process. Expert toxicologists and microbiologists facilitate pre-meetings with FDA, perform initial feasibility studies, identify appropriate data to support study reports, assist with the identification of an appropriate Contract Research Organization (CRO), coordinate study initiation and management with the CRO as well as provide on-going monitoring of study protocols and outcomes. Once the data is ready for FDA submission, EAS assists with dossier preparation and submission.