EAS Assists Food and Hemp Firms with FDA GRAS Submissions

 EAS Assists Food and Hemp Firms with FDA GRAS Submissions

 

June 5, 2019 
For Immediate Release

Alexandria, VA: EAS Consulting Group, LLC, leaders in FDA regulatory consulting services offers comprehensive services to food and hemp firms seeking to file a Generally Recognized as Safe (GRAS) and other submissions documenting food safety for new food ingredients to the U.S. Food and Drug Administration (FDA). 

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 is pleased to provide comprehensive and expansive services through all phases of the highly technical GRAS or Independent Self-GRAS filing process. Our 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. 

Should your company be in the market research phase of a new or reformulated product that requires GRAS, including the development of a hemp-derived ingredient or a new infant formula, contact EAS Consulting Group to learn more about our services and how we may support your efforts. You may view GRAS information our website, review our GRAS services sheet or contact Cathryn Sacra directly at [email protected] or 571-447-5505. 

About EAS Consulting Group:
EAS Consulting Group continues 55 plus years of leadership in providing regulatory consulting to the industries regulated by FDA and other federal and state agencies. Our network of independent advisors and consultants enables EAS to provide comprehensive consulting, training and auditing services to the dietary supplement, pharmaceutical, food, medical device, tobacco and cosmetic industries. Whether the need is assistance with general FDA or USDA regulatory compliance or more specific needs such as product development, New Dietary Ingredient submissions, FSMA regulation compliance, generic or customized compliance trainings, 483 responses, product market withdrawals or recalls, mock-FDA audits, expert witness services, GRAS & food additive issues, dietary supplement labeling compliance or the development of a detailed import strategy and policy, EAS, with its over 150 consultants, former FDA compliance officials and industry experts, is able to assist. With vast expertise in FDA’s policies and enforcement, EAS is the proven choice for assistance in FDA and other regulatory matters.