Salient features for GRAS status affirmation

Abstract

Background: To satisfy the need for thorough yet flexible food safety guidelines, the GRAS (Generally Recognized as Safe) certification process was introduced in 1958, establishing a process for food products and additives to be considered safe for consumption. It involves a multitude of steps from multiple parties: the author advocating for their new food product, a group of panelists who will evaluate the safety of the product, and the FDA (Food and Drug Administration), who has the final say in the GRAS status of the product. The first step involves the author submitting documents with their basic information and product details, including lab trials and experimentation. Next, the panelists follow thorough guidelines to carefully evaluate the product and its safety in the context of its intended usage. The final step involves the FDA reviewing evidence from both previous groups and reaches a singular conclusion that will determine the GRAS status of the product at the end. Overall, the GRAS process established a concrete set of guidelines to determine the safety of food products. Different conclusions and safety levels were produced to set a general standard for companies and other organizations to abide by. These different groups and multiple safety procedures are all required to maintain the highly renowned status of GRAS certification and overall maintain a standardized level of quality for all food products that are exported to the United States. This article will also evaluate the candidacy of functional food products, comparing both processes with regards to sending a functional food product to market and the GRAS notification process overall. Functional foods proved to be an excellent candidate for the GRAS certification process, passing every component of the requirements and serving as a great example of exactly what authors should be expecting when putting their food products through the GRAS certification procedure. 

Keywords: GRAS, GRAS notification, functional food product, FDA