Food additives are subjected to premarket review by the FDA, although an exemption applies if a petitioner can demonstrate that an ingredient is Generally Recognized as Safe (GRAS) under its intended conditions of use. There are 2 paths available when obtaining a GRAS status:
Whether you’re preparing for a self-affirmed GRAS or an FDA-notified GRAS, you’re going to need a GRAS dossier. A GRAS dossier is a compilation and array of documents regarding the safety, efficacy, and quality information of an ingredient and must include an extensive amount of information presented over seven distinct sections, as outlined below.
In part 1 of a GRAS dossier, information on the organization, notified substance, intended uses, and basis of the GRAS conclusion must be provided, along with signatures from a representative of the organization related to the availability, completeness, and confidentiality of the information within the submission.
Part 2 of a GRAS dossier requires technical information on the substance, such as its chemical name, empirical and structural formula, CAS number, physical and chemical characteristics, stability, and a detailed description of the manufacturing process.
This section of a GRAS dossier considers the estimated level of exposure to the substance from its intended use in addition to exposure from all dietary sources that may also contain the notified substance, based on food consumption data within the United States.
In this section, the self-limited level of use of the substance must be discussed, if applicable. This is the limit to the amount of the ingredient that can be added to food before the product may become technologically unfeasible or unpalatable.
In most cases, the basis of the GRAS conclusion will be supported through scientific procedures. However, in part 5 of a GRAS dossier, the notifier has the opportunity to substantiate the GRAS status of a substance based on an extensive history of consumption prior to January 1, 1958, if sufficient historical evidence is provided. GRAS conclusions based on common use are extremely rare as retrieving supporting evidence of use prior to 1958 is very difficult.
In Part 6 of the GRAS dossier, a narrative that supports the basis of the GRAS conclusion for the substance under its intended conditions of use must be provided. The narrative must include the totality of available data on the substance, and any information that is inconsistent with the GRAS conclusion must be discussed. The GRAS conclusion must be primarily based on publicly available safety evidence, while unpublished studies may be used as corroborating documentation.
Part 7 of the GRAS dossier is where all the data discussed in Part 6 of the GRAS dossier to support the safety of the substance must be provided, including specifications on which data is published as well as unpublished.
Competitive advantage takes much more than just establishing the safety of your product or ingredient. Setting yourself apart from your competitors also includes demonstrating that your product or ingredient is effective. A product’s efficacy is demonstrated through human clinical trials necessary to substantiate health claims.
dicentra assists with all phases of ingredient and product development, from GRAS, NDI, and Food Additive Petition filing to full-service contract research operations that support the design and conduct of human clinical trials.
While the information above provides a general overview of GRAS dossier requirements, the technical and scientific details for each unique ingredient vary significantly. Get in Contact with us today to find out how our regulatory professionals can help determine the best regulatory pathway for your food additive ingredient, and outline specific data gaps in order to fulfill the requirements to obtain GRAS status.