With over 22 years of experience, dicentra is one of North America’s most respected brands in regulatory affairs consulting. Whether you’re an entrepreneur launching an exciting new product, a large international company managing thousands of products, or someone in between, dicentra’s consulting services are expertly positioned to support your business.
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Navigating the introduction of novel ingredients in the U.S. market involves proper classification—be it as Generally Recognized as Safe (GRAS), or as a New Dietary Ingredient (NDI) or Old Dietary Ingredient (ODI). Our focus here is on our specialized GRAS services, recognizing it as a commonly chosen pathway to market success. However, if your ingredient falls under an NDI or ODI classification, rest assured that dicentra can offer you tailored support and expertise to meet your unique needs.
There are two separate routes for obtaining GRAS recognition: a GRAS Notification submission to the FDA, where the government issues a letter after an assessment, or a Self GRAS Determination where the FDA is not involved and the stakeholder is responsible for verifying safe use with the review of an expert panel.
In either case, the applicant needs to demonstrate that the substance will not cause harm when the ingredient is ingested under the intended use.
Feasibility Review and Classification: Ingredients can be classified as an Old Dietary Ingredient, a New Dietary Ingredient, a Food Additive, or be Generally Recognized as Safe. We will help you determine which path is right for your ingredient
Data Gathering & Literature Searches: This involves searching and gathering all available data, both proprietary, and within the scientific literature
Gap Analysis: This involves reviewing all available data and providing a report outlining gaps needed in order to prepare a complete GRAS dossier
Coordinating the conduct of toxicological studies when required
Research for scientific evidence demonstrating that the substance is safe under the conditions of its intended use
Prepare and file FDA GRAS Notifications and liaison with FDA and USDA
Mediate independent expert panel reports on GRAS conclusions
Prepare Self-Affirmed GRAS dossiers