GENERALLY RECOGNIZED AS SAFE (GRAS)
According to the United States Food and Drug Administration any substance that is intentionally added to food products must show proof of being generally recognized as safe (GRAS). Unless the product includes ingredients that have already been approved as a food additive or a prior sanctioned substance by the FDA, the ingredient must have GRAS status. In order for a product to reach GRAS status, the manufacturer must either submit a GRAS Notification to the FDA or perform a Self-Determined GRAS dossier that proves the safety of an ingredient through the review of an expert panel. It must be noted that the FDA’s timeline in response to a GRAS Notification submission can generally take up to 180 days, but can be extended an extra 90 days at the discretion of the FDA.
REJIMUS has many talented regulatory specialists with decades of experience with GRAS Notification dossiers as well as intermediaries between the manufacturer, expert panel, and FDA. We can help streamline the notification process by assisting in the evaluation, development, management and submission from start to finish.
Our services include:
• Assessing ingredient development and regulatory strategies and requirements
• Literature reviews and research inclusive of all scientific data, protocols, and supporting documentation
• Toxicological study and data reviews
• Dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation)
• Notification submission to the FDA and Response Support
• Dedicated Project Management Platform with Client-side access