Generally Regarded as Safe (GRAS) dossier preparation supporting safety for intended use filed with the FDA
A technical dossier supporting safety of an ingredient for its intended use in foods without filing with FDA.
A New Dietary Ingredient (NDI) notification for an ingredient used in dietary supplements that was not marketed prior to October 15, 1994.
Prepare a dossier for non-nutritive food components for submission to the FDA’s Office of Food Additive Safety.
Self-affirmed GRAS is a dossier to support safety of an ingredient but the documents are not filed with FDA. GRAS Notification typically has the same contents as self-affirmed GRAS but is structured to conform with FDA’s requirements for their review.
GRAS is used to support safety of food ingredient but could also support a dietary ingredient found in the food supply. NDI supports safety of the ingredient to be used in dietary supplements. GRAS is not mandatory but NDI filings are mandatory. Also NDI safety data can be confidential whereas GRAS safety data must be public information.
Yes, GRAS applies to pet food and animal feed ingredients. Evidence must support safety in the respective animal species which the substance is intended to be fed.
GRAS notifications are a voluntary program. Self-affirmation GRAS is another route that does not involve filing a GRAS notice with FDA.
Though this timeline has been impacted by covid, FDA’s performance standard is to respond to the GRAS notice within 180 days and an extension of 90 days beyond the 180-day timeframe.
FDA will conclude if they have no further questions based on the information provided in the GRAS notice dossier. FDA also includes statements that the letter is not an affirmation. This is a legal disclaimer to absolve FDA from any liability or responsibility.
Preparing a GRAS notification or self-affirmed GRAS depends on several factors related to the ingredient its respective complexity that determines the scope of work involved. Call us at 1-800-396-5144 to speak to a sales specialist who can assist you.
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