Generally regarded as Safe dossier supporting safety for its intended use filed with FDA .
A technical dossier supporting safety of an ingredient for its intended use in foods without filing with FDA.
A New Dietary ingredient notification for an ingredient used in dietary supplements that was not marketed prior to October 15, 1994.
Prepare dossier and application for non-nutritive food component to Office of Food Additive Safety at FDA.
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 not 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.
A Natural Product Number associated with a single medicinal ingredient and with health claims.
A dossier that contains safety, efficacy, quality, including manufacturing processes and kept confidential with Health Canada and customer seeking access to the file.
An ingredient that serves the purpose to support the food and don’t typically contribute to the nutritional value of the food.
A new food that has nutritional value introduced into the Canadian marketplace.
NPN stands for Natural Product Number and is issued for natural health product (dietary supplement) finished products or single ingredients.
The value of an ingredient NPN is that there are approved health claims associated with the NPN. This NPN can be shared to the ingredient buyer so they can reference your NPN and associated health claims (with your permission) on their own NHP Licence to sell their finished product in Canada. This could help the assessment officer to review their application more expeditiously. This adds value and could provide a competitive advantage compared to other similar ingredients.
Depending on the NHP class Health Canada can issue an NPN in as little as 60 days to as long as 210 days.
You can prepare a letter of authorization with the NPN license number so they can reference this on their product licence application.
NPN licence is publically listed on the Health Canada website and its details ie. Medicinal ingredient quantity and respective approved health claims. A NHP Mater file would be kept confidential with Health Canada and, when an ingredient supplier references the NHP-MF on their product licence Health Canada will review the master file and any questions from the file will be directed both to the product licence applicant and to the master file holder. The ingredient buyer will not be able to see the contents of the master file.
NPNs are used for natural health products and for the purpose of raw material suppliers, the ingredient for the intended use in NHPs/Dietary Supplements in Canada. A novel food submission is to be used in foods with no health claims, just safety subststantiation. You cannot use an NPN to support a novel food that would be used in a food format and used for food consumption.
The performance standard is 410 days which Health Canada has historically met 90 percent of the time. This does not include pre-submission consultation and meetings that may be arranged.
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