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Filing an NDI or a GRAS - PharmaFacts
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Filing an NDI or a GRAS

Is filing an NDI or GRAS new territory for you? 

We can guide you through the entire regulatory process from the gathering of the critical documents, explanation of guidance’s, preliminary conversations with the FDA and interpretation of their expectations.  We can either compile the entire submission for you or work in partnership with your staff to get the job done.

This will maximize on the probability of approval of your submission and you can then move on to marketing your supplement. 

Need Help With a Resubmission?

Perhaps you have already had conversations with the FDA, submitted your application and been rejected?  You may now be scratching your heads about the points of disconnect.  We can review your submission, help you understand the gaps and support you in the resubmission process.

What is an NDI?

Any new dietary supplement marketed after October 15, 1994 must be approved by the FDA http://www.fda.gov/Food/DietarySupplements/default.htm.  This requires submission of an NDI (New Dietary Ingredient) notification.  The two main areas that need to be addressed are manufacturing controls and documented evidence establishing safety with recommended usage.  This notification of intention to market must be made at least 75 days in advance of the first sale date.

The NDI submission process can be a challenge and more than 80% of NDI notifications are rejected by the FDA. The most common cause is inadequate evidence of manufacturing quality, insufficient evidence for safety, and incomplete documentation of claims.  Inappropriate labeling statements and misunderstandings of dossier compilation requirements are also contributors to this high failure rate.

At PharmaFacts our consultants have an in depth understanding of chemical manufacturing control standards, expertise in accessing key documents that support safety, knowledge of labeling expectations and general filing requirements.  We understand the regulatory landscape and will guide you through the process and support you in FDA interactions.  If more testing is needed we can direct you to the appropriate lab and make sure that the work is done to the correct standards whether it is manufacturing or toxicology.

 

Final Rule Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, June 25th 2007 http://www.fda.gov/OHRMS/DOCKETS/98fr/07-3039.pdf

 

What is GRAS?

 
The designation of a food ingredient as Generally Regarded As Safe (GRAS) by the FDA is intended to provide criteria by which substances in the food can be exempted from the premarket approval requirements of the Federal Food, Drug and Cosmetic Act.  A notification procedure is now in place where by the FDA will access whether a submitted notice provides a sufficient basis for GRAS determination in the interests of public safety.

 


At PharmaFacts, we can advise you of the appropriateness of this approach to qualification of your supplemant rather than an NDI. You may already have a considerable knowledge and database.  We can work with you to compile all the necessary documentation and provide expert consultation and support in accessing the scientific basis for claims of safety.