NDI and GRAS Notification – A How To

Online

105 minutes

Course Overview

According ​to ​the ​Dietary ​Supplement ​Health ​and ​Education ​Act ​(DSHEA), ​any ​company ​that ​sells ​a ​dietary ​supplement ​containing ​a ​new ​dietary ​ingredient ​must ​submit ​a ​New ​Dietary ​Ingredient ​Notification ​(NDIN) ​to ​the ​FDA. ​In ​this ​course ​we ​will ​provide ​guidance ​on ​how ​to ​determine ​when ​an ​NDIN ​is ​required, ​what ​kind ​of ​information ​you ​will ​need ​to ​include ​in ​an ​NDIN, ​and ​common ​pitfalls. ​The ​course ​is ​directed ​toward ​dietary ​supplement ​and ​food ​ingredient ​manufacturers ​and ​suppliers ​who ​are ​interested ​in ​understanding ​the ​basic ​requirements ​for ​NDINs ​so ​they ​can ​better ​communicate ​with ​regulators ​and ​specialists.

Learning Objectives:
  • Assess the need to submit an NDIN and determine if another regulatory pathway is more appropriate
  • Understand the similarities and differences in the requirements for an NDIN submission and a GRAS notification to the FDA
  • Identify what kind of information and testing to include for a successful FDA review
  • Establish safety under the intended use conditions
  • Analyze and document information to demonstrate that the intended use will not result in any adverse health effects
  • Identify and avoid common issues associated with NDIN submissions through real-world examples
A PDF of the presentation will not be distributed for this recording.
You'll have access to the recording for 15 days once you complete your registration.

Pricing

$250