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ISAPP posts comments with the FDA on Dietary Supplements

December 9, 2016. ISAPP posts comments with the FDA on Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry.

Comments discussed:

  1. Exclusion of novel substances as dietary ingredients
  2. Identity of a live microbial ingredient
  3. Chemical alteration
  4. Assessment of antibiotic resistance gene transfer
  5. History of safe use
  6. Strain- vs. species-specific information
  7. Requirements for filing a NDIN for the product, rather than the ingredient