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