Federal Regulation of Probiotics
Regulatory Articles, Comments and Links
Articles
- Mattia A and Merker R. 2008. Regulation of Probiotic Substances as Ingredients in Foods: Premarket Approval or “Generally Recognized as Safe” Notification. Clinical Infectious Diseases 46:S115-8. [PDF]
Links
- Live biotherapeutics draft guidance
- IND applications/human research draft guidance
- Food Advisory Committee meeting on probiotics, September 26-27, 2000 – Meeting transcripts
- Guidance on substantiation of structure/function claims for dietary supplements
- Dietary supplement NDI Notifications
- Dietary supplement GMPs
- GRAS process
- GRAS inventory (see specifically GRN 000049)
- FDA warning letters
- Food Labeling Claims information
More on Probiotics Regulation
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