for Food
Somacy-FP100 is approved as GRAS and NDI.
(*First in the world for Pantoea bacteria LPS)
Somacy-FP100, which contains Pantoea LPS as the active ingredient, is a GRAS (Generally Recognised As Safe) and NDI (New Dietary Ingredients) substance, a sign of confirmed safety in the USA.
In the USA, ingredients for use in general foods must be approved as GRAS and ingredients for use in dietary supplements must be approved as NDI. Both are subject to review with regard to safety, proper manufacturing processes and quality control, etc. The decision on whether a GRAS substance is acceptable or not is made by a panel of qualified experts. NDI substances are reviewed and approved by the Food and Drug Administration (FDA).
GRAS and NDI substances mean that, as judged by qualified experts, they are sufficiently safe and have been manufactured in a GMP-compliant process.
Liquid
■Somacy-FL100
- Display name
- Fermented flour extract
- Production method
- LPS was extracted from wheat Pantoea cultured in a medium containing wheat flour
- Active ingredient
- LPS derived from Pantoea agglomerans isolated from wheat
- LPS concentration
- 1% (10mg/ml)
- Implemented safety test
- In Vitro chromosomal aberration, Bacterial reverse mutation, Single oral dose toxicity, and 28-days Repeated oral dose toxicity tests
- Recommended blending amount for food
- 15-50mg/day (150-500μg/day as LPS)
- Note
-
Analyzed by LGC Limited (UK) for absence of anti-doping banned substances
Powder
■Somacy-FP100
- Display name
- Fermented flour extract
- Production method
- LPS was extracted from wheat Pantoea cultured in a medium containing wheat flour and then spray dried using dextrin as a carrier.
- Active ingredient
- LPS derived from Pantoea agglomerans isolated from wheat
- LPS concentration
- 1% (10mg/g)
- Implemented safety test
- In Vitro chromosomal aberration, Bacterial reverse mutation, Single oral dose toxicity, and 28-days Repeated oral dose toxicity tests
- Recommended blending amount for food
- 15-50 mg/day (150-500μg/day as LPS)
- Note
-
- Analyzed by LGC Limited (UK) for absence of anti-doping banned substances
- U.S. Self-Affirmed GRAS
- U.S. FDA notified NDI
■SomacyRB-FP100
- Display name
- Fermented rice bran extract
- Production method
- LPS was extracted from wheat Pantoea cultured in a medium containing rice bran and then spray dried using dextrin as a carrier.
- Active ingredient
- LPS derived from Pantoea agglomerans isolated from wheat
- LPS concentration
- 1% (10mg/g)
- Implemented safety test
- In Vitro chromosomal aberration, Bacterial reverse mutation, Single oral dose toxicity, and 90-days Repeated oral dose toxicity tests
- Recommended blending amount for food
- 15-50 mg/day (150-500μg/day as LPS)
- Note
-
Analyzed by LGC Limited (UK) for absence of anti-doping banned substances
