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GRAS Criteria: Comparing a GRASSubstance to a Food AdditiveFood AdditiveGRAS SubstanceFDA“TechnicalElement”“CommonKnowledgeElement”“TechnicalElement”GenerallyavailableGenerallyaccepted
GRAS Notification Procedurebased on the April 1997 FR Proposal• Voluntary• Notifier informs FDA of notifier’s viewthat a use of a substance is GRAS• FDA responds by letter
Page 5 and 6: A Core Statute for Food IngredientS
Page 7 and 8: House of Representatives, Report No
Page 9 and 10: REASONABLE CERTAINTY OF NO HARMLegi
Page 11 and 12: Reasonable Certainty ofNo HarmWhat
Page 13 and 14: Traditional Safety Evaluation(Petit
Page 15 and 16: The “Toxicological” Safety Asse
Page 17 and 18: The “Circle” ofReasonable Certa
Page 19 and 20: “Olestra”a macronutrient substi
Page 21 and 22: Olestra: Molecular Structure
Page 28 and 29: Beyond “Toxicity” Studies• Fo
Page 30 and 31: Beyond “Toxicity” StudiesIn fac
Page 32 and 33: Summary of Olestra Data Review• I
Page 34 and 35: Summary of Olestra Data ReviewDrug
Page 36 and 37: Studies to Assess Nutritional Effec
Page 38 and 39: Summary of Olestra Data Review8-Wk
Page 40 and 41: Summary of Olestra Data ReviewStudi
Page 42 and 43: Carotenoids• Serum levels are aff
Page 44 and 45: GI Effects• After review by FDA o
Page 46 and 47: FDA’s s Safety Review: Summary•
Page 48 and 49: Labeling of FoodsContaining Olestra
Page 50 and 51: A More Complex “Circle” ofReaso
Page 52 and 53: “Generally Recognized as Safe”(
Page 56 and 57: 3 Types of Responseto a GRAS Notice
Page 58 and 59: Other Examples of “Bioactive”Fo
Page 60 and 61: Nutritional Risk Assessment?• For
Page 62 and 63: Nutritional Risk Assessment• An u
Page 64 and 65: A Still More Complex “Circle” o
Page 66 and 67: Relative Food-Related Concerns(A Po
Page 68: The End!Thank You!

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