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Volumn 105, Issue , 2017, Pages 140-150

GRAS from the ground up: Review of the Interim Pilot Program for GRAS notification

Author keywords

FDA; Food additive; Food toxicology; Generally recognized as safe; GRAS

Indexed keywords

FOOD ADDITIVE;

EID: 85017446392     PISSN: 02786915     EISSN: 18736351     Source Type: Journal    
DOI: 10.1016/j.fct.2017.03.064     Document Type: Article
Times cited : (23)

References (42)
  • 2
    • 0345507964 scopus 로고    scopus 로고
    • Reducing Underage Drinking: a Collective Responsibility
    • The National Academies Press
    • Bonnie, R.J., O'Connell, M.E., Reducing Underage Drinking: a Collective Responsibility. 2004, The National Academies Press.
    • (2004)
    • Bonnie, R.J.1    O'Connell, M.E.2
  • 3
    • 0034066729 scopus 로고    scopus 로고
    • Dietary supplements and lessons to be learned from GRAS
    • Burdock, G.A., Dietary supplements and lessons to be learned from GRAS. Regul. Toxicol. Pharmacol. 31 (2000), 68–76.
    • (2000) Regul. Toxicol. Pharmacol. , vol.31 , pp. 68-76
    • Burdock, G.A.1
  • 4
    • 1842531785 scopus 로고    scopus 로고
    • Generally recognized as safe (GRAS): history and description
    • Burdock, G.A., Carabin, I.G., Generally recognized as safe (GRAS): history and description. Toxicol. Lett. 150 (2004), 3–18.
    • (2004) Toxicol. Lett. , vol.150 , pp. 3-18
    • Burdock, G.A.1    Carabin, I.G.2
  • 5
    • 33644643867 scopus 로고    scopus 로고
    • The importance of GRAS to the functional food and nutraceutical industries
    • Burdock, G.A., Carabin, I.G., Griffiths, J.C., The importance of GRAS to the functional food and nutraceutical industries. Toxicology 221 (2006), 17–27.
    • (2006) Toxicology , vol.221 , pp. 17-27
    • Burdock, G.A.1    Carabin, I.G.2    Griffiths, J.C.3
  • 7
    • 0033046843 scopus 로고    scopus 로고
    • Inulin and oligofructose: safe intakes and legal status
    • Coussement, P.A., Inulin and oligofructose: safe intakes and legal status. J. Nutr. 129 (1999), 1412S–1417S.
    • (1999) J. Nutr. , vol.129 , pp. 1412S-1417S
    • Coussement, P.A.1
  • 8
    • 85017471958 scopus 로고    scopus 로고
    • LLP, Accessed 15 January. FDA issues final determination withdrawing the GRAS status of PHO's. 2015.
    • Covington & Burling, LLP, Accessed 15 January 2017. FDA issues final determination withdrawing the GRAS status of PHO's. 2015 https://www.cov.com/∼/media/files/corporate/publications/2015/06/fda_issues_final_determination_withdrawing_the_gras_status_of_phos.pdf.
    • (2017)
  • 9
    • 0016998137 scopus 로고
    • Food safety–then and now. A Bicentennial study
    • Day, H.G., Food safety–then and now. A Bicentennial study. J. Am. Diet. Assoc. 69 (1976), 229–234.
    • (1976) J. Am. Diet. Assoc. , vol.69 , pp. 229-234
    • Day, H.G.1
  • 10
    • 84888059008 scopus 로고    scopus 로고
    • Immunomodulation by dietary long chain omega-3 fatty acids and the potential for adverse health outcomes
    • Accessed 15 January 2017. How U.S. FDA's GRAS Notification Program Works
    • Fenton, J.I., Hord, N.G., Ghosh, S., Gurzell, E.A., Immunomodulation by dietary long chain omega-3 fatty acids and the potential for adverse health outcomes. Prostagl. Leukot. Essent. Fat. Acids 89 (2013), 379–390 Accessed 15 January 2017. How U.S. FDA's GRAS Notification Program Works http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.
    • (2013) Prostagl. Leukot. Essent. Fat. Acids , vol.89 , pp. 379-390
    • Fenton, J.I.1    Hord, N.G.2    Ghosh, S.3    Gurzell, E.A.4
  • 12
    • 0029044742 scopus 로고
    • FEMA GRAS–a GRAS assessment program for flavor ingredients. Flavor and Extract Manufacturers Association
    • Hallagan, J.B., Hall, R.L., FEMA GRAS–a GRAS assessment program for flavor ingredients. Flavor and Extract Manufacturers Association. Regul. Toxicol. Pharmacol. 21 (1995), 422–430.
    • (1995) Regul. Toxicol. Pharmacol. , vol.21 , pp. 422-430
    • Hallagan, J.B.1    Hall, R.L.2
  • 13
    • 58149498309 scopus 로고    scopus 로고
    • Under the conditions of intended use - new developments in the FEMA GRAS program and the safety assessment of flavor ingredients
    • Hallagan, J.B., Hall, R.L., Under the conditions of intended use - new developments in the FEMA GRAS program and the safety assessment of flavor ingredients. Food Chem. Toxicol. 47 (2009), 267–278.
    • (2009) Food Chem. Toxicol. , vol.47 , pp. 267-278
    • Hallagan, J.B.1    Hall, R.L.2
  • 15
    • 84962604835 scopus 로고    scopus 로고
    • General and genetic toxicology of guayusa concentrate (Ilex guayusa)
    • Kapp, R.W. Jr., Mendes, O., Roy, S., McQuate, R.S., Kraska, R., General and genetic toxicology of guayusa concentrate (Ilex guayusa). Int. J. Toxicol. 35 (2016), 222–242.
    • (2016) Int. J. Toxicol. , vol.35 , pp. 222-242
    • Kapp, R.W.1    Mendes, O.2    Roy, S.3    McQuate, R.S.4    Kraska, R.5
  • 16
    • 40049086357 scopus 로고    scopus 로고
    • Regulation of probiotic substances as ingredients in foods: premarket approval or “generally recognized as safe” notification
    • S115-118; discussion S144–151
    • Mattia, A., Merker, R., Regulation of probiotic substances as ingredients in foods: premarket approval or “generally recognized as safe” notification. Clin. Infect. Dis., 46(Suppl. 2), 2008 S115-118; discussion S144–151.
    • (2008) Clin. Infect. Dis. , vol.46
    • Mattia, A.1    Merker, R.2
  • 17
    • 84989840415 scopus 로고    scopus 로고
    • Overview of the ISRTP October 2014 workshop on GRAS determinations
    • Accessed 15 January 2017. The future of GRAS regulations
    • McColl, D.B., Janus, E.R., Overview of the ISRTP October 2014 workshop on GRAS determinations. Regul. Toxicol. Pharmacol. 79:Suppl. 2 (2016), S95–S98 Accessed 15 January 2017. The future of GRAS regulations http://www.nutritionaloutlook.com/magazine/future-gras-regulations.
    • (2016) Regul. Toxicol. Pharmacol. , vol.79 , pp. S95-S98
    • McColl, D.B.1    Janus, E.R.2
  • 18
    • 84883715483 scopus 로고    scopus 로고
    • Data gaps in toxicity testing of chemicals allowed in food in the United States
    • Neltner, T.G., Alger, H.M., Leonard, J.E., Maffini, M.V., Data gaps in toxicity testing of chemicals allowed in food in the United States. Reprod. Toxicol. 42 (2013), 85–94.
    • (2013) Reprod. Toxicol. , vol.42 , pp. 85-94
    • Neltner, T.G.1    Alger, H.M.2    Leonard, J.E.3    Maffini, M.V.4
  • 19
    • 44049087903 scopus 로고    scopus 로고
    • Caffeinated cocktails: energy drink consumption, high-risk drinking, and alcohol-related consequences among college students
    • O'Brien, M.C., McCoy, T.P., Rhodes, S.D., Wagoner, A., Wolfson, M., Caffeinated cocktails: energy drink consumption, high-risk drinking, and alcohol-related consequences among college students. Acad. Emerg. Med. 15 (2008), 453–460.
    • (2008) Acad. Emerg. Med. , vol.15 , pp. 453-460
    • O'Brien, M.C.1    McCoy, T.P.2    Rhodes, S.D.3    Wagoner, A.4    Wolfson, M.5
  • 20
    • 84960157841 scopus 로고    scopus 로고
    • The safety and regulatory process for low calorie sweeteners in the United States
    • Roberts, A., The safety and regulatory process for low calorie sweeteners in the United States. Physiol. Behav. 164 (2016), 439–444.
    • (2016) Physiol. Behav. , vol.164 , pp. 439-444
    • Roberts, A.1
  • 21
    • 84977527188 scopus 로고    scopus 로고
    • A hard look at FDA's review of GRAS notices
    • Roberts, A., Haighton, L.A., A hard look at FDA's review of GRAS notices. Regul. Toxicol. Pharmacol. 79:Suppl. 2 (2016), S124–S128.
    • (2016) Regul. Toxicol. Pharmacol. , vol.79 , pp. S124-S128
    • Roberts, A.1    Haighton, L.A.2
  • 22
    • 84858322534 scopus 로고    scopus 로고
    • Nonnutritive, low caloric substitutes for food sugars: clinical implications for addressing the incidence of dental caries and overweight/obesity
    • 625701
    • Roberts, M.W., Wright, J.T., Nonnutritive, low caloric substitutes for food sugars: clinical implications for addressing the incidence of dental caries and overweight/obesity. Int. J. Dent., 2012, 2012 625701.
    • (2012) Int. J. Dent. , vol.2012
    • Roberts, M.W.1    Wright, J.T.2
  • 23
    • 84907809153 scopus 로고    scopus 로고
    • Regulatory status of caffeine in the United States
    • Rosenfeld, L.S., Mihalov, J.J., Carlson, S.J., Mattia, A., Regulatory status of caffeine in the United States. Nutr. Rev. 72:Suppl. 1 (2014), 23–33.
    • (2014) Nutr. Rev. , vol.72 , pp. 23-33
    • Rosenfeld, L.S.1    Mihalov, J.J.2    Carlson, S.J.3    Mattia, A.4
  • 25
    • 56849118251 scopus 로고    scopus 로고
    • Alcohol, Energy Drinks, and Youth: a Dangerous Mix
    • Marin Institute San Rafael, CA
    • Simon, M., Mosher, J., Alcohol, Energy Drinks, and Youth: a Dangerous Mix. 2007, Marin Institute, San Rafael, CA.
    • (2007)
    • Simon, M.1    Mosher, J.2
  • 30
    • 34047105837 scopus 로고    scopus 로고
    • Metabolism of diacylglycerol in humans
    • Takase, H., Metabolism of diacylglycerol in humans. Asia Pac J. Clin. Nutr. 16:Suppl. 1 (2007), 398–403.
    • (2007) Asia Pac J. Clin. Nutr. , vol.16 , pp. 398-403
    • Takase, H.1
  • 31
    • 85017450022 scopus 로고    scopus 로고
    • Substances Generally Regarded as Safe
    • 62FR18939
    • United States Food and Drug Administration, Substances Generally Regarded as Safe. 1997 62FR18939 https://www.gpo.gov/fdsys/pkg/FR-1997-04-17/pdf/97-9706.pdf.
    • (1997)
    • United States Food and Drug Administration1
  • 32
    • 85017412146 scopus 로고    scopus 로고
    • FDA's Approach to the GRAS Provision: a History of Processes
    • Accessed 15 January 2017
    • United States Food and Drug Administration, FDA's Approach to the GRAS Provision: a History of Processes. 2006 Accessed 15 January 2017 http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm094040.htm.
    • (2006)
    • United States Food and Drug Administration1
  • 33
    • 85014662317 scopus 로고    scopus 로고
    • Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients
    • United States Food and Drug Administration, Guidance for Industry and Other Stakeholders: Toxicological Principles for the Safety Assessment of Food Ingredients. 2007 http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM222779.pdf.
    • (2007)
    • United States Food and Drug Administration1
  • 34
    • 84856315197 scopus 로고    scopus 로고
    • Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices
    • United States Food and Drug Administration, Enzyme Preparations: Recommendations for Submission of Chemical and Technological Data for Food Additive Petitions and GRAS Notices. 2010 http://www.fda.gov/downloads/Food/GuidanceRegulation/UCM217735.pdf.
    • (2010)
    • United States Food and Drug Administration1
  • 35
    • 79955839369 scopus 로고    scopus 로고
    • FDA Should Strengthen its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS)
    • United States Government Accountability Office, FDA Should Strengthen its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS). 2010 http://www.gao.gov/assets/310/300743.pdf.
    • (2010)
    • United States Government Accountability Office1
  • 36
    • 85019966041 scopus 로고    scopus 로고
    • FDA, USDA, NOAA Statements on Food Safety
    • Accessed 15 January 2017
    • United States Food and Drug Administration, FDA, USDA, NOAA Statements on Food Safety. 2011 Accessed 15 January 2017 http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm248257.htm.
    • (2011)
    • United States Food and Drug Administration1
  • 37
    • 85017454012 scopus 로고    scopus 로고
    • Guidance for Industry: Frequently Asked Questions about GRAS for Substances Intended for Use in Human or Animal Food
    • United States Food and Drug Administration, Guidance for Industry: Frequently Asked Questions about GRAS for Substances Intended for Use in Human or Animal Food. 2016 http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM525233.pdf.
    • (2016)
    • United States Food and Drug Administration1
  • 38
    • 48349103888 scopus 로고    scopus 로고
    • Substances Generally Recognized as Safe
    • 81FR54960
    • United States Food and Drug Administration, Substances Generally Recognized as Safe. 2016 81FR54960 https://www.gpo.gov/fdsys/pkg/FR-2016-08-17/pdf/2016-19164.pdf.
    • (2016)
    • United States Food and Drug Administration1
  • 39
    • 85017413424 scopus 로고    scopus 로고
    • Consent Decree: Center for Food Safety Vs
    • US Department of Health and Human Services and US Food and Drug Administration Accessed 15 January 2017
    • United States District Court, Consent Decree: Center for Food Safety Vs. 2014, US Department of Health and Human Services and US Food and Drug Administration Accessed 15 January 2017 http://www.fdalawblog.net/CFSvsFDAGRASConsentDecree.pdf.
    • (2014)
    • United States District Court1
  • 40
    • 85017464466 scopus 로고    scopus 로고
    • GRAS Notices Inventory
    • Accessed 15 January 2017
    • United States Food and Drug Administration, GRAS Notices Inventory. 2017 Accessed 15 January 2017 http://www.accessdata.fda.gov/scripts/fdcc/?set=GRASNotices.
    • (2017)
    • United States Food and Drug Administration1
  • 41
    • 85017410043 scopus 로고    scopus 로고
    • Inspections, Compliance, Enforcement, and Criminal Investigations
    • Accessed 15 January 2017
    • United States Food and Drug Administration, Inspections, Compliance, Enforcement, and Criminal Investigations. 2017 Accessed 15 January 2017 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm.
    • (2017)
    • United States Food and Drug Administration1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.