Abstract
This chapter grounds itself in a detailed discussion of the regulation of food additives. It explores the legislative history that animates and the current regulations as well as the practical aspects of GRAS and food additive petitions. It begins by defining food additives and the drive to ease the FDA ’s burden regulated added substances under the adulteration provisions of the Act. The chapter then explores key concepts of direct and indirect additives , GRAS, irradiation, interim food additives, and food additive petitions. It also includes a comparison of food additive regulation to color additive and new dietary ingredient regulation.
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Notes
- 1.
678 F.2d 735 (7th Cir. 1982).
- 2.
Id. at 735.
- 3.
Id. at 736.
- 4.
Id.
- 5.
525 F.2d 1103 (1st Cir. 1975).
- 6.
Id. at 1104.
- 7.
613 F.2d 947 (D.C. Cir. 1979).
- 8.
Id. at 948.
- 9.
Id. 955.
- 10.
Id. at 954–956.
- 11.
See, 21 CFR 177.1030.
- 12.
Food Additives, thresholds of regulation for substances used in food-contact articles, 21 CFR 170.39.
- 13.
See United States v 29 Cartons of An Article of Food , 987 F.2d 33 (1st Cir. 1993); United States v. Two Plastic Drums, 984 F.2d 814, (7th Cir. 1993).
- 14.
29 Cartons Id. at 39.
- 15.
See Two Plastic Drums Id. at 819.
- 16.
29 Cartons Id. at 35, 37. Two Plastic Drums Id. at 816–17, 819.
- 17.
29 Cartons Id. at 38.
- 18.
See United States v. 21 Apprx. 190 Kg. Bulk Metal Drums, 761 F. Supp. 180, 182 (D. Me. 1991).
- 19.
21 USC 321(S)(6).
- 20.
Fmali Herb, Inc. v Heckler, 715 F.2d 1385, 1386(9th Cir. 1983).
- 21.
Id. at 1390 (emphasis original).
- 22.
Notice by the FDA, Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information, 78 FR 67169 (11/08/2013).
- 23.
FDA , How U.S. FDA’s GRAS Notification Program Works (2006) available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/ucm083022.htm
- 24.
Id.
- 25.
81 Fed. Reg. 54,960 (Aug. 17, 2016).
- 26.
PEW Charitable Trust, “Fixing the Oversight of Chemicals Added to Our Food: Findings and Recommendations of Pew’s Assessment of the U.S. Food Additives Program” (Nov. 2013) available at: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/FoodAdditivesCapstoneReportpdf.pdf
- 27.
21 U.S.C. §201(s)(4).
- 28.
United States v. An Article of Food …Coco, Rico, Inc., 752 F.2d 11, 16 (1st Cir. 1985); United States v. Articles of Food…Buffalo Jerky, 456 F. Supp. 207, 209–210 (D. Neb. 1978).
- 29.
USDA , FSIS , Nitrate Regulations 21 CFR 181.33–0.34.
- 30.
FDA Prior Sanction List 21 CFR 181.22–0.32.
- 31.
FDA Lapse of Prior Sanction, 21 CFR 170.6.
- 32.
21 CFR 171.1(i)(1).
- 33.
21 CFR 171.1(i)(2).
- 34.
FDA, Color Certification Reports; Fiscal Year 2013, available at: http://www.fda.gov/ForIndustry/ColorAdditives/ColorCertification/ColorCertificationReports/default.htm
- 35.
FDA , U. S. Regulatory Requirements for Irradiating Foods, May 1999, Presentation by George H. Pauli, available at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/ucm110730.htm
- 36.
FSIS Irradiation ; Irradiation and Food Safety Answers to Frequently Asked Questions available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/production-and-inspection/irradiation-and-food-safety/irradiation-food-safety-faq
- 37.
21 CFR Part 180.
- 38.
21 CFR 180.1(c)(2).
- 39.
21 CFR 180.22–0.37.
- 40.
FDA : Brominated vegetable oil (BVO) is safe, so removing its interim status is “not a priority,” By Elaine WATSON, 29-Jan-2013 Food Navigator, available at: http://www.foodnavigator-usa.com/Regulation/FDA-Brominated-vegetable-oil-BVO-is-safe-so-removing-its-interim-status-is-not-a-priority
- 41.
Consumer Reports, Caramel Color: The Health Risk that May be in Your Soda (February 10, 2014) available at http://www.consumerreports.org/cro/news/2014/01/caramel-color-the-health-risk-that-may-be-in-your-soda/index.htm
- 42.
EFSA, Food Additives (July 2014) available at: http://www.efsa.europa.eu/en/topics/topic/additives.htm
- 43.
Canadian Food and Drug Regulations §B.01.001.
- 44.
Health Canada, Food and Nutrition, Policy for Differentiating Food Additives and Processing Aids (December 2008) available at: http://www.hc-sc.gc.ca/fn-an/pubs/policy_fa-pa-eng.php#fnb2-ref.
- 45.
Health Canada, Food and Nutrition, List of Permitted Food Additives, available at: http://www.hc-sc.gc.ca/fn-an/securit/addit/list/index-eng.php
- 46.
Ministry of Health and Welfare, Food Additives available at: http://www.mhlw.go.jp/english/topics/foodsafety/foodadditives/
- 47.
Id.
- 48.
Bendig, Paul et al., Brominated Vegetable Oil in Soft Drinks – An Underrated Source of Human Organobromine Intake, Food Chemistry 133, 678–682, 679 (2012).
- 49.
Id. at 678.
References
Bendig P et al (2012) Brominated vegetable oil in soft drinks – an underrated source of human Organobromine intake. Food Chem 133:678–682, 679
Consumer Reports (2014) Caramel color: the health risk that may be in your soda. Available at http://www.consumerreports.org/cro/news/2014/01/caramel-color-the-health-risk-that-may-be-in-your-soda/index.htm (last visited August 28, 2014)
FDA (2013) Brominated vegetable oil (BVO), is safe, so removing its interim status is ‘not a priority’, By Elaine WATSON, Food Navigator. Available at: http://www.foodnavigator-usa.com/Regulation/FDA-Brominated-vegetable-oil-BVO-is-safe-so-removing-its-interim-status-is-not-a-priority (last visited August 28, 2014)
PEW Charitable Trust (2013) Fixing the oversight of chemicals added to our food: findings and recommendations of Pew’s Assessment of the U.S. Food Additives Program. Available at: http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/reports/FoodAdditivesCapstoneReportpdf.pdf (last visited August 28, 2014)
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Sanchez, M.C. (2018). Food Additives. In: Food Law and Regulation for Non-Lawyers. Food Science Text Series. Springer, Cham. https://doi.org/10.1007/978-3-319-71703-6_7
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