Abstract
This chapter presents the first of two prohibited acts under US food law—adulteration. The concept of adulteration will be traced from its origins in the 1906 Act through the adulteration amendments of the 1950s and 1960s. It will define regulatory definitions and standards of proof required for regulatory agencies to take enforcement actions. The chapter expounds on the idea of economic adulteration, intentional adulteration, indirect adulteration, and the relationship to FSMA, GMPs, tolerances, action levels, and standards of identity. It introduces the adulteration amendments, covering topics such as food additives, animal drug residues, and the Delaney Clause. It leaves for a later chapter a deeper discussion on food and color additives.
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Notes
- 1.
34 Stat. 768 (repealed 1938).
- 2.
21 U.S.C. § 342(a)(1) (2014).
- 3.
21 U.S.C. § 346.
- 4.
United States Department of Agriculture, Food Safety Inspection Service, Additives in Meat and Poultry Products, available at http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/food-labeling/additives-in-meat-and-poultry-products/additives-in-meat-and-poultry-products.
- 5.
Id.
- 6.
see F. Leslie Hart, A History of the Adulteration of Food Before 1906, 7 Food Drug Cosmetic Law Journal 5 (Jan. 1952).
- 7.
MOU 225 - 71- 8003, Memorandum of Understanding between the Federal Trade Commission and the Food and Drug Administration, available at: http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm115791.htm.
- 8.
United States v. 100 Barrels of Calcium Acid Phosphate, White & Gates 58 (N.D. Cal. 1909).
- 9.
Weeks v. United States, 224 Fed. 64 (2 s Cir. 1915), aff’d on other grounds 245 U.S. 618 (1918).
- 10.
United States v. Schider, 246 Y, S, 519 (1918).
- 11.
see Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (2000).
- 12.
see Guidance for Industry: Action Levels for Poisonous or Deleterious Substances in Human Food and Animal Feed (2000) available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/chemicalcontaminantsmetalsnaturaltoxinspesticides/ucm077969.htm#merc.
- 13.
United States v. An Article of Food Consisting of Cartons of Swordfish, 395 F. Supp. 1184 (S.D.N.Y. 1975) (held mercury in fish was an “added” substance even though present for centuries because it did not occur naturally).
- 14.
622 F.2d 157 (5th Cir. 1980).
- 15.
Id. at 158–159.
- 16.
Id. at 162.
- 17.
United States Department of Agriculture, Food Safety Inspection Service, Entry Training: FSIS Statutes And Your Role, available at http://www.fsis.usda.gov/wps/wcm/connect/b751f8c8-ed46-428b-8867-0e5f70c3e394/PHVt-Statutes_Role.pdf?MOD=AJPERES
- 18.
275 F.3d 432 (5th Cir. 2001).
- 19.
232 U.S. 399 (1914).
- 20.
Id. at 412.
- 21.
Id. at 410–11.
- 22.
Id. at 411.
- 23.
Id. at 411.
- 24.
see Fleming v. Florida Citrus Exch., 358 U.S. 153, 161 (1958).
- 25.
43 F.Supp. 749 (W.D. Mo. 1942).
- 26.
Flippin and Eisenberg (1960).
- 27.
NBC News, Foster Farms Salmonella Outbreak Expands (July 4, 2013) available at: http://www.nbcnews.com/health/health-news/foster-farms-salmonella-outbreak-expands-n148466.
- 28.
Department of Health and Human Services, Center for Disease Control and Prevention , 2013 Progress Report on Six Key Pathogens Compared to 2006 − 208, available at: http://www.cdc.gov/foodnet/data/trends/trends-2013-progress.html.
- 29.
United States Department of Agriculture, Food Safety and Inspection Service, FSIS Regulatory Perspective (available at: http://www.aphl.org/conferences/proceedings/Documents/2012/2012-PulseNet-OutbreakNet/007-Edelstein.pdf).
- 30.
see Id.
- 31.
see Id.
- 32.
H.R. Rep. No. 82-2356 at 4 (1952).
- 33.
see Color Additives: Provisional Regulations; Postponement of Closing Dates, 42 Fed. Reg. 6991(1977).
- 34.
see Listing of D&C Orange No. 17 for Use in Externally Applied Drugs and Cosmetics, 51 Fed. Reg. 28,331 (1986); Listing of D&C Red No. 19 for Use in Externally Applied Drugs and Cosmetics, 51 Fed. Reg. 28,346, 28,539 (1986).
- 35.
Public Citizen v. Young, 831 F.2d 1108 (D.C. Cir. 1987).
- 36.
Id. at 122.
- 37.
Norman and Goldsmith (1950).
- 38.
FDA Consumer Magazine, Animal Health and Consumer Protection (2006) available at: http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/AnimalHealthandConsumerProtection/.
- 39.
(Posada de La Paz et al. 2001)
- 40.
(Pickert 2008).
References
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Sanchez, M. (2015). Adulteration. In: Food Law and Regulation for Non-Lawyers. Food Science Text Series. Springer, Cham. https://doi.org/10.1007/978-3-319-12472-8_3
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