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1 ¹ Peter Barton Hutt, Government Regulation of the Integrity of the Food Supply, 4 ANNU. REV. NUTR. 1 (1984).

2 ² Id.

3 ³ See, e.g., MICHAEL E. PORTER, THE COMPETITIVE ADVANTAGE OF NATIONS, 648–49 (1990).

4 ⁴ JOHN P. SWANN, HISTORY OF THE FDA, FDA History Office (Dec. 17, 2001).

5 ⁵ FDA, FDA BACKGROUNDER: MILESTONES IN U.S. FOOD AND DRUG LAW HISTORY (updated May 5, 2012).

6 ⁶ For more on the Poison Squad, see Deborah Blum, The Poison Squad: One Chemist's Single‐Minded Crusade for Food Safety at the Turn of the Twentieth century (Penguin 2018).

7 ⁷ The data is collected in the USDA, Bureau of Chemistry, bulletin no. 84 (1902–1908).

8 ⁸ Philip J. Hilts, The FDA at Work: Cutting‐Edge Science Promoting Public Health, FDA CONSUM. MAG. (Jan.–Feb. 2006).

9 ⁹ Id.

10 ¹⁰ Id.

11 ¹¹ Id.

12 ¹² 21 U.S.C. § 1 et seq.

13 ¹³ 21 U.S.C. § 601 et seq.

14 ¹⁴ PHILIP J. HILTS, PROTECTING AMERICA'S HEALTH: THE FDA, BUSINESS, AND ONE HUNDRED YEARS OF REGULATION 89–92 (2003).

15 ¹⁵ The FDA Food Safety Modernization Act, Pub. L. 111‐353 (2011).

16 ¹⁶ “Codification” is the arrangement of the laws (statutes or regulations) into an organized code. The volumes of the Code of Federal Regulations are organized by subject matter.

17 ¹⁷ Although the U.S. Constitution is at the root of all American law, nonlawyers seldom read the document. Do not be intimidated by the document's importance. Its language is surprisingly simple to understand.

18 ¹⁸ See the Appendix to this chapter.

19 ¹⁹ The U.S. Constitution provides that the Constitution, and the Laws of the United States which shall be made in pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, anything in the Constitution or Laws of any State to the Contrary notwithstanding. U.S. CONST. art.VI.

20 ²⁰ Of course, state and federal laws may be different without direct conflict. Generally, states may pass more restrictive or stringent food safety laws (or weaker laws) than those promulgated at the federal level, so long as there is no direct conflict in the specifics of the laws.

21 ²¹ “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively or to the people.” U.S. CONST. amend. X.

22 ²² Article I of the Constitution authorizes Congress to make all laws which shall be necessary and proper for carrying into execution the government's constitutional powers. The “Commerce Clause,” in article I, section 8, clause 3 of the Constitution, authorizes Congress to regulate commerce with foreign nations, among the several States and with the Indian tribes.

23 ²³ “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively or to the people.” U.S. CONST. amend. X.

24 ²⁴ United States v. Lopez, 514 U.S. 549 (1995).

25 ²⁵ Gibbons v. Ogden, 22 U.S. 1 (1824) (Police powers “form a portion of that immense mass of legislation which embraces everything within the territory of the state, not surrendered to the general government; all of which can advantageously be exercised by the states themselves. Inspection laws, quarantine laws, health laws of every description … are component parts of this mass.”)

26 ²⁶ See Chapter 15 for greater detail and United States v. 40 Cases … “Pinocchio Brand … Blended … Oil,” 289 F.2d 343 (2d Cir. 1961).

27 ²⁷ Alden v. Maine, 527 U.S. 706 (1999).

28 ²⁸ At least sixteen states have shellfish safety laws.

29 ²⁹ New Ice Co. v. Liebman, 285 U.S. 262, 311 (1932); United States v. Lopez, 514 U.S. 549, 581 (1995).

30 ³⁰ MCL §289.8103; for background on sulfites, see Ruth Papazian, Sulfites: Safe for Most, Dangerous for Some, FDA CONSUM. (Dec. 1996).

31 ³¹ Food and Drug Branch, California Department of Public Health, History of the California Cannery Inspection Program (2008) (“From 1899 to 1949, there were 483 outbreaks of botulism reported in North America (the United States and Canada) involving 1319 cases and 851 deaths.”)

32 ³² Cornell University, Heat Treatments and Pasteurization (Apr. 2, 2008).

33 ³³ 21 C.F.R. § 1240.61.

34 ³⁴ See Chapter 14 for greater detail.

35 ³⁵ Mathews v. Eldridge, 424 U.S. 319; 96 S.Ct. 893 (1976).

36 ³⁶ Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984).

37 ³⁷ Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (1971).

38 ³⁸ MARION NESTLE, FOOD POLITICS 112 (2002).

39 ³⁹ Queenside Hills Realty Co., Inc. v. Saxl, Commissioner of Housing and Buildings of the City of New York, 328 U.S. 80 (1946).

40 ⁴⁰ New York v. United States, 505 U.S. 144 (1992).

41 ⁴¹ See, e.g., Hale v. Henkel, 201 U.S. 43, at 74–5 (1906) (a corporation is a creation of the state, and there is a reserved right to unimpaired access to records to ensure compliance with the regulatory limits of the state).

42 ⁴² See, Braswell v. United States, 487 U.S. 99 (1988).

43 ⁴³ See, Shapiro v. United States, 335 U.S. 1 (1948).

44 ⁴⁴ Marchetti v. United States, 390 U.S. 39 (1968).

45 ⁴⁵ FRANK P. GRAD, THE PUBLIC HEALTH LAW MANUAL 272–78 (2d ed. Washington, D.C., American Public Health Association 1990) (New York City took this approach in its self‐inspection program for food establishments. N.Y.C. Health Code §§ 81.39(a), 131.03(d), 131.05(b)).

46 ⁴⁶ Yick Wo v. Hopkins, 118 U.S. 356 (1886).

47 ⁴⁷ Derived from FDA, FDA BACKGROUNDER: FOOD SAFETY: A TEAM APPROACH (Sept. 24, 1998).

48 ⁴⁸ For a listing of the statutory responsibilities of the FDA, see 21 C.F.R. § 5.10.

49 ⁴⁹ FDA‐regulated egg products include hard boiled eggs, cooked omelets, frozen egg patties, imitation egg products, egg substitutes, noodles, cake mixes, freeze‐dried products, dietary foods, dried no‐bake custard mixes, egg nog mixes, acidic dressings, mayonnaise, milk and egg dip, foods containing egg extracts, French toast, sandwiches containing eggs or egg products, and balut and other similar ethnic delicacies. FDA also has jurisdiction in establishments not covered by USDA; e.g., restaurants, bakeries, and cake mix plants.

50 ⁵⁰ The definition of “egg product” includes dried, frozen, or liquid eggs, with or without added ingredients, but contains many exceptions. Exemptions include freeze‐dried products, egg substitutes, egg nog, etc.

51 ⁵¹ See, e.g., U.S. GENERAL ACCOUNTING OFFICE (GAO), U.S. NEEDS A SINGLE AGENCY TO ADMINISTER A UNIFIED, RISK-BASED INSPECTION SYSTEM, GAO/T‐RCED‐99‐256 (Aug. 4, 1999).

52 ⁵² Pub. L. 90‐201 (1967).