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).
2 WHAT IS FOOD?
2.1 INTRODUCTION TO THE FOOD, DRUG, AND COSMETIC ACT
The Federal Food, Drug, and Cosmetic Act (FD&C Act)1 regulates more products that Americans use in our daily activities than any other federal statute. Most foods are regulated under the FD&C Act as well as pharmaceuticals, medical devices, and cosmetics.
The regulation of these products and food share many similarities; however, the requirements applying to food differ significantly from those for drugs. Accordingly, the law’s classification of a product as a food or drug can determine how rigorously the product is regulated—or whether the product is even legal. Thus, the statute’s definitions of these products deserve close attention.
After you complete this chapter, you will have an understanding of:
what
