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 makes an article subject to FD&C Act;
what makes an article a food, a drug, or a product outside the scope of the FD&C Act; and
the central role of intended use.
2.1.1 Definitions
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SEC. 201. [321] 2 For the purposes of this Act—
….
(f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any other such article.
(g) (1) The term “drug” means….
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C) … .
(i) The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
….
(s) The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—
1 a pesticide chemical in or on a raw agricultural commodity; or
2 a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or
3 a color additive; or
4 any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph pursuant to this … or
5 a new animal drug; or
6 an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
….
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