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2 WHAT IS FOOD? 2.1 INTRODUCTION TO THE FOOD, DRUG, AND COSMETIC ACT

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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.

Food Regulation

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