Unit_21_-_Laws_and_Regulations - Unit 21 - Laws and...

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1 Unit 21 - Laws and Regulations Like other industries, packaging is subject to a wide array of regulations covering all aspects of the business. The most significant regulations are usually issued by the federal government, but there are many regulatory agencies within state and local governments as well. In addition, private organizations of various types exert regulatory influences. There are also international regulations that apply to certain classes of products. 21.1 Food and Drug Administration (FDA) FDA, as the name implies, is responsible for regulating the food and drug industries. The FDA was established in response to pressures from journalists who were attacking abuses in the food industry and the sales of patent medicines which had no beneficial effect and, at times, were actually harmful. However, other regulations predated the FDA by many years. For example, in 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread with such ingredients as ground peas or beans. Adulteration of food is still an issue in some cases, such as the unauthorized addition of water to milk. Regulation of food in the United States began in early colonial times and the first instance of federal control over the drug supply began with inspection of imported drugs in 1848. There were many laws and regulations that were passed before the final establishment of the FDA in 1906. The initial laws were mostly aimed at regulation of food. There were numerous public events (and some disasters) which lead to several efforts at piecemeal regulation, culminating in The Federal Food, Drug, and Cosmetic Act of 1938 and a number of other regulatory efforts. FDA has broad based authority to regulate drugs and medical devices intended for application to or onto both humans and animals. FDA also regulates label claims, packaging, additives, and a variety of other activities, technologies, and practices in both the medical and food industries. A thorough discussion of FDA regulations is beyond the scope of this class, but we will examine some selected examples in the next unit, beginning with a look at requirements for food labeling. 21.2 Other Federal Regulatory Agencies As discussed above, FDA is the primary agency responsible for food and drug regulation, including packaging; however, FDA does not work alone. There are numerous other federal agencies which also regulate aspects of the packaging industry. The following section briefly illustrates the activities of a selected set of such agencies. 21.2.1 Environmental Protection Agency (EPA) EPA is responsible for regulations aimed at protecting air and water quality. An early regulatory effort by EPA, based on the Clean Water Act, was aimed at the paper industry which was a major polluter of streams and other surface water. As a result, the
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This note was uploaded on 10/17/2011 for the course PKG 101 taught by Professor Haroldhughes during the Spring '08 term at Michigan State University.

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Unit_21_-_Laws_and_Regulations - Unit 21 - Laws and...

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