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
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