Pure food and drug laws, in the United States, are
federal regulations designed to protect the consumer from adulterated
or otherwise harmful food, drugs, and
cosmetics.
Federal efforts to control food and drug adulterationÑwhich had long been considered the domain of the statesÑbegan in the second half of the 19th century, and Congress finally passed the Pure Food and Drug Act in 1906. It defined adulteration, outlawed interstate transportation of adulterated foods, and prohibited the misbranding of foods and drugs.
By 1906 relatively little use had been made of advertising, other than the claims made on the label of the product. Hence it was felt that an emphasis on stating the truth on the label would be an adequate protection against misrepresentation. Since the act applied only to interstate commerce, however, it was evaded in an unexpected way: Goods were shipped without labels, which were added only after the goods were safely within state jurisdiction. The effectiveness of the law also suffered because it did not anticipate the dramatic changes taking place in consumer marketing and advertising. It did not cover cosmetics, obesity cures, curative devices of a mechanical nature, or the newer habit-forming drugs. The law helped, however, in cutting down on adulterated foods and drugs, contributed somewhat to improved sanitary conditions under which they were made, and discouraged misrepresentation of the labels.
Later, more sharply targeted legislation included the Federal Meat Inspection Act of 1906; the Sherley Amendment of 1912, which tightened the ban on mislabeling; the Net Weight Amendment of 1913; the Gould Amendment of 1913 requiring quantity labels on packaged goods; and the establishment of butter standards in 1923. In 1927 enforcement of the food and drug regulations became the responsibility of the newly created Food, Drug, and Insecticide Administration, renamed in 1931 the Food and Drug Administration (now part of the Department of Health and Human Services).
In 1938 all these acts and amendments were for the most part superseded by a new comprehensive law, the Pure Food, Drug, and Cosmetic Act. This legislation expanded the affected commodity list, increased penalties, broadened the concepts of adulteration and misbranding, and paid special attention to particularly harmful commodities. Cosmetics and therapeutic devices were brought under the law. Adulteration included the presence of any filthy or decomposed materials or anything that was prepared under unsanitary conditions. False or misleading labeling was banned. Containers that were made, formed, or filled so as to be misleading also were prohibited. Goods were banned from interstate shipment unless they had labels. The law also called for more information on labelsÑfor example, products that contained certain drugs were required to indicate their habit-forming nature. Cosmetics were to be considered adulterated if they contained any poisonous materials that might render them injurious if the products were used in the manner prescribed.
Provisions were set up to define quality and standards of identity for food items. Tolerances for potentially poisonous or otherwise dangerous ingredients, such as food preservatives, also were regulated strictly. Food additives could not be used that would make a commodity appear to be bulkier or that would reduce its quality. The use of coal-tar coloring products was regulated. Injunctions could be used to bar questionable practices pending final action. The 1938 Wheeler-Lea Amendment contained specific provisions against false advertising for foods, drugs, cosmetics, and therapeutic devices. Enforcement, however, continued to suffer from inadequate budgets and from judicial interpretations that denied the right of the government to inspect a manufacturer's premises without prior consent. This right was given by Congress to the Food and Drug Administration in 1953.
While it remains the basic federal legisltion, since 1938 other amendments have been added to the Pure Food, Drug, and Cosmetic Act. New regulations effective in 1994 required that food labels list detailed nutritional information. Long unresolved, however, was another controversy over pesticide residues on food. The Delaney Clause, a 1958 addition to the Food, Drug, and Cosmetic Act, prohibited even trace amounts of any cancer-causing chemical residue on commodities that are used in processed food. Another rule, however, allowed small amounts of carcinogenic pesticide residues on raw foods, if the risk to health they pose was deemed "negligible"Ñwith less than a one-in-a-million chance of causing cancer. In 1996, Congress replaced the Delaney clause with a single standard for both fresh and processed foods, allowing pesticides that pose only a negligible risk.
Many other changes and challenges to the Food, Drug, and Cosmetic Act will arise as new technologies and new health concerns create their constituencies. Genetically engineered foods, for example, fall under FDA regulation. In 1993 the agency approved the use of recombinant bovine growth hormone (rBGH) to increase milk production in dairy herds, and in 1994 it approved the distribution of a genetically altered tomato. Both were controversial decisions.