Pure food and drug laws establish health and safety standards for foods, drugs, medical devices, and cosmetics. The basic food and drug law of the United States is the Federal Food, Drug, and Cosmetic Act. This act, which was passed in 1938, prohibits the distribution of impure foods, drugs, or cosmetics in the United States. It also forbids false or misleading labeling on such products.
The Food and Drug Administration (FDA)—an agency in the Department of Health and Human Services—enforces the Federal Food, Drug, and Cosmetic Act. The FDA checks food and drug products to make certain they meet federal standards. If the FDA finds evidence of violations, it gives the evidence to a federal court. Federal courts receive several hundred new cases annually that deal with such violations.
Foods
A major section of the Federal Food, Drug, and Cosmetic Act gives the FDA power to set standards for both human and animal foods. Food standards define what ingredients a food must contain and how the food should be labeled. The FDA sets standards for only the most common food products. The food section of the federal act contains provisions that cover (1) impurities in foods, (2) food additives, and (3) labeling of foods.
Impure foods
are foods that do not meet the safety, purity, or cleanliness standards of the Federal Food, Drug, and Cosmetic Act. They include foods that have dirty or rotten contents or have been prepared or packaged under unsanitary conditions. The most frequent sources of impurities found in food are insects, mice, and rats.
In addition, harmful chemicals may be the cause of impurities. Such chemicals may be present in food on which producers have used a poisonous spray. Harmful chemicals also may be found in fish that have lived in polluted water.
Food additives
are substances that food producers can legally add to their products. They include spices and many other substances used to flavor or preserve food. The Federal Food, Drug, and Cosmetic Act requires that these substances be proved safe by scientific tests before they are put on the market. More than 3,000 food additives have been approved. Permitted additions to foods also include color additives. The FDA must approve every batch of color that is used in the preparation of foods, drugs, and cosmetics.
The safe use of pesticides is also permitted. Food growers often use pesticides on or around food. The Environmental Protection Agency determines how much pesticide may remain on a food crop. It sets these levels far below those that would make the food dangerous to eat. The FDA tests food products for pesticide and takes them off the market if too much remains on them.
Labeling of foods.
The Federal Food, Drug, and Cosmetic Act requires food producers to provide certain information on the labels of their products. This information includes the name of the product and of its manufacturer, packer, or distributor; the amount of food in the package or container; a complete list of ingredients, except for some standardized foods; and the name of any chemical substance added. In addition, a food label must tell if artificial color or flavor has been used, except for some colors that are added to butter, cheese, and ice cream. The Nutrition Labeling and Education Act of 1990 requires that all packaged and processed foods sold in the United States also carry labels with nutritional information (see Nutrition [Nutrition guidelines]).
Drugs and devices
The Federal Food, Drug, and Cosmetic Act defines drugs as products intended for use in the medical care of people or animals. The act covers several kinds of drugs, including (1) prescription drugs, (2) over-the-counter drugs, (3) biological drugs. It also covers medical and other devices.
Before a producer can sell a new drug, the drug must be tested thoroughly to find out if it is safe and effective when used as directed. The producer must give the FDA a report on all tests and on all the ingredients of the drug and the methods for testing their strength and purity. The producer must submit the proposed label directions and any needed warnings. The FDA, after approving a new drug, keeps watch on its use and effects.
Prescription drugs
are dangerous to use except under medical supervision. The Federal Food, Drug, and Cosmetic Act defines the kinds of drugs that should be in this group. The act forbids the sale of such drugs unless a physician or a dentist has prescribed them. The act also prohibits the sale of a prescription drug for an animal unless a veterinarian has prescribed it.
Over-the-counter drugs
may be sold without a prescription. Such drugs must be safe for use without medical supervision. Label directions and warnings on over-the-counter drugs must be clear and easily seen, so that consumers can use the drugs safely and effectively.
Biological drugs
are made from animal or human substances. These drugs include serums and vaccines, and drug products made from human blood. A manufacturer may not sell such a drug unless the FDA has licensed it. An FDA license assures the purity, safety, and strength of the drug.
Devices.
Medical devices are products used in the control or treatment of disease. The Federal Food, Drug, and Cosmetic Act requires them to be safe and effective. Such devices include artificial parts for the human body, fever thermometers, and sun lamps. Many medical devices need FDA approval before they go on the market. The FDA also tests radiation-emitting devices such as X-ray machines, televisions, and microwave ovens to ensure that they do not endanger health.
Cosmetics
Cosmetics include such products as deodorants, lipsticks, perfumes, shampoos, and toothpaste. The Federal Food, Drug, and Cosmetic Act requires cosmetics to be safe and properly labeled. It also requires cosmetic producers to make and package their products under sanitary conditions. The ingredients used in a cosmetic must be listed on the label. The labels must include the manufacturer’s name and address. Labels of coal tar hair dyes must warn that the product should be tested for possible skin irritation before being used.
Enforcement
The Food and Drug Administration publishes regulations that explain the Federal Food, Drug, and Cosmetic Act. However, manufacturers sometimes violate the act, accidentally or intentionally. In most cases, the FDA does not prosecute if the manufacturer voluntarily stops shipping an illegal product. If an illegal product has already been sold, the manufacturer may be required to notify the people who bought it and arrange to take the unsold stocks of the product off the market. This procedure is called a recall.
Evidence of violations of the act is gathered by hundreds of FDA field investigators and inspectors. These employees inspect factories and warehouses and investigate complaints of illness or injury caused by impure or mislabeled foods, drugs, or cosmetics. In addition, FDA inspectors supervise the enforcement of court rulings on violations.
The FDA also employs hundreds of scientists in field jobs, including microbiologists, chemists, and veterinarians. These experts use laboratory tests to check the purity, safety, and effectiveness of foods, drugs, cosmetics, and devices. In addition, the agency employs hundreds of other scientists and physicians who review and approve new drugs and serve as experts in other scientific areas.
Three kinds of legal action can be taken if the FDA finds that a producer has violated the federal food and drug laws: (1) A federal court may issue an injunction (court order) directing the manufacturer to stop. (2) The court, acting on evidence from the FDA, may seize a product that violates the law. (3) Prosecution for such violations can result in a fine or imprisonment or both.
History
Since ancient times, there have been food and drug laws regulating the quality of meat, milk, and flour products. By about A.D. 1300, European merchants had set up powerful trade organizations to inspect food and drugs. During the Industrial Revolution, which occurred in the 1700’s and early 1800’s, food producers began using chemicals to preserve and color food.
In 1784, Massachusetts passed the first general pure food and drug law in the United States. Early state laws were difficult to enforce, however, because they often did not define pure, and what was considered pure in one state could be ruled impure in another. Also, some people felt it was unfair to punish a merchant for selling foods or drugs that the merchant did not know were considered impure in a particular state.
In 1848, Congress passed the first federal drug law, the Import Drug Act, to stop drugs of poor quality from coming into the country. Beginning in 1883, Harvey W. Wiley, chief of the Bureau of Chemistry in the U.S. Department of Agriculture, began studies of food purity. He favored passage of a federal law that would define impure and misnamed foods and drugs for all states. Public support for passage of such a law grew as journalists wrote about certain chemical preservatives and other harmful substances in foods and about dangerous ingredients, such as alcohol and opium, in drugs. As a result, Congress passed two food and drug acts in 1906—the Meat Inspection Act and the federal Food and Drugs Act. Stronger legislation—the Federal Food, Drug, and Cosmetic Act—was passed in 1938. The act has been revised many times since then.
In 1995, the FDA declared that nicotine was a drug and that cigarettes and other tobacco products were nicotine “delivery devices.” As a result, the FDA introduced restrictions on the marketing and sale of tobacco products to young people. In 2000, however, the Supreme Court of the United States ruled that the FDA does not have the authority to regulate tobacco products. The Food and Drug Administration Amendments Act of 2007 allowed the FDA to perform more comprehensive reviews of potential new drugs and devices. The Food Safety Modernization Act of 2010 gave the FDA increased authority to inspect food processing facilities and to recall contaminated foods.
Food and drug laws in Canada
Parliament passed Canada’s first food and drug law in 1875. Today, the nation’s main food and drug laws are the Food and Drugs Act and the Canadian Food Inspection Agency Act.
The Canadian food and drug acts prohibit the production or sale of impure food and drug products. Like the United States law, these acts set standards of purity and safety for foods, drugs, cosmetics, and medical devices. The acts are enforced by Health Canada and the Canadian Food Inspection Agency.
