The first federal food and drug law was passed in 1906 and was replaced in 1938 by a more comprehensive Federal Food, Drug, and Cosmetic Act – also known as the “Pure Food and Drug Law.” This law pertains to food, other than meat and poultry products, sold in interstate commerce and imported and exported foods. It requires that foods be pure, wholesome, and honestly labeled.

Amendments. Several amendments to the law have been enacted. The Miller Pesticide Amendment of 1954 enables the establishment of safe tolerances of pesticides that may remain in foods after they have been harvested. The Additives Amendment of 1958 provides that an additive may be used in a food product only if it can be shown to improve the nutritive quality, appearance, or keeping properties of a food and not to cover up the use of an inferior food. The amendment requires the manufacturer to submit evidence from experimental work on animals that an additive is safe before it may be included in a food product for sale. The Food and Drug Administration examines the evidence, seeks further proof if necessary, and then issues or refuses a permit for the use of the additive, depending upon its findings. The Color Additive Amendment of 1960 provides for the establishment of safe tolerance levels for all colors used in foods. The Fair Packaging and Labeling Act passed by Congress in 1966 authorizes the FDA to set up regulations for packaging and labeling that avoids deceptive practices.

GRAS list. In 1958 when the Food Additives Amendment was enacted about 600 substances were excluded from testing. They had been used for long periods of time without any known harm to consumers, and were “generally recognized as safe” (GRAS). The list included salt, baking powder, baking soda, spices, and minerals and vitamins added to food for enrichment, as well as other substances.

In 1968 the public as well as some scientists became concerned when cyclamates (one of the artificial sweeteners on the GRAS list) were found to produce bladder cancer in animals. The amount of cyclamate required to produce the cancer was so large, that a human being would find it impossible to consume an equivalent amount. Nonetheless, the Delaney clause of the additives amendment specifies that no substance may be added to food if it produces cancer at any level whatsoever. As a result the entire GRAS list is being tested to determine whether any of the substances will produce cancer at any level of feeding.

Enforcement. The food and drug law, together with its amendments, is enforced by the Food and Drug Administration of the Department of Health, Education, and Welfare. Under the law, factories and warehouses may be inspected to ascertain that the raw materials together with processing, packaging, and storage facilities are sanitary. Adulterated and misbranded products may be seized by inspectors and destroyed or relabeled, depending upon the nature of the offense. Flagrant violations may result in the imposition of fines or imprisonment by the courts.

Interpretation of the law. A food is adulterated if it contains dirt, filth, or decomposed material or any substance harmful to health; if it is prepared, packaged, or stored under unsanitary conditions; if it is made from diseased animals; if it contains additives that conceal the poor quality of the food; if it contains unsafe additives, uncertified food colors, or pesticide residues in excess of tolerances; if the packaging material contains substances harmful to health.

Misbranded food is that which has a false, misleading label; a package that

fails to specify the weight, measure, or count of the food; a package that is of misleading size, so that the consumer thinks he is getting more than he actually is; a label that does not clearly state the use of imitations, including artificial color, flavorings, and preservatives; a label that fails to list the name of the manufacturer, packer, or distributor; a label that does not list the amounts of nutrients in products for which a nutritional claim is made.

The Food and Drug Administration also establishes what a product actually is by setting standards of identity, quality, and fill. Foods for which an official standard has been set must contain amounts of ingredients not below the prescribed minimum nor above the legal maximum. This regulation applies also to the addition of required amounts of nutrients for enrichment and fortification. For non-standardized products the ingredients are listed in order from the greatest amount to the least. Standards of quality for canned vegetables, fruits, and meats, and other products pertain to the color, flavor, and freedom from defects. Standards of fill specify how full a container must be.

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GENERAL HEALTH