Nutritional regulations and legislation--past developments, future implications.

Laws to prohibit adulteration of foods were enacted before 1900, but the first steps in the development of nutritional regulations were taken only after passage of the Food, Drug and Cosmetic Act of 1938. This act authorized the Food and Drug Administration (FDA) to establish Standards of Identity for foods, including standards for enrichment with vitamins and minerals to meet Minimum Daily Requirements (MDRs). The legal definition of nutrients, however, has remained unclear. Vitamins are foods when used as supplements but drugs when prescribed as therapeutic agents. To protect consumers, in 1962 the FDA proposed Standards of Identity for Special Dietary Foods, e.g., vitamin supplements. Opposition to the proposal has been vigorous and was the subject of the longest hearings on record. Implementation of standards has been contested in the courts and curtailed by Congressional action. A bill passed in 1975 prohibits the FDA from establishing Standards of Identity for special dietary foods for adults. During the legal and political controversy, the validity of Recommended Dietary Allowances as nutritional standards was challenged but subsequently confirmed. Revised regulations for vitamin and mineral preparations, taking into account the Congressional and court actions, will become effective January 1, 1978, sixteen years after first being proposed.