ABSTRACT
On January 4, 1972 the Food and Drug Administration (FDA) embarked on a major program to ensure the safety, effectiveness, and adequate labeling of all nonprescription drugs and drug products on the domestic market. As of 1981, the FDA had published final orders or monographs covering four categories of drug products: antacids, antiflatulents, daytime sedatives, and sweet spirits of niter. The FDA maintains that final Over-The-Counter (OTC) review orders are substantive, having the force and effect of law. Industry members, however, have contended that the documents should be considered as interpretative. Self-medication is the American consumer's first line of defense in health care. Self-treatment with nonprescription OTC products fulfills a series of valuable and sometimes crucial functions for individuals, health care systems, and the national economy. One should keep in mind that advertising supports self-medication by informing consumers about the nature and benefits of nonprescription medicines and by making marketed products, their ingredients, and their indications for use highly recognizable.
