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Abstract

The Infant Formula Act of 19802 (hereinafter the Act) was a culmination of the efforts of mothers, physicians, reporters, administrators, businessmen and congressmen to provide regulations and guidelines to prevent similar tragic episodes in the future. This comment will focus on the Act, as well as the events leading up to its promulgation. The examination will begin with the remarkable discovery in infants of the rare affliction known as metabolic alkalosis and the subsequent research which has established a direct correlation between the defective formulas and the infants' conditions. Despite an expedient voluntary recall of the formulas, controversy raged in the media and in the Congress concerning the effectiveness of that recall, criminal sanctions for alleged liable parties, and the enforcement policy of the Food and Drug Administration (hereinafter FDA). Resolution of these issues, however, will not foretell the future development of the affected children. Only time and long-range studies will provide reliable answers to the questions of worried parents.

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