The infant formula industry, the Infant Formula Act of 1980, and quality control

Throughout the months following the discovery of the low-chloride problem in infant formula, the industry undertook independent and voluntary measures to ensure the compositional quality of formulas. Members of the Infant Formula Council reviewed industry procedures, practices, and policies, and submitted a detailed description of its quality control and clinical testing procedures to the Food and Drug Administration. New product concepts and product reformulation proposals are based on medical and nutritional findings, on changes in medical concepts for nutritional support, on availability of improved nutrient sources, or on improved ingredients or processing technologies. Quality control is maintained throughout the manufacturing process through inspection of raw materials, analysis of major and minor constituents, equipment and process controls, and continuous product monitoring. However, despite cooperation of the infant formula industry with FDA and Congress during the development of the infant formula bills, the proposed document was too rigid and did not take into account that manufacturing methods of a given manufacturer often vary for the same product, for different products, and on different production equipment. The statistical criteria established uneven and inconsistent requirements for various manufacturers. Congress did not forsee that the proposed regulatory procedures would significantly affect industry.