Gelardi R C
J Assoc Off Anal Chem. 1982 Nov;65(6):1509-13.
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.
在婴儿配方奶粉中发现低氯问题后的几个月里，该行业采取了独立的自愿措施，以确保配方奶粉的成分质量。婴儿配方奶粉委员会的成员审查了行业程序、做法和政策，并向食品药品监督管理局提交了其质量控制和临床测试程序的详细说明。新产品概念和产品重新配方建议基于医学和营养研究结果、营养支持医学概念的变化、改良营养素来源的可用性、改良成分或加工技术。通过对原材料的检验、主要和次要成分的分析、设备和工艺控制以及持续的产品监测，在整个制造过程中保持质量控制。然而，尽管婴儿配方奶粉行业在婴儿配方奶粉法案制定过程中与美国食品药品监督管理局和美国国会进行了合作，但拟议文件过于严格，没有考虑到特定制造商的制造方法通常会因同一产品、不同产品以及不同生产设备而有所不同。所制定的统计标准对各制造商提出了不均衡且不一致的要求。国会没有预见到拟议的监管程序会对该行业产生重大影响。
