The rule amends the FDA’s quality control procedures, notification, and record and reporting requirements for manufacturers of formula use by infants without medical or dietary problems.
Detecting contamination is a significant part of the interim rule. By establishing good manufacturing practices, including required testing for microbial contamination, manufacturers can prevent the distribution of contaminated products.
Many companies manufacturing infant formula in the United States already voluntarily conduct the good manufacturing practices set forth by the rule.
The FDA also issued two draft guidance documents addressing formula manufactured for infants with unusual medical or dietary problems and how manufactures can demonstrate that their products meet the quality factor requirements of the interim rule.
Last year, the FDA banned manufacturers from using BPA in infant formula packaging, although most had already quite the practice.
The FDA is accepting comments from the public on the interim final rule for 45 days at http://www.regulations.gov (Docket Number FDA-1995-N-0036).
Updated FDA requirements for infant formula will maintain high-quality standards and help ensure healthy growth of infants [Food and Drug Administration]