Earlier this month, the U.S. Food and Drug Administration published an interim rule that “will maintain high-quality standards and help ensure healthy growth of infants.” The rule, which implements the provisions of the 1986 amendments to the Infant Formula Act of 1980, becomes effective on July 10, 2014.
The rule touches on all areas of processing. Among other things, it requires manufacturers to develop and implement a written plan or set of procedures designed to prevent adulteration of infant formula. It also mandates comprehensive testing of the formula at its final product stage, before distribution. Representative samples must be tested for microbial contamination and for the presence of appropriate levels of all required nutrients. The rule also calls for regular audits of current good manufacturing practices and quality control procedures
. The FDA is accepting comments from the public until March 27, 2014. For more information on the rule, or to submit a comment, click here.
To read the FDA news release, click here.
