The U.S. Food and Drug Administration (FDA) released a rule last month that establishes new safety standards for infant formula, including mandatory tests for dangerous contaminants such as salmonella. The interim final rule sets current good manufacturing practices specific to infant formula and changes the quality control procedures for the products. The required testing of product samples for microbial contamination is included in the new manufacturing standards.
The rule is designed to ensure that manufacturers put all of the nutrients required by federal regulations — such as protein, fat and some vitamins and minerals — into their formula. Under the regulation, manufacturers are required to notify the FDA about new or changed formulas. Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, said in a statement:
The FDA sets high-quality standards for infant formulas because nutritional deficiencies during this critical time of development can have a significant impact on a child’s long-term health and well-being. This rule will help to prevent adulteration in infant formula and ensure infant formula supports normal physical growth.
The requirements stemming from the Infant Formula Act of 1980 had previously been the standard for formula manufacturers. According to the FDA, manufacturers are already following many of the current good manufacturing practices in the rule. The rule does not apply to formula made for infants with special dietary needs or unusual health problems. The agency released a draft guidance document on Thursday for manufacturers of those products. It issued a second draft guidance document advising manufacturers as to how they can show they have met the final interim rule’s quality factor requirements. The regulation becomes effective on July 10. The FDA is accepting comments on the rule for 45 days.
The FDA was forced to back the safety of the U.S. formula supply five years ago, after test results showed trace amounts of the chemical melamine in a sample of one popular formula made by Nestle SA, and the presence of cyanuric acid, a chemical related to melamine, in a second formula made by Mead Johnson & Co., a unit of Bristol-Myers Squibb Co. Separately from the FDA’s probe, Abbott Laboratories, another major formula maker, revealed that in-house tests had also detected trace levels of melamine. Earlier in 2008, the FDA had determined that it was safe to consume food and drink with melamine below 2.5 parts per million, with the exception of infant formula, but the agency later clarified that it would allow a trace amount of the chemical to be present in such products.
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