The Food and Drug Administration (FDA) has set new standards for manufacturers of infant formula in an ongoing effort to ensure the products are safe and support healthy growth in the babies who consume them.
The new standards come from an interim rule that was published last February, and take into consideration comments received after that time. The finalized rule includes modifications and clarifications, and sets a Sept. 8, 2014, date for manufacturer compliance.
Under the new rule, manufacturers of infant formula are required to test their products for harmful pathogens, and disease-causing bacteria such as Salmonella and Cronobacter. Manufacturers are also required to demonstrate that the formulas they produce support normal physical growth. Infant formulas will also be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.
The final rule only applies to infant formulas intended for use by healthy infants without unusual medical or dietary problems.
The FDA points out that many companies who market infant formulas in the United States provide safe products, and have voluntarily followed many of the current good manufacturing practices and quality control procedures outlined in the final rule. The new standards make the requirements enforceable by the federal government.
The FDA does not approve infant formulas before they are marketed, however manufacturers must meet federal nutrient guidelines. This does not change under the new rule. The agency inspects all facilities that manufacture infant formula on an annual basis and collects and analyzes product samples. If a product is found to present a risk to human health, the manufacturer would be required to conduct a recall.