FDA new rules on infant formula focus on safety and nutrition

The Food and Drug Administration (FDA) has just released an updated set of safety requirements for manufacturers of infant formula, which includes testing for pathogens like Salmonella and Cronobacter prior to distribution.

This new set of safety requirements were published in an interim final rule which "amends the FDA's quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products."

The interim final rule is accompanied by two draft guidance documents for industry. One of the draft guidance document covers the requirements governing the manufacture of infant formula that are specially made for infants with special dietary problems and medical problems, which are not covered by the interim final rule.

The other draft guidance document covers the guidelines for demonstration of quality of those manufacturers of currently and previously marketed infant formulas.

The new set of rules requires that infant formula contain all nutrients required by the federal government, such as certain proteins, carbohydrates, fats, vitamins, and minerals. These nutrients must also be of good quality, for the purpose of supporting the normal physical growth of infants and keeping them healthy.

The interim final rule applies only to infant formulas that are part of the recommended diet of infants who have no special dietary problems or special medical needs.

"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," said Michael Taylor, the FDA's deputy commissioner for foods.

In 1980, the Congress passed the Infant Formula Act that require manufacturers of infant formula to include certain specific nutrients in their products. This was after it found out that a manufacturer of infant formula reformulated its product and omitted salt. After just a year, infants who were given the formula contracted chloride deficiency.

In 2002, Cronobacter was found in an unopened powdered formula. Some infants have been diagnosed with Cronobacter, which is found in hospitals and homes, and which multiplies when the formula has been left out in between feedings.

In 2011 four infants were diagnosed with Cronobacter in four different states, and two of the infants died. This prompted the FDA and the Centers for Disease Control and Prevention (CDC) to test infant formula. They found no Cronobacter in the formula that they tested, and they were unable to provide enough evidence to link the four cases together. However, this new set of rules now includes testing for Cronobacter as a requirement.

The agency has reiterated that breastfeeding is still best for newborns. However, about 25 percent of infants born are given formula straight away. By the time they are three months, two-thirds of all infants rely on formula to a great degree for their nutrition.

The FDA is accepting comments from the public on the interim final rule for the next 45 days. A website has been set up to facilitate this.

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