Posted On: June 27, 2014 by Patrick A. Malone

New Rules Should Protect Quality of Baby Formula

Earlier this month, the FDA finalized new guidelines for manufacturers of infant formula in order to better protect babies from contaminated products. The move is a response to several prominent nationwide recalls of different formula products in the last several years.

As reported by MSN.com, in 2010, 5 million containers of Similac were recalled by Abbott Laboratories because they might have been contaminated by insect parts. In 2011, powdered versions of Enfamil, made by Mead Johnson Nutrition, were yanked from store shelves over concerns of contamination, which later proved unfounded.

Still, the red flag was raised, and now companies that make baby formula will be required to test for the presence of two kinds of bacteria, salmonella and cronobacter, that pose serious health risks to wee ones. They’ll also have to monitor their products for a longer period.

Salmonella can cause diarrhea and fever, sometimes to a life-threatening degree; cronobacter, which prefers dry environments such as powdered formula, can cause swelling of the brain — meningitis — in infants.

Most public health officials and medical professionals say breast milk is best for babies, but for various reasons of both necessity and convenience, many mothers don’t breast feed. So, many infants get all or part of their nutrition from formula.

Baby formula is not subject to FDA approval prior to sale. But all formula sold in the U.S. must meet federal nutrient requirements, and they do not change with the new regs. Infant formula manufacturers are required to register with FDA, and notify the agency before they market a new formula.

The FDA conducts yearly inspections of all facilities that manufacture infant formula. It collects and analyzes product samples, and inspects new facilities. If the feds determine that a formula presents a risk to human health, its manufacturer must conduct a recall.

The new requirements, according to the FDA, are meant to establish the "good manufacturing practices" that many companies voluntarily follow. These regulations establish federally enforceable standards for safety and quality.

They apply to formula sold "for use by healthy infants without unusual medical or dietary problems," said the FDA.

Under the new rules, companies must test their products' nutrient content and prove that the formulas can "support normal physical growth," the agency said. They must test the nutrient content in the final product stage, before entering the market and at the end of the products’ shelf life.

According to FDA, about 1 million U.S. infants are fed formula from birth; by the time they are three months old, about 2.7 million rely on formula for at least part of their nutrition.

Infant formula comes in three forms:


  • powder — the least expensive of the infant formulas, it must be mixed with water before feeding;

  • liquid concentrate — must be mixed with an equal amount of water;

  • ready-to-feed — the most expensive form of formula that requires no mixing.

The protein source varies among the different types of formula. The FDA’s nutrient specifications are set to meet the nutritional needs of average, healthy infants. Manufacturers use nutrient levels that usually exceed the FDA minimum. So babies fed infant formulas don’t need added nutrients unless they are fed a low-iron formula.

The formulas currently available in the U.S are either “iron-fortified” — with about 12 milligrams of iron per liter — or “low iron” — with about 2 milligrams of iron per liter. The American Academy of Pediatrics (AAP) recommends that formula-fed infants be fed iron-fortified formula to help reduce the prevalence of iron-deficiency anemia.

To learn more about safety and infant formula, such as proper storage, visit the FDA website. To learn more about childhood nutrition, see our blogs on the topic.

Families interested in learning more about our firm's legal services, including legal representation for children who have suffered serious injuries in Washington, D.C., Maryland and Virginia due to medical malpractice, defective products, birth-related trauma or other injuries, may ask questions or send us information about a particular case by phone or email. There is no charge for contacting us regarding your inquiry. An attorney will respond within 24 hours.

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