PhotoBreastfeeding is one of those things that everybody -- well, mothers anyway -- say they're going to do. But for various reasons it often doesn't happen, leaving about 25 percent of newborns to start out in life as consumers of formula.

By the time they're three months old, two-thirds of U.S. infants rely on formula for at least some of their daily bread, so to speak. The U.S. Food and Drug Administration, taking note of this, is publishing a new rule that's intended to make sure that formula is both safe and nutritious.

“Many families rely on infant formula as either the sole source of nutrition or an integral part of an infant’s diet through 12 months of age,” said Michael R. Taylor, the FDA’s deputy commissioner for Foods and Veterinary Medicine. “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.” 

Formula, of course, is supposed to be roughly similar to mother's milk but similar isn't the same as identical.


PhotoThe formula produced in the United States basically uses byproducts of milk -- whey and casein for protein, along with vegetable oils for fat, lactose as a carbohydrate and assorted vitamins and minerals. Exact formulas vary from one manufacturer to another. Some use soy in place of milk. 

Like all packaged foods, there are safety issues to worry about -- spoilage, contamination, etc. And since most families buy powdered rather than liquid formula, safe preparation also becomes an issue.

Improper preparation and the use of contaminated water can cause serious health problems, including death. Consumer groups routinely demonize formula manufacturers for promoting their products in underdeveloped nations where sanitation standards make it hard to ensure the safe preparation of formula. 

Severe health consequences are rare in the U.S. but there are many critics who argue that not enough is done to encourage mothers to breast feed.

In 2008, some formula was found to contain melamine a chemical approved for use in production of some plastics in the U.S., but not approved for use in food. It had earlier shown up in food products imported from China, causing numerous pet injuries and deaths in 2007, and prompting recalls of some milk products. A number of Chinese babies were killed or injured after drinking infant formula containing melamine.

The FDA later said the amounts of melamine found in formula were safe.

"Interim final rule"

Today's FDA document is called an "interim final rule." Yes, it sounds contradictory but that's how they talk in Washington.

The agency says the rule amends its quality control procedures, notification, and record and reporting requirements for manufacturers of applicable infant formula products. The rule, in part, will ensure that infant formula contains all federally required nutrients. It also establishes current good manufacturing practices specifically designed for infant formula, including required testing for microbial contamination.

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