by Amy Spangler
June 29, 2010

The decline in farm fresh foods has given rise to a government database known as EAFUS—Everything Added to Food in the United States. Maintained by the U.S. Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN), EAFUS contains more than 3,000 chemicals and ingredients used in food production, everything from acacia to zoalene.

Some are directly regulated by the FDA, but many are Generally Recognized As Safe—a classification known as GRAS. Under the Federal Food, Drug, and Cosmetic Act, any substance that is intentionally added to food is considered a food additive. As such, additives are subject to pre-market review and approval by the FDA, unless the substance is generally recognized by qualified experts as safe.

Zoe Neuberger of the Center on Budget and Policy Priorities recently examined a number of “functional ingredients”—food additives that manufacturers claim are not only safe but beneficial—and found some disturbing results: few were worth the added cost and most had not been adequately studied or had been studied only by the manufacturer.

Neuberger investigated the newly revised food packages given to participants in the Supplemental Food Program for Women, Infants, and Children (WIC), a program administered by the United States Department of Agriculture (USDA).

“WIC food packages should be based on science,” says Neuberger. And so too should the “functional ingredients” added to many of the foods WIC offers—including infant formula, baby food, infant cereal, eggs, and juice, adds Neuberger.

Although the Food and Drug Administration (FDA) is responsible for ensuring that ingredients in foods are safe or generally recognized as safe, neither the FDA nor the USDA assess whether the ingredients actually deliver the benefits cited by the manufacturers—claims based on studies typically conducted by the companies themselves, making the results somewhat suspect.

The United States Breastfeeding Committee (long concerned over the negative effect on breastfeeding of false claims by infant formula manufacturers) has joined with the Center on Budget and Policy Priorities in asking that language be added to the Child Nutrition Reauthorization legislation giving the USDA the authority to require scientific analysis of functional ingredients by the Institutes of Medicine (IOM) before allowing these ingredients to be added to WIC foods.

Neuberger cites the addition of DHA/ARA to infant formulas in 2002 as an example of why such language is needed. According to the Center on Budget and Policy Priorities, WIC spent $850 million on infant formula in 2009—more than 10 percent ($91 million) was spent on more costly formulas (those containing DHA/ARA) despite inconclusive evidence as to the effectiveness of added DHA/ARA. The Cochrane Collaboration conducted a systematic review of the scientific literature in 2007. It concluded that while added DHA/ARA may offer some benefit for pre-term infants, there is no scientific consensus that these additives offer any benefits for healthy, full-term babies. A similar conclusion was reached by the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO). However, the FAO and WHO chose to recommend that all infants receive amounts of DHA and ARA equivalent to that found in human milk.

Why is it so important that the USDA be given the authority to secure scientific analysis of food additives? There is growing pressure to contain government costs. Informed decision-making requires a thorough cost-benefit analysis. In the absence of clear scientific evidence, a rigorous review process would at least ensure that the increased benefits justify the increased costs.

It should come as no surprise that manufacturers of infant formula and other foods are opposing such a provision, given prior efforts to block revisions of the WIC food packages. The IOM (a non-profit, non-governmental organization) was instrumental in overcoming the opposition. Functional ingredients were new to the market at that time, so the IOM was not asked to review ingredients such as DHA and ARA. As a result, state WIC agencies have been tasked with deciding whether to include foods with functional ingredients in their food packages, a job they are ill-equipped to do.

Neuberger stated, “According to the National WIC Association, formula manufacturers heavily lobbied state WIC programs and elected officials—which lacked comprehensive evidence to use to assess the manufacturers’ claims—and eventually limited the availability of formula without DHA and ARA.” The states had no choice but to offer formulas with DHA and ARA which even at wholesale prices range from 7 to 30 percent more than the cost of standard formulas—an increase that the federal government (taxpayers) assumes.

On the heels of DHA and ARA are pre- and probiotics, lycopene, and lutein—a seemingly endless array of functional ingredients all at higher cost. One can only hope that by allowing the IOM to review the science behind specific ingredients, an unbiased decision can be made as to what is and is not appropriate. Perhaps one day such an analysis will be required for all foods, not just those given to WIC participants.