“Helps develop a baby’s immune system. . . . ” “Comforting probiotics to reduce excessive crying. . . . ” “With soy for fussiness. . . ”
When new parents see this kind of marketing for infant formula, they’re likely to believe such claims are based on rigorous scientific support, or maybe even actual testing by the Food and Drug Administration (FDA). Accordingly, parents may understandably assume from such claims that one brand of formula is superior to another, or even that a particular formula is the equivalent of breastfeeding.
But none of those assumptions are necessarily true.
While the FDA does have oversight over the basic nutritional content of infant formulas, there’s no FDA pre-approval process when manufacturers make so-called “structure/function” claims for their products. (Structure/function claims describe a product’s alleged effects on the structure or function of the body, but without mentioning any specific disease. To use a common dietary supplement as an example, “Cranberry cures urinary tract infections” is a health claim requiring FDA approval, while “Cranberry supports urinary tract health” is a structure/function claim which does not.)
Structure/function claims must be “truthful and not misleading,” but the adequacy of the scientific support is left to manufacturers’ discretion. And as the infant formula market grows more competitive, the industry is creating more “specially formulated” variants to capture market share – and making new structure/function claims to go along with them.
According to a new UConn Rudd Center for Food Policy and Obesity report on “Nutrition and Marketing of Baby and Toddler Food and Drinks,” infant formulas now come in “multiple varieties designed for specialized infant feeding needs, including for newborns, supplementing breastmilk, reducing fussiness, gas, or spit-up, as well as soy-based formula.” Even so, a recent Clinical Pediatrics review of such structure/function claims (paywall protected) found “insufficient evidence” to support many of them.
The primary existing check on misleading formula claims are advertising challenges brought by competitors before the National Advertising Division (NAD), a self-regulatory body established by the Better Business Bureau. But as Cara Wilking, a consulting attorney to the Berkeley Media Studies Group, notes in her own recent report, the NAD is ill-equipped to adjudicate these cases because it’s not a scientific body. Indeed, its own standards for infant formula claims (in the area of direct comparisons to breast milk) have actually weakened over the years. Yet Wilking notes that the Federal Trade Commission, which should serve as another, more powerful watchdog, remains “highly deferential to self-regulation,” including decisions by the NAD.
Now, though, the FDA is stepping in to try to clean up the formula industry’s act.
Several weeks ago, the agency issued draft guidance on structure/function claims for infant formula, suggesting that in order to be substantiated, such claims require “competent and reliable evidence,” preferably from randomized, double blind studies – a rigorous scientific standard. While the guidance, if finalized, would remain voluntary, Wilking believes the FDA’s action “signals to industry that [it] plans to take a more active role in policing infant formula marketing.”
Marion Nestle, writing on her blog Food Politics, applauds the FDA’s move, telling readers it “deserves enthusiastic support.” If you’d like to lend that support or offer any other input, you can leave a comment on the FDA’s draft guidance by clicking here and selecting the first blue “Comment Now” button on the right.
You need to do so by Tuesday, November 8th, unless the formula industry has its way: last month, the Infant Formula Nutrition Council of America, the formula industry’s lobbying group, asked the FDA to extend the comment period on the draft guidance for an additional three months, perhaps hoping that after the presidential election the draft guidance will be further delayed or even dropped.
I’ll keep you posted on the status of the guidance, but in the meantime, do check out the entire UConn Rudd Center baby and toddler report, which goes well beyond a discussion of infant formula. For example, here’s one eye-opening infographic from the report discussing the nutritional value of baby and toddler snacks:
An executive summary of the Rudd BabyFoodFACT findings is here.
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