Will This Formula Make My Baby Cry Less?

In All, Food Products, Nutrition by Keri Szejda

What type and quantity of research should back statements placed on the product labels of infant formula?

Today the Federal Drug Administration (FDA) has made the case for scientific rigor, publishing draft guidelines for infant formula manufacturers and distributers regarding the research that should substantiate certain product label claims. The document is titled Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling.

Though breastfeeding rates continue to rise in the U.S, only about half of infants are still breastfeeding at 6 months, and only about a third are still breastfeeding at 12 months. This means that a lot of infants depend on formula to meet their nutritional needs.

The time period during which infants consume breastmilk or formula (the first 12 months or longer) is also a critical time for long-term growth and development. From this perspective, infant formula is arguably the most impactful food product on the market.

Also during this time period, babies tend to fuss and cry a lot – leaving their parents just a tad sleep-deprived! When choosing which formula to purchase, many tired and desperate parents may be especially susceptible to product label claims that imply a modified formula will help their baby sleep more or cry less.

In May 2016, researchers from the Albert Einstein Medical College published an article in the journal, Clinical Pediatrics. The authors assessed formula product claims and found that approximately half of the products made claims related to gastrointestinal distress. Examples of these claims included “for fussiness and gas,” “easy to digest for excessive crying, colic, and fussiness,” and “easy to digest gentle protein”. The authors also evaluated the available research on these formula modifications, including casein and whey protein hydrolysate, reduced lactose, and added pre- and probiotics. Their conclusion?

“Our review of the evidence for these claims demonstrates a distinct paucity of evidence for the claims as written.”

Under current FDA rule, these types of statements are classified as “structure/function” claims. A structure/function claim describes the effect a component has on the normal structure or function of the human body – without referencing disease. For example, in the case of infant formula, a product might make a claim that added probiotics “support digestive health”.

Because these types of claims do not mention a specific disease, they do not currently require disclaimers about the scientific evidence backing them. Rather, they must only be “truthful and not misleading.”

Recognizing the vulnerable development period of infancy and the critical dietary role that formula plays for many infants in the U.S., the FDA guidelines outline expectations for scientific rigor of the research backing infant formula structure/function claims. In the document, the FDA concluded that infant formula manufactures and distributors should “consider the meaning of the claims of the labeling as a whole”. Further, in order to obtain the best evidence for a cause-and-effect relationship, the document also strongly recommends relying on the “results of infant feeding intervention studies that are randomized, double-blind, and parallel-controlled.”

Parents should be able to trust that a claim made on a label is something that is backed up by solid research. In this case, the guidelines make recommendations about what should constitute solid research, including the type and quality of research. The public comment period will be open for 60 days, after which the FDA will finalize these non-binding recommendations.