Formula Series 3 – Formula Regulation

FDA Regulation, Pediatrician Education, and Industry

bottles - yellow

There is much confusion regarding how infant formula is regulated on the federal level.  I often encounter the general opinion of “how different could all these formulas really be?  All formula is regulated, right?”  Well yes… technically.  All infant formula is regulated, but likely not nearly to the extent that you think it is.

Because infant formula is a food, it falls under the regulations of the Federal Food and Drug and Cosmetics act (FFDCA).  Additional requirements for infant formula are stated in section 412 of the FFDCA and in 21 CFR 106 and 107.  These regulations demand that all formulas marketed in the United States must meet certain requirements.  These requirements set minimum concentrations of 29 essential nutrients that must be in formula.  For a company to have a new formula approved, they must meet these requirements, and then show that infants fed their formula grow normally.  I’ll add here that “normal” growth is considered as anything above failure-to-thrive.  Infants who gain too much weight are still considered “normal” in this scenario.  When a company adds something to a formula that is not on the list of 29 required nutrients (like when they started adding the fatty acid “DHA”), they again must establish that infants grow “normally” on this formula.  These regulations are really very minimal compared to what most people assume, and they leave much room for significant variation in ingredients between infant formula brands.  While minimal, these requirements do guarantee infants will not fail-to-thrive and will not need supplemental nutrition.  They represent great strides in research and a great improvement on the home-made formula days.  However, these requirements leave plenty of room for some formulas to be better than others.

This is the perfect moment to introduce you to my motto:  You must read the list of ingredients!  Because 29 of the nutrients in formula are regulated, this means nutrition label, which lists calories, fat, and amounts of vitamins and minerals, is going to look almost the same between different formulas.  You will only be able to find the differences by looking at the list of ingredients.  Where is the protein coming from? What additional fillers are added? Are non-required but beneficial nutrients added?  I’ll explain how to answer each of these questions in the upcoming articles.  When you are in the store with a potential formula can in-hand, you can’t answer any of these questions by looking just at the nutrition label alone.  You must read the list of ingredients! 

But your pediatrician should know all of this, right?  Wrong.  Pediatricians are incredible doctors who are experts in child health, but receive little to no training in Nutrition.  The average doctor receives only a few hours of nutrition education during the course of med school.  Pediatricians and Neonatologists will receive extensive training on the nutritional needs of infants with certain diseases but minimal to no training about the nutrient needs of the average healthy baby beyond “breast is best”.  Historically, the formula industry was only allowed to market formulas to pediatricians and thus doctors received some education about formula ingredients this way.  However, when the companies began marketing directly to the public, this avenue of education shrank.  The good news is, the information about formula ingredients is now available to parents.  The bad news is, this information is often un-interpretable to the average Mom or Dad.  Most parents I work with have no idea that different formulas are really different from each other.  When they call their pediatrician for a recommendation, they often get recommended whichever brand the doctor happens to have samples of.  Well I am determined to end that!  I am here to be your translator so you can read that jibberish on the back of the formula can and decide intelligently which formulation is going to be the best for your baby.


Take-Home Messages

  • The amount of 29 essential nutrients are regulated in infant formula.  The amount and source of all other nutrients and non-nutrient ingredients can vary quite a lot between brands.
  • You may not be able to distinguish differences between brands by looking at the nutrition label alone, since this label mostly lists the amounts of the 29 required nutrients.  To make an informed decision, You must read the list of ingredients! 
  • Your pediatrician likely does not have this information.  This is no fault of his/hers!  There is a severe lack of nutrition education in medical school and practice.




One thought on “Formula Series 3 – Formula Regulation

  1. This is an excellent contribution on a hugely important issue, not only in the U.S. but worldwide.

    I have illustrated some of the difficulties in a recent article, “Regulating fatty acids in infant formula: critical assessment of U.S. policies and practices.” International Breastfeeding Journal, 2014,9:2 doi:10.1186/1746-4358-9-2.

    Also, readers might be interested in my 2011 book, Regulating Infant Formula, from Hale Publishing in Amarillo, Texas.

    Aloha, George Kent

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