Menu Close

The Safety and Efficacy of Infant Formula? Three Questions. No Clear Answers.

Myth: The FDA puts infant formulas through rigorous testing to ensure safety and efficacy before it is released for use by infants.

Fact:  The FDA sets standards for infant formula manufacturers to follow.

It would be natural to assume that the U.S. Food and Drug Administration (FDA) takes every possible step to ensure the safety and efficacy of the many infant formulas available. We might also assume they take the step of testing the products before they are released and monitoring them thereafter. After all, the FDA notes that it is responsible for “protecting the public health by ensuring the safety, efficacy, and security of … our nation’s food supply,” which certainly includes artificial infant formulas.

It’s more accurate to say that the agency “regulates” artificial infant formula by setting standards for manufacturers, and that it sets minimum and maximum nutrient levels “as resources permit.” The FDA also allows some other ingredients to be added at the manufacturer’s discretion (e.g., fatty acids DHA and ARA). Whether such ingredients are safe or efficacious – or even consistently present – is entirely debatable.

To be clear, the FDA does not test and pre-approve formulas before they are marketed. The agency does not require manufacturers to provide any product samples or conduct any studies on their formulas before marketing their products, only to notify the FDA that they are making an infant formula.

All of this leaves me with three major questions about the safety and efficacy of infant formula.

Who ensures the formula is “safe”?

The most recent infant formula regulations available on the FDA’s website note what happens once an infant formula is released for general consumption. The manufacturer must notify the FDA of their products and “maintain and analyze records of consumer complaints … [and] report to the FDA cases where the evidence suggests a reasonable possibility of a link between consumption of the formula and an infant illness, death, or a reduction in intake of required nutrients.”

So, infant formula is passively regulated, relying on the manufacturer to test its own products, as well as to collect and evaluate consumer complaints for the “reasonable possibility” of frightening outcomes – including malnutrition, serious illness, and even death.

In December 2016, the FDA released its records of Adverse Events from 2004 through August 2016 to the public, with quarterly updates anticipated. However, evaluating these records is a process that is awkward, at best.

The “Adverse Events” file is large, since it includes so many years’ worth of reports, as well as reports for the many types of products the FDA regulates. But looking at just the available 2016 reports (from January through August), the “Baby Foods” category has nearly 30 reports of adverse events reported for babies fed infant formula.

After wading through to find the relevant data, how can one interpret its meaning?  Information on adverse events is presented as it was received by the FDA; this isn’t a clear statement of cause-and-effect.

Everyone agrees that safety is an essential need. One might argue that with only 30 reported adverse events for the many, many bottles of formula that must have been consumed by babies in the U.S. during that timeframe points to relative safety. (Note that the reality may be more than 30 adverse events; many parents or providers may not take the step of reporting.) But would you deem formula safe if YOUR baby had consumed one or more of those 30 bottles?

It seems we can’t be sure formula is safe.

What about efficacy?

Safety and efficacy are two words often used in the same sentence. But are they?

In his book “Regulating Infant Formula,” George Kent, PhD notes that the purpose of infant formula isn’t just to be safe; it is actually to support infant growth and development. It is marketed as a suitable sole source of nutrition for an infant, from birth through six months of age.

But even if it is safe and supports infant growth, I am left wondering: is our greatest hope for the next generation?  Shouldn’t we aim to provide our babies with optimal health? There’s only one source of nutrition that does that: a mother’s own milk!

The FDA holds that the pharmaceuticals it regulates must show “benefit.” Yet the infant formulas it regulates don’t have to meet this standard. Not that they could ever show more benefit than mother’s milk. As George Kent points out, “even under the safest conditions, we find that health outcomes for infants who feed with formula are worse than the health outcomes of infants who are breastfed.” One product’s claimed “benefits” might exceed those of another infant formula, but not human milk.

What does the FDA’s infant formula ingredients list mean?

The FDA insists that infant formula is safe because it must contain certain nutrients, in certain quantities. But how the infant formula manufacturer accomplishes that is up to them. They may use ingredients that are generally recognized as safe (accepted as causing no harm) but for which they are not required to show a benefit.

The FDA has set some quality control standards for manufacturing out of concern for microbiological contamination. They have set nutrient guidelines, directed manufacturers to conduct growth-monitoring studies to measure physical growth of healthy infants on their formulas. And, they have set forth “good manufacturing standards.” But the FDA does not test the infant formulas on the market for benefit. Manufacturers are left to do that, if they wish.

In spite of the FDA’s statement that infant formula is “wholly satisfying,” George Kent reminds us that infant nutrition is a bit more complicated than a list of ingredients.  “The idea that infant food is nothing more than a collection of ingredients that you can put into a blender is bizarre.”

Even if we feel we can be “reasonably certain” that the ingredients are not harmful, we don’t have any reason to believe they are beneficial.

Infant formula is rife with uncertainty

We know that the FDA has set standards for a list of ingredients in specific amounts that should be in formula. We can be certain that the FDA requires quality control standards. But we can also be certain that the FDA isn’t testing formula regularly. That’s in the hands of the manufacturers.

We may think that formula contains the list of ingredients and doesn’t have any harmful contaminants. But since we are entirely dependent on the formula companies’ own reports for information about ingredients and their effects, that’s just an assumption. (We’ve been wrong about that before.)

Can we be certain that the FDA’s criteria for safety is accurate? The Institute of Medicine points out that the principles for “safety considerations” that regulate adult food might not be appropriate for children. The Cornucopia Institute, which has for years raised concerns about possible gastrointestinal side effects of the additives DHA and ARA, would argue that’s not good enough.

Finally, can we be certain that formula will provide optimal health outcomes?  Kent points out that studies of babies who are breastfed don’t stop at measuring growth; rather, they look at overall infant health. Shouldn’t formula studies look at those outcomes, too?

Where it comes to the safety and efficacy of infant formula, I have more questions than answers. What about you? Tell me in the comments below!

Share this


  1. Marie

    I’m so glad! I, too, often need little nudges, and honestly, it’s folks like you give a reply to these blogs that give me nudges to write more! Thanks, Florencio!

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.