FDA Launches Probe into Infant Formula Makers’ Health Claims

The Food and Drug Administration is launching a probe into the claims made by manufacturers of formula and specifically formula containing omega-3 fatty acids or Docosahexaenoic acid (DHA). As Kimberly Seals Allers writes in Women’s E News, infant formula companies have marketed such products as “just as good” as breast milk for years, to the point that one mother told a lactation consultant that she wanted to use “the formula with breast milk in it.”

There is absolutely no such thing. But infant formula companies have been claiming that products containing omega-3 fatty acids or DHA are “better than breast milk,” says The Atlantic. Noting that the composition of all infant formulas is highly regulated because, for those infants given formula, it is their sole food, Marion Nestle professor of Nutrition, Food Studies, and Public Health at New York University, emphasizes that all infant formulas have the same composition, and all are virtually indistinguishable.

Nestle quotes the following three paragraphs from a chapter of her book What to Eat in which infant formula is discussed: 

Competition for market share explains why formula companies want to put distinctive nutrients in their formulas-especially nutrients considered “conditional.” A conditional nutrient is one that might have some benefits under some circumstances. Even if the health benefits are minimal or questionable, they can be used in advertising. 

That is the principal reason why so many formulas now have fatty acids added–omega 6 arachidonic acid (ARA) and omega-3 docosahexaenoic acid–the same one that is in fish oil. These two fatty acids are normally present in breast milk, and there is some evidence, weak and questionable as it may be, that they support infant brain development and vision. 

Formula makers got the FDA to agree that ARA and DHA are normal components of food (which they are) and, therefore, are Generally Recognized As Safe (GRAS). This means that companies could add ARA and DHA to infant formulas without having to prove that either of them really did anything useful or beneficial. 

Currently, there are no clinical studies published that support the claims that omega-3 fatty acids in infant formula have ‘any long-term beneficial effects.’

Adding omega-3 fatty acids does have the effect of manufacturers raising the price on their formula. Whereas, if you breastfeed, the cost is (ok, there is the price of the breast pump and those plastic bags to store your milk in), basically…free.

As Allers — who, like Nestle, myself, and countless other women, offers three cheers to the FDA for the probe of infant formula companies’ claims — writes:

I can certainly understand the business dilemma of the formula makers: There is no money to be made from breastfeeding. Plain and simple. 

When your No. 1 competition is free, and you can’t compete on price, you have to be creative. Really creative. And even misleading.


Photo by Roebot.


April Thompson
April Thompson6 years ago

Breast milk is aiways best!

Paula L.
Paula L6 years ago

I am well past child bearing age, but I want to say to start, hooray for the women who can and will breast feed their babies. But for those who have problems producing milk, formulas are necessary if breast milk is not available for them to obtain. And they depend on the labels on those formula products. Companies should never be allowed to boast something about formulas that replace breast feeding of babies that is not the truth. Any formulas containing genetically grown products, positively needs to be listed on the label.

I was not able to breast my children when they were born. My glands just did not produce properly. I am thankful that at that time only a couple of formulas were actually available, and the eras of big money, dog eat dog to control the market in anyway you can had not got off the ground yet, so additives were not so much of a worry. My heart felt feelings goes out to the moms who have to choose formulas for their infants in todays world of commerce.

Bon L.
Bon L6 years ago

Thanks for the info.

Pamela H.
Pamela H6 years ago

The simple solution is to breast feed. Back to nature. That way we don't need to rely on greedy commerce and dodgy products.

Gretchen V.
Past Member 6 years ago

Would like to clarify somethings.......I'm a nutrition research consultant with no stake in infant formula. I do want to see healthy moms and infants.
--ARA is not found in fish oil - it is an omega-6
--Isolate DHA from algae can not be labeled Organic
--According to independent research, DHA should be a conditional nutrient in fetal development. We do NOT want infants born with too little or get too little the first 2 years of life (as we have witnessed in humans and observed clinically in monkeys). DHA is selectively required for normal brain and eye development. The infant is entirely dependent on mom or formula, and mom is entirely dependent on her diet.
Infant formula is NOT breast milk by a long shot, no should it be marketed that way. I fully support breastfeeding - and see a real need for education of breastfeeding moms.
GMO soy can be labeled "natural" - that concerns me.

Sue Matheson
Sue Matheson6 years ago

thanks for this post.

Kalpana Dangi
Kalpana Dangi6 years ago

Thanks to Care2 for bringing us information on health and the environment. Every piece of information really helps in bringing change. It is very upsetting to hear that our govt. is only interested in making money.

Catherine F.

FDA investigating infant formula health claims? What a joke! FDA should be removing all genetically modified organisms from infant formula, particularly soy formula that is made with GMO soy, since over 92% of all USA grown soy is Monsanto GMO seeds.
The Committee for Independent Research and Information on Genetic Engineering found toxicity from glyphosate herbicides in Roundup formulations in soy [soy plants are GMOd to withstand glyphosate, Roundup] from 10(5) times dilutions on umbilical, embryonic, and placental cells because of mitochondrial succinate dehydrogenase activity that caused cell death in their research that they published Jan2009. FDA really needs to get its act together to protect human health not corporate profits, in my humble opinion. Demand more from Congress's oversight of the FDA; you/we deserve better than we are getting, in my opinion.

Ernie Miller
william Miller6 years ago

Wow hot topic. I do believe that babies should be breast fed. That people wake up and realize it is natural and thet breast are not something dirty only to be used in the sex trade. Its natural people should see it Children should see it and every one should apload when a mother has the courage to feed her child naturally the way mother nature intended.

Annie Urban
Annie Urban6 years ago

Let's hope they have more luck than the Canadians. Without regulations and specific penalties in place, the formula companies just keep claiming whatever they want to claim despite a 3 year crackdown.