What does Hypoallergenic Mean?

Most consumers today believe that a product labeled as hypoallergenic will not cause an allergic reaction, but is this really true?

Let’s start with the basics. The technical definition of “hypoallergenic” is that a product is less likely to cause an allergic reaction, or will cause fewer allergic reactions. There are few federal standards that regulate the use of this term for consumer goods. For many products, like cosmetics, the term “hypoallergenic” may be used without ANY evidence or support. Some companies will conduct certain tests for a product to support that it’s hypoallergenic, but they aren’t required.

For infant formulas, however, you can rest assured that the term “hypoallergenic” can ONLY be used when certain criteria are met.

What is a Hypoallergenic Infant Formula?

When it comes to infant formulas, based on calls our nutrition specialists receive on a regular basis, many people think the term hypoallergenic means the formula is totally void of any and all things that could trigger an allergic reaction. The reality is a bit more complex.

For an infant formula to be labeled “hypoallergenic” it needs to be studied in a clinical trial. The method is based on recommendations by the American Academy of Pediatrics (AAP). According to the AAP, a hypoallergenic infant formula must:

  • Be studied in a clinical trial
  • Be studied in children with confirmed cow milk allergy
  • Have been shown to be tolerated by at least 90% of the patients

“Tolerated” means that the formula did not cause an allergic reaction. That means a participant in the trial did not have defined symptoms, such as hives, anaphylaxis, or other symptoms of a food allergy.  Only infant formulas made with free amino acids – like Neocate – or extensively hydrolyzed protein, also called peptides, have met the necessary criteria in these studies and can be labeled as hypoallergenic. 

Other types of infant formulas in the US are NOT hypoallergenic. These include formulas made with whole dairy protein, formulas made with soy protein, and formulas made with partially hydrolyzed protein. (Hydrolyzed protein comes from dairy protein, but partially hydrolyzed protein is not broken down as much as extensively hydrolyzed protein.)

Difference Between a Hydrolyzed Formula and Amino Acid-Based Formula

Hydrolyzed formulas are made using protein from dairy (or soy), but the milk proteins in those formulas have been broken down into small fragments. The body’s immune system may not detect the smaller protein fragments as being an allergen. In some patients with a cow milk allergy, however, the body still reacts to the protein fragments in extensively hydrolyzed formula, resulting in allergic reactions.

Amino acid-based formulas, which used to be referred to as elemental formulas, use only amino acids as the source of protein. Amino acids are the building blocks of protein, and are too small for the body to recognize as being foreign. They are a non-allergenic option that can be used in place of protein and peptides.

To help you visualize the difference between these two types of formulas, picture a pearl necklace. In this example our necklace represents the strand of amino acids that make a protein.  Take the necklace and break it into smaller length strands with several pearls are connected: this is like the peptides used in partially-hydrolyzed formulas. Even shorter strands of fewer pearls will are like the smaller peptides used in an extensively hydrolyzed formula.

If you start with individual pearls, then you have an idea of amino acids. In an amino acid-based formula like Neocate, the amino acids are not linked to each other. In Neocate, the amino acids are NOT derived from dairy or soy protein. The amino acids in Neocate are synthetic, meaning they’re not derived from meat. Most of them are made from plant sugars, and some are completely synthetic.

Here’s another way to look at infant formulas and their potential for triggering an allergic reaction:

Can a Child React to a Hypoallergenic Infant Formula?

It is possible for a child with food allergies react to formulas made with hydrolyzed protein, or peptides. Amino acid-based formulas, on the other hand, are the least allergenic type of formula, meaning they’re least likely to cause a food allergy reaction. That’s because the amino acids are non-allergenic.

While two types of infant formulas can claim to be hypoallergenic, based on the information above you can see that the term alone doesn’t guarantee that there will NOT be an allergic reaction. The healthcare team will look at your child’s individual case to determine which hypoallergenic formula – amino acid-based or extensively hydrolyzed – would be best for your little one.

Here are some additional resources that can be helpful if you are currently evaluating various formula types

Last updated January 24, 2019

Published: 03/30/2017
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