What does Hypoallergenic Formula Mean?

What does Hypoallergenic means?What is Hypoallergenic Formula? Most consumers today believe that a product labeled as hypoallergenic will not cause an allergic reaction, but is this 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. Few federal standards regulate the use of this term for consumer goods. 

For infant formulas, however, you can rest assured that the term “hypoallergenic” has to meet specific criteria.

What is a Hypoallergenic Infant Formula?

When it comes to infant formulas, based on calls, our nutrition specialists receive regularly; many people think hypoallergenic ensures that no allergens are present. The reality is a bit more complicated.

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

  • Studied in a clinical trial
  • Considered in children with confirmed cow milk allergy
  • 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 signs of a food allergy.  Only formulas made of free amino acids of hydrolyzed protein– like Neocate – are 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 that comes from dairy.

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 an extensively hydrolyzed formula, resulting in allergic reactions.

Amino acid-based formulas, p 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 replaces protein and peptides.

To help you visualize the difference between these two types of formulas, picture a pearl necklace. The process is like breaking the necklace into smaller pieces with some pearls attached.  these pieces are the peptides used in partially-hydrolyzed formulas. Even shorter strands of fewer beads 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 acid chains are not together. Neocate has synthetic amino acids instead of those from meat or dairy. These amino acids derive from plant sugars, and some are entirely synthetic.

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

What does Hypoallergenic means?

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 determines the right hypoallergenic formula for your child – amino acid-based or extensively hydrolyzed -.

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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