How Hydrolyzed are the Proteins in HiPP HA?

Recently, a dietitian wrote and asked me about HiPP HA Combiotik infant formula, which is the HiPP hydrolyzed formula. This savvy question is about infant formula safety. The abbreviation “HA” stands for hypoallergenic, a word that in the United States has a specific definition. Is it the same for European-made infant formulas? No, it is not.

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Hypoallergenic European-made infant formulas contain partially hydrolyzed proteins. They are made for who are babies at-risk for allergy because they have least one parent or sibling has asthma, hay fever or atopic dermatitis.

Hypoallergenic infant formulas on the US market usually contain extensively hydrolyzed proteins. They are made for infants with existing symptoms of cow’s milk protein allergy (CMPA). Some hypoallergenic formulas are made only with amino acids, the building blocks of proteins.

Therefore HiPP hydrolyzed formula is not for a baby with a cow’s milk allergy.

What is the safety difference between partial and extensive hydrolyzed formula?

Hydrolysis is a chemical process that uses water to break a compound down into smaller pieces (from Greek, hydro = water; lysis = break down). These pieces are called peptides. Both whey and casein milk proteins can be hydrolyzed, either partially (a little) or extensively (a lot). Proteins that have not been altered are called intact proteins. Importantly, hydrolyzed proteins contain a mixture of peptide sizes and can still include some intact proteins.

Cow’s milk protein allergy (CMPA) is the most common food allergy in in infants. Mistaking milk protein as a harmful invader, the immune system defensively reacts causing a variety of symptoms including vomiting, diarrhea, mucous or blood or both in the stool.  Hydrolyzed proteins (peptides) however, can be small enough to evade the immune system’s faulty radar and not cause a reaction.

Many intact proteins remain after partial hydrolysis. Indeed, a Grand Canyon sized gulf exists between the number of intact proteins founds in partially hydrolyzed protein verses extensively hydrolyzed milk proteins. Partially hydrolyzed protein contains 1000 – 100, 000 times higher concentrations of intact milk protein than is found in extensively hydrolyzed milk protein ingredients. Extensively hydrolyzed proteins do not cause reactions in about 90% of infants with cow’s milk protein allergy, because they contain much smaller protein snippets.  Partially hydrolyzed proteins are well-known to cause reactions in infants experiencing CMPA.

Why would the European Safety Commission allow partially hydrolyzed formulas to be labeled as hypoallergenic if they are not safe be used for allergies?

Hypoallergenic is a generic term that simply describes the likelihood that a substance will cause an allergic reaction!

Some evidence suggests that babies at-risk for allergy may have a reduced risk for developing atopic dermatitis as a young child, if they drink partially hydrolyzed proteins in place of intact proteins. This relationship meets the definition of hypoallergenic.  The European Food Safety Authority accepts this evidence. The US Food and Drug Administration does not. Each has labeling laws that reflect their interpretation of the evidence.

The spacious difference in labeling laws is one of the primary concerns that US health providers have with use of infant formulas outside their intended market. Partial hydrolysate infant formulas cannot be labeled as hypoallergenic in the United States. Caregivers can easily mistake these formulas as identical to those made in the United States. Parents in the European Union would not make this mistake, because they get a prescription formula for their infant with CMPA. They do not buy the formula on the grocery shelf.

To read more on this topic, you can read a paper on the differences between European and US infant formula labeling, US FDA analysis,  European Food Safety Authority analysis , and the American Academy of Pediatrics policy statements on atopic disease.

 

photo credit: public domain, National Park Service

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