2005Q-0298 Qualified Health Claim (QHC): 100b0Whey Protein Hydrolyzed in Infant Formula and Reduced Risk of Allergy in Infants
FDA Comment Number : EC5
Submitter : Dr. John Kerner Date & Time: 10/04/2005 03:10:47
Organization : Stanford University Medical Center
Category : Individual Consumer
Issue Areas/Comments
I am writing to enthusiastically endorse this claim petition.The incidence of allergic conditions is dramatically increasing in pediatrics. As a pediatric gastroenterologist, I am particularly impressed with the increased incidence of allergic gastrointestinal disorders (especially eosinophilic esophagitis); my dermatology colleagues have noted a marked increase in the incidence of atopic dermatitis.
Regarding proteins, our feeding options for infants (intact cow or soy proteins) have not changed for many decades, despite the fact they are clearly allergenic.
In fact, intact cow milk proteins are the most common food allergens for infants. So we need to re-think the way we are feeding infants who don't breast feed.
Improvements in safely modifying these proteins to reduce the risk of these allergies are needed and welcome.
As Director of Nutrition in our Department of Pediatrics, it is my feeling that in today's healthcare environment it is critical for health care professionals to make nutrition, and particularly preventive nutrition, a top priority. Specific extensively hydrolyzed products (with extensively hydrolyzed casein) have served well for therapy of protein induced food allergy. They have also demonstrated their efficacy for primary prevention, although their significantly higher cost and poor palatability makes it very difficult to use them as a recommendation for prevention of allergy in the general population. The partially hydrolyzed whey product addressed in this specific
claim petition has a long history of safe use in healthy infants, is readily
accessible to all, has a taste that is acceptable (particularly important
for parents), and has the well demonstrated effect of leading to less allergic manifestations compared to intact cow milk protein formulas. A very recent peer-reviewed article by Hays and Wood (Arch Pediatr Adolesc Med 2005; 159:810-816) critically examined the extensive literature on hydrolyzed formulas and concluded that both extensively hydrolyzed casein formulas and partially hydrolyzed whey formulas are appropriate alternatives to breast milk for allergy prevention in infants at risk.
A more provocative question might be posed from the point of view of the future health of infants in North America. It can be argued that hydrolyzed infant formulas in fact do not really prevent allergy; they simply cause less allergies than those induced by using intact cow milk instead of human milk as a protein source for infants. So, given intact cow milk proteins are the most common food allergen we give infants, and there are at least two options (an extensively hydrolyzed casein formula and the partially hydrolyzed whey formula in this claim petition) available to safely feed infants and decrease their risk of allergy, should we ethically continue to recommend intact cow milk protein formulas as a routine starter feeding to healthy infants? This question needs to be addressed.
In summary, given the epidemic of allergic conditions we are witnessing, adequate and broadly applicable recommendations for minimizing the risks for non-breast fed infants become even more important, particularly if this can be done safely, and at no added cost.
No part of any preventive strategy or intervention can be effective without adequately informing and educating parents and consumers about the risks and benefits of available feeding choices; allowing this information to be communicated to parents is an absolute necessity. I strongly support any efforts to communicate this information to parents, consumers, and the general public.

Sincerely, John Kerner, M.D.
Professor and Director of Nutrition
Director of Pediatric Gastroenterology Fellowship
Associate Director of Pediatric GI, Hepatology, Nutrition
Director, Nutrition Support Team
Lucile Packard Children's Hospital/Stanford University Medical Center