The new FDA qualified health claim for early peanut introduction
It is such an exciting time for food allergy research. Last week, the FDA determined that current scientific evidence supports a qualified health claim (QHC) for the relationship between products containing ground peanut and reduction in peanut allergy development.
Cool, right? Yes, if you know what it means for your family and your new food introduction practices. If you find yourself like most new moms and dads, you probably don’t have time to read the FDA letter and you definitely don’t have time to read the hundreds of pages of scientific research discussed within. Not to worry, we’ve got it covered. Below, we’ve summarized exactly what the FDA determined and what it means for you and your family.
Let’s start with the basics: what is a QHC? A QHC describes the relationship between a substance (in this case, ground peanut) and a disease or health-related condition (in this case, a peanut allergy). This disease or health-related condition must be something the U.S. population (or subpopulation) is at risk for developing. Peanut allergy is an adverse immune reaction that can lead to a severe, potentially fatal reaction called anaphylaxis. Peanut allergies have been increasing in prevalence over the last decade or so, and are now estimated to affect up to 2% of US children.
QHCs exist for a wide variety of substances and health-related conditions and are featured on select products currently on the market. One you may be familiar with describes the relationship between fluoridated water and reduced risk of dental cavities and tooth decay. The QHC reads: “Drinking fluoridated water may reduce the risk of tooth decay.”
One important result of each new QHC is increased awareness of a public health benefit. With research surrounding early peanut introduction being so new, many parents and even pediatricians are not yet aware of the new guidance. We are excited that this new QHC will help bring early peanut introduction the attention that it deserves and help to relieve some of the misinformation and fear surrounding peanut allergy development.
The FDA determined that there was significant scientific agreement and evidence to support a QHC describing the relationship between ground peanuts and a reduced risk of developing peanut allergy for a specific population of infants and children over a specific period of time. The graphic below contains the entire QHC.
There are a couple important things to note about the language used in this claim. Let’s break it down:
First, the FDA asserts that the form of peanuts is important: they must be ground and not include ground or chopped peanuts (which pose a choking risk to infants). They also note that peanut butter should not be fed directly from a spoon or in lumps to children less than four years of age. This is reflected in the above language.
Next, the FDA chose to set a very specific population for whom the claim applies. This is because the evidence from just one study, the LEAP Study, was used to support the QHC. The LEAP Study only followed the effects of early peanut introduction in infants with severe eczema and/or egg allergy. This population and the fact that the findings are based on one study are also reflected in the final language.
Importantly, the FDA provided a clearer definition of “early peanut introduction.” Early introduction is often misunderstood to mean feeding a food once to see if an infant is allergic. In reality, early introduction should be understood as an ongoing process that starts as young as 4 months (or when baby is eating other solids foods) and continues until at least 5 years (60 months) of age. Of course, peanuts should not be fed to infants and children who are allergic to peanuts.
Lastly, because certain symptoms of severe eczema or egg allergy may also be the same symptoms experienced if an infant were allergic to peanuts, the FDA added that it is important to talk to your pediatrician/healthcare provider about all the choices that you make with early peanut introduction.
But how will this new QHC will affect your new food introduction practices? The advice from the American Academy of Allergy, Asthma and Immunology and the National Institute of Allergy and Infectious Diseases still holds true: there’s no reason to delay the introduction of allergens past 4-6 months of age. What else may change? Labels on ground peanut products (like peanut flour or pureed recipes) and the attention that early peanut introduction receives from news sources, friends, and even your pediatrician!