Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim advising that early introduction of peanuts to certain high-risk infants may reduce risk of peanut allergy

As the science governing allergies and diets continues to evolve, so do expert recommendations around how best to safely introduce babies and children to various foods. Perhaps one of the most challenging decisions for parents of my generation is when and how to introduce foods that pose a potential for a significant allergic reaction. These decisions are made more difficult as the prevalence of certain food allergies appear to be on the rise. Peanut allergy is one of the most common food allergies. It’s also one of the most dangerous. Peanut allergy is the leading cause of death related to food-induced anaphylaxis in the United States. For these reasons, it’s rightly a cause of significant concern among new parents. The majority of individuals who are allergic to peanuts developed the allergy early in life and never outgrew it. You would be hard pressed to find a parent who doesn’t know a child who suffers from a serious peanut allergy. Even if our own children don’t have a peanut allergy, most of us have friends or relatives whose children do. That’s not surprising, given that the prevalence of peanut allergy has more than doubled in children from 1997 to 2008 alone. Today, about two percent of American children are allergic to peanuts.

As the incidence of peanut allergy grew, along with an awareness of the consequences, doctors began advising parents not to introduce peanut-containing foods to children under the age of three who were at high risk for peanut allergy. While this advice was well intended, new evidence-based guidelines recommend that the medical community consider a different approach. A recent landmark clinical trial funded by the National Institutes of Health found that introducing foods containing smooth peanut butter to babies as early as 4 months of age who are at high risk of developing a peanut allergy -- due to severe eczema or egg allergy or both -- reduces their risk of developing peanut allergy later in childhood by about 80 percent. That finding led the NIH to issue new guidelines in January, recommending that parents of infants with severe eczema, egg allergy, or both introduce peanut-containing foods into a child’s diet as early as 4 to 6 months of age. The guidelines advise parents to check with their infant’s healthcare provider before feeding their baby peanut-containing foods in order to determine whether an allergy test is needed first and whether feeding should be done under a doctor’s supervision.

Along with the information that you currently see on food labels, which disclose when a food contains peanuts or peanut residue, the new advice about the early introduction to peanuts and reduced risk of developing peanut allergy will soon be found on the labels of some foods containing ground peanuts that are suitable for infant consumption. Whole peanuts, on the other hand, are a choking hazard for young children and should not be consumed. Recognizing the importance of science-based food decisions, the FDA has responded to a petition for a new qualified health claim that states “for most infants with severe eczema and/or egg allergy who are already eating solid foods, introducing foods containing ground peanuts between 4 and 10 months of age and continuing consumption may reduce the risk of developing peanut allergy by 5 years of age.” This is the first time the FDA has recognized a qualified health claim to prevent a food allergy. Our goal is to make sure parents are abreast of the latest science and can make informed decisions about how they choose to approach these challenging issues.

The new claim on food labels will recommend that parents check with their infant’s healthcare provider before introducing foods containing ground peanuts. It will also note that the claim is based on one study. The FDA will continue to monitor the research related to peanut allergy. If new scientific information further informs what we know about peanut allergy, the FDA will evaluate whether the claim should be updated.

We know that there’s more to learn about food allergies. The more we learn, the better we can consider how best to introduce allergenic foods, as well as prevent and treat food allergies. We need to continue to invest in the science related to our diets. The FDA remains committed to advancing and supporting research and innovations that help lower the rate of food allergies and better protect the public health.

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