Recently, the U.S. Food and Drug Administration (FDA) released new guidance on feeding infants at a higher risk of developing a peanut allergy. This guidance is based on the January 2017 Addendum “Guidelines for the Diagnosis and Management of Food Allergies” from the National Institutes of Health (NIH). The new “qualified guidance” by the FDA means “health claims are supported by credible scientific evidence, but do not meet the more rigorous 'significant scientific agreement' standard required for an authorized health claim.” This is the first time the FDA has recognized a qualified health claim to prevent a food allergy.
The rate of peanut allergies is thought to have doubled from 1997-2008, to 2% of children, and those found allergic early in life may never outgrow the allergy. An allergy to peanuts is the leading cause of anaphylactic (life-threatening) shock and death for food allergies. In the landmark NIH randomized controlled study, over 600 infants participated. The study showed that infants with severe eczema and/or egg allergy, a population at high risk of developing peanut allergy, beginning consumption of peanut-containing foods between 4 and 10 months of age reduced the risk by more than 80 percent of developing peanut allergy by 5 years of age. For those at highest risk of developing a peanut allergy, who react to peanut testing with the antibody IgE, referral to an allergy specialist is recommended.
Per the FDA, “…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.
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.
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
FDA Acknowledges Qualified Health Claim Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy
All accessed 9.18.17