September 7, 2017
After conducting a systematic review of the available scientific evidence, the U.S. Food and Drug Administration has determined that it intends to exercise enforcement discretion for the use of a qualified health claim for infants with severe eczema and/or egg allergy characterizing the relationship between the consumption of foods containing ground peanuts beginning between 4 and 10 months of age and a reduced risk of developing peanut allergy by 5 years of age.
The claim, which manufacturers can use immediately, reads:
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. FDA has determined, however, that the evidence supporting this claim is limited to one study.
If your infant has severe eczema and/or egg allergy, check with your infant’s healthcare provider before feeding foods containing ground peanuts.
The qualified health claim was in response to a petition filed by Assured Bites, Inc. Qualified health claims are not the same as “authorized health claims,” which must be supported by significant scientific agreement among experts in the field. Qualified 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. As such, they are accompanied by qualifying language or a disclaimer so that the level of scientific evidence supporting the claim is accurately communicated. The FDA’s intent to exercise enforcement discretion for the use of the qualified health claim means that the agency does not intend to object to its use as long as the products bearing the claim are consistent with the factors FDA stated in the Letter of Enforcement Discretion.
Epidemiological evidence suggests that the prevalence of peanut allergy in U.S. children has at least doubled from 1997 to 2008. Peanut allergy is one of the most common food allergies and, in the majority of individuals, it begins early in life and persists throughout life. There are no FDA-approved treatments for preventing or curing peanut allergy, and it is the leading cause of death related to food-induced anaphylaxis in the United States. Thus, interventions that may prevent development of peanut allergy could be beneficial to public health.
Published in 2015, the Learning Early about Peanut Allergy (LEAP) study involving more than 600 infants was the first randomized intervention trial to study early introduction to peanut protein in infants as a preventive strategy. The study demonstrated that for infants with severe eczema and/or egg allergy, a population at high risk of developing peanut allergy, beginning consumption of peanut-containing foods in infancy (between 4 and 10 months of age) reduced the risk of developing peanut allergy by 5 years of age by more than 80 percent. In light of this finding and the public health consequences of peanut allergy, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), established a coordinating committee, which convened an expert panel to develop new clinical recommendations to prevent the development of peanut allergy. The Addendum Guidelines for the Prevention of Peanut Allergy in the United States provide three guidelines for the early introduction of peanut-containing foods in infants, based on their level of risk for developing peanut allergy.
This qualified health claim is supported by the same scientific evidence behind the first Addendum Guideline that recommends the introduction of peanut-containing foods to infants with severe eczema, egg allergy, or both, as early as 4 to 6 months of age to reduce the risk of peanut allergy.
For Additional Information:
- FDA Response to Petition for a Qualified Health Claim for Ground Peanuts and Reduced Risk of Developing Peanut Allergy
- FDA Commissioner Statement
- Questions and Answers: Qualified Health Claims in Food Labeling
- Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims
- Qualified Health Claims: Letters of Enforcement Discretion
- 2017 Addendum Guidelines for the Prevention of Peanut Allergy in the United States (NIAID, NIH)