Statement by LISA GABLE, CEO of FARE: Regarding FDA’s Dec. 8, 2021 notification letter announcing a FDAMA health claim on early introduction of peanuts to reduce the risk of developing peanut allergy

“FARE applauds FDA’s continuing efforts to support the food allergy community and is working closely with the agency, legislators and researchers to improve the quality of life and the health of the 32 million individuals with food allergies. We are grateful that the Agency made changes to its health claims for the first time in seven years and recognizes the importance of providing the early introduction of peanuts to infants to reduce the risk of developing a future food allergy. 

“FARE strongly supports FDA’s decision to allow a health claim based on authoritative statements in the Dietary Guidelines for Americans, 2020-2025, on the early introduction of food allergens (specifically peanut) in the diets of infants to reduce the risk of developing food allergy. 

“Peanut allergy is one of the most prevalent food allergies, regularly beginning in childhood and lasting a lifetime. The FDAMA (FDA Modernization Act) health claim acknowledges the success of the 2015 LEAP study that showed early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this life-threatening food allergy. The inclusion of the recommendation in the Dietary Guidelines for Americans, 2020-2025, to introduce food allergens early in the diets of infants to reduce the risk of developing food allergy is a milestone for prevention, and has the potential to dramatically reduce the prevalence of food allergy.” 

Background: FDAMA health claims are allowed by FDA based on notification from a manufacturer based on an authoritative statement from an appropriate scientific body of the US government, in this case the US Departments of Agriculture and Health & Human Services, or the National Academies or any of its subdivisions. Specifically, the December 2021 FDAMA health claim on early introduction of peanuts to reduce the risk of developing peanut allergy can be stated two ways:   

“If a baby has severe eczema, egg allergy or both, introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods” 

or 

“For babies with an increased risk of peanut allergy (babies with severe eczema, egg allergy or both), introducing age-appropriate, peanut-containing foods as early as 4 months may reduce the risk of developing a peanut allergy. Caregivers should check with the baby’s healthcare provider before feeding the baby peanut-containing foods.” 

For further information: 

Link to FDA’s FDAMA Health Claim notification decision: https://www.fda.gov/food/food-labeling-nutrition/health-claim-notification-introduction-allergenic-foods-infants-and-reduced-risk-developing-food 

Link to FDA’s CFSAN Constituent Update: https://www.fda.gov/food/cfsan-constituent-updates/fda-completes-review-notification-regarding-health-claim-related-peanut-allergies