Constituent Update

December 8, 2021

The U.S. Food and Drug Administration has completed the review of a notification regarding specific health claims related to the introduction of certain foods to infants and the reduction in the risk of developing food allergies.

FDA has concluded that manufacturers may use the below-specified claims on the label and in labeling of any food product that qualifies for the claims. The claims are based on authoritative statements from the Dietary Guidelines for Americans, 2020-2025.

“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.”

“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.”

These claims are in addition to the qualified health claim that the agency allowed in 2017 that links early peanut introduction and reduced risk of developing a peanut allergy.

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. The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has developed clinical recommendations to prevent the development of peanut allergy. The Addendum Guidelines for the Prevention of Peanut Allergy in the United States provides three guidelines for the early introduction of peanut-containing foods in infants, based on their level of risk for developing peanut allergy.

For Additional Information:

FDA Modernization Act (FDAMA) Claims
Dietary Guidelines for Americans, 2020-2025