On August 10, 2021, Prollergy Corporation (Prollergy) submitted a notification to FDA regarding health claims related to the introduction of allergenic foods to infants and the reduction in the risk of developing food allergies. Under the Federal Food, Drug and Cosmetic Act, as amended by the FDA Modernization Act (FDAMA), a manufacturer may submit to FDA a notification for a health claim based on an authoritative statement from a scientific body of the US Government or the National Academy of Sciences; in this case, the authoritative statement Dietary Guidelines for Americans 2020-2025 and 2020 Dietary Guidelines Advisory Committee.

On December 8, 2021, FDA announced that it had completed reviewing Prollergy’s notification, concluding that manufacturers may use the following claims on the label of any food product that qualifies for the claims:

• “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.”

Companies are permitted to start using the approved claims as of December 8, 2021.  These claims are in addition to a qualified health claim that FDA acknowledged in 2017, which was also related to the link between early peanut introduction and the reduced risk of developing peanut allergies.