FDA culminates review of notification on health claims related to infant peanut allergies

U.S – The U.S. Food and Drug Administration (FDA) has concluded 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.

On August 10, 2021, Prollergy Corporation, a health supplement manufacturing company, submitted to the agency a notification containing proposed health claims for conventional foods and dietary supplements for the introduction of allergenic foods to infants and reduced risk of developing food allergy.

Under the Federal Food, Drug, and Cosmetic Act, a manufacturer may submit to the FDA a notification of a health claim based on an authoritative statement from an appropriate scientific body of the United States Government or the National Academy of Sciences (NAS) or any of its subdivisions. 

The notification must be submitted to FDA at least 120 days before the food is introduced into interstate commerce. 

The August 10 notification cited statements from the Dietary Guidelines for Americans 2020-2025 and 2020 Dietary Guidelines Advisory Committee as the basis for the claims for the introduction of allergenic foods to infants and reduced risk of developing food allergy. 

FDA reviewed the statements cited in the context of the reports that they appeared in and in light of existing authorized health claims and current science.

Health claims to be concise

The agency clarified that is not acting to prohibit the claims, however, the proposed claims must be worded in a way that accurately represents the authoritative statement the claims refer to, as well as follow all of the other requirements for claims, as provided in the Guidance.

“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,” reads one of FDA’s permitted claims.

The claims are based on authoritative statements from the Dietary Guidelines for Americans, 2020-2025.

“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,” reads another example of accurately displayed claims.

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.

Given that the 120-day period from the date of receipt of the submission of the Prollergy notification lapsed on December 8th 2021, manufacturers may use the claims specified in the notification on the label and in labeling of any conventional food or dietary supplement product that meets FDA’s eligibility criteria.

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