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Health Claim Notification for Introduction of Allergenic Foods to Infants and Reduced Risk of Developing Food Allergy

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Under section 403(r)(2)(G) (21 U.S.C. §343(r)(2)(G)) of the Federal Food, Drug, and Cosmetic Act (Act), a manufacturer may submit to the Food and Drug Administration (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 claim may be made after 120 days from the date of submission of the notification until such time as 1) FDA issues a regulation prohibiting or modifying the claim or finding that the requirements for making the claim have not been met, or 2) a district court in an enforcement proceeding has determined that the requirements for making the claim have not been met.1

On August 10, 2021, Prollergy Corporation (Prollergy) submitted to the agency a notification (the August 10 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. The 120-day period from the date of receipt of the submission of the Prollergy notification is December 8, 2021. Therefore, after this date, 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 the eligibility criteria described below, unless or until FDA or a court acts to prohibit or modify the claim. The August 10 notification cited statements from the Dietary Guidelines for Americans 2020-20252 and 2020 Dietary Guidelines Advisory Committee3 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.

Claims Based on Authoritative Statement

The following statement from the Dietary Guidelines for Americans 2020-2025, listed in the August 10 notification, is considered an authoritative statement.

  1. “If an infant has severe eczema, egg allergy, or both (conditions that increase the risk of peanut allergy), age-appropriate, peanut containing foods should be introduced into the diet as early as age 4 to 6 months. This will reduce the risk of developing peanut allergy.” (Dietary Guidelines for Americans 2020-2025, page 58)

The claim language proposed by Prollergy in the August 10 notification is as follows:

“If a baby has severe eczema, egg allergy or both, introducing peanut as early as 4 months will reduce the risk of developing a peanut allergy.”

“For babies with an increased risk of peanut allergy, introducing peanut as early as 4 months will reduce the risk of developing a peanut allergy.”

FDA reviewed the authoritative statement from the Dietary Guidelines for Americans 2020-2025 (statement 1) in its context along with the proposed claims. FDA finds that the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 regarding introduction of peanuts and reduced risk of peanut allergy may be used as an authoritative statement to support a claim. However, the statement quoted in the notification is not the entirety of the conclusion/recommendation as provided in the Dietary Guidelines for Americans 2020-2025. The conclusion/recommendation goes on to state:

“Caregivers should check with the infant’s healthcare provider before feeding the infant peanut-containing foods. A blood test or skin prick may be recommended to determine whether peanut should be introduced to the infant, and, if so, the safest way to introduce it.”

The omitted language refers to the potential for infants to be allergic to peanuts prior to the introduction of peanuts into their diet. Because of the potential harm that could occur by feeding peanuts to infants who are peanut-allergic, the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 directs caregivers to consult healthcare providers before introducing peanuts. As discussed in the “Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body,”4; (the Guidance) the Act requires that such a claim be "stated in a manner so that the claim is an accurate representation of the authoritative statement referred to" and "so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet." FDA finds that the language about checking with a healthcare provider is an integral part of the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 and this information should be reflected in the proposed claims.

Additionally, the language of the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 specifically addresses the population of infants that has “severe eczema, egg allergy, or both” as the population of infants for whom the recommendation is directed toward. This population is identified because of its increased risk for developing peanut allergy. The conditions that increase the risk for infants are specific and limited and caregivers need that information to determine if introduction of peanuts would be beneficial for their infant. The description of the infant population should be reflected in the proposed claims for caregivers to clearly understand that infants with severe eczema, egg allergy, or both is the population at increased risk of developing peanut allergy.

Furthermore, the language of the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 refers to “age-appropriate, peanut-containing foods.” FDA also considers this information to be important to the conclusion/recommendation. Peanuts in their intact form pose a choking hazard to infants. In their discussion on introduction of solid foods to infants, the Dietary Guidelines for Americans 2020-2025 states that “Infants and young children should be given age- and developmentally appropriate foods to help prevent choking” and “[Offer] foods in the appropriate size, consistency, and shape that will allow an infant or young child to eat and swallow easily.” Because of the potential for harm of consuming whole, intact peanuts, the language in the conclusion/recommendation referring to “age-appropriate, peanut-containing foods” is important and should be reflected in the proposed claims.

Lastly, as the Guidance discusses, “Submitted health claims should use the word "may" to characterize the relationship between the nutrient and the disease or health related condition so as to indicate that the disease or health-related condition is caused by many factors.”5 While the language of the conclusion/recommendation in the Dietary Guidelines for Americans 2020-2025 does use the word “will” in the statement, for the purposes of food labeling, health claims should use the word “may.”

FDA 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. FDA considers the claim below as worded in a way that complies with all of the requirements:

“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.”

Accordingly, after December 8, 2021, manufacturers may use the above-specified claims on the label and in labeling of any food product that qualifies for the claims.

Claims Not Based on Authoritative Statements

The following statements from the Dietary Guidelines for Americans 2020-2025 and the 2020 Dietary Guidelines Advisory Committee, listed in the August 10 notification, are not considered authoritative statements.

  1. “Introducing peanut-containing foods in the first year reduces the risk that an infant will develop a food allergy to peanuts.” (Dietary Guidelines for Americans 2020-2025, page 58)
  2. “Introducing peanut and egg in the first year of life (after age 4 months) may reduce the risk of food allergy to peanuts and eggs.” (Scientific Report of the 2020 Dietary Guidelines Advisory Committee, page 409)

The claim language proposed by Prollergy in the August 10 notification is as follows:

“Introducing peanuts to a baby in the first year reduces the risk of developing an allergy to peanuts.”

“Introducing peanut and egg as early as 4 months of age may reduce the risk of developing peanut or egg allergy.”

The statement from the Dietary Guidelines for Americans 2020-2025 (statement 2) was included in the general discussion of the recommendations for introduction of potentially allergenic foods to infants. This discussion refers the reader to a highlighted section on the same page that provides the detailed conclusion and recommendation of the report regarding the introduction of peanuts. It is the detailed recommendation which is considered by the agency to be the authoritative statement of the Dietary Guidelines for Americans 2020-2025 for the introduction of peanuts and reduced risk of peanut allergy. The detailed recommendation is to be used as the basis for a health claim for peanut allergy. FDA has traditionally considered authoritative statements that were provided explicitly as findings, conclusions, or recommendations in a report and not statements contained within the general discussions of the report. Statements from the general discussion can be taken out of context or lack pertinent details of the conclusions and/or recommendations. In the case of the Dietary Guidelines for Americans 2020-2025, the complete recommendation regarding introduction of peanuts to infants is provided on page 58 in an individual, highlighted section. Statements in the general discussion would not be considered to be authoritative statements for the introduction of peanuts to infants and development of peanut allergy.

The statement provided in the August 10 notification from the Scientific Report of the 2020 Dietary Guidelines Advisory Committee (statement 3) also is not considered an authoritative statement. As discussed in the Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body6, FDAMA permits claims based on current, published authoritative statements from "a scientific body of the United States with official responsibility for public health protection or research directly related to human nutrition...or the National Academy of Sciences (NAS) or any of its subdivisions." The federal government often uses committees and panels to obtain independent expert advice on scientific, technical, and policy matters. However, federal advisory committees are not official scientific bodies of the United States, as the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC) would be, for example. Advisory committees are valuable resources for the development of federal policies but are not by themselves considered to be scientific bodies for the purpose of FDAMA claims.

Therefore, because the statement from the Dietary Guidelines for Americans 2020-2025 is not considered to be the full conclusion or recommendation of the report on the introduction of peanuts to infants and development of peanut allergy and because the 2020 Dietary Guidelines Advisory Committee is not considered to be a scientific body of the United States, FDA determines that the requirements of section 403(r)(2)(G) of FDAMA have not been met and the use of the proposed claims based on statements 2 and 3 is not authorized under FDAMA.

This notification and materials regarding the claim are publicly available from the FDA Dockets Management Staff (Docket No. FDA-2021-N-1179) at 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Persons interested in these documents may view them at https://www.regulations.gov or at the Dockets Management Staff, between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

1Guidance for Industry: Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body.
2 U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th Edition. December 2020. Available at DietaryGuidelines.gov.
3 Dietary Guidelines Advisory Committee. 2020. Scientific Report of the 2020 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human Services. U.S. Department of Agriculture, Agricultural Research Service, Washington, DC.
4 See supra, note 1.
5 See supra, note 1.
6 See supra, note 1.

 
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