5. Claim Requirements

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Infant Formula
USA

This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

5.1 Overview of Claims

5.1.1 Types & Definitions

A. Nutrient content claims - A nutrient content claim is a claim that expressly or in an implied manner characterizes the level of a nutrient that is of the type required to be in nutrition labeling.

B. Health claims - A health claim is a claim that characterizes the relationship of any nutrient which is of the type required to be on the label or labeling of food to a disease or a health-related condition. The US FDA has a prescriptive list of approved health claims, none of which are applicable to infant formula.

C. Qualified health claims - these claims characterize the relationship between a substance and a disease or health-related condition, but is a claim that has not been approved by FDA under the “Significant Scientific Agreement” standard that characterizes health claims, and thus must be accompanied by a disclaimer or otherwise qualified in such a way as to not mislead consumers. There is one qualified health claim that can be used for qualifying infant formula regarding the relationship between the consumption of 100% Whey-Protein Partially Hydrolyzed infant formula and a reduced risk of atopic dermatitis, if manufacturers meet specific conditions - details in the guidance document referenced here [1].

5.1.2 List of Prohibited Claims

No claims are permitted other than those noted above. [1]

Any interested person may petition the Food and Drug Administration (FDA) to issue a regulation regarding a health claim. An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer-readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.) If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's post office address to which any correspondence required by section 403 of the Federal Food, Drug, and Cosmetic Act may be sent.

Details on requirements to submit a claim can be found in CFR Chapter 21 Sub-part 101.70. [2]

5.2 Nutritional Claims

5.2.1 Permitted Claims

Please refer to section 5.1.1 above.

5.2.2 Nutritional Claim Registration

5.3 Health Claims

5.3.1 Permitted Claims

Please refer to section 5.1.1. above.

5.3.2 Health Claim Registration

Commonly required documents [2]:

A complete explanation of how the substance conforms to the requirements of §101.14(b) (21 CFR 101.14(b)
Summary of scientific data, which includes a statement of what public health benefit will derive from the use of the claim as proposed
Analytical data
Model health claim
Copies of any computer literature searches done by the petitioner
Copies of articles cited in the literature searches and other information

Estimated cost and duration for health claim approval process [3]:

There is a 100-day response standard for the FDA review process, although, in the current Cov-19 pandemic, this service standard is unlikely to be met.

Approving health claims in the USA is both costly and lengthy and depends on the nature of the claim, as significant clinical evidence is required, and in the case of infant formula, these requirements are set to very high standards. In order to obtain the data that meets the FDA's requirements, this is a process that could take many years and cost hundreds of thousands of dollars. More detail can be found in reference [3] below, including the distinction between a health claim and a qualified health claim.

To be approved by the FDA as an authorized health claim, there must be a significant scientific agreement (SSA) among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship.

5.4 Other Notes or Requirements for Claims

GMO Declaration - The US now has regulations in place regarding GMO declarations. Soy-based formula, or formula that contains significant quantities of an ingredient derived from certain genetically engineered crops, are now required to carry a GE disclosure on the principal display panel or on an adjacent panel if the PDP has no space as one disclosure option. Other options are available for disclosure, including text, symbol, electronic or digital link, and/or text message. Further details regarding GE disclosure requirements can be found in the link below. [4]

Mandatory compliance began January 1, 2022.