Health claims on food labels play a critical role in informing consumers about the relationship between a substance and its health benefits. These claims, however, must meet rigorous standards to ensure accuracy and transparency before being used on labes. The U.S. Food and Drug Administration (FDA) recognizes two types of health claims: Authorized Health Claims and Qualified Health Claims, each with distinct criteria and procedures for approval.
Authorized Health Claims: Evidence-Based and Rigorously Supported
Authorized Health Claims describe a relationship between the consumption of a substance, such as a specific food or ingredient, and its positive impact on health. These claims must be supported by Significant Scientific Agreement (SSA)—a consensus among qualified scientific experts that the claim is backed by robust and conclusive scientific evidence.
For instance, the claim “Adequate calcium may reduce osteoporosis risk” is an authorized health claim. This statement is based on comprehensive human studies and other evidence reviewed by the FDA, ensuring its reliability. The approval process for such claims involves the submission of a detailed dossier by the petitioner (the company), including extensive scientific data from human, animal, and in vitro studies. Once reviewed, the FDA issues a final rule to confirm the claim’s authorization.
While the process is thorough, only about a dozen authorized health claims have been approved since 1990. You can view these claims on the FDA’s official website here.
Qualified Health Claims: Balancing Evidence with Transparency
In contrast, Qualified Health Claims address health benefits that are supported by scientific evidence but do not meet the stringent SSA standard. These claims must use qualifying language to convey the uncertainty in the scientific body of evidence, ensuring that consumers are not misled.
For example, a qualified health claim might state: “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of type 2 diabetes.” This phrasing transparently communicates the limitations of the supporting evidence while still informing the public about potential health benefits.
The approval process for qualified health claims mirrors that of authorized claims but with slightly shorter timelines. The initial phases of dossier review may take up to 60 days, while the evaluation process can extend to 270 days. Following the evaluation, the FDA issues a letter of enforcement discretion, which allows the claim to be used on labels with the appropriate qualifiers. For a complete list of qualified health claims, visit the FDA’s resource here.
The Approval Process: A Comprehensive and Transparent Evaluation
Both authorized and qualified health claims require the submission of a petition to the FDA. The petitioner must compile a dossier that includes detailed scientific evidence, primarily from human studies, but also supported by animal and in vitro research. The dossier undergoes a rigorous evaluation process comprising the following steps:
- Petition Receipt: The FDA confirms the receipt of the petition.
- Completeness Review: The FDA assesses whether the dossier is complete for review or requires additional information.
- Evaluation Phase: If accepted, the dossier is made publicly available on the FDA website, and the claim undergoes thorough scientific evaluation.
- Outcome Notification: The petitioner is informed of the decision through either a letter of enforcement discretion (for qualified claims) or a final rule (for authorized claims).
Transparency is a cornerstone of this process, as the dossiers are published for public consultation during the evaluation phase. However, questions remain regarding the confidentiality of specific studies, particularly when proprietary research is involved.
The FDA’s stringent criteria ensure that health claims provide consumers with reliable information about food products and their potential benefits. Understanding the differences between authorized and qualified health claims, as well as the processes behind their approval, empowers consumers and businesses to make informed decisions about food labeling.
