Qualified health claims (QHCs) are supported by scientific evidence, but do not meet the more rigorous “significant scientific agreement” standard required for an authorized health claim. To ensure that these claims are not misleading, they must be accompanied by a disclaimer or other qualifying language to accurately communicate to consumers the level of scientific evidence supporting the claim.
Food manufacturers can petition the agency to consider exercising enforcement discretion for the use of a qualified health claim. The FDA does not “approve” qualified health claim petitions. For a QHC petition with credible scientific evidence, the FDA issues a Letter of Enforcement Discretion including specific claim language that reflects the level of supporting scientific evidence and details of all enforcement discretion factors under which the FDA will not object to the use of the QHC. The process does not involve rulemaking.
For more information, visit Questions and Answers: Qualified Health Claims in Food Labeling or explore the linked pages below.
- Qualified Health Claims: Letters of Enforcement Discretion
- Qualified Health Claims: Letters of Denial
- Qualified Health Claims: Withdrawn
- Electronic Submission of Health Claim Petitions and Notifications
- Search Qualified Health Claim Petitions Open for Comment
- Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims January 2009
- Withdrawal Notice: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements; Withdrawal of Guidance January 16, 2009
- Guidance for Industry: FDA's Implementation of "Qualified Health Claims": Questions and Answers May 12, 2006 (Includes: Timelines, Submitting a Petition)