Authorized Health Claims
What is an Authorized Health Claim?
An Authorized Health Claim describes a health claim that has been reviewed by the FDA and approved for use.
This means you can make an authorized health claim on your product or label without having for the FDA to approve it.
There must be a "significant scientific agreement" in order for the FDA to issue an Authorized Health Claim. This means that the science supporting that health claim is unlikely to change.
What are the Approved Health Claims?
You can get a full list of authorized health claims in our article Approved Health Claims You Can Use on Your Label
How Do I Submit a Health Claim for Approval?
Anyone may submit a petition to the FDA to issue a qualified health claim or an authorized health claim (note that only 12 authorized health claims were issued between 1990-2018).
The petition may include clinical laboratory studies, non-clinical laboratory studies and findings released by the FDA.
You can learn more about where to submit a health claim for approval on the FDA website and you can learn more about the requirements in the Code of Federal Regulations
Health claims will be reviewed based on the criteria defined in this FDA Guidance Document