Regulatory Pathway for Claim Approval
To use health claims on product labels, manufacturers must follow a systematic process:
Step | Details |
1. Determine the Claim | Identify the specific claim to be made, whether it relates to health, nutrient content, or structure/function. |
2. Conduct Scientific Research | Gather robust scientific evidence, including clinical trials, epidemiological studies, or other valid data, to support the claim. |
3. Submit a Petition | Provide the US FDA with a detailed petition outlining the evidence that supports the claim. |
4. FDA Review | The US FDA evaluates the evidence to determine if it meets the standard of “significant scientific agreement.” |
5. Label Approval | Upon approval, the manufacturer can include the claim on the product label. |
6. Timeline | Health claims under the Food and Drug Administration Modernization Act (FDAMA) can be used 120 days after notification, pending US FDA assessment. Overall timelines vary by claim complexity and evidence strength. |