The United States Food and Drug Administration (US FDA) regulates the claims manufacturers can make on food and dietary supplement labels. These claims fall into three primary categories:

Types of Claims for Food and Dietary Supplements in the US

Interesting News . Jan 10, 2025

The United States Food and Drug Administration (US FDA) regulates the claims manufacturers can make on food and dietary supplement labels. These claims fall into three primary categories:

1. Health Claims

These claims describe the relationship between a food or food component and a reduced risk of a disease or health-related condition.

Requirements:

2. Nutrient Content Claims

These claims highlight the level of a specific nutrient in a food product or supplement (e.g., “low fat” or “high in vitamin C”).

Requirements:

3. Structure/Function Claims

These claims describe how a food or supplement affects the structure or function of the human body (e.g., “supports digestive health”).

Requirements:

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.

Comparison of Claim Types

Claim Type Purpose Approval Required? Example
Health Claims Relates food to reduced disease risk Yes “Diets low in sodium may reduce the risk of hypertension.”
Nutrient Content Claims Highlights nutrient levels in a product Yes “High in fiber.”
Structure/Function Claims Describes effects on the body’s structure or function Notification only “Supports healthy digestion.”

Challenges and Timelines

Challenges:

Estimated Timelines:

How Food Research Lab Can Help

FRL supports manufacturers in navigating the complex US FDA regulatory landscape by offering:

For more information, connect with FRL to streamline the approval process and ensure compliance with regulatory standards.