Developing and Substantiating Claims

What is Formula Management?

In TraceGains, product claims are managed and accessed in the Formulas > Product Claims sub-tab. 

What is the Smart Library?

The Smart Library provides direct access to published research materials, which is essential for claim management and substantiation.

How does FM aid the claims process?

Part of marketing involves developing and substantiating label claims to give consumers confidence when making purchases and to help categorize products. Dietary supplements and natural product manufacturers use TraceGains and the Smart Library to help better manage health claims substantiation, accelerate new product development, and connect teams through a networked platform.

Types of Claims

There are three categories of claims defined by statute and/or FDA regulations:

• Health claims: describe a relationship between an ingredient, and reduced risk of a disease or health-related condition.
  • Example: A healthful diet paired with proper calcium intake may lower the risk of developing osteoporosis.
• Nutrient content claims: describe the level of a nutrient in the product, or they compare the level of a nutrient in a food or dietary supplement to that of another food or dietary supplement.
  • Example: Good source of calcium.
• Structure/function claims: describe the role of a nutrient or ingredient intended to affect the normal structure or function of the human body.
  • Example: Supports healthy bone function.

Develop and manage product claims

TraceGains offers out-of-box capabilities to specifically support dietary supplement formulations including potency and overage calculations to support label claims. To kickstart that claim substantiation process, Smart Library should be your first stop.

Smart Library contains a robust set of filters for users to narrow down their search by study type, health topic, ingredient, etc.

Read this article for an in-depth look at navigating Smart Library.

Read this article for instructions on how to create or evaluate claims or add them to formulas.

How to Connect a Claim to Existing Formulas, Items, Citations, or Documents

Once a claim is configured and set up for monitoring, it’s essential to keep it easily accessible and properly linked. Use the Formulas > Product Claims sub-tab to quickly find claims, connect them to the right formula or ingredient, and store supporting documents.

Step 1: Navigate to the Formulas > Product Claims sub-tab.

Step 2: Click the edit icon for a given claim. 

Step 3: Click the appropriate sub-tab to connect the claim to an Item/Formula/Document. 

In this example, we'll use the ‘Formulas' sub-tab to connect the claim to a formula. 

Step 4: Click Add Formulas, Add Items, or Add Documents.

Step 5: Click Assign on the desired formulas, items, or documents.

Step 6: Click Done.

Step 7: Click Save.