Developing and Substantiating Claims

What is Formula Management?

In TraceGains, product claims are managed and accessed in the Product Claims sub-tab of Formula Management (FM).

What is the Citation Library?

The Citation Library (AKA Smart Library) provides direct access to published research materials, which is essential for the process of 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 Citation 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, the Citation Library (AKA Smart Library) should be your first stop.

The Citation 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 the Smart Library sub-tab of Formula Management.

To start with claims, this article shows you how to use FM to:

1. Create a new claim
2. Add a claim within an existing formula
3. Evaluate a claim

Connect a claim to existing formulas, items, citations, or documents

After configuring a claim, and after learning how to edit and monitor it, it’s important to be able to 1) access it quickly 2) assign the claim to the correct formula, ingredient item, and/or store supporting documents. Luckily, connections are easy using the Product Claims sub-tab of Formula Management.

Step 1: Click the Formulas Tab

Step 2: Click the Product Claims sub-tab

Step 3: Click ‘Formulas,’ or any attribute you want to assign to the claim, including Items and Documents.

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.’