Claims substantiation in the nutraceutical industry


How healthy are your product and package labelling processes? asks Neil Gleghorn, CEO, Kallik

Claims substantiation in the nutraceutical industry

Each and every manufacturer of nutraceutical and healthcare products experiences many common labelling challenges. Whether it’s miscommunication between departments, duplicated data in multiple systems, elongated processes, time consuming manual audit creations or reliance on “tribal knowledge,” each issue can have a profound impact on labelling accuracy and, ultimately, the profitability and productivity of the business.

One common thread that manufacturers of nutraceutical products will undoubtedly experience is the challenge of effectively substantiating and managing product claims. Much of the evidence required to substantiate claims is typically stored in documents and emails.

These manual methods make information very difficult to find, especially when the pressure is on to substantiate those claims when challenged. Disconnected silos of information, resulting in little or no traceability, makes it especially difficult to manage the complex relationships between ingredients, claims, substantiation documents and notes.


It would certainly be easier if all related content could be managed in one place. It is actually possible today … but many organisations remain unaware of how cloud technologies and web-based applications can help to solve this problem. Uploading, managing and versioning content to a Digital Asset Manager or what Kallik refers to as a Claims Substantiation Manager, is the first step.

This approach allows all claims data to be captured quickly — accurately and securely — ensuring that all claims and documents are automatically indexed and managed under version control. Manufacturers can quickly understand the impact of change, including interrogating and finding all formulations using a specific claim and tracing all claims relating to a specific document. It also helps to ensure global compliance by capturing and storing local market translations of each claim too.

Claims substantiation in the nutraceutical industry

Legal requirement

By law, businesses need to ensure that any claim they make is backed up to be nationally or globally compliant. Regulatory affairs (RA) staff, being the gatekeepers of approved claims and documents, need to be able to quickly find all related documents, as well as understand the structured relationships between claims, substantiation documents and dosages for new claims.

The approach suggested above would make it easier for RA to manage and publish the claims for any combination of ingredients, and manage relationships between claims and substantiation documents. A more enhanced solution could involve data sheets being automatically generated and indexed by being version controlled, published and shared with colleagues in other departments.

Controlled compliance

Working within a business that has a clear, compliant and defined system in place when validating claims will empower employees and increase levels of user adoption. Regulatory functions will find it easier to collate and provide accurate information to other departments wishing to know what claims can be made for a specific set of ingredients or formulations. This would help to support clear communication across departments and ensure compliance is being adhered to throughout the business.

Staying updated

Out-of-date claims can result in costly fines. Managing all claims in one single repository, as opposed to being embedded in documents and uncontrolled emails, allows organisations to quickly understand the impact of change. If new research impacts a claim that has already been made, interrogating and finding all formulations using a specific claim now becomes much easier.

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Similarly, it becomes a simple exercise to trace all claims relying on a particular Substantiation Document. All such claims can be found, removed or updated as required. Similarly, all product labels using a specific claim can easily be traced and updated, reducing the risk of printing out of date claims.