Garnering An On-Pack Health Claim For A #1 Yogurt Brand

Regulatory & Scientific Affairs | Medical Marketing & Engagement


The Challenge

Functional food claims based on probiotics were not yet regulated in the market, and there were no active efforts to adapt the regulations, making the client’s desired health claim outside the scope of standard options.


The Approach

After identifying the need for the development of a new probiotic-claim regulation, SPRIM:

  • Partnered with scientific and regulatory experts locally to educate agency officials on scientific benefits demonstrated in the client’s research
  • Benchmarked probiotic regulations worldwide
  • Drafted recommended guidelines
  • Prepared and submitted scientific dossier and regulatory dossier
  • Collaborated with the regulatory officials to ensure implementation


The Results

The client was the first yogurt product with an on-pack health claim stating that ingestion would “help improve transit system” within a certain timeframe. ‘Barrier of entry’ granted SPRIM’s client exclusive use of the claim; regulations require clinical trial on final product to leverage claim on-pack.


Together Building The Future Of Health

We have a unique integrated service model enabling us to serve our clients throughout the lifecycle of a product or business concept. It is composed of four practices: Strategy & Innovation, Regulatory & Scientific Affairs, Research & Clinical Services and Medical Marketing & Engagement.