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

Medical Marketing & Engagement | Regulatory & Scientific Affairs

 

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.

 

Juntos Construimos el Futuro de la Salud

Tenemos un modelo de servicio integrado único que nos permite servir a nuestros clientes en cualquier etapa de innovación. Está compuesto por cuatro prácticas: Strategy & Innovation, Regulatory & Scientific Affairs, Research & Clinical Services and Medical Marketing & Engagement.

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.