Nutritionals and Nutraceuticals describe the product category occupying the regulatory border between food and drug products, and include dietary/food supplements like vitamins, minerals and herbal supplements; probiotics, prebiotics and synbiotics; medical foods and food with health claims. These products are generally purchased over-the-counter (OTC) and typically consumed for the benefit of health maintenance and wellbeing, or may be recommended by health practitioners for the dietary management of disease conditions.

Depending on the established mechanism of action, product presentation and product benefit or health claim positioning, similar products may fall into different regulatory classifications and attract different regulatory requirements. Across the globe, the myriad of different regulatory frameworks fashioned to ensure product safety or appropriate product claim definition inadvertently makes product development a complex pathway, full of regulatory hurdles and challenges.

Key challenges encompass:

  • Determination of regulatory status (Food with health claims, traditional herbal products, OTC incl. Better Regulation of Medicines Initiative – BROMI – Prescription Only Medicines – POM – General sale license – GSL)
  • Characterization as food components and botanical extracts
  • Design of clinical trials to support health claims
  • Biomarkers identification and qualification

VCLS Solutions

  • Identify registration path and pertinent regulatory requirements
  • Define optimal regulatory strategy for successful international market entry taking into consideration potential different regulatory requirements depending on targeted local markets
  • Ensure compliant strategies for labeling and promotion materials
  • Prepare and submit notification/registration dossiers in key global markets
  • Conduct vigilance reporting
  • Justify non-novel food or food ingredient classification
  • Construct appropriate regulatory dossier
  • Perform gap-analysis
  • Review regulatory dossier
  • Define appropriate clinical development program
  • Correct definition of study population and clinical end-points
  • Assist with protocol design for animal and human studies
  • Determine appropriate nutrition and health claims development strategies
  • Develop pertinent product claim dossier
  • Prepare international dossier submission and representation with the authorities