Health claims substantiation for probiotic and prebiotic products

Area of Science:

• Microbiology and Nutrition
• Regulatory Science
• Human Health

Background:

• The 8th International Scientific Association for Probiotics and Prebiotics (ISAPP) meeting addressed health claims substantiation for probiotic and prebiotic products.
• European regulatory reviews have resulted in numerous negative opinions for probiotic and prebiotic health claims, creating industry challenges.
• Companies seek clear research methodologies that meet scientific scrutiny and regulatory demands for health claim substantiation.

Framework:

• Regulatory distinctions between health and disease are often rigid, despite these states existing on a continuum.
• The concept of improved homeostasis is proposed as a framework for substantiating health claims.
• This approach focuses on measurable physiological parameters in healthy populations, aligning with food and supplement claim requirements.

Implementation:

• Utilizing statistically robust methods to measure physiological parameters is key.
• Research should target healthy populations to meet regulatory requirements for food and supplement claims.
• Navigating diverse global regulatory frameworks presents a significant challenge.

Implications:

• Harmonizing global regulatory approaches would simplify industry requirements and reduce consumer confusion.
• A clearer scientific framework is needed to guide research pathways for probiotic and prebiotic claims.
• Establishing robust substantiation methods is crucial for the future of health claims in the nutraceutical industry.