Nutrition and Health Claims
Anson assists companies working with nutraceuticals, dietary supplements, medical foods, and food additives. The regulatory landscape in this product area is challenging, both for companies first entering with product concepts or novel technology and for companies that are established in this product area but need assistance navigating recent changes and proposed new rules by FDA.
Anson supports:
- Product development, including regulatory pathways
- Product claims
- Structure/function claims
- Qualified vs. unqualified health claims
- Evidence required by claim category
- Product scientific data and literature review for health claims
- Standards of evidence associated with alternative regulatory pathways
- Product development plans and regulatory strategy
- Health claim regulatory compliance with existing and proposed rules or regulations
- Language in packaging and promotional literature review
- Novel food materials analysis
- Generally Regarded As Safe (GRAS) notification
- Surrogate endpoints for product claims
