The medical foods category is one regulatory pathway available to companies wishing to market foods intended for dietary management of patients unable to obtain nutrients through dietary modification. Typically, medical foods are used under medical supervision.
According to the U.S. Food and Drug Administration (FDA), medical foods are a regulatory category applicable to foods “formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Our regulatory team can guide your product strategy for medical foods based on your project objectives and target markets of interest. We can help companies with product classification, regulatory compliance with FDA requirements (including Generally Recognized as Safe [GRAS]) and liaising with the FDA on your behalf.
Explore our regulatory and clinical services for medical foods:
- Medical Food Applications
- Product Development Strategy
- Clinical Trials
- Compliance Consulting
- Health Claims Substantiation
- Product Classification
- Technical Label Review
- Nutrition Facts Panel Review
- Scientific Literature Reviews
- Generally Recognized as Safe (GRAS)
- New Dietary Ingredient Notifications (NDIN)
Product testing services for medical foods include:
Learn how we can help you overcome your research and regulatory challenges to successfully commercialize your medical food.
Case Study: A Multi-Centre Clinical Trial to Determine the Efficacy of an Omega-3 Medical Food in NAFLD
Learn how we helped one Sponsor gain market entry for a medical food with a unique health claim.