• Regulatory NewsRegulatory News

    Microbiome, Diet, Health, and Disease: Policy Needs to Move Forward

    This article covers policy needs concerning the rapidly evolving field of microbiome and diets with respect to health and disease. It captures some key outcomes of a multi-stakeholder dialogue (Brussels, May 2016), spearheaded by a joint effort of the Organisation for Economic Co-operation and Development (OECD) and the Department of Economy, Science and Innovation of the Flemish Government (Belgium), to help design and/or interpret regulatory frameworks for food and dru...
  • Regulatory NewsRegulatory News

    Innovating Patient Driven Nutritional Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multi-Stakeholder Initiative

    This article addresses a European public-private healthcare initiative to implement Optimal Nutrition Care for All (ONCA) for patients. It underlines the importance of an effective multi-stakeholder approach in 16 participating countries, based on sound policymaking. A fit-for-purpose, innovation-friendly regulatory framework is required to help provide appropriate, timely, and cost-efficient healthcare solutions for increased patient access. Introduction Disease-rela...
  • Regulatory NewsRegulatory News

    Overcoming Distinctive Regulatory Barriers for the Development of Medical Foods

    This article compares the legal definitions of drugs and medical food and outlines the distinctive regulatory hurdles for medical food, in particular, the need for substantiating distinctive nutritional requirements. The authors also make recommendations on how those regulatory hurdles could be overcome with definitive regulatory guidance for both distinctive nutritional requirements (DNR) and modification of normal diet alone (MODA). Introduction Novel nutrition ther...
  • Feature ArticlesFeature Articles

    Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities

    This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world. The regulatory criteria that a medical food/FSMP be uniquely formulated to address distinctive nutritional requirements for patients wit...