Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

Why Should You Attend:

The marketing and sale of a medical food is a relatively recent regulatory concept for the FDA. Products now regulated as medical foods were formerly regulated by FDA as drugs until about1972, when FDA began to consider them as a subcategory of foods for special dietary use.

This webinar will focus on the statutory and regulatory requirements for marketing and selling a medical food in the U.S. It will provide insight into FDA’s interpretation of the above requirements through a discussion of the Federal Register notices and relevant FDA guidance documents supporting this product category.

The session will also focus on FDA’s labeling and promotional rules for medical food products, and provide recommendations for complying with the Agency’s requirements. These recommendations will be based on a review and included discussion of recent FDA enforcement action that have specifically targeted marketed medical foods.

Learning Objectives:

• Gain a basic understanding of what is a Medical Food and when it would be appropriate to market a product as a medical food.
• Understand how FDA regulates medical foods, and learn where to find the Agency’s relevant statutory and regulatory requirements.
• Become familiar with FDA’s implemented regulation intended to help clarify what is a medical food.
• Understand the criteria FDA uses to distinguish between medical foods and other products such as conventional foods, a dietary supplements and drugs.
• Learn how to properly label a medical food.
• Recognize the potential marketing and promotional risks associated with selling a marketing food.
• Gain strategies for mitigating the risk of FDA enforcement action by reviewing recent FDA enforcement action against companies selling medical foods in the U.S.

Areas Covered in the Seminar:

• FDA’s regulation of Medical Foods.
• Regulation of a Medical Food.
• Determining what is a Medical Food.
• Labeling, Marketing and Promotion of a Medical Food.
• Advantages to Selling a product as a Medical Food.
• Strategies for Mitigating the Risks Associated with Selling a Medical Food.

Who Will Benefit:

• Regulatory Affairs Professionals
• Product Managers
• Consultants
• Scientists
• Research Analysts