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 about 1972, 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 Webinar:

• 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
• Companies selling medical foods, conventional foods, dietary supplements, OTC drug and Rx drugs
• Foreign Manufacturers
• Importers of medical foods
• Food and Dietary Supplement manufacturers
• Labelers
• Distributors exploring new potential product sectors
• Financial analysts and investors interested in the food, consumer product,life sciences and biotech industries

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

Topic Background:

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 about 1972, when FDA began to consider them as a subcategory of foods for special dietary use. See FDA Advance Notice of Proposed Rulemaking: Regulation of Medical Foods, 61Fed. Reg. 60661, 60662 (Nov. 29, 1996) legal category was formally recognized by Congress in 1988. The law states: The term “medical food” means a food which is 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. See 21 U.S.C. § 360ee(b)(3).

Thus, FDA’s statutory definition of a medical food requires that a product:

• Be formulated for oral or enteral administration,
• Be used under the supervision of a physician, and
• Be intended for the specific dietary management of a disease or condition that distinctive nutritional requirements, based on recognized scientific principles, established by medical evaluation.

FDA has since implemented regulations to clarify the statutory definition of a medical food. Under those regulations, a product is deemed a medical food only if all of the following conditions are met:

• It is a specially formulated and processed product (as opposed to naturally occurring foodstuffs used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;
• It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management which cannot be achieved by the modification of the normal diet alone;
• It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
• It is intended to be used under medical supervision; and
• It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

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