FDA Issues Final Guidance on Labeling Medical Foods

FDA issued its final guidance on the definition and labeling of medical foods and provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food could be used to manage, and updates prior responses from the previous edition of the guidance.

According to the “Frequently Asked Questions About Medical Foods: Second Edition", medical foods are specially formulated and processed for a patient who has a limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary food or certain nutrients, or who has other special medically determined nutrient requirements that cannot be met by modification of a normal diet alone. Medical foods are not those foods simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.

While medical foods don’t need premarket review and approvals like drugs, they must be based on sound medical and nutritional principles, and the FDA subjects them to monitoring. The products have active ingredients derived from food products or dietary ingredients that are generally recognized as safe (GRAS) by FDA.

So why am I talking about medical foods? The significance of this final guidance is important as the global medical food sector is poised for growth thanks in part to an increasing awareness about health, nutrition and diet among a diverse and aging population. In fact, food product manufacturers are developing new products with added health ingredients, and these companies are using marketing and providing quality products that meet consumers’ expectations.

Just last month I wrote about Nestlé S.A. expanding its footprint in the global nutrition sector by tapping into the estimated $15 billion market for medical foods. Other leading companies in the medical foods that develop medical foods include Groupe Danone S.A., General Mills, Abbott Laboratories, Pfizer and Mead Johnson and Co.