Lecture: Future Fuel: The Use of 'Medical Food' in Disease Management

Introduction

• Growing market for medical food due to increased prevalence of chronic disease.
• Used for nutrient deficiencies related to genetic/chronic diseases and associated drug treatments (e.g., PKU, UC, Crohn's disease).

History and Regulation

• Early example: Lofenalac for PKU.
• Pre-1972: Medical foods regulated as drugs by FDA.
• 1988: Orphan Drug Act amendment, defining medical food.

Definition of Medical Food

• Defined by Orphan Drug Act.
  • Formulated for consumption or enteral administration under physician supervision.
  • Intended for dietary management of diseases with distinct nutritional requirements.
• Differ from functional foods as they meet specific dietary needs for disease management under medical supervision.

Characteristics

• Not simple dietary recommendations or naturally occurring foods.
• For patients with impaired food/nutrient processing capacities.
• Exempt from nutrition-labeling regulations.
• Require ongoing medical supervision and patient instruction.

Categories of Medical Foods

1. Nutrient-complete Products: Exclude certain nutrients (e.g., phenylalanine, tyrosine).

   • Examples: Lofenalac, Ketonex-2, Propimex.

2. Modular Products: Capsules, pills, mixtures, beverages.

   • Examples: GlutarAde, Foltx.

3. Low-protein Foods: Baked goods, rice, meat, cheese, pasta substitutes.

Specific Examples

• LIPISORB: Treats AIDS-related fat malabsorption.
• Carb Zero: Used in keto diets.
• Souvenaid: Supports memory in early Alzheimer's.
• KetoVie Peptide: Manages intractable epilepsy.
• Cesinex: Treats diarrhea.

Controversies and Challenges

• Not subject to FDA regulation; no premarket review or approval.
• Dispensed without prescription.
• 2013 FDA guidance on IND application for research; sparked controversy.
• Concerns over insurance coverage variability.

Future Outlook

• Initially aimed at metabolic diseases, now expanding.
• Research and product development growing.
• Large-scale studies needed for effectiveness.
• Potential combination with other non-pharmacological methods.

Implications

• Medical foods should be used under physician supervision.
• Patient education on use is crucial.
• Coverage issues continue to challenge integration into care.