Medical foods

Coverage Decision

Medical foods and their convenience packs (“co-packs”) are not covered. There is a lack of good quality scientific evidence of efficacy for the intended disease or condition. Co-packs are unapproved drugs unless the FDA specifically approves them.

Examples of medical food products:

  • Deplin® (L-methylfolate)
  • Theramine® (arginine, glutamine, 5-hydroxytryptophan and choline)
  • Gabadone® (5-hydroxytryptophan, gamma aminobutyric acid and choline)

Examples of convenience packs (co-packs):

  • Theraproxen® (Theramine and naproxen)
  • Gaboxetine® (Gabadone and fluoxetine)

Medical food products contain nutritional supplements for the dietary management of diseases or conditions. These products are required to comply with provisions of medical foods and food manufacturing. However, they are not approved or registered with the FDA.