SitoMedica

SitoMedica is dedicated to providing top-quality, reliable and efficacious medical foods to the professional health care community.

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.

Regulatory Definition of Medical Foods

Specially formulated – not in diet
GRAS (Generally Recognized as Safe) ingredients
Enteral/Oral administration
Medically determined dietary need
Dietary management claims of the disease
Food GMP required
Exempt from nutritional product labeling
Based on recognized science (ie., preclinical, toxicology and clinical trials)
Given to a diseased population or for chronic conditions
Given under a physician’s supervision
Not approved, but meets FDA regulations

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