Medical food is a food which is specially formulated and processed for nutritive value. Medical foods are consumed or administered through tube. It should be administered only under the supervision of a physician through a medical facility.
The vital points listed out below would give you a fair idea on medical foods, its benefits and FDA regulations on Medical foods.
1. Specially formulated foods
Medical foods are foods which are not available as is in nature but these are specially formulated and processed for the partial or exclusive feeding of a patient by oral intake or tube.
2. Who needs Medical foods?
Medical foods are meant for a patient who has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients because of therapeutic or chronic medical needs, or other special medically-determined nutrient requirements that cannot be addressed through modification of the normal diet alone.
3. Non Medical Foods
Non medical foods are foods that are intended for healthy individuals, naturally occurring foodstuff used in its natural state. Foods that are not consumed enterally, e.g., injectable, topical, nasal come under non medical foods.
4. Regulations for Medical Foods
Medical foods do not require formal FDA approval, but Appropriate justification for safety and efficacy, Safety based on GRAS ingredients, Efficacy based on the Significant Scientific Agreement (SSA) standard, Label and advertising review for appropriate claims, Distribution Channels are limited and Appropriate formulation (pill may not be acceptable but powder is OK) is an important factor.
5. Other FDA requirements that apply to medical foods
Medical foods should abide by all FDA requirements that are applicable for foods, including the current Good Manufacturing Practice regulations (21 CFR part 110), Registration of Food Facilities regulations (21 CFR part 1 Subpart H) and, if applicable, rules particularly to the product manufacturing and processing, such as the Low-Acid Foods thermally processed and Packed in Hermetically Sealed Containers regulations (21 CFR part 113), Emergency Permit Control regulations (21 CFR part 108), Acidified Foods regulations (21 CFR part 114).