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Food
and Drug Administration, HHS
21
CFR Ch. 1 (4-1-95 Edition)
§
101.9
(8) Medical foods as defined in section 5(b) of the Orphan Drug
Act (21 U.S.C. 360ee(b)(3)). A medical food is 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. A food is subject to this exemption only if:
- It is
a specially formulated and processed product (as opposed to
a naturally occurring foodstuff used in its natural state) for
the partial or exclusive feeding of a patient by means of oral
intake or interal feeding by tube;
- It is
intended for the dietary management of a patient who, because
of therapeutic or chronic medical needs, has limited or impaired
capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs
or certain nutrients, or who has other special medically determined
nutrient requirements, the dietary management of which cannot
be achieved by the modification of the normal diet alone;
- It provides
nutritional support specifically modified for the management
of the unique nutrient needs that result from the specific disease
or condition, as determined by medical evaluation;
- It is
intended to be used under medical supervision; and
- It is
intended only for a patient receiving active and ongoing medical
supervision wherein the patient requires medical care on a recurring
basis for, among other things, instructions on the use of the
medical food.
From
the Office of the Federal Register, National Archives and Records
Administration.
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